News from the 2005 Annual Scientific Conference of the American College of Foot and Ankle Surgeons -
There's good news for anyone with
painful arthritic ankles -- a new surgical procedure imported from Europe is
showing encouraging results for relieving chronic arthritis pain without
taking away the overall movement and function of the joint.
The new ankle procedure was first reported in France and involves an
external-fixation procedure that applies tension to expand the joint and leave
room for new cartilage to form, thereby eliminating painful bone-on-bone
pressure, according to ACFAS President-elect James L. Thomas, DPM, FACFAS, a
foot and ankle surgeon practicing at the University of Alabama Birmingham.
"This is an exciting new approach for treating chronic ankle arthritis," said
Thomas.
In an oral presentation at the American College of Foot and Ankle Surgeons
Annual Scientific Conference, Brad Lamm, DPM, AACFAS, a foot and ankle surgeon
affiliated with Sinai Hospital in Baltimore, reported that ankle-joint
distraction with external fixation for treatment of ankle arthritis is
starting to gain acceptance among foot and ankle surgeons in the US, although
its use has been limited.
"Most patients with ankle arthritis want to preserve a functioning joint
and are looking for alternatives to ankle-fusion procedures and joint
replacements to relieve their pain," said Lamm. "While fusion surgery has
been a mainstay for many years and works very well for pain relief, fusing the
ankle joint makes it immobile and permanently stiff. Ankle joint distraction
with external fixation preserves the joint, eliminates pain and increases
function," he explained.
Though new for treating ankle arthritis, minimally invasive, external-
fixation techniques are widely used by foot and ankle surgeons to repair
fractures. Bones are immobilized with pins, screws or wires, which are
secured outside the skin with clamps and rods that form an external frame.
For treating ankle arthritis, wires inserted through the skin are attached
to the frame, and the resulting tension pulls apart the ankle joint, creating
space for new cartilage to replace what was destroyed by arthritis. Prior to
applying the fixators, the foot and ankle surgeon may perform ankle
arthroscopy to clean out arthritic tissue and bone spurs.
Most external-fixation surgeries are performed in less than three hours
and the risk of infection is minimal. The patient can walk with the frame in
place the day after surgery and the fixators remain in place for about four
months until new cartilage is in place.
Thomas noted that even though the initial experiences with external
fixation for chronic ankle arthritis have been encouraging, more long-term
studies are needed before the procedure becomes a mainstream treatment for
these patients.
For further information about foot and ankle conditions and treatments and
to locate a foot and ankle surgeon in your area, contact ACFAS at
FootPhysicians.
The American College of Foot and Ankle Surgeons is the professional
organization for foot and ankle surgeons, doctors of podiatric medicine (DPM)
who are graduates of four-year podiatric medical colleges and have completed
surgical residencies. The organization is dedicated to developing surgical
standards for the care of the foot and ankle, sponsoring research, and
providing continuing education for its members.
American College of Foot and Ankle Surgeons
FootPhysicians
понедельник, 30 мая 2011 г.
Compugen Announces Positive Therapeutic Effect Of CGEN-15001 In Animal Model Of Rheumatoid Arthritis
Compugen Ltd. (NASDAQ: CGEN) announced that administration of CGEN-15001 in an animal model of rheumatoid arthritis (RA) dramatically ameliorates the clinical symptoms of the disease. These results, combined with earlier results in an animal model of multiple sclerosis (MS), strongly support the therapeutic potential of CGEN-15001 for multiple autoimmune diseases and inflammatory conditions.
The recently completed study of CGEN-15001 utilized the collagen-induced arthritis (CIA) animal model. This well accepted animal model of RA manifests an autoimmune disease with clinical and pathological similarity to human rheumatoid arthritis. Upon treatment of mice with established RA disease, impressive therapeutic effects of CGEN-15001 were observed. Furthermore, CGEN-15001 showed efficacy similar to that observed through TNF-alpha blockade with TNFR-Fc, ENBREL®, a widely used biologic disease modifying anti-rheumatic drug (DMARD). In the study, both ENBREL® and CGEN-15001 were administered at the same dose and frequency.
TNF-alpha blockade therapy has revolutionized the treatment of RA; however, neutralization of TNF in patients receiving TNF blockers therapy leads to increased risk of infection, and particularly, of reactivating latent tuberculosis. In addition, significant proportions of patients do not respond to TNF blockers and require alternative effective treatments. Thus, novel drugs for RA that are devoid of such side effects and benefit additional patient populations remain an unmet clinical need. Among these are drugs targeting negative co-stimulatory pathways, which are of high industry interest.
The CIA model of RA is the second well recognized animal model of autoimmune disease in which CGEN-15001 has shown dramatic therapeutic potential; previous studies with CGEN-15001 demonstrated similar beneficial effects in an animal model of multiple sclerosis. Furthermore, in both the animal models of RA and of MS, the significant clinical potential for this novel molecule was underscored by the pronounced therapeutic effects demonstrated when CGEN-15001 was administered in the presence of established disease. These promising results in the two different autoimmune disease models further support the development of CGEN-15001 as a therapeutic agent for autoimmune and inflammatory diseases, such as multiple sclerosis, rheumatoid arthritis, and inflammatory bowel disease.
Dr. Richard Williams from the Kennedy Institute of Rheumatology, Imperial College London UK, a leading scientist in the field of rheumatoid arthritis who supervised the studies, stated, "These preliminary results are very impressive, with CGEN-15001 showing the same level of efficacy as ENBREL®. Furthermore, by testing CGEN-15001 in established disease we are setting the bar quite high, as not many compounds are effective in this setting. Therefore, based on the results seen to date, this molecule definitely should be further studied as a potential therapy for multiple autoimmune diseases."
Dr. Zurit Levine, Compugen's VP of R&D, stated, "We are extremely excited about the pronounced efficacy of CGEN-15001 in an additional autoimmune disease as it substantially broadens the therapeutic potential for this novel molecule and further validates our Protein Family Members Discovery Platform. Modulating the immune system by the use of protein therapeutics targeting B7/CD28-like negative co-stimulatory pathways, such as CGEN-15001 and its membrane protein form, is an area of extensive research and has substantial potential in the development of new therapies for multiple autoimmune and inflammatory diseases, as well as cancer. The high level of interest in this field led to Compugen's recent focus on the B7/CD28 protein family which has resulted thus far in the discovery of nine novel proteins predicted to be previously unknown members of this family. CGEN-15001 is the first of these nine molecules to undergo in vivo validation studies, and has now exhibited impressive therapeutic activity in well recognized animal models of both multiple sclerosis and rheumatoid arthritis."
About CGEN-15001
CGEN-15001 is a novel soluble Fc-fused protein comprised of the extracellular domain of a novel B7-like negative co-stimulatory protein, CGEN-15001T, discovered by Compugen through the Protein Family Members Discovery Platform. In vitro studies have demonstrated that CGEN-15001 inhibits T cell activation and differentiation of pro-inflammatory Th1 and Th17 cell types, while promoting regulatory Th2 responses. Administration of CGEN-15001 in an animal model of multiple sclerosis (MS) showed dramatic improvement of disease symptoms and complete abolishment of spontaneous relapses. CGEN-15001 appears to exert its beneficial effect by immunomodulation and induction of immune tolerance, demonstrated by the inhibition of epitope spreading, the underlying phenomenon which causes the relapsing nature of this disease. Furthermore, the remarkable beneficial effects observed with CGEN-15001 in the animal model for multiple sclerosis were also accompanied by inhibition of infiltration of reactive T lymphocytes into the central nervous system.
About rheumatoid arthritis
Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the immune system attacks the synovium (tissue lining the joint capsule). Autoimmune diseases are illnesses that occur when the body's tissues are mistakenly attacked by their own immune system. Rheumatoid arthritis is a common rheumatic disease, affecting 1% of the population and approximately 1.3 million people in the United States. This disease is three times more common in women than in men and can begin at any age, but it most often starts after 40 years of age and before 60 years of age. The disease causes chronic inflammation of the joints and can lead to the destruction of the cartilage, bone, and ligaments, causing deformity of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. Rheumatoid arthritis can also cause inflammation of the tissue around the joints, as well as in other organs in the body. Because it can affect multiple organs of the body, rheumatoid arthritis is referred to as a systemic illness and is also known as rheumatoid disease.
About the B7/CD28 families of positive and negative co-stimulatory proteins
Members of the B7/CD28 families have been intensively studied over the past decade and have brought much excitement to the field of immune regulation. The activation and development of an adaptive immune response is initiated by the engagement of a T-cell antigen receptor with an antigenic peptide-MHC complex. The outcome of this engagement is determined by both positive and negative co-stimulatory signals, generated mainly by the interaction between members of the B7 family ligands and their receptors, mainly members of the CD28 family. A growing body of evidence indicates that the dysfunction of immune regulation contributes to the development of autoimmune diseases.
Positive and negative co-stimulatory pathways play critical roles in immune regulation and are considered potential targets for modulating chronic inflammation in autoimmune diseases. To date, one soluble recombinant fusion protein that selectively blocks the co-stimulatory signal mediated by the prototype B7/CD28 pathway has been cleared for marketing in the U.S. for the treatment of moderate to severe rheumatoid arthritis, and is in clinical trials for other autoimmune indications. In addition, a number of clinical and preclinical studies for therapeutic agents targeting these protein families are underway at various companies.
Source:
Compugen
View drug information on Enbrel.
The recently completed study of CGEN-15001 utilized the collagen-induced arthritis (CIA) animal model. This well accepted animal model of RA manifests an autoimmune disease with clinical and pathological similarity to human rheumatoid arthritis. Upon treatment of mice with established RA disease, impressive therapeutic effects of CGEN-15001 were observed. Furthermore, CGEN-15001 showed efficacy similar to that observed through TNF-alpha blockade with TNFR-Fc, ENBREL®, a widely used biologic disease modifying anti-rheumatic drug (DMARD). In the study, both ENBREL® and CGEN-15001 were administered at the same dose and frequency.
TNF-alpha blockade therapy has revolutionized the treatment of RA; however, neutralization of TNF in patients receiving TNF blockers therapy leads to increased risk of infection, and particularly, of reactivating latent tuberculosis. In addition, significant proportions of patients do not respond to TNF blockers and require alternative effective treatments. Thus, novel drugs for RA that are devoid of such side effects and benefit additional patient populations remain an unmet clinical need. Among these are drugs targeting negative co-stimulatory pathways, which are of high industry interest.
The CIA model of RA is the second well recognized animal model of autoimmune disease in which CGEN-15001 has shown dramatic therapeutic potential; previous studies with CGEN-15001 demonstrated similar beneficial effects in an animal model of multiple sclerosis. Furthermore, in both the animal models of RA and of MS, the significant clinical potential for this novel molecule was underscored by the pronounced therapeutic effects demonstrated when CGEN-15001 was administered in the presence of established disease. These promising results in the two different autoimmune disease models further support the development of CGEN-15001 as a therapeutic agent for autoimmune and inflammatory diseases, such as multiple sclerosis, rheumatoid arthritis, and inflammatory bowel disease.
Dr. Richard Williams from the Kennedy Institute of Rheumatology, Imperial College London UK, a leading scientist in the field of rheumatoid arthritis who supervised the studies, stated, "These preliminary results are very impressive, with CGEN-15001 showing the same level of efficacy as ENBREL®. Furthermore, by testing CGEN-15001 in established disease we are setting the bar quite high, as not many compounds are effective in this setting. Therefore, based on the results seen to date, this molecule definitely should be further studied as a potential therapy for multiple autoimmune diseases."
Dr. Zurit Levine, Compugen's VP of R&D, stated, "We are extremely excited about the pronounced efficacy of CGEN-15001 in an additional autoimmune disease as it substantially broadens the therapeutic potential for this novel molecule and further validates our Protein Family Members Discovery Platform. Modulating the immune system by the use of protein therapeutics targeting B7/CD28-like negative co-stimulatory pathways, such as CGEN-15001 and its membrane protein form, is an area of extensive research and has substantial potential in the development of new therapies for multiple autoimmune and inflammatory diseases, as well as cancer. The high level of interest in this field led to Compugen's recent focus on the B7/CD28 protein family which has resulted thus far in the discovery of nine novel proteins predicted to be previously unknown members of this family. CGEN-15001 is the first of these nine molecules to undergo in vivo validation studies, and has now exhibited impressive therapeutic activity in well recognized animal models of both multiple sclerosis and rheumatoid arthritis."
About CGEN-15001
CGEN-15001 is a novel soluble Fc-fused protein comprised of the extracellular domain of a novel B7-like negative co-stimulatory protein, CGEN-15001T, discovered by Compugen through the Protein Family Members Discovery Platform. In vitro studies have demonstrated that CGEN-15001 inhibits T cell activation and differentiation of pro-inflammatory Th1 and Th17 cell types, while promoting regulatory Th2 responses. Administration of CGEN-15001 in an animal model of multiple sclerosis (MS) showed dramatic improvement of disease symptoms and complete abolishment of spontaneous relapses. CGEN-15001 appears to exert its beneficial effect by immunomodulation and induction of immune tolerance, demonstrated by the inhibition of epitope spreading, the underlying phenomenon which causes the relapsing nature of this disease. Furthermore, the remarkable beneficial effects observed with CGEN-15001 in the animal model for multiple sclerosis were also accompanied by inhibition of infiltration of reactive T lymphocytes into the central nervous system.
About rheumatoid arthritis
Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the immune system attacks the synovium (tissue lining the joint capsule). Autoimmune diseases are illnesses that occur when the body's tissues are mistakenly attacked by their own immune system. Rheumatoid arthritis is a common rheumatic disease, affecting 1% of the population and approximately 1.3 million people in the United States. This disease is three times more common in women than in men and can begin at any age, but it most often starts after 40 years of age and before 60 years of age. The disease causes chronic inflammation of the joints and can lead to the destruction of the cartilage, bone, and ligaments, causing deformity of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability. Rheumatoid arthritis can also cause inflammation of the tissue around the joints, as well as in other organs in the body. Because it can affect multiple organs of the body, rheumatoid arthritis is referred to as a systemic illness and is also known as rheumatoid disease.
About the B7/CD28 families of positive and negative co-stimulatory proteins
Members of the B7/CD28 families have been intensively studied over the past decade and have brought much excitement to the field of immune regulation. The activation and development of an adaptive immune response is initiated by the engagement of a T-cell antigen receptor with an antigenic peptide-MHC complex. The outcome of this engagement is determined by both positive and negative co-stimulatory signals, generated mainly by the interaction between members of the B7 family ligands and their receptors, mainly members of the CD28 family. A growing body of evidence indicates that the dysfunction of immune regulation contributes to the development of autoimmune diseases.
Positive and negative co-stimulatory pathways play critical roles in immune regulation and are considered potential targets for modulating chronic inflammation in autoimmune diseases. To date, one soluble recombinant fusion protein that selectively blocks the co-stimulatory signal mediated by the prototype B7/CD28 pathway has been cleared for marketing in the U.S. for the treatment of moderate to severe rheumatoid arthritis, and is in clinical trials for other autoimmune indications. In addition, a number of clinical and preclinical studies for therapeutic agents targeting these protein families are underway at various companies.
Source:
Compugen
View drug information on Enbrel.
Arthritis Causes And Symptoms
The literal meaning of arthritis is "joint inflammation" and it can affect joints in any part of the body. Joints are the places in the body where two bones meet. When you have arthritis, damage is caused to a lesser or greater degree to the joints and mostly occurs in the hands, arms and legs. The inflammation in one or more of the joints results in pain, swelling and limited movement. Arthritis is the leading cause of disability in those over the age of 65 and it generally affects people from the age of 60. However, arthritis can occur in people of all ages including children. About 37 million people in the US alone have some form of arthritis - that is almost 1 out of every 7 people. There are many different forms of arthritis, each of which has a different cause but unfortunately, they all feature pain.
Some of the symptoms you may experience with Arthritis are:
-- Joint pain and swelling
-- Stiffness particularly in the mornings
-- The feeling of warmth around a joint
-- Redness of skin around a joint
-- Inability to move the joint easily
Arthritis involves the breakdown of cartilage. This cartilage normally protects the joint thereby allowing for smooth movement. Cartilage is also useful for absorbing shock when you put pressure on the particular joint - for example when you are walking. With the breakdown of the cartilage, the bones lose their protection and start to rub together thus causing the pain, swelling and stiffness.
Some of the causes for the breakdown of the cartilage, and the subsequent inflammation of the joints can be:
-- Broken bone
-- Infection in the area (usually caused by either bacteria or viruses)
-- An autoimmune disease (this is where the body attacks itself because the immune system perceives a certain body part to be foreign)
-- General wear and tear on joints (possibly from old age, over exercise etc.)
The early stages of any of these causes are vitally important for treatment to be commenced immediately so that the sufferer from arthritis is given the best possible chance for the inflammation to go away and it often does. If the inflammation does not go away, there may be destruction resulting in long-term pain and deformity. This is called chronic arthritis.
Amoils offers all natural treatments for common conditions and ailments using essential oils. Visit our Arthritis page for more information.
amoils
Some of the symptoms you may experience with Arthritis are:
-- Joint pain and swelling
-- Stiffness particularly in the mornings
-- The feeling of warmth around a joint
-- Redness of skin around a joint
-- Inability to move the joint easily
Arthritis involves the breakdown of cartilage. This cartilage normally protects the joint thereby allowing for smooth movement. Cartilage is also useful for absorbing shock when you put pressure on the particular joint - for example when you are walking. With the breakdown of the cartilage, the bones lose their protection and start to rub together thus causing the pain, swelling and stiffness.
Some of the causes for the breakdown of the cartilage, and the subsequent inflammation of the joints can be:
-- Broken bone
-- Infection in the area (usually caused by either bacteria or viruses)
-- An autoimmune disease (this is where the body attacks itself because the immune system perceives a certain body part to be foreign)
-- General wear and tear on joints (possibly from old age, over exercise etc.)
The early stages of any of these causes are vitally important for treatment to be commenced immediately so that the sufferer from arthritis is given the best possible chance for the inflammation to go away and it often does. If the inflammation does not go away, there may be destruction resulting in long-term pain and deformity. This is called chronic arthritis.
Amoils offers all natural treatments for common conditions and ailments using essential oils. Visit our Arthritis page for more information.
amoils
Nitec Pharma Licenses Tarenflurbil For Chronic Inflammation And Pain
Nitec Pharma AG, an emerging specialty pharma company, announces the signing of an agreement with PAZ GmbH for the exclusive worldwide rights to Tarenflurbil, PAZ's anti-inflammatory drug, for the treatment of chronic inflammation and pain. The in-licensing of Tarenflurbil broadens Nitec's pipeline and underscores the company's ambition to become a significant player focused on treating unmet medical needs in chronic inflammation and pain. The financial terms of the deal were not disclosed.
Tarenflurbil is a novel inhibitor of the transcription regulator NF-kB and the transcription factor AP-1, both of which are important regulators of inflammation. Tarenflurbil inhibits the DNA binding activity of both targets reducing inflammation and its associated pain without any detectable effect on COX I/II so far. COX inhibition has in recent years been associated with safety concerns when used long term.
Potential indications of Tarenflurbil include Osteoarthritis, Rheumatoid Arthritis and related diseases such as Ankylosing Spondylitis. Osteoarthritis, the most common form of arthritis, is a major cause of pain and morbidity. Its prevalence is estimated to be 11-12% of the Western population, with women being affected significantly more than men. The disease impacts severely on the physical function and day-to-day quality of life of an individual. At clinically advanced stages, Osteoarthritis is characterized by tenderness, chronic joint pain, limitation of movement and inflammation.
"This licensing deal is a significant step in expanding the Nitec portfolio of development compounds," said Anders H?¤rfstrand the CEO of Nitec. "We have already validated our approach by successfully completing the clinical development of Lodotra, which is awaiting marketing authorization for Rheumatoid Arthritis in Europe. The licensing of Tarenflurbil broadens our portfolio and strengthens our position as an emerging specialty pharma company focused on chronic inflammation and pain."
Karl N?¤gler, Principal at Atlas Venture, added: "The in-licensing of Tarenflurbil is an important milestone in Nitec's development. It validates Nitec's ability to attract exciting development stage product opportunities based on the long standing experience and expertise of its team in developing and commercializing treatments in the field of inflammation."
Tarenflurbil has already demonstrated significant pain relief in a human pain model. Nitec will initiate clinical development of Tarenflurbil shortly and plans to conduct Phase IIa studies in the first indication. Tarenflurbil will be Nitec's second clinical product candidate after Lodotra.
About Nitec Pharma AG
Nitec Pharma is an emerging specialty pharma company focused on the development and commercialization of innovative medicines for the treatment of chronic inflammatory diseases and pain. Nitec is headquartered in Reinach, Switzerland, with a subsidiary in Mannheim, Germany. The Company's most advanced product is Lodotra ™, a circadian cytokine modulator (CCM) for the treatment of rheumatoid arthritis (RA). Nitec was originally founded in 2004 as a spin-out of Merck KGaA. The Company is financed by Atlas Venture, Global Life Science Ventures and NGN Capital.
nitecpharma
About PAZ GmbH
PAZ, headquarted in Frankfurt and with further subsidiaries in Germany, is specialised in the development, patenting and outlicensing of innovative compounds based on known active ingredients. Core of the company is the development of NCE??s based on pure enantiomers of known racemic compounds. Together with a licensee PAZ has developed dexibuprofen, the dextrorotatory enantiomer of ibuprofen as first product of this kind and launched it in 26 countries as an analgetic and antiinflammatory drug. PAZ's key compound in development is tarenflurbil which is now licenced to Nitec Pharma. Based on the newly-discovered mechanism of action of this drug class other therapeutical applications of tarenflurbil in addition to the use as analgetical, antiinflammatory drug are currently being evaluated. PAZ, an independent, privately owned company, was founded in 1980.
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
nitecpharma
Tarenflurbil is a novel inhibitor of the transcription regulator NF-kB and the transcription factor AP-1, both of which are important regulators of inflammation. Tarenflurbil inhibits the DNA binding activity of both targets reducing inflammation and its associated pain without any detectable effect on COX I/II so far. COX inhibition has in recent years been associated with safety concerns when used long term.
Potential indications of Tarenflurbil include Osteoarthritis, Rheumatoid Arthritis and related diseases such as Ankylosing Spondylitis. Osteoarthritis, the most common form of arthritis, is a major cause of pain and morbidity. Its prevalence is estimated to be 11-12% of the Western population, with women being affected significantly more than men. The disease impacts severely on the physical function and day-to-day quality of life of an individual. At clinically advanced stages, Osteoarthritis is characterized by tenderness, chronic joint pain, limitation of movement and inflammation.
"This licensing deal is a significant step in expanding the Nitec portfolio of development compounds," said Anders H?¤rfstrand the CEO of Nitec. "We have already validated our approach by successfully completing the clinical development of Lodotra, which is awaiting marketing authorization for Rheumatoid Arthritis in Europe. The licensing of Tarenflurbil broadens our portfolio and strengthens our position as an emerging specialty pharma company focused on chronic inflammation and pain."
Karl N?¤gler, Principal at Atlas Venture, added: "The in-licensing of Tarenflurbil is an important milestone in Nitec's development. It validates Nitec's ability to attract exciting development stage product opportunities based on the long standing experience and expertise of its team in developing and commercializing treatments in the field of inflammation."
Tarenflurbil has already demonstrated significant pain relief in a human pain model. Nitec will initiate clinical development of Tarenflurbil shortly and plans to conduct Phase IIa studies in the first indication. Tarenflurbil will be Nitec's second clinical product candidate after Lodotra.
About Nitec Pharma AG
Nitec Pharma is an emerging specialty pharma company focused on the development and commercialization of innovative medicines for the treatment of chronic inflammatory diseases and pain. Nitec is headquartered in Reinach, Switzerland, with a subsidiary in Mannheim, Germany. The Company's most advanced product is Lodotra ™, a circadian cytokine modulator (CCM) for the treatment of rheumatoid arthritis (RA). Nitec was originally founded in 2004 as a spin-out of Merck KGaA. The Company is financed by Atlas Venture, Global Life Science Ventures and NGN Capital.
nitecpharma
About PAZ GmbH
PAZ, headquarted in Frankfurt and with further subsidiaries in Germany, is specialised in the development, patenting and outlicensing of innovative compounds based on known active ingredients. Core of the company is the development of NCE??s based on pure enantiomers of known racemic compounds. Together with a licensee PAZ has developed dexibuprofen, the dextrorotatory enantiomer of ibuprofen as first product of this kind and launched it in 26 countries as an analgetic and antiinflammatory drug. PAZ's key compound in development is tarenflurbil which is now licenced to Nitec Pharma. Based on the newly-discovered mechanism of action of this drug class other therapeutical applications of tarenflurbil in addition to the use as analgetical, antiinflammatory drug are currently being evaluated. PAZ, an independent, privately owned company, was founded in 1980.
This press release contains specific forward-looking statements, e.g. statements including terms like believe, assume, expect or similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
nitecpharma
Greater Relief From Osteoarthritis Symptoms Found In Joint Replacement Surgery
The long term health outcomes of hip or knee replacement surgery in older adults are excellent despite taking several weeks to recover, according to a report released on July 14, 2008 in the Archives of Internal Medicine, one of the JAMA/Archives journals.
Osteoarthritis is a degenerative joint disease characterized by inflammation caused by damage to the cartilage that cushions them. It causes debilitating pain and can seriously restrict mobility and physical ability. While there are several non-invasive treatments, including medications and physical therapy, these seem to be of limited value for advanced stage osteoarthritis. Surgery is an option, but has previously been associated with risks and discomfort. Osteoarthritis often occurs in older people, and as the population of the United States ages, the number of older adults with this disease is increasing.
In order to investigate the risks and potential benefits of surgical
interventions, Mary Beth Hamel, M.D., M.P.H., and colleagues at Beth
Israel Deaconess Medical Center, Boston, examined the decisions and
treatment outcomes in patients over the age of 65 with severe
osteoarthritis. A total 174 patients were tracked, with an average age
of 75.2 years, and monitored for arthritis symptoms, functional status
between 2001 and 2004 with follow-up after 12 months. Additionally, any
patients who chose to have joint replacement surgery were assessed six
weeks, six months, and 12 months later.
In the 12 months of follow-up, 29% (51 patients) of the total group
underwent joint replacement surgery. This was composed of 30 knee and
21 hip replacements. Of these, none patients died, 17% had
postoperative complications, and 38% had pain that lasted more than
four weeks after the surgery. In a comparison of age, patients 75 and
older took approximately the same amount of time to return to regular
activities as patients between 65 and 74. Most patients required
assistance with activities like household chores and shopping for more
than one month after surgery.
In the measurement of osteoarthritis symptoms, at the 12 month mark,
scores improved more significantly in patients who underwent surgery
than those who did not. Approximately half of patients who did not have
surgery reported that this option was not offered to them. In
comparison with the post-surgical patients, participants who did not
have surgery were generally older, with lower incomes, and more worried
about surgical complications and a long recovery time.
The authors conclude that joint replacement surgery could be a useful
option for osteoarthritis sufferers. "Our findings of excellent
outcomes from joint replacement surgery in
elderly patients with severe hip or knee osteoarthritis corroborate and
extend the findings of previous studies," they say. "These
data should help inform discussion about joint replacement surgery and
allow patients to consider the risks and benefits of surgery as well as
the expected postoperative recovery experience."
?
Joint Replacement Surgery in Elderly Patients With Severe
Osteoarthritis of the Hip or Knee
Decision Making, Postoperative Recovery, and Clinical Outcomes
Mary Beth Hamel, MD, MPH; Maria Toth, MD, PhD; Anna Legedza, ScD; Max
P. Rosen, MD, MPH
Arch Intern Med. 2008;168(13):1430-1440.
Click
Here For Abstract
Written by Anna Sophia McKenney
Osteoarthritis is a degenerative joint disease characterized by inflammation caused by damage to the cartilage that cushions them. It causes debilitating pain and can seriously restrict mobility and physical ability. While there are several non-invasive treatments, including medications and physical therapy, these seem to be of limited value for advanced stage osteoarthritis. Surgery is an option, but has previously been associated with risks and discomfort. Osteoarthritis often occurs in older people, and as the population of the United States ages, the number of older adults with this disease is increasing.
In order to investigate the risks and potential benefits of surgical
interventions, Mary Beth Hamel, M.D., M.P.H., and colleagues at Beth
Israel Deaconess Medical Center, Boston, examined the decisions and
treatment outcomes in patients over the age of 65 with severe
osteoarthritis. A total 174 patients were tracked, with an average age
of 75.2 years, and monitored for arthritis symptoms, functional status
between 2001 and 2004 with follow-up after 12 months. Additionally, any
patients who chose to have joint replacement surgery were assessed six
weeks, six months, and 12 months later.
In the 12 months of follow-up, 29% (51 patients) of the total group
underwent joint replacement surgery. This was composed of 30 knee and
21 hip replacements. Of these, none patients died, 17% had
postoperative complications, and 38% had pain that lasted more than
four weeks after the surgery. In a comparison of age, patients 75 and
older took approximately the same amount of time to return to regular
activities as patients between 65 and 74. Most patients required
assistance with activities like household chores and shopping for more
than one month after surgery.
In the measurement of osteoarthritis symptoms, at the 12 month mark,
scores improved more significantly in patients who underwent surgery
than those who did not. Approximately half of patients who did not have
surgery reported that this option was not offered to them. In
comparison with the post-surgical patients, participants who did not
have surgery were generally older, with lower incomes, and more worried
about surgical complications and a long recovery time.
The authors conclude that joint replacement surgery could be a useful
option for osteoarthritis sufferers. "Our findings of excellent
outcomes from joint replacement surgery in
elderly patients with severe hip or knee osteoarthritis corroborate and
extend the findings of previous studies," they say. "These
data should help inform discussion about joint replacement surgery and
allow patients to consider the risks and benefits of surgery as well as
the expected postoperative recovery experience."
?
Joint Replacement Surgery in Elderly Patients With Severe
Osteoarthritis of the Hip or Knee
Decision Making, Postoperative Recovery, and Clinical Outcomes
Mary Beth Hamel, MD, MPH; Maria Toth, MD, PhD; Anna Legedza, ScD; Max
P. Rosen, MD, MPH
Arch Intern Med. 2008;168(13):1430-1440.
Click
Here For Abstract
Written by Anna Sophia McKenney
Biomarker Could Help Doctors Tailor Treatment For Rheumatoid Arthritis
Investigators have identified a biomarker that could help doctors select patients with rheumatoid arthritis who will benefit from therapy with drugs such as Enbrel, a tumor necrosis factor (TNF)-antagonist drug. The study, led by researchers at Hospital for Special Surgery in collaboration with rheumatologists at University of Southern California, appears in the February issue of the journal Arthritis & Rheumatism.
"While our study was performed on a relatively small group of patients and will need to be confirmed in a larger cohort, the data are promising and may be clinically significant for the medical management of patients," said Mary K. Crow, M.D., director of Rheumatology Research and co-director of the Mary Kirkland Center for Lupus Research at Hospital for Special Surgery. "Treatment with these drugs is very expensive; the drugs can cost around $16,000 or so per year. If you are going to use them, you would like to know that they are likely to work in your patient." Other well-known TNF-antagonists include Humira and Remicade.
While TNF antagonists have brought relief to thousands of people with rheumatoid arthritis, the drugs are not highly effective in 30 percent to 50 percent of patients. Clinicians thus run the risk of providing a therapy to patients that doesn't work well, is expensive and is potentially toxic. Patients taking TNF antagonists, which have been available for roughly ten years, can run the risk of developing bacterial or fungal infections.
While studies have identified factors associated with poor response to these drugs such as expression of certain genes, none of the factors has as yet provided doctors with a tool that will help select patients who are likely to respond to the drugs or identify those less likely to respond. Investigators at HSS hoped to remedy this and turned their attention to the type I interferon proteins, specifically a type called interferon beta (IFN-beta). Previous studies have revealed that levels of IFN-beta, a protein that can limit cell division, is present in the joint tissue of some patients with rheumatoid arthritis. The researchers wondered if variable levels of this protein could play a role in how patients respond to TNF-antagonist drugs. To test this hypothesis, the investigators set out to determine the relationship between levels of type I interferon activity in the blood prior to beginning therapy and the ability of the drug to control rheumatoid arthritis in patients. They studied the role of IFN-beta, and because they knew that IFN-beta induces interleukin-1 receptor antagonist (IL-1Ra), another protein, they also tested levels of IL-1Ra.
The study involved three cohorts of patients: patients who had rheumatoid arthritis and received a TNF antagonist (n=35), arthritis patients who received no drug (12), and healthy volunteers (n=50). Patients received their care at the Los Angeles County and University of Southern California Medical Center Rheumatology Clinics. Outcomes were evaluated during a window of therapy consisting of more than three months but fewer than nine months, allowing for sufficient time for clinicians to determine clinical response. Doctors used a tool commonly employed to gauge the severity of arthritis-the Disease Activity Score in 28 joints-to deem whether patients had a moderate, good, or no response to the drug.
The investigators found that patients with higher baseline levels of type I IFN were more likely to respond to therapy with TNF antagonists. Patients who had an increased IFN-beta/alpha ratio, meaning they had more IFN-beta, were also more likely to respond to therapy. They also observed significantly higher baseline levels of IL-1Ra in plasma samples from good responders as compared with those from nonresponders or moderate responders.
"We have drawn attention to a potential biomarker that, if our results are supported by additional future studies in other patient populations, might provide a tool to predict who might be a responder to this class of biologic rheumatoid arthritis therapies, the TNF antagonists, and who might be less likely to be a responder," Dr. Crow said. "For those who demonstrate low levels of blood interferon activity, that information might be useful to guide patients to alternative treatments that might be more likely to work for them." This could include the use of other drugs such as Rituximab, which is not a TNF antagonist.
Dr. Crow was recently named physician-in-chief and chair of the Division of Rheumatology at Hospital for Special Surgery. This appointment is effective as of April 1.
Other authors of the study are Clio P. Mavragani, M.D., at Hospital for Special Surgery, and Dan T. La, M.D., and William Stohl, M.D., Ph.D., at the Los Angeles County and University of Southern California Keck School of Medicine, Los Angeles. Dr. Mavragani's work was supported by a Stavros Niarchos Fellowship from the New York Chapter of the Arthritis Foundation. Dr. Crow's work was supported by a grant from the National Institutes of Health, the Alliance for Lupus Research, the Lupus Research Institute, and the Mary Kirkland Center for Lupus Research at Hospital for Special Surgery.
Source
Hospital for Special Surgery
View drug information on Enbrel; Humira; Remicade.
"While our study was performed on a relatively small group of patients and will need to be confirmed in a larger cohort, the data are promising and may be clinically significant for the medical management of patients," said Mary K. Crow, M.D., director of Rheumatology Research and co-director of the Mary Kirkland Center for Lupus Research at Hospital for Special Surgery. "Treatment with these drugs is very expensive; the drugs can cost around $16,000 or so per year. If you are going to use them, you would like to know that they are likely to work in your patient." Other well-known TNF-antagonists include Humira and Remicade.
While TNF antagonists have brought relief to thousands of people with rheumatoid arthritis, the drugs are not highly effective in 30 percent to 50 percent of patients. Clinicians thus run the risk of providing a therapy to patients that doesn't work well, is expensive and is potentially toxic. Patients taking TNF antagonists, which have been available for roughly ten years, can run the risk of developing bacterial or fungal infections.
While studies have identified factors associated with poor response to these drugs such as expression of certain genes, none of the factors has as yet provided doctors with a tool that will help select patients who are likely to respond to the drugs or identify those less likely to respond. Investigators at HSS hoped to remedy this and turned their attention to the type I interferon proteins, specifically a type called interferon beta (IFN-beta). Previous studies have revealed that levels of IFN-beta, a protein that can limit cell division, is present in the joint tissue of some patients with rheumatoid arthritis. The researchers wondered if variable levels of this protein could play a role in how patients respond to TNF-antagonist drugs. To test this hypothesis, the investigators set out to determine the relationship between levels of type I interferon activity in the blood prior to beginning therapy and the ability of the drug to control rheumatoid arthritis in patients. They studied the role of IFN-beta, and because they knew that IFN-beta induces interleukin-1 receptor antagonist (IL-1Ra), another protein, they also tested levels of IL-1Ra.
The study involved three cohorts of patients: patients who had rheumatoid arthritis and received a TNF antagonist (n=35), arthritis patients who received no drug (12), and healthy volunteers (n=50). Patients received their care at the Los Angeles County and University of Southern California Medical Center Rheumatology Clinics. Outcomes were evaluated during a window of therapy consisting of more than three months but fewer than nine months, allowing for sufficient time for clinicians to determine clinical response. Doctors used a tool commonly employed to gauge the severity of arthritis-the Disease Activity Score in 28 joints-to deem whether patients had a moderate, good, or no response to the drug.
The investigators found that patients with higher baseline levels of type I IFN were more likely to respond to therapy with TNF antagonists. Patients who had an increased IFN-beta/alpha ratio, meaning they had more IFN-beta, were also more likely to respond to therapy. They also observed significantly higher baseline levels of IL-1Ra in plasma samples from good responders as compared with those from nonresponders or moderate responders.
"We have drawn attention to a potential biomarker that, if our results are supported by additional future studies in other patient populations, might provide a tool to predict who might be a responder to this class of biologic rheumatoid arthritis therapies, the TNF antagonists, and who might be less likely to be a responder," Dr. Crow said. "For those who demonstrate low levels of blood interferon activity, that information might be useful to guide patients to alternative treatments that might be more likely to work for them." This could include the use of other drugs such as Rituximab, which is not a TNF antagonist.
Dr. Crow was recently named physician-in-chief and chair of the Division of Rheumatology at Hospital for Special Surgery. This appointment is effective as of April 1.
Other authors of the study are Clio P. Mavragani, M.D., at Hospital for Special Surgery, and Dan T. La, M.D., and William Stohl, M.D., Ph.D., at the Los Angeles County and University of Southern California Keck School of Medicine, Los Angeles. Dr. Mavragani's work was supported by a Stavros Niarchos Fellowship from the New York Chapter of the Arthritis Foundation. Dr. Crow's work was supported by a grant from the National Institutes of Health, the Alliance for Lupus Research, the Lupus Research Institute, and the Mary Kirkland Center for Lupus Research at Hospital for Special Surgery.
Source
Hospital for Special Surgery
View drug information on Enbrel; Humira; Remicade.
ORENCIA® (abatacept) Data Demonstrated Improvement In Children And Adolescents With Juvenile Idiopathic Arthritis
Bristol-Myers Squibb Company (NYSE: BMY) today announced results of the double-blind phase of an ongoing study, which show ORENCIA® (abatacept) demonstrated improvement in children with active juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate or TNF antagonists, as measured by the ACR's Pediatric (ACR Pedi) criteria for improvement of JIA. In addition, no child receiving ORENCIA during the six-month double-blind phase had a serious adverse event (SAE) or discontinued due to an adverse event (AE). The data were presented today at a late-breaking session of the 2006 American College of Rheumatology (ACR) Annual Scientific Meeting.
The study, designed to assess the efficacy and safety of ORENCIA in children and adolescents (ages 6-17 years) with a mean age of 12.4 years with JIA, consists of three phases: a four-month treatment period in which all participants received ORENCIA and response was assessed (Part A), a six-month randomized double-blind phase where responders received either ORENCIA or placebo (Part B) and an open-label phase designed to assess long-term safety and efficacy (Part C). Results from Part A were presented at an ACR Concurrent Abstract Session on Sunday, November 12; findings from the double- blind phase (Part B) were presented at a late-breaking data presentation at ACR today.
"In this trial of children with active JIA, approximately 53 percent of participants withdrawn from ORENCIA treatment and given placebo experienced disease flares compared to 20 percent of participants continuing to receive ORENCIA," said Edward H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, OH, co-principal investigator of the study and presenter of the late-breaker data from the double-blind placebo phase of the study. Co-principal investigator Daniel J. Lovell, M.D., M.P.H., Professor of Pediatrics, Cincinnati Children's Hospital Medical Center, presented the open-label phase of the study on Sunday, November 12.
Details of Part A of the Trial
In the initial four-month phase of the trial, 190 children and adolescents with JIA, 72 percent of whom were female, who had inadequately responded to one or more DMARDs received ORENCIA (10 mg/kg IV; maximum 1,000 mg). Of the 190 participants, 28 percent previously had failed one or more biologic DMARDs. Seventy-four percent were on methotrexate (MTX) at study start and continued to receive MTX throughout the study (mean dosage was 13.2 mg/m2/week). Participants discontinued any DMARD other than MTX prior to the first dose of study medication.
The participants were evaluated using the ACR's validated scale for the assessment of improvement of JRA/JIA (ACR Pedi). Of the 190 participants, 123 (64.7 percent) had an ACR Pedi 30 response; 49.5 percent had an ACR Pedi 50 response and 28.4 percent had an ACR Pedi 70 response.
Of the six SAEs reported during Part A of the study, three were related to JIA (flare and arthropathy). The remaining three were varicella, ovarian cyst and acute lymphocytic leukemia. All SAEs were considered by the investigators to be unlikely related to or unrelated to study medication. Adverse events (AEs) were reported in 70 percent of participants. Those reported in greater than or equal to 5 percent of participants included headache (13 percent), nausea (10 percent), cough (9 percent), diarrhea (9 percent), upper respiratory tract infection (7 percent), pyrexia (6 percent), nasopharyngitis (6 percent) and upper abdominal pain (5 percent).
Details of Part B of the Trial
For the second phase of the study, 122 of the 123 participants who achieved an ACR Pedi 30 response in the first phase were randomized in a 1:1 ratio to receive double-blind therapy with either ORENCIA or placebo every 28 days for up to six months. The primary objective of the study was time to disease flare. Forty-eight patients in the ORENCIA group and 46 in the placebo group received concomitant MTX therapy. The mean dosage of MTX was 13.5 mg/m2/week for the ORENCIA group and 12.9 mg/m2/week for the placebo group. Approximately 70 percent of both the ORENCIA and placebo groups were female. Those who experienced disease flares during the trial were offered open-label ORENCIA therapy in Part C of the trial. Safety assessments were performed at each visit. Of the 122 participants, a total of 33 out of 62 (53.2 percent) of the children receiving placebo experienced disease flares compared to 12 out of 60 (20 percent) receiving ORENCIA.
Two of the participants receiving placebo experienced SAEs: one case of hematoma and one case of both varicella and encephalitis; neither child discontinued participation in the trial. No child receiving ORENCIA during the six-month double-blind phase had an SAE.
Adverse events were reported in 61.7 percent (n=36) of participants treated with ORENCIA and 54.8 percent (n=34) of participants receiving placebo. Those occurring in greater than or equal to 3.5 percent in the ORENCIA and placebo groups, respectively, included:
Influenza: 8.3 percent (n=5) and 6.5 percent (n=4)
Bacteriuria: 6.7 percent (n=4) and 0 percent
Nasopharyngitis: 6.7 percent (n=4) and 4.8 percent (n=3)
Pyrexia: 6.7 percent (n=4) and 8.1 percent (n=5)
Upper respiratory tract infection: 6.7 percent (n=4) and 8.1 percent (n=5)
Abdominal pain: 5 percent (n=3) and 1.6 percent (n=1)
Gastroenteritis: 5 percent (n=3) and 1.6 percent (n=1)
Headache: 5 percent (n=3) and 1.6 percent (n=1)
Sinusitis: 5 percent (n=3) and 3.2 percent (n=2)
Nausea: 3.3 percent (n=2) and 6.5 percent (n=4)
Rhinitis: 1.7 percent (n=1) and 6.5 percent (n=4)
Infusional AEs occurred in two participants from each group.
About Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis (JIA) -- also commonly known as juvenile rheumatoid arthritis (JRA) -- is a chronic, autoimmune disease, causing chronic pain, stiffness and swelling of the joints, which may ultimately lead to joint damage and deformities. The disease begins before the age of 16 and affects about 1 child in every 1,000 in the United States. Despite current therapies, some individuals with JIA experience ongoing disease and many eventually worsen, resulting in severe joint damage and abnormal joint function.
Important Safety Information about ORENCIA® (abatacept)
Before receiving treatment with ORENCIA, individuals should notify their healthcare providers if they currently are receiving treatment with a TNF antagonist (e.g., Enbrel®, Humira®, Remicade®) or Kineret® to treat rheumatoid arthritis (RA). These individuals may have a higher risk of experiencing serious infections if they receive treatment with ORENCIA together with other biologic medications for RA. People receiving treatment with ORENCIA also should notify their healthcare providers if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should discuss their risks of infection with their healthcare providers. People should inform their healthcare providers of any infections that they may have, including infections in a specific location in or on the body (such as an open cut or sore), or an infection that involves the whole body (such as the flu), as these types of infection could put individuals at risk for serious side effects from ORENCIA. Additionally, individuals should alert their healthcare providers if they have infections that won't heal or have histories of recurring infections.
People who have had tuberculosis (TB), have had a positive skin test for TB, or who recently have been in close contact with someone who has had TB should inform their healthcare providers. If these individuals develop any of the symptoms of TB (i.e., a dry cough that doesn't improve, weight loss, fever, night sweats, etc.), they should notify their healthcare providers immediately. Before initiating treatment with ORENCIA, healthcare providers may examine individuals for TB or perform a skin test to determine the presence of TB.
Additionally, individuals should inform their healthcare providers if they are scheduled to have surgery, or if they recently received a vaccination or are scheduled to receive any vaccinations. Before receiving ORENCIA, people should alert their healthcare providers if they have a history of chronic obstructive pulmonary (lung) disease (COPD), as taking ORENCIA may cause their COPD symptoms to worsen.
Pregnant women, women planning to get pregnant or women thinking about becoming pregnant should inform their healthcare providers prior to starting treatment with ORENCIA®(abatacept). It is not known if exposure to ORENCIA poses risks to unborn infants. Women should alert their healthcare providers if they are breastfeeding, as these individuals will need to decide either to breastfeed or to receive treatment with ORENCIA, but not both.
Like all medicines that affect the immune system, ORENCIA can cause serious side effects, including serious infections, allergic reactions and malignancies. Individuals receiving treatment with ORENCIA are at increased risk for developing infections including pneumonia and other infections caused by viruses, bacteria or fungi. Individuals should immediately contact their healthcare providers if they feel sick or experience any infection during treatment with ORENCIA. Allergic reactions to ORENCIA therapy may also occur. These reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion and can include hives, swollen face, eyelids, lips, tongue, throat or difficulty breathing. There have been two serious allergic reactions reported in individuals following ORENCIA infusion. There have also been cases of certain kinds of cancer in individuals receiving ORENCIA. In clinical trials, the frequency of malignancies for ORENCIA was 1.3 percent. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat and nausea.
For full prescribing information, please visit orencia/ or bms/
Dosing and Administration
ORENCIA is administered as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with ORENCIA and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion-related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
About ORENCIA® (abatacept)
ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA, a selective modulator of a co-stimulatory signal required for full T-cell activation, was discovered and developed by Bristol-Myers Squibb Company.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Bristol-Myers Squibb Company
bms/
orencia/
View drug information on Enbrel; Humira; Kineret.
The study, designed to assess the efficacy and safety of ORENCIA in children and adolescents (ages 6-17 years) with a mean age of 12.4 years with JIA, consists of three phases: a four-month treatment period in which all participants received ORENCIA and response was assessed (Part A), a six-month randomized double-blind phase where responders received either ORENCIA or placebo (Part B) and an open-label phase designed to assess long-term safety and efficacy (Part C). Results from Part A were presented at an ACR Concurrent Abstract Session on Sunday, November 12; findings from the double- blind phase (Part B) were presented at a late-breaking data presentation at ACR today.
"In this trial of children with active JIA, approximately 53 percent of participants withdrawn from ORENCIA treatment and given placebo experienced disease flares compared to 20 percent of participants continuing to receive ORENCIA," said Edward H. Giannini, M.Sc., Dr.P.H., Professor of Pediatrics, Division of Rheumatology, Cincinnati Children's Hospital Medical Center, OH, co-principal investigator of the study and presenter of the late-breaker data from the double-blind placebo phase of the study. Co-principal investigator Daniel J. Lovell, M.D., M.P.H., Professor of Pediatrics, Cincinnati Children's Hospital Medical Center, presented the open-label phase of the study on Sunday, November 12.
Details of Part A of the Trial
In the initial four-month phase of the trial, 190 children and adolescents with JIA, 72 percent of whom were female, who had inadequately responded to one or more DMARDs received ORENCIA (10 mg/kg IV; maximum 1,000 mg). Of the 190 participants, 28 percent previously had failed one or more biologic DMARDs. Seventy-four percent were on methotrexate (MTX) at study start and continued to receive MTX throughout the study (mean dosage was 13.2 mg/m2/week). Participants discontinued any DMARD other than MTX prior to the first dose of study medication.
The participants were evaluated using the ACR's validated scale for the assessment of improvement of JRA/JIA (ACR Pedi). Of the 190 participants, 123 (64.7 percent) had an ACR Pedi 30 response; 49.5 percent had an ACR Pedi 50 response and 28.4 percent had an ACR Pedi 70 response.
Of the six SAEs reported during Part A of the study, three were related to JIA (flare and arthropathy). The remaining three were varicella, ovarian cyst and acute lymphocytic leukemia. All SAEs were considered by the investigators to be unlikely related to or unrelated to study medication. Adverse events (AEs) were reported in 70 percent of participants. Those reported in greater than or equal to 5 percent of participants included headache (13 percent), nausea (10 percent), cough (9 percent), diarrhea (9 percent), upper respiratory tract infection (7 percent), pyrexia (6 percent), nasopharyngitis (6 percent) and upper abdominal pain (5 percent).
Details of Part B of the Trial
For the second phase of the study, 122 of the 123 participants who achieved an ACR Pedi 30 response in the first phase were randomized in a 1:1 ratio to receive double-blind therapy with either ORENCIA or placebo every 28 days for up to six months. The primary objective of the study was time to disease flare. Forty-eight patients in the ORENCIA group and 46 in the placebo group received concomitant MTX therapy. The mean dosage of MTX was 13.5 mg/m2/week for the ORENCIA group and 12.9 mg/m2/week for the placebo group. Approximately 70 percent of both the ORENCIA and placebo groups were female. Those who experienced disease flares during the trial were offered open-label ORENCIA therapy in Part C of the trial. Safety assessments were performed at each visit. Of the 122 participants, a total of 33 out of 62 (53.2 percent) of the children receiving placebo experienced disease flares compared to 12 out of 60 (20 percent) receiving ORENCIA.
Two of the participants receiving placebo experienced SAEs: one case of hematoma and one case of both varicella and encephalitis; neither child discontinued participation in the trial. No child receiving ORENCIA during the six-month double-blind phase had an SAE.
Adverse events were reported in 61.7 percent (n=36) of participants treated with ORENCIA and 54.8 percent (n=34) of participants receiving placebo. Those occurring in greater than or equal to 3.5 percent in the ORENCIA and placebo groups, respectively, included:
Influenza: 8.3 percent (n=5) and 6.5 percent (n=4)
Bacteriuria: 6.7 percent (n=4) and 0 percent
Nasopharyngitis: 6.7 percent (n=4) and 4.8 percent (n=3)
Pyrexia: 6.7 percent (n=4) and 8.1 percent (n=5)
Upper respiratory tract infection: 6.7 percent (n=4) and 8.1 percent (n=5)
Abdominal pain: 5 percent (n=3) and 1.6 percent (n=1)
Gastroenteritis: 5 percent (n=3) and 1.6 percent (n=1)
Headache: 5 percent (n=3) and 1.6 percent (n=1)
Sinusitis: 5 percent (n=3) and 3.2 percent (n=2)
Nausea: 3.3 percent (n=2) and 6.5 percent (n=4)
Rhinitis: 1.7 percent (n=1) and 6.5 percent (n=4)
Infusional AEs occurred in two participants from each group.
About Juvenile Idiopathic Arthritis
Juvenile idiopathic arthritis (JIA) -- also commonly known as juvenile rheumatoid arthritis (JRA) -- is a chronic, autoimmune disease, causing chronic pain, stiffness and swelling of the joints, which may ultimately lead to joint damage and deformities. The disease begins before the age of 16 and affects about 1 child in every 1,000 in the United States. Despite current therapies, some individuals with JIA experience ongoing disease and many eventually worsen, resulting in severe joint damage and abnormal joint function.
Important Safety Information about ORENCIA® (abatacept)
Before receiving treatment with ORENCIA, individuals should notify their healthcare providers if they currently are receiving treatment with a TNF antagonist (e.g., Enbrel®, Humira®, Remicade®) or Kineret® to treat rheumatoid arthritis (RA). These individuals may have a higher risk of experiencing serious infections if they receive treatment with ORENCIA together with other biologic medications for RA. People receiving treatment with ORENCIA also should notify their healthcare providers if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal products.
Individuals should discuss their risks of infection with their healthcare providers. People should inform their healthcare providers of any infections that they may have, including infections in a specific location in or on the body (such as an open cut or sore), or an infection that involves the whole body (such as the flu), as these types of infection could put individuals at risk for serious side effects from ORENCIA. Additionally, individuals should alert their healthcare providers if they have infections that won't heal or have histories of recurring infections.
People who have had tuberculosis (TB), have had a positive skin test for TB, or who recently have been in close contact with someone who has had TB should inform their healthcare providers. If these individuals develop any of the symptoms of TB (i.e., a dry cough that doesn't improve, weight loss, fever, night sweats, etc.), they should notify their healthcare providers immediately. Before initiating treatment with ORENCIA, healthcare providers may examine individuals for TB or perform a skin test to determine the presence of TB.
Additionally, individuals should inform their healthcare providers if they are scheduled to have surgery, or if they recently received a vaccination or are scheduled to receive any vaccinations. Before receiving ORENCIA, people should alert their healthcare providers if they have a history of chronic obstructive pulmonary (lung) disease (COPD), as taking ORENCIA may cause their COPD symptoms to worsen.
Pregnant women, women planning to get pregnant or women thinking about becoming pregnant should inform their healthcare providers prior to starting treatment with ORENCIA®(abatacept). It is not known if exposure to ORENCIA poses risks to unborn infants. Women should alert their healthcare providers if they are breastfeeding, as these individuals will need to decide either to breastfeed or to receive treatment with ORENCIA, but not both.
Like all medicines that affect the immune system, ORENCIA can cause serious side effects, including serious infections, allergic reactions and malignancies. Individuals receiving treatment with ORENCIA are at increased risk for developing infections including pneumonia and other infections caused by viruses, bacteria or fungi. Individuals should immediately contact their healthcare providers if they feel sick or experience any infection during treatment with ORENCIA. Allergic reactions to ORENCIA therapy may also occur. These reactions are usually mild or moderate, generally occur within the first 24 hours of an infusion and can include hives, swollen face, eyelids, lips, tongue, throat or difficulty breathing. There have been two serious allergic reactions reported in individuals following ORENCIA infusion. There have also been cases of certain kinds of cancer in individuals receiving ORENCIA. In clinical trials, the frequency of malignancies for ORENCIA was 1.3 percent. The role of ORENCIA in the development of cancer is not known.
The more common side effects with ORENCIA are headache, upper respiratory tract infection, sore throat and nausea.
For full prescribing information, please visit orencia/ or bms/
Dosing and Administration
ORENCIA is administered as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with ORENCIA and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion-related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.
About ORENCIA® (abatacept)
ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.
ORENCIA, a selective modulator of a co-stimulatory signal required for full T-cell activation, was discovered and developed by Bristol-Myers Squibb Company.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Bristol-Myers Squibb Company
bms/
orencia/
View drug information on Enbrel; Humira; Kineret.
Most Women Unaware Of Risk For Debilitating Fractures
Underscoring what researchers call a serious global public health concern, results from a new study led by Columbia University Medical Center reveal that many women at an elevated level of risk for osteoporosis-associated fractures fail to perceive the implications of the risk factors.
"We found that many women aren't making the connection between their risk factors and the serious consequences of fractures," said the lead author Ethel Siris, M.D., director of the Toni Stabile Osteoporosis Center at NewYork-Presbyterian Hospital/Columbia University Medical Center, and the Madeline C. Stabile Professor of Clinical Medicine at Columbia University College of Physicians and Surgeons. "Without a clear understanding of their risks, women cannot begin to protect themselves from fracture."
This study, part of the Global Longitudinal Study of Osteoporosis in Women (GLOW), which is based at the Center for Outcomes Research at the University of Massachusetts Medical School, was published online by the journal Osteoporosis International on April 2, 2010. The study, conducted at 17 GLOW study sites worldwide, included more than 60,000 postmenopausal women in 10 countries in Europe, North America and Australia.
Results showed that among postmenopausal women diagnosed with osteoporosis a condition associated with a high risk for fractures, as it causes bones to become fragile and more likely to break only 43 percent thought their risk of a fracture was higher than other women their age. Additionally, only one in three (33 percent) women who reported two or more major risk factors for fracture, perceived themselves as being at higher risk for fracture than their age-matched peers.
Because many fractures can be prevented by appropriate treatment, it is important that elevated risk be recognized.
One in two women will suffer an osteoporosis-related fracture after age 50; these fractures often carry with them chronic pain, reduced mobility, loss of independence and in the case of hip fracture, an increased risk of death. Because the likelihood of fractures increases substantially with age, fracture numbers are projected to rise as the population ages. Osteoporosis-related fractures are an international public health problem; in addition to the human suffering associated with these fractures, they also are the source of enormous health-care costs.
Improved education of physicians and postmenopausal women about osteoporosis risk factors is urgently needed, according to the study authors. If left untreated, osteoporosis can progress painlessly until a fracture occurs. Several risk factors for fractures have been identified and should be considered by physicians treating women age 55 and older:
-- older age
-- low weight
-- parental hip fracture
-- personal history of fracture (clavicle, arm, wrist, spine, rib, hip, pelvis, upper leg, lower leg, ankle) since age 45
-- two or more falls in the past year
-- current use of cortisone or prednisone (steroids often prescribed for a number of medical conditions)
-- rheumatoid arthritis
-- cigarette smoking
-- consumption of three or more alcoholic beverages daily
Other risk factors for fractures include a variety of medical conditions and medications. Tools for diagnosis and risk assessment, including bone-density testing and the World Health Organization FRAX fracture risk-assessment tool, are widely available; still, the connection between identified risk factors and serious fracture outcomes is not being made by a majority of women at highest risk.
"We hope the insight we obtain from GLOW will help physicians and patients work together to identify those at risk for fracture and to enhance understanding of the meaning of that risk," said Siris. "Education is critical if we are to reduce the burden of fractures worldwide."
GLOW is a prospective, international cohort study of women 55 years of age and older who visited their primary-care physician during the two years prior to enrollment in the study. More than 60,000 women were recruited by more than 700 primary-care physicians in 17 cities in 10 countries (Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom and the United States). GLOW is gathering information on osteoporosis risk factors, treatments, patient behaviors and fracture outcomes during a five-year period. Self-perceived risk of fracture was assessed using a five-point scale ranging from "much lower" to "much higher" risk than other women of the same age.
Of the 28,000 U.S. women participating in GLOW, 3,500 were from New York, enrolled at the Helen Hayes Hospital in West Haverstraw, an affiliate hospital of NewYork-Presbyterian Healthcare System. A quarter (25 percent) of these women reported an osteoporosis diagnosis, 23 percent had a previous fracture, 17 percent were low weight, 37 percent reported recent falls, and 20 percent a parental hip fracture. Despite the high prevalence of risk factors, only 36 percent of women with two or more major risk factors perceived themselves to be at higher risk of a fracture than their peers. This failure by women to appreciate their personal risk of fracture presents a barrier to them receiving appropriate management and safe and effective treatments.
GLOW is supported by a grant from The Alliance for Better Bone Health (formerly Sanofi-aventis and P&G Pharmaceuticals, now Sanofi-aventis and Warner Chilcott) and is being directed by the Center for Outcomes Research, University of Massachusetts Medical School.
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the most comprehensive medical research enterprise in New York City and State and one of the largest in the United States. Columbia University Medical Center is affiliated with NewYork-Presbyterian Hospital, the nation's largest not-for-profit hospital provider.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/The Allen Hospital and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.
About the Center for Outcomes Research (COR)
COR is based at the University of Massachusetts, Worcester, Mass. The mission of COR is to collect and evaluate data that reflect real-world practices and outcomes and to provide physicians with confidential reports that allow comparison of their practices to evidence-based performance standards
Source: Columbia University Medical Center
"We found that many women aren't making the connection between their risk factors and the serious consequences of fractures," said the lead author Ethel Siris, M.D., director of the Toni Stabile Osteoporosis Center at NewYork-Presbyterian Hospital/Columbia University Medical Center, and the Madeline C. Stabile Professor of Clinical Medicine at Columbia University College of Physicians and Surgeons. "Without a clear understanding of their risks, women cannot begin to protect themselves from fracture."
This study, part of the Global Longitudinal Study of Osteoporosis in Women (GLOW), which is based at the Center for Outcomes Research at the University of Massachusetts Medical School, was published online by the journal Osteoporosis International on April 2, 2010. The study, conducted at 17 GLOW study sites worldwide, included more than 60,000 postmenopausal women in 10 countries in Europe, North America and Australia.
Results showed that among postmenopausal women diagnosed with osteoporosis a condition associated with a high risk for fractures, as it causes bones to become fragile and more likely to break only 43 percent thought their risk of a fracture was higher than other women their age. Additionally, only one in three (33 percent) women who reported two or more major risk factors for fracture, perceived themselves as being at higher risk for fracture than their age-matched peers.
Because many fractures can be prevented by appropriate treatment, it is important that elevated risk be recognized.
One in two women will suffer an osteoporosis-related fracture after age 50; these fractures often carry with them chronic pain, reduced mobility, loss of independence and in the case of hip fracture, an increased risk of death. Because the likelihood of fractures increases substantially with age, fracture numbers are projected to rise as the population ages. Osteoporosis-related fractures are an international public health problem; in addition to the human suffering associated with these fractures, they also are the source of enormous health-care costs.
Improved education of physicians and postmenopausal women about osteoporosis risk factors is urgently needed, according to the study authors. If left untreated, osteoporosis can progress painlessly until a fracture occurs. Several risk factors for fractures have been identified and should be considered by physicians treating women age 55 and older:
-- older age
-- low weight
-- parental hip fracture
-- personal history of fracture (clavicle, arm, wrist, spine, rib, hip, pelvis, upper leg, lower leg, ankle) since age 45
-- two or more falls in the past year
-- current use of cortisone or prednisone (steroids often prescribed for a number of medical conditions)
-- rheumatoid arthritis
-- cigarette smoking
-- consumption of three or more alcoholic beverages daily
Other risk factors for fractures include a variety of medical conditions and medications. Tools for diagnosis and risk assessment, including bone-density testing and the World Health Organization FRAX fracture risk-assessment tool, are widely available; still, the connection between identified risk factors and serious fracture outcomes is not being made by a majority of women at highest risk.
"We hope the insight we obtain from GLOW will help physicians and patients work together to identify those at risk for fracture and to enhance understanding of the meaning of that risk," said Siris. "Education is critical if we are to reduce the burden of fractures worldwide."
GLOW is a prospective, international cohort study of women 55 years of age and older who visited their primary-care physician during the two years prior to enrollment in the study. More than 60,000 women were recruited by more than 700 primary-care physicians in 17 cities in 10 countries (Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom and the United States). GLOW is gathering information on osteoporosis risk factors, treatments, patient behaviors and fracture outcomes during a five-year period. Self-perceived risk of fracture was assessed using a five-point scale ranging from "much lower" to "much higher" risk than other women of the same age.
Of the 28,000 U.S. women participating in GLOW, 3,500 were from New York, enrolled at the Helen Hayes Hospital in West Haverstraw, an affiliate hospital of NewYork-Presbyterian Healthcare System. A quarter (25 percent) of these women reported an osteoporosis diagnosis, 23 percent had a previous fracture, 17 percent were low weight, 37 percent reported recent falls, and 20 percent a parental hip fracture. Despite the high prevalence of risk factors, only 36 percent of women with two or more major risk factors perceived themselves to be at higher risk of a fracture than their peers. This failure by women to appreciate their personal risk of fracture presents a barrier to them receiving appropriate management and safe and effective treatments.
GLOW is supported by a grant from The Alliance for Better Bone Health (formerly Sanofi-aventis and P&G Pharmaceuticals, now Sanofi-aventis and Warner Chilcott) and is being directed by the Center for Outcomes Research, University of Massachusetts Medical School.
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the most comprehensive medical research enterprise in New York City and State and one of the largest in the United States. Columbia University Medical Center is affiliated with NewYork-Presbyterian Hospital, the nation's largest not-for-profit hospital provider.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,242 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including more than 230,000 visits to its emergency departments more than any other area hospital. NewYork-Presbyterian provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/The Allen Hospital and NewYork-Presbyterian Hospital/Westchester Division. One of the largest and most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons.
About the Center for Outcomes Research (COR)
COR is based at the University of Massachusetts, Worcester, Mass. The mission of COR is to collect and evaluate data that reflect real-world practices and outcomes and to provide physicians with confidential reports that allow comparison of their practices to evidence-based performance standards
Source: Columbia University Medical Center
Differing Patient And Doctor Expectations From Joint Replacement Surgeries
While physicians strive to set realistic expectations for patients undergoing knee and hip joint replacements, a new study reveals that doctor and patient expectations are sometimes not aligned. The study, reported by Hospital for Special Surgery researchers at the American Academy of Orthopedic Surgeons being held March 9-13 in New Orleans (poster P140), suggests that steps need to be taken to bridge the expectation gap.
This study is among the first to examine discrepancies in patient and physician expectation with joint replacement surgeries, according to Hassan Ghomrawi, Ph.D., MPH, outcomes research scientist, Biostatistics and Epidemiology, at Hospital for Special Surgery (HSS) in New York, who led the study.
The two joint replacement surgeries studied are known technically as total hip replacement (THR) and total knee replacement (TKR). These procedures are common in individuals over 50 and usually result from normal wear and tear that causes osteoarthritis. At Hospital for Special Surgery alone, nearly 4,000 THRs and 4,000 TKRs are performed each year.
At HSS, patients are required to attend a 90 minute class before surgery where they receive education from a specialized nurse about what they can expect during the surgery and recovery. "A leader in offering such classes, HSS has been giving a preoperative class for many years. This practice is becoming a trend in big hospitals for this type of surgery," Dr. Ghomrawi said. The results from this study indicate that such classes could be refined and steps can be taken to use these classes to improve patient and physician dialogue.
In a study that compared expectations of 42 patients with their doctors through surveys, investigators found clinically meaningful disagreement in 68 percent of patients with 53 percent of the patients' expectations exceeding the expectations of the surgeons.
"The take home message for the surgeon is that inexpensive, educational interventions like a preoperative class can be used to better align the patient's and the surgeon's expectations prior to surgery," said Alejandro Gonzalez Della Valle, M.D., associate attending orthopaedic surgeon at HSS, who was involved with the study. "This may ultimately result in higher perceived outcome."
"If a patient has unrealistic expectations that are not properly trimmed preoperatively or achieved after surgery, the patient will most likely be dissatisfied with some aspects of the final result. Conversely, if the patient has low expectations for function after surgery, it is likely that he or she will not enthusiastically engage in the different phases of the postoperative recovery including physically therapy. That patient will probably have a lower than expected functional result.
"For the patient, the take home message is that it is paramount to discuss the expectations for pain relief and function with the surgeon and in the class before undergoing a total joint replacement to make sure that the expectations of the physician and the patient are similar," said Dr. Gonzalez Della Valle.
The study included patients who were scheduled to receive a hip or knee replacement by a dedicated hip and knee surgeon. Both patient and doctor completed either a THR or TKR recovery expectation questionnaire. The surveys involved various questions with a scale from 1 to 5, ranging from a 1 being "return to normal," to a 4 being "very little improvement," and 5 being "I don't have this expectation."
The hip joint replacement survey had 18 questions involving improvement in psychological well-being, pain relief, ability to walk, ability to stand, getting rid of a limp, getting rid of a cane, ability to go up and down stairs, ability to raise from the sitting position, and improvement in social activities that range from working at a job or doing housework to recreation including the participation in sports. Other questions evaluated the mobility of an individual's hip such as whether a person could cut their own toenails.
The knee joint replacement survey had 19 questions involving improvement in psychological well-being, pain relief, ability to walk different distances, getting rid of a cane, going up and down stairs, kneeling, squatting, using transportation, the ability to be employed, and the ability to participate in recreation, social activities, sports, and sexual activity.
The numbers from each of the questions on the survey were then plugged into a formula that calculated a score ranging from 0 to 100, with 100 being the highest expectation. The study involved 25 patients undergoing THR and 17 patients undergoing TKR. Both patients and doctors completed surveys. The average surgeon expectation score was 75 (range 43 to 93) and the average patient expectation score was 84 (range 47 to 100).
"We observed a lot of variability between what the surgeon expected and what the patient expected. In an ideal world, the expectations of the patient and the surgeon should be similar," Dr. Gonzalez Della Valle said.
Based on results from this pilot study, the National Institutes of Health has awarded Dr. Ghomrawi a five-year career development award. "The hope is to be able to study the relationship between expectation discordance and several outcomes down the road, including rehabilitation outcomes at discharge, and six month and two-year follow-up functional outcomes," Dr. Ghomrawi said. "We are trying to see which items of discordance are clinically meaningful. And then we want to use all this information to improve the doctorpatient dialogue as well as to reassess the class content, so that expectations are aligned."
"The larger study will be more complex. We will try to analyze the discrepancies that different doctors may have for the same patient and that different doctors have between themselves when assessing the same patient," Dr. Gonzalez Della Valle said. "What are the physician factors and patient factors that can predict higher or lower expectations? The goal of THR and TKR surgeries is to provide durable pain relief and improvement of function so that patients can go back to an enjoyable, productive life. We want to make patients satisfied. We know that hip and knee replacement operations are very successful. But we are trying to go a step further, looking at the psychology of the patient recovery."
Other authors of this pilot study are Lisa Mandl, M.D., Huong Do, M.S., and Nuria Franco, M.D., from Hospital for Special Surgery. Dr. Ghomrawi is also an instructor in Public Health in the Division of Health Policy at Weill Cornell Medical College.
Source:
Phyllis Fisher
Hospital for Special Surgery
This study is among the first to examine discrepancies in patient and physician expectation with joint replacement surgeries, according to Hassan Ghomrawi, Ph.D., MPH, outcomes research scientist, Biostatistics and Epidemiology, at Hospital for Special Surgery (HSS) in New York, who led the study.
The two joint replacement surgeries studied are known technically as total hip replacement (THR) and total knee replacement (TKR). These procedures are common in individuals over 50 and usually result from normal wear and tear that causes osteoarthritis. At Hospital for Special Surgery alone, nearly 4,000 THRs and 4,000 TKRs are performed each year.
At HSS, patients are required to attend a 90 minute class before surgery where they receive education from a specialized nurse about what they can expect during the surgery and recovery. "A leader in offering such classes, HSS has been giving a preoperative class for many years. This practice is becoming a trend in big hospitals for this type of surgery," Dr. Ghomrawi said. The results from this study indicate that such classes could be refined and steps can be taken to use these classes to improve patient and physician dialogue.
In a study that compared expectations of 42 patients with their doctors through surveys, investigators found clinically meaningful disagreement in 68 percent of patients with 53 percent of the patients' expectations exceeding the expectations of the surgeons.
"The take home message for the surgeon is that inexpensive, educational interventions like a preoperative class can be used to better align the patient's and the surgeon's expectations prior to surgery," said Alejandro Gonzalez Della Valle, M.D., associate attending orthopaedic surgeon at HSS, who was involved with the study. "This may ultimately result in higher perceived outcome."
"If a patient has unrealistic expectations that are not properly trimmed preoperatively or achieved after surgery, the patient will most likely be dissatisfied with some aspects of the final result. Conversely, if the patient has low expectations for function after surgery, it is likely that he or she will not enthusiastically engage in the different phases of the postoperative recovery including physically therapy. That patient will probably have a lower than expected functional result.
"For the patient, the take home message is that it is paramount to discuss the expectations for pain relief and function with the surgeon and in the class before undergoing a total joint replacement to make sure that the expectations of the physician and the patient are similar," said Dr. Gonzalez Della Valle.
The study included patients who were scheduled to receive a hip or knee replacement by a dedicated hip and knee surgeon. Both patient and doctor completed either a THR or TKR recovery expectation questionnaire. The surveys involved various questions with a scale from 1 to 5, ranging from a 1 being "return to normal," to a 4 being "very little improvement," and 5 being "I don't have this expectation."
The hip joint replacement survey had 18 questions involving improvement in psychological well-being, pain relief, ability to walk, ability to stand, getting rid of a limp, getting rid of a cane, ability to go up and down stairs, ability to raise from the sitting position, and improvement in social activities that range from working at a job or doing housework to recreation including the participation in sports. Other questions evaluated the mobility of an individual's hip such as whether a person could cut their own toenails.
The knee joint replacement survey had 19 questions involving improvement in psychological well-being, pain relief, ability to walk different distances, getting rid of a cane, going up and down stairs, kneeling, squatting, using transportation, the ability to be employed, and the ability to participate in recreation, social activities, sports, and sexual activity.
The numbers from each of the questions on the survey were then plugged into a formula that calculated a score ranging from 0 to 100, with 100 being the highest expectation. The study involved 25 patients undergoing THR and 17 patients undergoing TKR. Both patients and doctors completed surveys. The average surgeon expectation score was 75 (range 43 to 93) and the average patient expectation score was 84 (range 47 to 100).
"We observed a lot of variability between what the surgeon expected and what the patient expected. In an ideal world, the expectations of the patient and the surgeon should be similar," Dr. Gonzalez Della Valle said.
Based on results from this pilot study, the National Institutes of Health has awarded Dr. Ghomrawi a five-year career development award. "The hope is to be able to study the relationship between expectation discordance and several outcomes down the road, including rehabilitation outcomes at discharge, and six month and two-year follow-up functional outcomes," Dr. Ghomrawi said. "We are trying to see which items of discordance are clinically meaningful. And then we want to use all this information to improve the doctorpatient dialogue as well as to reassess the class content, so that expectations are aligned."
"The larger study will be more complex. We will try to analyze the discrepancies that different doctors may have for the same patient and that different doctors have between themselves when assessing the same patient," Dr. Gonzalez Della Valle said. "What are the physician factors and patient factors that can predict higher or lower expectations? The goal of THR and TKR surgeries is to provide durable pain relief and improvement of function so that patients can go back to an enjoyable, productive life. We want to make patients satisfied. We know that hip and knee replacement operations are very successful. But we are trying to go a step further, looking at the psychology of the patient recovery."
Other authors of this pilot study are Lisa Mandl, M.D., Huong Do, M.S., and Nuria Franco, M.D., from Hospital for Special Surgery. Dr. Ghomrawi is also an instructor in Public Health in the Division of Health Policy at Weill Cornell Medical College.
Source:
Phyllis Fisher
Hospital for Special Surgery
NicOx Receives FDA Feedback That No Cardiovascular Outcomes Study Required For Naproxcinod NDA
NicOx S.A.
(Eurolist: NICOX) today announced that the United States Food and Drug
Administration (FDA) has provided feedback on the requirements for
long-term safety data needed for the submission of a New Drug Application
(NDA) for naproxcinod (HCT 3012). The FDA correspondence stated that based
on the information available at this time, a large clinical cardiovascular
outcomes study would not be required at the time of NDA submission for
naproxcinod. Naproxcinod is in phase 3 clinical development for the
treatment of the signs and symptoms of osteoarthritis.
Based on this current feedback and previous discussions held with the
FDA, NicOx believes that its global registration plan for naproxcinod (see
NOTE 1) will be adequate to satisfy current requirements in the US with
regards to demonstrating the efficacy and safety of naproxcinod for
treating the signs and symptoms of osteoarthritis.
Philippe Serrano, Senior Director of Regulatory Affairs at NicOx,
commented: "This response from the FDA confirms that our previously
announced clinical plan for naproxcinod will provide an adequate safety
database for NDA submission and is consistent with recent advice received
from the EMEA. We will continue with our existing clinical plan, with the
goal of submitting an NDA and MAA for naproxcinod in the US and Europe in
the first quarter of 2009."
Naproxcinod is a unique anti-inflammatory agent and the first compound
in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class. Following its
review of the non-clinical, pharmacokinetic and clinical data supplied by
NicOx regarding naproxcinod and COX inhibition, the FDA has concluded that
a large clinical cardiovascular outcomes study would not be required for
naproxcinod at the time of NDA submission. As with the development of any
new molecular entity, additional safety studies could be required if any
safety signals were to be observed in the development program.
NOTE 1: NicOx's global registration plan for naproxcinod consists of
three phase 3 efficacy trials, the first of which reported top-line data on
October 27, 2006 (the 301 study). This trial is expected to be followed by
the initiation of two additional studies in knee and hip osteoarthritis
during 2007 (the 302 and 303 studies).
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric oxide-
donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of pain and inflammation and cardio-metabolic disease.
Resources are focused on two lead compounds, naproxcinod (formerly HCT
3012), in phase 3 development for the treatment of osteoarthritis, and NCX
4016, in phase 2 for type 2 diabetes. NicOx has strategic partnerships with
some of the world's leading pharmaceutical companies, including Pfizer Inc.
and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a
public company listed on the Eurolist of Euronext Paris (segment: Next
Economy).
The elements included in this communication may contain forward-looking
statements subject to certain risks and uncertainties. Actual results of
the company may differ materially from those indicated in the
forward-looking statements because of different risks factors described in
the company's document de reference.
NicOx S.A.
nicox
(Eurolist: NICOX) today announced that the United States Food and Drug
Administration (FDA) has provided feedback on the requirements for
long-term safety data needed for the submission of a New Drug Application
(NDA) for naproxcinod (HCT 3012). The FDA correspondence stated that based
on the information available at this time, a large clinical cardiovascular
outcomes study would not be required at the time of NDA submission for
naproxcinod. Naproxcinod is in phase 3 clinical development for the
treatment of the signs and symptoms of osteoarthritis.
Based on this current feedback and previous discussions held with the
FDA, NicOx believes that its global registration plan for naproxcinod (see
NOTE 1) will be adequate to satisfy current requirements in the US with
regards to demonstrating the efficacy and safety of naproxcinod for
treating the signs and symptoms of osteoarthritis.
Philippe Serrano, Senior Director of Regulatory Affairs at NicOx,
commented: "This response from the FDA confirms that our previously
announced clinical plan for naproxcinod will provide an adequate safety
database for NDA submission and is consistent with recent advice received
from the EMEA. We will continue with our existing clinical plan, with the
goal of submitting an NDA and MAA for naproxcinod in the US and Europe in
the first quarter of 2009."
Naproxcinod is a unique anti-inflammatory agent and the first compound
in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class. Following its
review of the non-clinical, pharmacokinetic and clinical data supplied by
NicOx regarding naproxcinod and COX inhibition, the FDA has concluded that
a large clinical cardiovascular outcomes study would not be required for
naproxcinod at the time of NDA submission. As with the development of any
new molecular entity, additional safety studies could be required if any
safety signals were to be observed in the development program.
NOTE 1: NicOx's global registration plan for naproxcinod consists of
three phase 3 efficacy trials, the first of which reported top-line data on
October 27, 2006 (the 301 study). This trial is expected to be followed by
the initiation of two additional studies in knee and hip osteoarthritis
during 2007 (the 302 and 303 studies).
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric oxide-
donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of pain and inflammation and cardio-metabolic disease.
Resources are focused on two lead compounds, naproxcinod (formerly HCT
3012), in phase 3 development for the treatment of osteoarthritis, and NCX
4016, in phase 2 for type 2 diabetes. NicOx has strategic partnerships with
some of the world's leading pharmaceutical companies, including Pfizer Inc.
and Merck and Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a
public company listed on the Eurolist of Euronext Paris (segment: Next
Economy).
The elements included in this communication may contain forward-looking
statements subject to certain risks and uncertainties. Actual results of
the company may differ materially from those indicated in the
forward-looking statements because of different risks factors described in
the company's document de reference.
NicOx S.A.
nicox
Promising Phase III Psoriatic Arthritis Data For Humira(REG) (Adalimumab)
New Phase III study findings show that patients with active psoriatic arthritis who had failed a previous non-steroidal
anti-inflammatory drug (NSAID) therapy achieved significant improvement in both joint and skin signs and symptoms after
treatment with Abbott's HUMIRA®. The study, presented this week at the American College of Rheumatology (ACR) annual meeting,
found that patients experienced sustained response with HUMIRA therapy beyond the 12-week primary endpoint. At the 24-week
follow-up, nearly one-fourth of patients achieved a 70 percent improvement in arthritis signs and symptoms, and 42 percent of
patients achieved at least a 90 percent reduction in psoriasis activity.
Patients in the trial experienced marked improvement in both arthritis and psoriasis response as early as two weeks after
initiation of therapy and patient response was sustained through 24 weeks. These results were statistically significant.
"Psoriatic arthritis takes an enormous toll on patients' quality of life," said Philip Mease, M.D., lead study investigator
of Swedish Medical Center and University of Washington School of Medicine, Seattle. "In this study, patients on HUMIRA
achieved rapid improvement in arthritis symptoms as well as quality of life and function. Even more encouraging, they also
displayed significant improvement in skin symptoms."
Psoriatic arthritis is an autoimmune disorder that combines symptoms of psoriasis, such as dry, scaly skin and patches of
red, raised skin known as plaques, with arthritis symptoms including joint pain and inflammation. Common symptoms of
psoriatic arthritis include varying degrees of psoriasis activity along with stiffness, pain, swelling and tenderness of the
joints that can lead to a reduced range of motion and potential severe joint destruction.
Study Overview
This placebo-controlled, double-blind study assessed the efficacy and tolerability of HUMIRA in 313 adults with active
psoriatic arthritis (defined as three or more swollen joints and three or more tender joints) who had failed therapy with
NSAIDs. Patients received 40 mg of HUMIRA or placebo administered subcutaneously every other week. Efficacy was assessed
using ACR20 response (20 percent improvement in tender and swollen joint count and other clinical measures), one of the
primary study endpoints.
Secondary endpoints included ACR50/70, Psoriasis Area and Severity Index (PASI) (which measures the extent and severity of
psoriasis) measurement in patients with more than three percent body surface area involvement and other clinical assessments.
Arthritis Response
In the HUMIRA treatment group, improvement in arthritis signs and symptoms was rapid, with 27 percent of patients achieving
an ACR20 response after two weeks and 52 percent of patients achieving an ACR20 response after just four weeks, compared with
six percent and nine percent for patients taking placebo. At 24 weeks, 39 percent of patients treated with HUMIRA achieved an
ACR50 response and 23 percent achieved ACR70, compared to six percent and one percent, respectively, in the placebo group.
Psoriasis Response
In patients with more than three percent body surface area involvement, 42 percent of patients taking HUMIRA achieved a PASI
90 response at 24 weeks, which reflects at least 90 percent improvement in psoriasis symptoms assessed by the PASI. Nearly
one-third (30 percent) achieved 90 percent improvement at the week 12 visit. At 24 weeks, 59 percent of patients in the
HUMIRA arm achieved a PASI 75 response (75 percent improvement), compared with one percent of patients taking placebo.
"These results are important for both rheumatologists and dermatologists, but more importantly the patients who suffer from
both the joint and skin symptoms of psoriatic arthritis," said Jeffrey Leiden, M.D., Ph.D., president and chief operating
officer, Pharmaceutical Products Group, and chief scientific officer, Abbott. "The promising results of this trial reinforce
our plan to submit applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) by
the end of the year to request approval for this new use."
The rates of adverse events and serious adverse events were comparable between HUMIRA and the placebo. Among patients taking
HUMIRA, the most common adverse events (those affecting at least five percent of patients) were upper respiratory infection,
nasopharyngitis, injection site reaction, headache and hypertension. The safety profile of HUMIRA in the psoriatic arthritis
population was similar to that observed in the rheumatoid arthritis population.
About Psoriatic Arthritis
Left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include
debilitating disease of the hands and feet, as seen in rheumatoid arthritis, as well as tendonitis and arthritis of the
spine. Psoriatic arthritis affects between 10 and 30 percent of the 4.5 million Americans who have psoriasis, a
non-contagious, chronic skin disease characterized by red plaques covered with silvery scales. Most people with psoriatic
arthritis first developed psoriasis.
Important Safety Information
Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including
fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in
patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to
infections. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic
reactions. Infrequent reports of serious blood disorders and rare reports of lymphoma have been reported with TNF-blocking
agents. Patients with rheumatoid arthritis, particularly those with highly active disease are at a higher risk for the
development of lymphoma. The potential role of TNF-blocking therapy in the development of malignancies is not known.
The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo)
were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection
site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11
percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with
any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inhibiting the
progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid
arthritis (RA) who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs). HUMIRA can
be used alone or in combination with methotrexate or other DMARDs. HUMIRA offers convenient every-other-week dosing by
subcutaneous injection (shot beneath the skin) via a specially designed, pre-filled syringe.
Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases, including juvenile
rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and ankylosing spondylitis.
HUMIRA was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As
part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team
would discover human antibody therapeutics. HUMIRA was isolated and optimized by Abbott and CAT as part of this
collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development,
manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on
HUMIRA sales.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch
Center, founded in 1989 in Worcester, Massachusetts, United States, is a world-class discovery and basic research facility
committed to finding new treatments for autoimmune diseases. More information about Abbott Immunology and HUMIRA, including
full prescribing information, is available on the Web sites abbottimmunology and HUMIRA, or in the United States by calling Abbott Medical
Information at (800) 633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000
people and markets its products in more than 130 countries.
View drug information on Humira.
anti-inflammatory drug (NSAID) therapy achieved significant improvement in both joint and skin signs and symptoms after
treatment with Abbott's HUMIRA®. The study, presented this week at the American College of Rheumatology (ACR) annual meeting,
found that patients experienced sustained response with HUMIRA therapy beyond the 12-week primary endpoint. At the 24-week
follow-up, nearly one-fourth of patients achieved a 70 percent improvement in arthritis signs and symptoms, and 42 percent of
patients achieved at least a 90 percent reduction in psoriasis activity.
Patients in the trial experienced marked improvement in both arthritis and psoriasis response as early as two weeks after
initiation of therapy and patient response was sustained through 24 weeks. These results were statistically significant.
"Psoriatic arthritis takes an enormous toll on patients' quality of life," said Philip Mease, M.D., lead study investigator
of Swedish Medical Center and University of Washington School of Medicine, Seattle. "In this study, patients on HUMIRA
achieved rapid improvement in arthritis symptoms as well as quality of life and function. Even more encouraging, they also
displayed significant improvement in skin symptoms."
Psoriatic arthritis is an autoimmune disorder that combines symptoms of psoriasis, such as dry, scaly skin and patches of
red, raised skin known as plaques, with arthritis symptoms including joint pain and inflammation. Common symptoms of
psoriatic arthritis include varying degrees of psoriasis activity along with stiffness, pain, swelling and tenderness of the
joints that can lead to a reduced range of motion and potential severe joint destruction.
Study Overview
This placebo-controlled, double-blind study assessed the efficacy and tolerability of HUMIRA in 313 adults with active
psoriatic arthritis (defined as three or more swollen joints and three or more tender joints) who had failed therapy with
NSAIDs. Patients received 40 mg of HUMIRA or placebo administered subcutaneously every other week. Efficacy was assessed
using ACR20 response (20 percent improvement in tender and swollen joint count and other clinical measures), one of the
primary study endpoints.
Secondary endpoints included ACR50/70, Psoriasis Area and Severity Index (PASI) (which measures the extent and severity of
psoriasis) measurement in patients with more than three percent body surface area involvement and other clinical assessments.
Arthritis Response
In the HUMIRA treatment group, improvement in arthritis signs and symptoms was rapid, with 27 percent of patients achieving
an ACR20 response after two weeks and 52 percent of patients achieving an ACR20 response after just four weeks, compared with
six percent and nine percent for patients taking placebo. At 24 weeks, 39 percent of patients treated with HUMIRA achieved an
ACR50 response and 23 percent achieved ACR70, compared to six percent and one percent, respectively, in the placebo group.
Psoriasis Response
In patients with more than three percent body surface area involvement, 42 percent of patients taking HUMIRA achieved a PASI
90 response at 24 weeks, which reflects at least 90 percent improvement in psoriasis symptoms assessed by the PASI. Nearly
one-third (30 percent) achieved 90 percent improvement at the week 12 visit. At 24 weeks, 59 percent of patients in the
HUMIRA arm achieved a PASI 75 response (75 percent improvement), compared with one percent of patients taking placebo.
"These results are important for both rheumatologists and dermatologists, but more importantly the patients who suffer from
both the joint and skin symptoms of psoriatic arthritis," said Jeffrey Leiden, M.D., Ph.D., president and chief operating
officer, Pharmaceutical Products Group, and chief scientific officer, Abbott. "The promising results of this trial reinforce
our plan to submit applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) by
the end of the year to request approval for this new use."
The rates of adverse events and serious adverse events were comparable between HUMIRA and the placebo. Among patients taking
HUMIRA, the most common adverse events (those affecting at least five percent of patients) were upper respiratory infection,
nasopharyngitis, injection site reaction, headache and hypertension. The safety profile of HUMIRA in the psoriatic arthritis
population was similar to that observed in the rheumatoid arthritis population.
About Psoriatic Arthritis
Left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include
debilitating disease of the hands and feet, as seen in rheumatoid arthritis, as well as tendonitis and arthritis of the
spine. Psoriatic arthritis affects between 10 and 30 percent of the 4.5 million Americans who have psoriasis, a
non-contagious, chronic skin disease characterized by red plaques covered with silvery scales. Most people with psoriatic
arthritis first developed psoriasis.
Important Safety Information
Cases of tuberculosis (TB) have been observed in patients receiving HUMIRA. Serious infections and sepsis, including
fatalities, have been reported with the use of TNF-blocking agents, including HUMIRA. Many of these infections occurred in
patients also taking other immunosuppressive agents that in addition to their underlying disease could predispose them to
infections. The combination of HUMIRA and anakinra is not recommended.
TNF-blocking agents, including HUMIRA, have been associated in rare cases with demyelinating disease and severe allergic
reactions. Infrequent reports of serious blood disorders and rare reports of lymphoma have been reported with TNF-blocking
agents. Patients with rheumatoid arthritis, particularly those with highly active disease are at a higher risk for the
development of lymphoma. The potential role of TNF-blocking therapy in the development of malignancies is not known.
The most frequent adverse events seen in the placebo-controlled clinical trials in rheumatoid arthritis (HUMIRA vs. placebo)
were injection site reactions (20 percent vs. 14 percent), upper respiratory infection (17 percent vs. 13 percent), injection
site pain (12 percent vs. 12 percent), headache (12 percent vs. 8 percent), rash (12 percent vs. 6 percent) and sinusitis (11
percent vs. 9 percent). Discontinuations due to adverse events were 7 percent for HUMIRA and 4 percent for placebo. As with
any treatment program, the benefits and risks of HUMIRA should be carefully considered before initiating therapy.
About HUMIRA
HUMIRA is the only fully human monoclonal antibody approved by the FDA for reducing the signs and symptoms, inhibiting the
progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid
arthritis (RA) who have had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs). HUMIRA can
be used alone or in combination with methotrexate or other DMARDs. HUMIRA offers convenient every-other-week dosing by
subcutaneous injection (shot beneath the skin) via a specially designed, pre-filled syringe.
Clinical trials are currently underway evaluating the potential of HUMIRA in other autoimmune diseases, including juvenile
rheumatoid arthritis (JRA), psoriasis, psoriatic arthritis, Crohn's disease and ankylosing spondylitis.
HUMIRA was discovered through a broad scientific collaboration between Abbott and Cambridge Antibody Technology (CAT). As
part of the collaboration, Abbott had the right to select several target antigens for which a joint Abbott/CAT research team
would discover human antibody therapeutics. HUMIRA was isolated and optimized by Abbott and CAT as part of this
collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development,
manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on
HUMIRA sales.
Abbott's Commitment to Immunology
Abbott is focused on the discovery and development of innovative treatments for immunologic diseases. The Abbott Bioresearch
Center, founded in 1989 in Worcester, Massachusetts, United States, is a world-class discovery and basic research facility
committed to finding new treatments for autoimmune diseases. More information about Abbott Immunology and HUMIRA, including
full prescribing information, is available on the Web sites abbottimmunology and HUMIRA, or in the United States by calling Abbott Medical
Information at (800) 633-9110.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 55,000
people and markets its products in more than 130 countries.
View drug information on Humira.
Evidence For An Increased Cancer Risk Following The Use Of Radioactive Radium-224 In The Therapy For Ankylosing Spondylitis
In the course of an epidemiological study, scientists of the Institute of Radiation Biology of the Helmholtz Zentrum Munchen German Research Center for Environmental Health have established an unfavourable benefit-risk-ratio for ankylosing spondylitis patients treated with Radium-224 therapy (Rheumatology 2008; 47: 855-59).
Ankylosing Spondylitis (Bechterew's Disease) is a painful chronic inflammatory rheumatic disease, associated with stiffening of the vertrebral column. Between 100,000 and 150,000 cases have already been diagnosed in Germany, but milder forms of the disease may remain undiagnosed.
The research team, led by Dr. Roland R. Wick, with Dr. Elke A. Nekolla, Prof. Dr. Albrecht M. Kellerer and the late Prof. Dr. Wolfgang Gossner have conducted a long-term follow-up study of 1,471 ankylosing spondylitis patients, whose disease symptoms were treated with repeated intravenous injections of 224Radium. A control cohort of 1,324 ankylosing spondylitis patients treated without the use of radioactive compounds and/or X-rays were also studied.
In the current publication an elevated rate of leukaemias was seen, a malignant disease of the haematopoietic system: In all, 19 observed cases of leukaemia were documented compared with 6.8 cases that would be expected in an age- and gender-matched cohort of a normal population. In particular, the incidence of acute myeloid leukaemia was significantly increased with 7.0 cases compared with 1.8 cases expected in a "normal" population.
Furthermore, four additional cases of preleukaemic diseases of the bone marrow were present in the exposed group and no cases in the control group. The frequency of leukaemia was not increased significantly in the control group compared with the expected value for a normal population.
"It is rather unlikely that impurities present in the radium preparations used before 1950 are responsible for the elevated appearance of myeloproliferative diseases in the exposed group observed here," commented Dr. Roland R. Wick. "In addition, the increased incidence of leukaemia is in line with experimental observations involving the treatment of animals with similar alpha emitting radioisotopes."
The results of these studies by the Helmholtz Zentrum M??nchen have contributed decisively to 224Radium preparations being declared obsolete and have resulted in the revocation of the licensing of SpondylAT ® by the Federal Institute for Drugs and Medical Devices (BfArM) and the decision by the licence holders to discontinue development of the treatment. In earlier legal proceedings the Cologne Administrative Court, in its decision of October 26th, 2006, came to the conclusion that the "increase of myeloid leukaemia [??¦] could be explained causally with the deposition of radium as a calcium-like element into the bone", because, due to its short half-life of only 3.66 days, the radiation released from 224Radium has its effect mainly at the bone surface in the proximity of the blood-forming bone marrow cells.
Although previous studies have shown that radium treatment has an analgesic effect the risks of 224Radium treatment exceed its benefit, particularly, since there are many other therapeutic options available. Accordingly, the Committee for Quality Assurance of the German Society for Rheumatology no longer include this therapy in its recommendations.
HELMHOLTZ ZENTRUM MUENCHEN - GERMAN RESEARCH CENTRE FOR ENVIRONMENTAL HEALTH
Ingolstaedter Landstra??e 1
D-85764 Neuherberg
gsf.de
Ankylosing Spondylitis (Bechterew's Disease) is a painful chronic inflammatory rheumatic disease, associated with stiffening of the vertrebral column. Between 100,000 and 150,000 cases have already been diagnosed in Germany, but milder forms of the disease may remain undiagnosed.
The research team, led by Dr. Roland R. Wick, with Dr. Elke A. Nekolla, Prof. Dr. Albrecht M. Kellerer and the late Prof. Dr. Wolfgang Gossner have conducted a long-term follow-up study of 1,471 ankylosing spondylitis patients, whose disease symptoms were treated with repeated intravenous injections of 224Radium. A control cohort of 1,324 ankylosing spondylitis patients treated without the use of radioactive compounds and/or X-rays were also studied.
In the current publication an elevated rate of leukaemias was seen, a malignant disease of the haematopoietic system: In all, 19 observed cases of leukaemia were documented compared with 6.8 cases that would be expected in an age- and gender-matched cohort of a normal population. In particular, the incidence of acute myeloid leukaemia was significantly increased with 7.0 cases compared with 1.8 cases expected in a "normal" population.
Furthermore, four additional cases of preleukaemic diseases of the bone marrow were present in the exposed group and no cases in the control group. The frequency of leukaemia was not increased significantly in the control group compared with the expected value for a normal population.
"It is rather unlikely that impurities present in the radium preparations used before 1950 are responsible for the elevated appearance of myeloproliferative diseases in the exposed group observed here," commented Dr. Roland R. Wick. "In addition, the increased incidence of leukaemia is in line with experimental observations involving the treatment of animals with similar alpha emitting radioisotopes."
The results of these studies by the Helmholtz Zentrum M??nchen have contributed decisively to 224Radium preparations being declared obsolete and have resulted in the revocation of the licensing of SpondylAT ® by the Federal Institute for Drugs and Medical Devices (BfArM) and the decision by the licence holders to discontinue development of the treatment. In earlier legal proceedings the Cologne Administrative Court, in its decision of October 26th, 2006, came to the conclusion that the "increase of myeloid leukaemia [??¦] could be explained causally with the deposition of radium as a calcium-like element into the bone", because, due to its short half-life of only 3.66 days, the radiation released from 224Radium has its effect mainly at the bone surface in the proximity of the blood-forming bone marrow cells.
Although previous studies have shown that radium treatment has an analgesic effect the risks of 224Radium treatment exceed its benefit, particularly, since there are many other therapeutic options available. Accordingly, the Committee for Quality Assurance of the German Society for Rheumatology no longer include this therapy in its recommendations.
HELMHOLTZ ZENTRUM MUENCHEN - GERMAN RESEARCH CENTRE FOR ENVIRONMENTAL HEALTH
Ingolstaedter Landstra??e 1
D-85764 Neuherberg
gsf.de
Targeted Drug-delivery Approaches By Nanoparticulate Carriers In The Therapy Of Inflammatory Diseases
Limitations in therapy induced by adverse effects due to unselective drug availability and therefore the use of potentially too high doses are a common problem. One prominent example for this dilemma are inflammatory diseases.
The therapeutic drawback can be overcome using nanocarrier-based drug targeting strategies which improve the selective delivery of drugs to the site of action, the so called drug targeting.
Specific uptake of nanoparticles by immune related cells in inflamed barriers offers selective drug targeting to the inflamed tissue. Common inflammatory disorders like rheumatoid arthritis, multiple sclerosis, uveitis or inflammatory bowel disease can be efficiently treated using nanocarrier-based drug delivery strategies which avoid common adverse effects.
Source
Journal of the Royal Society Interface
The therapeutic drawback can be overcome using nanocarrier-based drug targeting strategies which improve the selective delivery of drugs to the site of action, the so called drug targeting.
Specific uptake of nanoparticles by immune related cells in inflamed barriers offers selective drug targeting to the inflamed tissue. Common inflammatory disorders like rheumatoid arthritis, multiple sclerosis, uveitis or inflammatory bowel disease can be efficiently treated using nanocarrier-based drug delivery strategies which avoid common adverse effects.
Source
Journal of the Royal Society Interface
Treating Pain Effectively - New Study Results Confirm Improved Gastrointestinal Tolerability Of Tapentadol
Results from two phase III clinical studies of tapentadol immediate
release tablets (IR) suggest a significantly improved gastrointestinal
tolerability(1) as well as safety(2) profile compared to oxycodone HCl IR.
The data were presented by the German pharmaceutical company Grunenthal at
this year's Annual Congress of the European League against Rheumatism (EULAR,
June 11-14, Paris, France).
In Europe, one in five adults experiences chronic pain(3) in their life.
To reduce pain effectively, especially with chronic pain conditions, the use
of strong analgesics such as opioids is expanding.(4) However, a substantial
number of patients receiving pain therapy do not feel satisfied with their
treatment(5),(6),(7) and stop their opioid therapy against medical
recommendation.(8) The most important reasons for this are gastrointestinal
(GI) side effects like nausea and vomiting in the first few days and
constipation in the course of ongoing treatment(9); GI tolerability is one of
the leading causes of treatment discontinuation for patients who take
prescription pain medications.
Tapentadol is a novel centrally acting analgesic that acts by two
mechanisms of action, combining mu-opioid receptor agonism and noradrenaline
reuptake inhibition properties in a single molecule. New results from two
phase III studies with tapentadol were presented at the EULAR meeting. A
study in patients with end-stage joint disease showed that treatment with a
50 mg or 75 mg tapentadol IR resulted in significantly higher pain relief
compared to placebo (P
While in the oxycodone HCl IR 10 mg group the discontinuation rate was 29
percent, only 13 and 18 percent of the patients in the tapentadol IR 50- and
75 mg group, respectively, discontinued the treatment before the end of the
study.
The second study presented at the EULAR congress further demonstrates the
improved tolerability profile of tapentadol IR in comparison to oxycodone HCl
IR; for the first time data was collected over a treatment period of 90
days.(2)
The objective of this phase III, randomized 4:1 vs. oxycodone IR,
double-blind, flexible dose study was to assess the safety of tapentadol IR
for treating low back pain or osteoarthritis pain of the hip or knee over a
period of 90 days. Treatment included tapentadol IR (50 or 100 mg) every four
to six hours as needed up to 600 mg per day or oxycodone HCl IR (10 or 15 mg)
every four to six hours as needed up to 90 mg per day. A total of 679 and 170
patients in the tapentadol IR and oxycodone HCl IR groups, with average pain
intensity at inclusion on an 11-point numerical rating scale of 7.0 and 7.2,
respectively(10), were included in the efficacy and safety analyses.
Both treatment groups indicated a comparable analgesic effect at the
specified doses. The incidences of nausea, vomiting, constipation, and the
composite of nausea and/or vomiting in the tapentadol IR group were
significantly lower than in the oxycodone HCl IR group (P
release tablets (IR) suggest a significantly improved gastrointestinal
tolerability(1) as well as safety(2) profile compared to oxycodone HCl IR.
The data were presented by the German pharmaceutical company Grunenthal at
this year's Annual Congress of the European League against Rheumatism (EULAR,
June 11-14, Paris, France).
In Europe, one in five adults experiences chronic pain(3) in their life.
To reduce pain effectively, especially with chronic pain conditions, the use
of strong analgesics such as opioids is expanding.(4) However, a substantial
number of patients receiving pain therapy do not feel satisfied with their
treatment(5),(6),(7) and stop their opioid therapy against medical
recommendation.(8) The most important reasons for this are gastrointestinal
(GI) side effects like nausea and vomiting in the first few days and
constipation in the course of ongoing treatment(9); GI tolerability is one of
the leading causes of treatment discontinuation for patients who take
prescription pain medications.
Tapentadol is a novel centrally acting analgesic that acts by two
mechanisms of action, combining mu-opioid receptor agonism and noradrenaline
reuptake inhibition properties in a single molecule. New results from two
phase III studies with tapentadol were presented at the EULAR meeting. A
study in patients with end-stage joint disease showed that treatment with a
50 mg or 75 mg tapentadol IR resulted in significantly higher pain relief
compared to placebo (P
While in the oxycodone HCl IR 10 mg group the discontinuation rate was 29
percent, only 13 and 18 percent of the patients in the tapentadol IR 50- and
75 mg group, respectively, discontinued the treatment before the end of the
study.
The second study presented at the EULAR congress further demonstrates the
improved tolerability profile of tapentadol IR in comparison to oxycodone HCl
IR; for the first time data was collected over a treatment period of 90
days.(2)
The objective of this phase III, randomized 4:1 vs. oxycodone IR,
double-blind, flexible dose study was to assess the safety of tapentadol IR
for treating low back pain or osteoarthritis pain of the hip or knee over a
period of 90 days. Treatment included tapentadol IR (50 or 100 mg) every four
to six hours as needed up to 600 mg per day or oxycodone HCl IR (10 or 15 mg)
every four to six hours as needed up to 90 mg per day. A total of 679 and 170
patients in the tapentadol IR and oxycodone HCl IR groups, with average pain
intensity at inclusion on an 11-point numerical rating scale of 7.0 and 7.2,
respectively(10), were included in the efficacy and safety analyses.
Both treatment groups indicated a comparable analgesic effect at the
specified doses. The incidences of nausea, vomiting, constipation, and the
composite of nausea and/or vomiting in the tapentadol IR group were
significantly lower than in the oxycodone HCl IR group (P
Chicken Capsules Good For Aching Joints
Chicken collagen can provide relief from rheumatoid arthritis (RA) symptoms. A randomised, controlled trial, published in BioMed Central's open access journal Arthritis Research & Therapy, has found that Chicken type II collagen (CCII), a protein extracted from the cartilage of chicken breast, is a safe and effective treatment for RA.
Wei Wei, from Anhui Medical University, China, worked with a team of researchers to test the novel treatment by comparing it to the established antirheumatic drug methotrextate, in 503 RA patients. Patients who received a 12-week course of CCII capsules showed significantly improved joint function, with fewer and milder adverse effects than those taking methotrexate. According to Wei, "We've shown that CCII is a promising alternative therapeutic strategy that may be used as a nutritional supplement against rheumatoid arthritis".
RA is an autoimmune disease caused by the body mounting a response against its own cartilage - the rubbery tissue, composed mainly of collagen, which cushions and lubricates joints. By dosing patients with collagen in the form of CCII capsules, the researchers believe that 'oral tolerance' can be developed. Wei said "Oral tolerance is a reduction in autoimmune activity caused by repeated dietary exposure to the offending substance. Treatment of autoimmune diseases by induction of oral tolerance is attractive because of the few side effects and easy clinical implementation of this approach. Indeed, our work confirms that treatment with oral CCII leads to improvement in arthritis with no significant side effects".
A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis
Wei Wei, Ling-Ling Zhang, Jian-Hua Xu, Feng Xiao, Chun-De Bao, Li-Qing Ni, Xing-Fu Li, Yu-Qiong Wu, Ling-Yun Sun, Rong-Hua Zhang, Bao-Liang Sun, Sheng-Qian Xu, Shuang Liu, Wei Zhang, Jie Shen, Hua-Xiang Liu and Ren-Cheng Wang
Arthritis Research & Therapy (in press)
Source:
Graeme Baldwin
BioMed Central
Wei Wei, from Anhui Medical University, China, worked with a team of researchers to test the novel treatment by comparing it to the established antirheumatic drug methotrextate, in 503 RA patients. Patients who received a 12-week course of CCII capsules showed significantly improved joint function, with fewer and milder adverse effects than those taking methotrexate. According to Wei, "We've shown that CCII is a promising alternative therapeutic strategy that may be used as a nutritional supplement against rheumatoid arthritis".
RA is an autoimmune disease caused by the body mounting a response against its own cartilage - the rubbery tissue, composed mainly of collagen, which cushions and lubricates joints. By dosing patients with collagen in the form of CCII capsules, the researchers believe that 'oral tolerance' can be developed. Wei said "Oral tolerance is a reduction in autoimmune activity caused by repeated dietary exposure to the offending substance. Treatment of autoimmune diseases by induction of oral tolerance is attractive because of the few side effects and easy clinical implementation of this approach. Indeed, our work confirms that treatment with oral CCII leads to improvement in arthritis with no significant side effects".
A multicenter, double-blind, randomized, controlled phase III clinical trial of chicken type II collagen in rheumatoid arthritis
Wei Wei, Ling-Ling Zhang, Jian-Hua Xu, Feng Xiao, Chun-De Bao, Li-Qing Ni, Xing-Fu Li, Yu-Qiong Wu, Ling-Yun Sun, Rong-Hua Zhang, Bao-Liang Sun, Sheng-Qian Xu, Shuang Liu, Wei Zhang, Jie Shen, Hua-Xiang Liu and Ren-Cheng Wang
Arthritis Research & Therapy (in press)
Source:
Graeme Baldwin
BioMed Central
Osteoarthritis A Major Consequence Of Obesity Epidemic, Claims Charity In New Report
Obese people are four times as likely to develop osteoarthritis of the knee as they are to develop high blood pressure or type-2 diabetes, according to a leading arthritis charity, launching a new online report on the subject. But whereas high blood pressure and diabetes may be substantially improved on losing weight and are relatively easy to control with therapy, the changes resulting from osteoarthritis are irreversible, as worn cartilage cannot currently be repaired.
However, according to Professor Alan Silman, medical director of the Arthritis Research Campaign, there is good news for the obese and overweight whose knees become painful due to osteoarthritis as a result of their weight.
"Research shows that losing weight, however modest, when combined with exercise, is a panacea at every stage," said Professor Silman.
"Achieving a healthy weight reduces the risk of developing the disease in the first place, relieves existing symptoms and helps to prevent further deterioration. And weight loss and exercise has been shown to achieve the same level of symptom relief as joint replacement surgery."
The medical research charity is concerned that while rising rates of obesity have been linked to a number of serious disorders and health concerns, the risk of potentially crippling osteoarthritis have been, if not ignored, then certainly under-estimated.
The true impact of obesity in the development of knee osteoarthritis has only recently become clear, said the charity, pointing to a study which revealed that at the most extreme, very obese people with a body mass index of 36 or more have a 14-fold higher risk of knee osteoarthritis compared to those in the healthy BMI range.
Professor Silman warned there was a real concern that unless rocketing rates of obesity were tackled, the numbers of people needing joint replacement surgery would soar, which would have a considerable impact on the NHS.
"There are two major risk factors for developing osteoarthritis - ageing and obesity - and as both these factors are on the rise in the UK, it's an obvious prediction to make that the outcome could be a massive cost to the health service," he added.
Joint replacements are more likely to fail earlier in obese patients, and the heavier the patients the less likely it is that surgery will bring about an improvement in symptoms.
Very obese women are 19 times more likely to need knee replacement and four times more likely to need hip replacement surgery compared to women of a healthy weight.
A series of studies have shown that even modest weight loss and exercise can help to reduce not only pain but also mobility and the ability to perform everyday activities.
Professor Silman's comments follow the publication of the charity's online report, Osteoarthritis and obesity, which warns the public of the hitherto little publicised dangers to their health and quality of life of obesity on their joints.
The Arthritis Research Campaign's report, Osteoarthritis and obesity, can be accessed on its website at arc.uk from July 15.
Source
Arthritis Research Campaign
However, according to Professor Alan Silman, medical director of the Arthritis Research Campaign, there is good news for the obese and overweight whose knees become painful due to osteoarthritis as a result of their weight.
"Research shows that losing weight, however modest, when combined with exercise, is a panacea at every stage," said Professor Silman.
"Achieving a healthy weight reduces the risk of developing the disease in the first place, relieves existing symptoms and helps to prevent further deterioration. And weight loss and exercise has been shown to achieve the same level of symptom relief as joint replacement surgery."
The medical research charity is concerned that while rising rates of obesity have been linked to a number of serious disorders and health concerns, the risk of potentially crippling osteoarthritis have been, if not ignored, then certainly under-estimated.
The true impact of obesity in the development of knee osteoarthritis has only recently become clear, said the charity, pointing to a study which revealed that at the most extreme, very obese people with a body mass index of 36 or more have a 14-fold higher risk of knee osteoarthritis compared to those in the healthy BMI range.
Professor Silman warned there was a real concern that unless rocketing rates of obesity were tackled, the numbers of people needing joint replacement surgery would soar, which would have a considerable impact on the NHS.
"There are two major risk factors for developing osteoarthritis - ageing and obesity - and as both these factors are on the rise in the UK, it's an obvious prediction to make that the outcome could be a massive cost to the health service," he added.
Joint replacements are more likely to fail earlier in obese patients, and the heavier the patients the less likely it is that surgery will bring about an improvement in symptoms.
Very obese women are 19 times more likely to need knee replacement and four times more likely to need hip replacement surgery compared to women of a healthy weight.
A series of studies have shown that even modest weight loss and exercise can help to reduce not only pain but also mobility and the ability to perform everyday activities.
Professor Silman's comments follow the publication of the charity's online report, Osteoarthritis and obesity, which warns the public of the hitherto little publicised dangers to their health and quality of life of obesity on their joints.
The Arthritis Research Campaign's report, Osteoarthritis and obesity, can be accessed on its website at arc.uk from July 15.
Source
Arthritis Research Campaign
Guideline For Treating Chronic Non-Cancer Pain With Opioid Medications
A national panel of pain management experts representing the American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) has published the first comprehensive, evidence-based clinical practice guideline to assist clinicians in prescribing potent opioid pain medications for patients with chronic non-cancer pain. The long-awaited guideline appears in the current issue of The Journal of Pain, jpain.
To create this guideline, researchers in the Oregon Evidence-based Practice Center (EPC) at Oregon Health & Science University collaborated with the APS and AAPM for two years, reviewing more than 8,000 published abstracts and nonpublished studies to assess clinical evidence on which the new recommendations are based.
"This guideline was a true multidisciplinary effort that sought to address in a balanced manner the many challenging issues that clinicians face with regard to when and how to prescribe opioids for chronic noncancer pain," said Roger Chou, M.D., principal investigator; director of the American Pain Society Clinical Practice Guidelines Program; scientific director of the Oregon Evidence-Based Practice Center at OHSU; and associate professor of medical informatics and clinical epidemiology, and medicine (general internal medicine and geriatrics) in the OHSU School of Medicine.
"A key part of this process was performing a comprehensive literature review to inform the recommendations - though an important take-home message is that even though the recommendations represent the best judgment of the panel based on the currently available literature, there is still a lot of research that needs to be done."
The expert panel concluded that opioid pain medications are safe and effective for carefully selected, well-monitored patients with chronic non-cancer pain. They made 25 specific recommendations and achieved unanimous consensus on nearly all.
Opioid prescribing has increased significantly due to growing professional acceptance that the drugs can relieve chronic non-cancer pain, and the guideline acknowledges there are widespread concerns about increases in prescription opioid abuse, addiction and diversion.
Opioids, such as morphine, oxycodone, oxymorphone and fentanyl are potent analgesics. They traditionally have been used to relieve pain following surgery, from cancer and at the end of life. Today opioids are used widely to relieve severe pain caused by chronic low-back injury, accident trauma, crippling arthritis, sickle cell, fibromyalgia, and other painful conditions.
Prior to initiating chronic opioid therapy, the guideline advises clinicians to determine if the pain can be treated with other medications. If opioids are appropriate, the clinician should conduct a thorough medical history and examination and assess potential risk for substance abuse, misuse or addiction.
Diligent Patient Monitoring Is Essential
A key recommendation urges clinicians to continuously assess patients on chronic opioid therapy by monitoring pain intensity, level of functioning and adherence to prescribed treatments. Periodic drug screens should be ordered for patients at risk for aberrant drug behavior.
Other recommendations in the APS/AAPM clinical practice guideline include:
Methadone: Use of methadone for pain management has increased dramatically but few trials have evaluated its benefits and harms for treatment of chronic non-cancer pain. Methadone, therefore, should be started at low doses and titrated slowly. Because of its long half-life and variable pharmacokinetics, the panel recommends methadone not be used to treat breakthrough pain or as an as-needed medication.
Abusers: Chronic opioid therapy must be discontinued in patients known to be diverting their medication or in those engaging in serious aberrant behaviors.
Breakthrough Pain: As-needed opioids can be prescribed based on initial and ongoing analysis of therapeutic benefit versus risk.
High Doses: Patients who need high doses of opioids (200 mg daily of morphine or equivalent) should be evaluated for adverse events on an ongoing basis, and clinicians should consider rotating pain medications when patients experience intolerable side effects or inadequate benefit despite appropriate dose increases.
Driving and Work Safety: Patients should be educated about the greater risk for impairment when starting chronic opioid therapy and counseled not to drive or engage in potentially dangerous work if impaired.
Pregnancy: Clinicians should counsel women about risks of opioids in pregnancy and encourage minimal or no use of chronic opioid therapy unless potential benefits outweigh risks.
The guideline on opioid therapy for chronic non-cancer pain is the first such collaboration between APS and AAPM. It is the sixth evidenced-based, pain management clinical practice guideline published by APS. Others have covered sickle-cell disease, arthritis, cancer, fibromyalgia, and low back pain.
About Oregon Health & Science University
Oregon Health & Science University is the state's only health and research university and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.
What are Opioids?
For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
Source: Tamara Hargens-Bradley
Oregon Health & Science University
View drug information on Oxycodone and Aspirin.
To create this guideline, researchers in the Oregon Evidence-based Practice Center (EPC) at Oregon Health & Science University collaborated with the APS and AAPM for two years, reviewing more than 8,000 published abstracts and nonpublished studies to assess clinical evidence on which the new recommendations are based.
"This guideline was a true multidisciplinary effort that sought to address in a balanced manner the many challenging issues that clinicians face with regard to when and how to prescribe opioids for chronic noncancer pain," said Roger Chou, M.D., principal investigator; director of the American Pain Society Clinical Practice Guidelines Program; scientific director of the Oregon Evidence-Based Practice Center at OHSU; and associate professor of medical informatics and clinical epidemiology, and medicine (general internal medicine and geriatrics) in the OHSU School of Medicine.
"A key part of this process was performing a comprehensive literature review to inform the recommendations - though an important take-home message is that even though the recommendations represent the best judgment of the panel based on the currently available literature, there is still a lot of research that needs to be done."
The expert panel concluded that opioid pain medications are safe and effective for carefully selected, well-monitored patients with chronic non-cancer pain. They made 25 specific recommendations and achieved unanimous consensus on nearly all.
Opioid prescribing has increased significantly due to growing professional acceptance that the drugs can relieve chronic non-cancer pain, and the guideline acknowledges there are widespread concerns about increases in prescription opioid abuse, addiction and diversion.
Opioids, such as morphine, oxycodone, oxymorphone and fentanyl are potent analgesics. They traditionally have been used to relieve pain following surgery, from cancer and at the end of life. Today opioids are used widely to relieve severe pain caused by chronic low-back injury, accident trauma, crippling arthritis, sickle cell, fibromyalgia, and other painful conditions.
Prior to initiating chronic opioid therapy, the guideline advises clinicians to determine if the pain can be treated with other medications. If opioids are appropriate, the clinician should conduct a thorough medical history and examination and assess potential risk for substance abuse, misuse or addiction.
Diligent Patient Monitoring Is Essential
A key recommendation urges clinicians to continuously assess patients on chronic opioid therapy by monitoring pain intensity, level of functioning and adherence to prescribed treatments. Periodic drug screens should be ordered for patients at risk for aberrant drug behavior.
Other recommendations in the APS/AAPM clinical practice guideline include:
Methadone: Use of methadone for pain management has increased dramatically but few trials have evaluated its benefits and harms for treatment of chronic non-cancer pain. Methadone, therefore, should be started at low doses and titrated slowly. Because of its long half-life and variable pharmacokinetics, the panel recommends methadone not be used to treat breakthrough pain or as an as-needed medication.
Abusers: Chronic opioid therapy must be discontinued in patients known to be diverting their medication or in those engaging in serious aberrant behaviors.
Breakthrough Pain: As-needed opioids can be prescribed based on initial and ongoing analysis of therapeutic benefit versus risk.
High Doses: Patients who need high doses of opioids (200 mg daily of morphine or equivalent) should be evaluated for adverse events on an ongoing basis, and clinicians should consider rotating pain medications when patients experience intolerable side effects or inadequate benefit despite appropriate dose increases.
Driving and Work Safety: Patients should be educated about the greater risk for impairment when starting chronic opioid therapy and counseled not to drive or engage in potentially dangerous work if impaired.
Pregnancy: Clinicians should counsel women about risks of opioids in pregnancy and encourage minimal or no use of chronic opioid therapy unless potential benefits outweigh risks.
The guideline on opioid therapy for chronic non-cancer pain is the first such collaboration between APS and AAPM. It is the sixth evidenced-based, pain management clinical practice guideline published by APS. Others have covered sickle-cell disease, arthritis, cancer, fibromyalgia, and low back pain.
About Oregon Health & Science University
Oregon Health & Science University is the state's only health and research university and Oregon's only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.
What are Opioids?
For more information on what opioids are, and opioid-induced constipation (OIC), please see:
All About Opioids and Opioid-Induced Constipation (OIC)
Source: Tamara Hargens-Bradley
Oregon Health & Science University
View drug information on Oxycodone and Aspirin.
What is the difference between Arthritis and Rheumatism?
Arthritis is a term applied to a large number of diseases which affect the joints. Rheumatism is the general name given to diseases which cause pain and stiffness of joints, bones, tendons or ligaments.
Let's take a look at Rheumatism first.
Rheumatism does not necessarily affect the joints. For example, a form of rheumatism commonly called fibrositis, is an illness usually involving your muscles. Bursitis, another form of rheumatism, is an inflammation of a small sac between your tendon and bone or between your muscles.
Arthritis, on the other hand, includes at least 25 different diseases. The most common forms are osteoarthritis (sometimes called degenerative joint disease), rheumatoid arthritis and gout. In addition to attacking joints, these illnesses may also strike neighboring structures such as muscles or even distant parts of the body such as heart, kidneys, lungs and liver.
These conditions tend to be chronic, that is, once a person has them, they are likely to last a long time and may be a source of trouble off and on all the rest of his life. The number of cases of chronic physical disability resulting from arthritis is second only to heart disease.
Osteoarthritis or degenerative joint disease is the form which often affects older people. As one gets older, the joints just wear out. This often happens along with some softening of the bones. This softening of the bones is called osteoporosis and it often affects older women.
Children also can suffer from rheumatic diseases and it is estimated about a quarter million American children have them.
Special tests are necessary to determine what type of rheumatism or arthritis a person has. Treatment then is tailored to fit the individual case.
Let's take a look at Rheumatism first.
Rheumatism does not necessarily affect the joints. For example, a form of rheumatism commonly called fibrositis, is an illness usually involving your muscles. Bursitis, another form of rheumatism, is an inflammation of a small sac between your tendon and bone or between your muscles.
Arthritis, on the other hand, includes at least 25 different diseases. The most common forms are osteoarthritis (sometimes called degenerative joint disease), rheumatoid arthritis and gout. In addition to attacking joints, these illnesses may also strike neighboring structures such as muscles or even distant parts of the body such as heart, kidneys, lungs and liver.
These conditions tend to be chronic, that is, once a person has them, they are likely to last a long time and may be a source of trouble off and on all the rest of his life. The number of cases of chronic physical disability resulting from arthritis is second only to heart disease.
Osteoarthritis or degenerative joint disease is the form which often affects older people. As one gets older, the joints just wear out. This often happens along with some softening of the bones. This softening of the bones is called osteoporosis and it often affects older women.
Children also can suffer from rheumatic diseases and it is estimated about a quarter million American children have them.
Special tests are necessary to determine what type of rheumatism or arthritis a person has. Treatment then is tailored to fit the individual case.
Potential New Test For Early Diagnosis Of Osteoarthritis Identified
Researchers at King's College London's Department of Twin Research and Genetic Epidemiology, based at St Thomas' Hospital have discovered new ways of measuring biological markers in the blood which could be used to diagnose osteoarthritis earlier.
Osteoarthritis is a condition that affects the joints and is the most common type of arthritis in the UK. It mostly occurs in the knees, hips and small joints of the hands, but almost any joint can be affected.
The new biochemical test called metabolomics allows the scientists to test for 163 chemical signals at the same time from a single blood sample. These chemical signals are intermediate products of the metabolism of human cells and their 26,000 metabolite ratios represent the rate of the chemical reactions in the human body.
The team first studied 123 white women with osteoarthritis of the knee and 299 healthy women from the Twins UK register, comparing the difference in the metabolites and the 26,000 metabolite ratios between the two groups. They found that 14 metabolite ratios were significantly associated with osteoarthritis. The team then tested these signals to see if they were replicated in an independent sample consisting of 76 women with knee arthritis and 100 healthy women. Two ratios - valine to histidine and xleucine to histidine - were successfully confirmed in the replication sample.
Dr Guangju Zhai, lead author on the paper published in the journal, Annals of Rheumatic Diseases, said: "Osteoarthritis affects an estimated 8.5 million people in the UK and one of its main characteristics is damage to cartilage, the strong smooth muscle that lines the bones and allows joints to move easily and without friction. The search for biomarkers, or traits, which can be used to measure or indicate the effects or progress of a condition is a hugely exciting area of clinical research. The two novel metabolic biomarkers found through our study could indicate increased cartilage breakdown and we now want to study these mechanisms in more detail."
Professor Tim Spector, senior author of the paper added: "Ours is the first study using a metabolomics approach to identify novel metabolic biomarkers for osteoarthritis. We hope that further research will lead to these two metabolite ratios being adopted into clinical practice, enabling doctors to diagnose the condition, or identify that osteoarthritis is developing, earlier. Our study also shows the enormous clinical potential of metabolomics, and we hope in future that they could be used to monitor the effectiveness of treatments. At the moment we relay on x-rays and scans - and our dependence on these methods is a major obstacle to the development of new drugs for osteoarthritis."
Research studies such as this underpin King's Health Partners Academic Health Sciences Centre, a pioneering collaboration between King's College London, and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts which aims to deliver medical breakthroughs to patients at the earliest opportunity.
The study was funded by the European Community Framework 7 large collaborative project grant Treat-OA, The Wellcome Trust, and Arthritis Research UK. It also received support from the NIHR comprehensive Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London.
A patent application relating to these metabolic markers being developed under this study has been filed by King's Business Limited.
Source:
Andrea Ttofa
King's College London
Osteoarthritis is a condition that affects the joints and is the most common type of arthritis in the UK. It mostly occurs in the knees, hips and small joints of the hands, but almost any joint can be affected.
The new biochemical test called metabolomics allows the scientists to test for 163 chemical signals at the same time from a single blood sample. These chemical signals are intermediate products of the metabolism of human cells and their 26,000 metabolite ratios represent the rate of the chemical reactions in the human body.
The team first studied 123 white women with osteoarthritis of the knee and 299 healthy women from the Twins UK register, comparing the difference in the metabolites and the 26,000 metabolite ratios between the two groups. They found that 14 metabolite ratios were significantly associated with osteoarthritis. The team then tested these signals to see if they were replicated in an independent sample consisting of 76 women with knee arthritis and 100 healthy women. Two ratios - valine to histidine and xleucine to histidine - were successfully confirmed in the replication sample.
Dr Guangju Zhai, lead author on the paper published in the journal, Annals of Rheumatic Diseases, said: "Osteoarthritis affects an estimated 8.5 million people in the UK and one of its main characteristics is damage to cartilage, the strong smooth muscle that lines the bones and allows joints to move easily and without friction. The search for biomarkers, or traits, which can be used to measure or indicate the effects or progress of a condition is a hugely exciting area of clinical research. The two novel metabolic biomarkers found through our study could indicate increased cartilage breakdown and we now want to study these mechanisms in more detail."
Professor Tim Spector, senior author of the paper added: "Ours is the first study using a metabolomics approach to identify novel metabolic biomarkers for osteoarthritis. We hope that further research will lead to these two metabolite ratios being adopted into clinical practice, enabling doctors to diagnose the condition, or identify that osteoarthritis is developing, earlier. Our study also shows the enormous clinical potential of metabolomics, and we hope in future that they could be used to monitor the effectiveness of treatments. At the moment we relay on x-rays and scans - and our dependence on these methods is a major obstacle to the development of new drugs for osteoarthritis."
Research studies such as this underpin King's Health Partners Academic Health Sciences Centre, a pioneering collaboration between King's College London, and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts which aims to deliver medical breakthroughs to patients at the earliest opportunity.
The study was funded by the European Community Framework 7 large collaborative project grant Treat-OA, The Wellcome Trust, and Arthritis Research UK. It also received support from the NIHR comprehensive Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London.
A patent application relating to these metabolic markers being developed under this study has been filed by King's Business Limited.
Source:
Andrea Ttofa
King's College London
An Occupational Hazard For Percussionists?
You've heard of tennis elbow and runner's knee, but how about "percussionist's wrist"? A case of overuse injury of the wrist occurring in a professional percussionist is presented in a report in the August issue of JCR: Journal of Clinical Rheumatology. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health, a leading provider of information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, and pharmacy.
Drs. Naoto Yokogawa and H. Ralph Schumacher, Jr., rheumatologists at the University of Pennsylvania, Philadelphia, describe and illustrate this unusual occupational injury.
Playing Percussion Leads to Unusual Injury
The patient was a 70-year-old man with a growing but painless mass on his left wrist. He had previously had a similar growth on the right wrist, which cleared up without treatment. The patient had no obvious recent injuries to the wrists or hands. However, he had been a professional percussionist for more than 30 years.
Both hands were stiff, with limited movement of the wrists. A sample of fluid drained from the mass on the left wrist showed no signs of infection. However, x-rays revealed a specific type of wrist deformity called scapholunate advanced collapse (SLAC), in which there is "collapse" of certain bones of the wrist joint. An MRI scan showed that the mass on the patient's hand was caused by tenosynovitis inflammation of the tissues surrounding the wrist tendons.
Tenosynovitis and arthritis of the hands are common problems in percussionists. The SLAC wrist is a common form of arthritis in the wrist, caused by trauma, manual labor, or other causes. When painful, surgery may be needed to correct the wrist deformity.
However, as in the reported patient, the SLAC wrist deformity may be painless, in which case surgery is usually unnecessary. Drs. Yokogawa and Schumacher believe this case of "percussionist's wrist" was an overuse injury similar to elbow tendinitis occurring in tennis players or knee or other leg problems developing in runners. They think that repeated "microtrauma," caused damage to the wrist ligaments over time, eventually leading to the SLAC wrist deformity.
Source: Lippincott Williams & Wilkins
Drs. Naoto Yokogawa and H. Ralph Schumacher, Jr., rheumatologists at the University of Pennsylvania, Philadelphia, describe and illustrate this unusual occupational injury.
Playing Percussion Leads to Unusual Injury
The patient was a 70-year-old man with a growing but painless mass on his left wrist. He had previously had a similar growth on the right wrist, which cleared up without treatment. The patient had no obvious recent injuries to the wrists or hands. However, he had been a professional percussionist for more than 30 years.
Both hands were stiff, with limited movement of the wrists. A sample of fluid drained from the mass on the left wrist showed no signs of infection. However, x-rays revealed a specific type of wrist deformity called scapholunate advanced collapse (SLAC), in which there is "collapse" of certain bones of the wrist joint. An MRI scan showed that the mass on the patient's hand was caused by tenosynovitis inflammation of the tissues surrounding the wrist tendons.
Tenosynovitis and arthritis of the hands are common problems in percussionists. The SLAC wrist is a common form of arthritis in the wrist, caused by trauma, manual labor, or other causes. When painful, surgery may be needed to correct the wrist deformity.
However, as in the reported patient, the SLAC wrist deformity may be painless, in which case surgery is usually unnecessary. Drs. Yokogawa and Schumacher believe this case of "percussionist's wrist" was an overuse injury similar to elbow tendinitis occurring in tennis players or knee or other leg problems developing in runners. They think that repeated "microtrauma," caused damage to the wrist ligaments over time, eventually leading to the SLAC wrist deformity.
Source: Lippincott Williams & Wilkins
Acupuncture Improved Knee Pain, But Sham Acupuncture Did Too
In a study of 1,007 patients with osteoarthritis knee pain, both acupuncture and sham acupuncture improved knee pain compared with standard treatment of doctor visits and anti-inflammatory drugs (Article, p. 12).
About 53 percent of the acupuncture group said they had less pain and better function at 26 weeks, compared to 51 percent of the sham acupuncture group and 29.1 percent of the no-acupuncture group.
All participants could receive six physical therapy treatments and could take anti-inflammatory medications as needed.
Authors say the study supports using acupuncture in "multimodal treatment" of patients with knee osteoarthritis, "even if the mechanisms of its effects remain unclear."
Annals of Internal Medicine Tip Sheet for July 4, 2006
Contact: Susan Anderson
American College of Physicians
About 53 percent of the acupuncture group said they had less pain and better function at 26 weeks, compared to 51 percent of the sham acupuncture group and 29.1 percent of the no-acupuncture group.
All participants could receive six physical therapy treatments and could take anti-inflammatory medications as needed.
Authors say the study supports using acupuncture in "multimodal treatment" of patients with knee osteoarthritis, "even if the mechanisms of its effects remain unclear."
Annals of Internal Medicine Tip Sheet for July 4, 2006
Contact: Susan Anderson
American College of Physicians
A Phase IIb Study Testing The Combination Of Methotrexate And CF101 In Rheumatoid Arthritis Patients Failed To Achieve Primary Efficacy Endpoint
Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced that top line results from its Phase IIb study in rheumatoid arthritis (RA) patients indicate that the study failed to achieve its primary efficacy endpoint.
The Phase IIb RA study enrolled 230 patients in 21 sites in Europe and in Israel. The patients were randomized into 3 groups treated, twice daily, orally, with 0.1 mg or 1 mg of CF101, or placebo. In this study CF101 was given for 12 weeks to patients who were also treated concomitantly with methotrexate.
The primary efficacy endpoint of the study was an ACR20 response. Top level results indicated that there was no statistically significant difference between the groups that received CF101 and the placebo group. Detailed review of the data is ongoing.
CF101 is undergoing two other Phase II clinical studies, one in dry eye (keratoconjunctivitis sicca-KCS) and the other in psoriasis. In distinction from the rheumatoid arthritis study, where CF101 was administered to patients in combination with methotrexate, in the dry eye and the psoriasis studies CF101 is given to patients as monotherapy.
Dr. Pnina Fishman, Can-Fite's CEO, stated that "although the results are disappointing, they are nonetheless a very important milestone in the development of CF101. The lesson to be learned from the Phase IIb RA study is that CF101 will likely not work in combination with methotrexate and the focus should thus be on stand-alone therapeutic uses. In addition to the ongoing Phase II studies in KCS and psoriasis, we have plans to also conduct clinical studies in other indications in which CF101 will be given as a single drug by itself and not in combination. The excellent safety profile and other attributes continue to render CF101 a highly attractive drug candidate."
The company also continues to develop of another drug, CF102. Two Phase I/II studies, one in patients with primary liver cancer (hepatocellular carcinoma) and one in patients with hepatitis C virus infection, are about to begin shortly in Israel.
Source
Can-Fite Biopharma LTD
The Phase IIb RA study enrolled 230 patients in 21 sites in Europe and in Israel. The patients were randomized into 3 groups treated, twice daily, orally, with 0.1 mg or 1 mg of CF101, or placebo. In this study CF101 was given for 12 weeks to patients who were also treated concomitantly with methotrexate.
The primary efficacy endpoint of the study was an ACR20 response. Top level results indicated that there was no statistically significant difference between the groups that received CF101 and the placebo group. Detailed review of the data is ongoing.
CF101 is undergoing two other Phase II clinical studies, one in dry eye (keratoconjunctivitis sicca-KCS) and the other in psoriasis. In distinction from the rheumatoid arthritis study, where CF101 was administered to patients in combination with methotrexate, in the dry eye and the psoriasis studies CF101 is given to patients as monotherapy.
Dr. Pnina Fishman, Can-Fite's CEO, stated that "although the results are disappointing, they are nonetheless a very important milestone in the development of CF101. The lesson to be learned from the Phase IIb RA study is that CF101 will likely not work in combination with methotrexate and the focus should thus be on stand-alone therapeutic uses. In addition to the ongoing Phase II studies in KCS and psoriasis, we have plans to also conduct clinical studies in other indications in which CF101 will be given as a single drug by itself and not in combination. The excellent safety profile and other attributes continue to render CF101 a highly attractive drug candidate."
The company also continues to develop of another drug, CF102. Two Phase I/II studies, one in patients with primary liver cancer (hepatocellular carcinoma) and one in patients with hepatitis C virus infection, are about to begin shortly in Israel.
Source
Can-Fite Biopharma LTD
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