New data, presented today at the Annual European Congress of Rheumatology show for the first time that a rheumatoid arthritis (RA) treatment, rituximab, is able to significantly inhibit the structural damage to joints caused by RA in patients who have long-standing disease and an inadequate response to one or more TNF (Tumour Necrosis Factor) inhibitors.
Prevention of joint structural damage in rheumatoid arthritis is a critical therapeutic outcome. Many patients respond well to the TNF inhibitors, a relatively new class of therapy which prevents TNF protein causing inflammation in rheumatoid arthritis, however approximately 30% - 40% of patients treated with this therapy experience either an inadequate response or are intolerant to such therapies. As such, the study was designed to investigate the effect at 1 year of rituximab (a new therapy targeting B-cells - cells which create abnormal antibodies causing rheumatoid arthritis symptoms) plus methotrexate (an antimetabolite drug which inhibits the synthesis of DNA, RNA and protein, previously the gold standard in the treatment of rheumatoid arthritis) on joint structural damage, compared to methotrexate alone in rheumatoid patients with inadequate response to one or more TNF inhibitors.
The results reveal bone erosions in patients in the rituximab group were reduced by over half during the course of a year compared to patients receiving placebo (erosion scores of 0.59 and 1.32 respectively), as were the narrowing of joint spaces (scores of 0.41 and 0.99 respectively). In addition the proportion of patients with no change in erosion score was significantly higher in the rituximab group compared to placebo.
"These findings suggest that treatment with rituximab plus methotrexate is associated with significant inhibition of joint structural damage, an important finding in patients who do not currently respond to other treatments" explained Professor Edward Keystone, Rheumatology Department at the University of Toronto, Canada, one of the studies principle investigators. "Stopping joint damage indicates that the disease pathway has been interrupted, a goal we strive for in the treatment of rheumatoid arthritis. As such, today's results have the potential to offer many patients a new hope".
Jim Baxter - Onsite tel: +44 (0) 7900 605652
Jo Spadaccino - Onsite tel: +44 (0) 7773 271930
Mia Gannedahl - Office tel: +44 (0) 20 7331 2325
Abstract number: OP0016
About EULAR
* The European League Against Rheumatism (EULAR) is the organization which represents the patient, health professional and scientific societies of rheumatology of all the European nations.
* The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with musculoskeletal diseases by the governing bodies in Europe.
* Diseases of bones and joints, such as rheumatoid arthritis and osteoarthritis cause disability in 4 - 5 % of the adult population and are predicted to rise as people live longer.
* As new treatments emerge and cellular mechanisms are discovered, the 7th Annual European Congress of Rheumatology in Amsterdam (EULAR 2006) brings together more than 10,000 experts - scientists, clinicians, healthcare workers, pharmaceutical companies and patients - to share their knowledge in a global endeavour to challenge the pain and disability caused by musculo-skeletal disorders.
* To find out more information about the activities of EULAR, visit: eular/.
Contact: Mia Gannedahl
European League Against Rheumatism
среда, 26 октября 2011 г.
воскресенье, 23 октября 2011 г.
Treating Gum Disease Helps Rheumatoid Arthritis Sufferers
Not yet convinced about keeping your healthy teeth, here's another reason.
People, who suffer from gum disease and also have a severe form of rheumatoid arthritis, reduced their arthritic pain, number of swollen joints and the degree of morning stiffness when they cured their dental problems. Researchers from the Case Western Reserve University School of Dental Medicine and University Hospitals of Cleveland reported on this new intervention for arthritis in the Journal of Periodontology.
"It was exciting to find that if we eliminated the infection and inflammation in the gums, then patients with a severe kind of active rheumatoid arthritis reported improvement on the signs and symptoms of that disease," said Nabil Bissada, D.D.S., chair of the department of periodontics at the dental school.
"It gives us a new intervention," adds Bissada.
This is not the first time that gum disease and rheumatoid arthritis have been linked. According to another researcher in the study, Ali Askari, M.D., chair of the department of rheumatology at University Hospitals, "From way back, rheumatologists and other clinicians have been perplexed by the myth that gum disease may have a big role in causing systematic disease."
He added that historically teeth were pulled or antibiotics given for treatment of rheumatoid arthritis, which actually treated the periodontitis. The patients got better.
Askari and Bissada are part of a team of researchers that studied 40 patients with moderate to severe periodontal disease and a severe form of rheumatoid arthritis.
The study results should prompt rheumatologists to encourage their patients to be aware of the link between periodontal disease and rheumatoid arthritis, says Askari.
Bissada notes that gum disease tends to be prevalent in rheumatoid arthritis patients.
Both inflammatory diseases share similarities in the progression of the disease over time. In both diseases, the soft and hard tissues are destroyed from inflammation caused by toxins from bacterial infection.
One toxin from the inflamed areas called tumor neurosis factor-alpha (TNF-?±) is a marker present in the blood when inflammation is present in the body. TNF-?± can initiate new infections or aggravate sites where inflammation already exists.
The study's participants were divided into four groups. Two groups of patients were receiving a new group of anti-TNF-?± drugs that block the production of TNF-?± at inflamed rheumatoid arthritis sites. Two groups were not on this new medication. Half of group of the participant on the medication and half not receiving the new drug received a standard nonsurgical form of periodontal treatment to clean and remove the infection from the bones and tissues in the gum areas. The other half of those studied did not receive the treatment until after completion of the study.
After receiving treatment for the gum disease, improvement in rheumatoid arthritis symptoms was seen in patients who did and did not receive the anti-TNF-?± medications, which block the production of TNF-?± that aggravate or can cause inflammation. Patients on the TNF- ?± inhibitors showed even greater improvements over those not receiving the drugs.
"I'm optimistic that someday the biologic agents that we use successfully in treatment of rheumatoid arthritis will lead to improvement of periodontitis and would be available for use and treatment of this perplexing problem," says Askari.
"Again we are seeing another link where good oral health improves the overall health of an individual," says Bissada, who adds that studies have linked gum disease to premature births, heart disease and diabetes.
Other researchers contributing to findings in the article, "Periodontal Therapy Reduces the Severity of Active Rheumatoid Arthritis in Patients Treated with or Without Tumor Necrosis Factor Inhibitors," were P. Ortiz, Yiping Han, Leena Palomo, and Ashok Panneerselvam from Case Western Reserve University; and M.S. Al-Zahrani from King Abdulaziz University.
Case Western Reserve University is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case Western Reserve is distinguished by its strengths in education, research, service, and experiential learning. Located in Cleveland, Case Western Reserve offers nationally recognized programs in the Arts and Sciences, Dental Medicine, Engineering, Law, Management, Medicine, Nursing, and Social Work.
Source: Case Western Reserve University
People, who suffer from gum disease and also have a severe form of rheumatoid arthritis, reduced their arthritic pain, number of swollen joints and the degree of morning stiffness when they cured their dental problems. Researchers from the Case Western Reserve University School of Dental Medicine and University Hospitals of Cleveland reported on this new intervention for arthritis in the Journal of Periodontology.
"It was exciting to find that if we eliminated the infection and inflammation in the gums, then patients with a severe kind of active rheumatoid arthritis reported improvement on the signs and symptoms of that disease," said Nabil Bissada, D.D.S., chair of the department of periodontics at the dental school.
"It gives us a new intervention," adds Bissada.
This is not the first time that gum disease and rheumatoid arthritis have been linked. According to another researcher in the study, Ali Askari, M.D., chair of the department of rheumatology at University Hospitals, "From way back, rheumatologists and other clinicians have been perplexed by the myth that gum disease may have a big role in causing systematic disease."
He added that historically teeth were pulled or antibiotics given for treatment of rheumatoid arthritis, which actually treated the periodontitis. The patients got better.
Askari and Bissada are part of a team of researchers that studied 40 patients with moderate to severe periodontal disease and a severe form of rheumatoid arthritis.
The study results should prompt rheumatologists to encourage their patients to be aware of the link between periodontal disease and rheumatoid arthritis, says Askari.
Bissada notes that gum disease tends to be prevalent in rheumatoid arthritis patients.
Both inflammatory diseases share similarities in the progression of the disease over time. In both diseases, the soft and hard tissues are destroyed from inflammation caused by toxins from bacterial infection.
One toxin from the inflamed areas called tumor neurosis factor-alpha (TNF-?±) is a marker present in the blood when inflammation is present in the body. TNF-?± can initiate new infections or aggravate sites where inflammation already exists.
The study's participants were divided into four groups. Two groups of patients were receiving a new group of anti-TNF-?± drugs that block the production of TNF-?± at inflamed rheumatoid arthritis sites. Two groups were not on this new medication. Half of group of the participant on the medication and half not receiving the new drug received a standard nonsurgical form of periodontal treatment to clean and remove the infection from the bones and tissues in the gum areas. The other half of those studied did not receive the treatment until after completion of the study.
After receiving treatment for the gum disease, improvement in rheumatoid arthritis symptoms was seen in patients who did and did not receive the anti-TNF-?± medications, which block the production of TNF-?± that aggravate or can cause inflammation. Patients on the TNF- ?± inhibitors showed even greater improvements over those not receiving the drugs.
"I'm optimistic that someday the biologic agents that we use successfully in treatment of rheumatoid arthritis will lead to improvement of periodontitis and would be available for use and treatment of this perplexing problem," says Askari.
"Again we are seeing another link where good oral health improves the overall health of an individual," says Bissada, who adds that studies have linked gum disease to premature births, heart disease and diabetes.
Other researchers contributing to findings in the article, "Periodontal Therapy Reduces the Severity of Active Rheumatoid Arthritis in Patients Treated with or Without Tumor Necrosis Factor Inhibitors," were P. Ortiz, Yiping Han, Leena Palomo, and Ashok Panneerselvam from Case Western Reserve University; and M.S. Al-Zahrani from King Abdulaziz University.
Case Western Reserve University is among the nation's leading research institutions. Founded in 1826 and shaped by the unique merger of the Case Institute of Technology and Western Reserve University, Case Western Reserve is distinguished by its strengths in education, research, service, and experiential learning. Located in Cleveland, Case Western Reserve offers nationally recognized programs in the Arts and Sciences, Dental Medicine, Engineering, Law, Management, Medicine, Nursing, and Social Work.
Source: Case Western Reserve University
четверг, 20 октября 2011 г.
Rigel Announces Initiation Of Phase 1 Clinical Trial Of R348 For Rheumatoid Arthritis, Psoriasis And Other Immune Disorders
Rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that it has begun
enrolling patients in a Phase 1 study to evaluate the safety and
tolerability of R348, an orally available, potent inhibitor of Janus Kinase
3 (JAK3), as a potential treatment for patients with rheumatoid arthritis
(RA), psoriasis and other immune disorders. In preclinical studies, R348
was shown to be effective in reducing arthritic symptoms, bone destruction
and swelling. It has also shown efficacy in models of psoriasis and
transplant rejection. This is Rigel's fourth novel product candidate in
clinical trials.
"R348 enters the clinic at a time when Rigel's product portfolio is
demonstrating its potential contribution to the field of immunology," said
Donald G. Payan, M.D., executive vice president and chief scientific
officer at Rigel. "With R348 targeting T-cells and our oral syk kinase
inhibitor, R788, targeting B-cells and other immune cells, Rigel has
mounted a comprehensive assault on autoimmune disorders," he added.
This study will evaluate the safety and pharmacokinetics of R348 in
young, healthy males using a double blind, placebo controlled, single dose
and multiple rising doses of R348. Results are expected in mid-2008.
JAK3 in RA and Other Immune Disorders
RA affects approximately 1% of the population worldwide --
approximately 2.1 million Americans -- and is a debilitating and
degenerative autoimmune disease. Psoriasis affects approximately 7.5
million in the U.S. and an estimated 125 million worldwide, and is a
lifelong skin disease. About 10-30% of patients with psoriasis also develop
psoriatic arthritis, which causes pain, swelling and stiffness of the
joints. These diseases are mediated by activated T-cells, which rely on
JAK3 signaling.
Current treatments for these diseases include steroids, methotrexate
and various injectable biologic agents. Rigel's product candidate, R348, is
believed to be orally bio-available and may provide an attractive
alternative or supplement to currently used agents.
R348 is also being studied as a potential treatment for transplant
rejection and graft vs. host disease.
About Rigel
Rigel is a clinical-stage drug development company that discovers and
develops novel, small-molecule drugs for the treatment of
inflammatory/autoimmune diseases and cancer, as well as viral and metabolic
diseases. Our goal is to file one new investigational new drug (IND)
application in a significant indication each year. Rigel has achieved this
goal every year since 2002. Our pioneering research focuses on
intracellular signaling pathways and related targets that are critical to
disease mechanisms. Rigel's productivity has resulted in strategic
collaborations with large pharmaceutical partners to develop and market our
product candidates. Rigel has product development programs in
inflammatory/autoimmune diseases such as rheumatoid arthritis,
thrombocytopenia and asthma, as well as in cancer.
This press release contains "forward-looking" statements, including
statements related to the potential efficacy and commercial potential of
R348 and Rigel's plans to pursue further clinical development thereof. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements. Words such
as "believes," "plans," "potential," and similar expressions are intended
to identify these forward-looking statements. There are a number of
important factors that could cause Rigel's results to differ materially
from those indicated by these forward-looking statements, including risks
associated with the timing and success of clinical trials and the
commercialization of product candidates, potential problems that may arise
in the clinical testing and approval process and Rigel's need for
additional capital, as well as other risks detailed from time to time in
Rigel's SEC reports, including its Form 10-Q for the quarter ended
September 30, 2007. Rigel does not undertake any obligation to update
forward-looking statements.
Rigel Pharmaceuticals, Inc.
rigel
Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that it has begun
enrolling patients in a Phase 1 study to evaluate the safety and
tolerability of R348, an orally available, potent inhibitor of Janus Kinase
3 (JAK3), as a potential treatment for patients with rheumatoid arthritis
(RA), psoriasis and other immune disorders. In preclinical studies, R348
was shown to be effective in reducing arthritic symptoms, bone destruction
and swelling. It has also shown efficacy in models of psoriasis and
transplant rejection. This is Rigel's fourth novel product candidate in
clinical trials.
"R348 enters the clinic at a time when Rigel's product portfolio is
demonstrating its potential contribution to the field of immunology," said
Donald G. Payan, M.D., executive vice president and chief scientific
officer at Rigel. "With R348 targeting T-cells and our oral syk kinase
inhibitor, R788, targeting B-cells and other immune cells, Rigel has
mounted a comprehensive assault on autoimmune disorders," he added.
This study will evaluate the safety and pharmacokinetics of R348 in
young, healthy males using a double blind, placebo controlled, single dose
and multiple rising doses of R348. Results are expected in mid-2008.
JAK3 in RA and Other Immune Disorders
RA affects approximately 1% of the population worldwide --
approximately 2.1 million Americans -- and is a debilitating and
degenerative autoimmune disease. Psoriasis affects approximately 7.5
million in the U.S. and an estimated 125 million worldwide, and is a
lifelong skin disease. About 10-30% of patients with psoriasis also develop
psoriatic arthritis, which causes pain, swelling and stiffness of the
joints. These diseases are mediated by activated T-cells, which rely on
JAK3 signaling.
Current treatments for these diseases include steroids, methotrexate
and various injectable biologic agents. Rigel's product candidate, R348, is
believed to be orally bio-available and may provide an attractive
alternative or supplement to currently used agents.
R348 is also being studied as a potential treatment for transplant
rejection and graft vs. host disease.
About Rigel
Rigel is a clinical-stage drug development company that discovers and
develops novel, small-molecule drugs for the treatment of
inflammatory/autoimmune diseases and cancer, as well as viral and metabolic
diseases. Our goal is to file one new investigational new drug (IND)
application in a significant indication each year. Rigel has achieved this
goal every year since 2002. Our pioneering research focuses on
intracellular signaling pathways and related targets that are critical to
disease mechanisms. Rigel's productivity has resulted in strategic
collaborations with large pharmaceutical partners to develop and market our
product candidates. Rigel has product development programs in
inflammatory/autoimmune diseases such as rheumatoid arthritis,
thrombocytopenia and asthma, as well as in cancer.
This press release contains "forward-looking" statements, including
statements related to the potential efficacy and commercial potential of
R348 and Rigel's plans to pursue further clinical development thereof. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements. Words such
as "believes," "plans," "potential," and similar expressions are intended
to identify these forward-looking statements. There are a number of
important factors that could cause Rigel's results to differ materially
from those indicated by these forward-looking statements, including risks
associated with the timing and success of clinical trials and the
commercialization of product candidates, potential problems that may arise
in the clinical testing and approval process and Rigel's need for
additional capital, as well as other risks detailed from time to time in
Rigel's SEC reports, including its Form 10-Q for the quarter ended
September 30, 2007. Rigel does not undertake any obligation to update
forward-looking statements.
Rigel Pharmaceuticals, Inc.
rigel
понедельник, 17 октября 2011 г.
ArGentis Acquires Rights To Rheumatoid Arthritis Therapy Entering Phase I Clinical Trial
arGentis Pharmaceuticals, LLC announced that it will collaborate with the University of Tennessee Health Science Center (UTHSC) and the Veterans Affairs Medical Center of Memphis (VAMC) to initiate the first human clinical evaluation of an oral altered peptide ligand (APL), ARG301, in a Phase I study of Rheumatoid Arthritis patients. ARG301 is a synthetic peptide, which in animal studies appears to down regulate autoimmunity to Type II collagen (CII), a known autoantigen in RA. Investigators at the UTHSC and Memphis VAMC developed the therapy and have received a Clinical Merit Review Grant from the Department of Veterans Affairs to conduct the trial.
"Due to its unique mechanism of action and compelling preclinical data, we are hopeful that ARG301 will offer a novel therapeutic approach for rheumatoid arthritis," said Tom I. Davis, II, Chief Executive Officer of arGentis. "In continuing our partnership with UTHSC and University of Tennessee Research Foundation, arGentis is very pleased to add this promising oral therapeutic consistent with our autoimmunity R&D approach."
Research in animal models suggests APLs (Altered Peptide Ligands) are effective in preventing and ameliorating tissue-specific autoimmune diseases. Trials of APLs administered intravenously or subcutaneously in human autoimmune disease have had mixed results. None of these trials, however, incorporated a pre-selection step to test the ability in vitro of the APL, to down regulate Th1 response by patient's peripheral blood mononuclear cells (PBMC) stimulated by a disease-specific autoantigen such as CII in RA patients.
In preclinical testing, mice susceptible to Collagen Induced Arthritis (CIA) bear a transgene for the human RA MHC susceptibility genes, DR1 or DR4. These mice appear to be resistant to CIA after oral administration of ARG301. Although the precise mechanism by which the specific peptide comprising ARG301 exerts its effect is not yet clear, the interaction of the APL/MHC complex with the TCR appears to play a key role in influencing the differentiation of naive T cells into effector cells.
Based on the experience in animals, oral administration of APLs to preselected "in vitro" responders should provide a nontoxic and highly defined therapy for humans with tissue-specific autoimmune diseases such as RA.
42 RA patients will be enrolled a Phase I Trial at the Memphis VAMC which will evaluate multiple ascending doses of ARG301 to be administered orally. The primary objectives of the trial will be to determine if one or more of the three doses of ARG301 given to Rheumatoid Arthritis patients will generate functional T regulatory cells and decrease immune reactivity to CII. The study will have 3 ARG301 treatment arms, each with 10 patients and a placebo arm of 12 patients. Patients will be enrolled who have demonstrated T cell immunity to CII and have an in vitro response to ARG301 at the screening visit. Patients will be randomized to one of the 4 arms, and each of the 3 ARG301 and placebo treatments will be given for 16 weeks.
About ARG301
The altered peptide ligand ARG301 is an oligopeptide derived from human CII sequence with substituted amino acids that binds to the MHC class II and interacts with the T cell receptor. ARG301 acts to change the cytokine profile from Th1 to Th2. Preclinically, DR1 or DR4 transgenic mice treated with oral or parenterally administered ARG301 were protected from arthritis induced by CII immunization. Short term toxicity studies using 100x the maximal human dose of ARG301 on a weight basis in mice did not cause any detectable toxicity. ARG301 is anticipated to have an exceptionally good safety profile in the clinic. To prove concept, ARG301 will eventually be evaluated in a broader trial of Rheumatoid Arthritis patients.
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints and is the most common form of inflammatory arthritis. RA most often affects the smaller joints, such as those of the hands and/or feet, wrists, elbows, knees, and/or ankles. The cause of RA is not known but usually develops between 30 and 50 years of age. Although there is no cure for RA, the disease can be controlled in most people. Early, aggressive therapy to stop or slow down inflammation in the joints can prevent or reduce symptoms, joint destruction and deformity.
RA has a significant impact on both individual lives and society, including:
- According to the Centers for Disease Control and Prevention (CDC), arthritis and other rheumatic conditions are the leading cause of disability in the U.S.,
- 3 million RA sufferers in the U.S.,
- 2.2 million are women,
- U.S. incidence expected to increase to 5.8 million in the U.S. by 2013,
- According to Johns Hopkins, disability is higher among patients with rheumatoid arthritis, with 60 percent being unable to work 10 years after disease onset,
- People with rheumatoid arthritis have an increased risk of mortality or death rate compared to the general population, living 10-15 years less than healthy counterparts.
About Veterans Affairs Medical Center
The Department of Veterans Affairs Medical Center is affiliated with the University of Tennessee Health Science Center. Since 1922, the Memphis VAMC has been improving the health of the men and women who have so proudly served our nation with services available to more than 196,000 veterans living in a 53-county area of western Tennessee, northern Mississippi and northwest Arkansas.
Source
arGentis Pharmaceuticals
"Due to its unique mechanism of action and compelling preclinical data, we are hopeful that ARG301 will offer a novel therapeutic approach for rheumatoid arthritis," said Tom I. Davis, II, Chief Executive Officer of arGentis. "In continuing our partnership with UTHSC and University of Tennessee Research Foundation, arGentis is very pleased to add this promising oral therapeutic consistent with our autoimmunity R&D approach."
Research in animal models suggests APLs (Altered Peptide Ligands) are effective in preventing and ameliorating tissue-specific autoimmune diseases. Trials of APLs administered intravenously or subcutaneously in human autoimmune disease have had mixed results. None of these trials, however, incorporated a pre-selection step to test the ability in vitro of the APL, to down regulate Th1 response by patient's peripheral blood mononuclear cells (PBMC) stimulated by a disease-specific autoantigen such as CII in RA patients.
In preclinical testing, mice susceptible to Collagen Induced Arthritis (CIA) bear a transgene for the human RA MHC susceptibility genes, DR1 or DR4. These mice appear to be resistant to CIA after oral administration of ARG301. Although the precise mechanism by which the specific peptide comprising ARG301 exerts its effect is not yet clear, the interaction of the APL/MHC complex with the TCR appears to play a key role in influencing the differentiation of naive T cells into effector cells.
Based on the experience in animals, oral administration of APLs to preselected "in vitro" responders should provide a nontoxic and highly defined therapy for humans with tissue-specific autoimmune diseases such as RA.
42 RA patients will be enrolled a Phase I Trial at the Memphis VAMC which will evaluate multiple ascending doses of ARG301 to be administered orally. The primary objectives of the trial will be to determine if one or more of the three doses of ARG301 given to Rheumatoid Arthritis patients will generate functional T regulatory cells and decrease immune reactivity to CII. The study will have 3 ARG301 treatment arms, each with 10 patients and a placebo arm of 12 patients. Patients will be enrolled who have demonstrated T cell immunity to CII and have an in vitro response to ARG301 at the screening visit. Patients will be randomized to one of the 4 arms, and each of the 3 ARG301 and placebo treatments will be given for 16 weeks.
About ARG301
The altered peptide ligand ARG301 is an oligopeptide derived from human CII sequence with substituted amino acids that binds to the MHC class II and interacts with the T cell receptor. ARG301 acts to change the cytokine profile from Th1 to Th2. Preclinically, DR1 or DR4 transgenic mice treated with oral or parenterally administered ARG301 were protected from arthritis induced by CII immunization. Short term toxicity studies using 100x the maximal human dose of ARG301 on a weight basis in mice did not cause any detectable toxicity. ARG301 is anticipated to have an exceptionally good safety profile in the clinic. To prove concept, ARG301 will eventually be evaluated in a broader trial of Rheumatoid Arthritis patients.
About Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints and is the most common form of inflammatory arthritis. RA most often affects the smaller joints, such as those of the hands and/or feet, wrists, elbows, knees, and/or ankles. The cause of RA is not known but usually develops between 30 and 50 years of age. Although there is no cure for RA, the disease can be controlled in most people. Early, aggressive therapy to stop or slow down inflammation in the joints can prevent or reduce symptoms, joint destruction and deformity.
RA has a significant impact on both individual lives and society, including:
- According to the Centers for Disease Control and Prevention (CDC), arthritis and other rheumatic conditions are the leading cause of disability in the U.S.,
- 3 million RA sufferers in the U.S.,
- 2.2 million are women,
- U.S. incidence expected to increase to 5.8 million in the U.S. by 2013,
- According to Johns Hopkins, disability is higher among patients with rheumatoid arthritis, with 60 percent being unable to work 10 years after disease onset,
- People with rheumatoid arthritis have an increased risk of mortality or death rate compared to the general population, living 10-15 years less than healthy counterparts.
About Veterans Affairs Medical Center
The Department of Veterans Affairs Medical Center is affiliated with the University of Tennessee Health Science Center. Since 1922, the Memphis VAMC has been improving the health of the men and women who have so proudly served our nation with services available to more than 196,000 veterans living in a 53-county area of western Tennessee, northern Mississippi and northwest Arkansas.
Source
arGentis Pharmaceuticals
пятница, 14 октября 2011 г.
Arthritis Care Chief Executive Appointed As 'Patient And Public Champion', UK
The first 'Patient and Public Champion' to monitor NHS efforts to reach the Government's target of reducing waiting times to 18 weeks has been announced by health minister, Andy Burnham.
Neil Betteridge, chief executive of Arthritis Care will take up the appointment from today (4 May 2007). He will work closely with ministers and the NHS to ensure that patients are at the centre of the 18 week pledge. Mr Betteridge will highlight their needs as reforms to meet the target are implemented across England. He will also consult with patients and the public, and encourage them to influence the reforms locally.
The Government has pledged that, by a deadline of December 2008, all patients can expect to start their treatment within 18 weeks of referral.
Announcing the appointment, the health minister said:
"Our commitment to improving the NHS means that by 2008 all patients will be assured of faster treatment. Not simply another target, 18 weeks captures the whole patient journey - from referral to start of treatment - with many patients seen even more quickly than that.
"This will be a major achievement for the NHS, making it more streamlined and productive as well as leading to a much better experience for patients - and helps change people's lives by improving care and cutting unnecessary delays.
"I'm delighted to appoint Neil Betteridge as patient champion for this important policy. He has an outstanding track record of speaking up for patients and his appointment underlines how we want the NHS transformed into a truly patient led service."
Mr Betteridge said:
"I'm delighted to be asked to take up this important role on behalf of all patients. This is a once in a lifetime opportunity for patients and the public to help shape the future delivery of services.
As the NHS changes, it is crucial that patients are right at the heart of any improvements. My role will be to keep the focus on people not just the target.
Currently many people with long term conditions, such as arthritis, are in long queues and the wrong queues. For the first time in nearly 60 years, this initiative will perhaps bring an end to waiting in the NHS" said Mr Betteridge.
Neil Betteridge biography
Neil developed rheumatoid arthritis at the age of 3, which had a major impact on his life for the next ten years or so and continues to inform all his work.
Growing up in Nuneaton, Warwickshire, Neil battled through years of intensive physiotherapy and hydrotherapy and was one of the lucky few with severe arthritis to regain much of his mobility. He progressed from being a wheelchair user at age 6 to being appointed captain of the school football team at age 11.
Neil studied and taught at Liverpool University for most of the 1980s. Whilst completing his M Phil on the work of T. S. Eliot he became a trustee at Toxteth Victim Support and subsequently took up a paid position with Liverpool Children's Holiday Organisation. Within one year he was made Director of the organisation.
Following a brief spell teaching in Italy, Neil has since worked as a public policy specialist and campaigner on arthritis and pan-disability issues.
Formerly Head of Public Policy and Campaigning at RADAR (Royal Association of Disability and Rehabilitation), he is now Chief Executive at Arthritis Care. He is additionally Chair of ARMA, the umbrella group for arthritis in the UK and it lead for all of their lobbying work for the EU and European Parliament; Chair of the UK government's Disabled Persons Transport Advisory Committee (DPTAC); and a member of the Commission for Integrated Transport.
He was, until recently, Chair of the PARE Manifesto, the European campaigns network of arthritis patient groups and he has recently completed 4 years as Vice President of EULAR (European League Against Rheumatism) as well as a 3 year term of office as a trustee with the Long Term Medical Conditions Alliance.
Throughout 2004 and 2005 Neil served as a 'patient advisor' on the steering group of the Department for Health-sponsored Musculoskeletal Services Framework.
arthritiscare.uk
Neil Betteridge, chief executive of Arthritis Care will take up the appointment from today (4 May 2007). He will work closely with ministers and the NHS to ensure that patients are at the centre of the 18 week pledge. Mr Betteridge will highlight their needs as reforms to meet the target are implemented across England. He will also consult with patients and the public, and encourage them to influence the reforms locally.
The Government has pledged that, by a deadline of December 2008, all patients can expect to start their treatment within 18 weeks of referral.
Announcing the appointment, the health minister said:
"Our commitment to improving the NHS means that by 2008 all patients will be assured of faster treatment. Not simply another target, 18 weeks captures the whole patient journey - from referral to start of treatment - with many patients seen even more quickly than that.
"This will be a major achievement for the NHS, making it more streamlined and productive as well as leading to a much better experience for patients - and helps change people's lives by improving care and cutting unnecessary delays.
"I'm delighted to appoint Neil Betteridge as patient champion for this important policy. He has an outstanding track record of speaking up for patients and his appointment underlines how we want the NHS transformed into a truly patient led service."
Mr Betteridge said:
"I'm delighted to be asked to take up this important role on behalf of all patients. This is a once in a lifetime opportunity for patients and the public to help shape the future delivery of services.
As the NHS changes, it is crucial that patients are right at the heart of any improvements. My role will be to keep the focus on people not just the target.
Currently many people with long term conditions, such as arthritis, are in long queues and the wrong queues. For the first time in nearly 60 years, this initiative will perhaps bring an end to waiting in the NHS" said Mr Betteridge.
Neil Betteridge biography
Neil developed rheumatoid arthritis at the age of 3, which had a major impact on his life for the next ten years or so and continues to inform all his work.
Growing up in Nuneaton, Warwickshire, Neil battled through years of intensive physiotherapy and hydrotherapy and was one of the lucky few with severe arthritis to regain much of his mobility. He progressed from being a wheelchair user at age 6 to being appointed captain of the school football team at age 11.
Neil studied and taught at Liverpool University for most of the 1980s. Whilst completing his M Phil on the work of T. S. Eliot he became a trustee at Toxteth Victim Support and subsequently took up a paid position with Liverpool Children's Holiday Organisation. Within one year he was made Director of the organisation.
Following a brief spell teaching in Italy, Neil has since worked as a public policy specialist and campaigner on arthritis and pan-disability issues.
Formerly Head of Public Policy and Campaigning at RADAR (Royal Association of Disability and Rehabilitation), he is now Chief Executive at Arthritis Care. He is additionally Chair of ARMA, the umbrella group for arthritis in the UK and it lead for all of their lobbying work for the EU and European Parliament; Chair of the UK government's Disabled Persons Transport Advisory Committee (DPTAC); and a member of the Commission for Integrated Transport.
He was, until recently, Chair of the PARE Manifesto, the European campaigns network of arthritis patient groups and he has recently completed 4 years as Vice President of EULAR (European League Against Rheumatism) as well as a 3 year term of office as a trustee with the Long Term Medical Conditions Alliance.
Throughout 2004 and 2005 Neil served as a 'patient advisor' on the steering group of the Department for Health-sponsored Musculoskeletal Services Framework.
arthritiscare.uk
вторник, 11 октября 2011 г.
New Research Shows Exercise Prevents Arthritis Symptoms In Women
Women in their 70s who keep active could be dodging painful arthritis symptoms, according to research published today in Arthritis Research & Therapy. The study is the first to show that the more you exercise, the better your chances of preventing the onset of stiff and painful joints.
Kristiann Heesch and colleagues at the University of Queensland, Australia examined data on middle-aged (48-55) and older (72-79) women collected using surveys over three years as part of the Australian Longitudinal Study on Women's Health. Excluding women who reported arthritis symptoms at the beginning of the study, the authors looked at those who began reporting stiff or painful joints 'often' and how much exercise they undertook.
The results suggest that for women in the older age bracket, doing a little over an hour of moderate physical activity each week will lessen your chances of developing frequent arthritis symptoms in the next three years. Pushing that up to 2 ?? hours per week is even more likely to prevent arthritis symptoms appearing. These results were not seen for the middle-aged group.
A debilitating health problem which is more likely to strike as we get older and affects more women than men, arthritis is almost as common as cardiovascular disease in Australia, affecting 17% of the population. By 2020 this figure is set to approach US levels, where arthritis is the most prevalent chronic condition for middle aged and older people, affecting over a fifth of the population. Exercising into old age could ensure movement without stiffness and pain for longer, and could reduce the burden of arthritis on the healthcare system.
Relationship between physical activity and stiff or painful joints in mid-aged and older women: a 3 year prospective study
Kristiann C Heesch, Yvette D Miller and Wendy J Brown
Arthritis Research & Therapy
Kristiann Heesch and colleagues at the University of Queensland, Australia examined data on middle-aged (48-55) and older (72-79) women collected using surveys over three years as part of the Australian Longitudinal Study on Women's Health. Excluding women who reported arthritis symptoms at the beginning of the study, the authors looked at those who began reporting stiff or painful joints 'often' and how much exercise they undertook.
The results suggest that for women in the older age bracket, doing a little over an hour of moderate physical activity each week will lessen your chances of developing frequent arthritis symptoms in the next three years. Pushing that up to 2 ?? hours per week is even more likely to prevent arthritis symptoms appearing. These results were not seen for the middle-aged group.
A debilitating health problem which is more likely to strike as we get older and affects more women than men, arthritis is almost as common as cardiovascular disease in Australia, affecting 17% of the population. By 2020 this figure is set to approach US levels, where arthritis is the most prevalent chronic condition for middle aged and older people, affecting over a fifth of the population. Exercising into old age could ensure movement without stiffness and pain for longer, and could reduce the burden of arthritis on the healthcare system.
Relationship between physical activity and stiff or painful joints in mid-aged and older women: a 3 year prospective study
Kristiann C Heesch, Yvette D Miller and Wendy J Brown
Arthritis Research & Therapy
суббота, 8 октября 2011 г.
Psoriatic Arthritis: New Drug Shows Promising Results
Psoriatic arthritis affects about 11 percent of patients with psoriasis. Anti-tumor necrosis factor ?± (anti-TNF?±) agents, which block signaling molecules that induce inflammation, improve the symptoms of psoriatic arthritis. Golimumab is a new human monoclonal antibody that works against TNF?± and has been shown to be beneficial within two weeks of the first subcutaneous injection in a phase II rheumatoid arthritis trial. A new phase III, multicenter, randomized, double-blind, placebo-controlled trial, the largest of its kind to be completed with a biologic agent to treat psoriatic arthritis and the first placebo-controlled study evaluating the effect of a TNF inhibitor on nail psoriasis, found that golimumab significantly improved active psoriatic arthritis and associated skin and nail psoriasis. The study was published in the April issue of Arthritis & Rheumatism (www3.interscience.wiley/journal/76509746/home).
Led by Arthur Kavanaugh of the University of California San Diego in La Jolla, CA the study involved 405 patients with active psoriatic arthritis even after having taken disease-modifying antirheumatic drugs or nonsteroidal anti-inflammatory drugs. Patients were randomized to receive subcutaneous injections of placebo, golimumab 50 mg, or golimumab 100 mg every four weeks for 24 weeks. Patients with less than 10 percent improvement in swollen and tender joints at week 16 were switched from placebo to 50 mg golimumab or from 50 mg to 100 mg. The primary end point of the study was the proportion of patients who met the American College of Rheumatology 20 percent improvement criteria (ACR20 response) at week 14. This response included at least a 20 percent improvement in swollen and tender joint counts and other measures such as pain, disease activity, physical function, and C-reactive protein. ACR50 and ACR70 responses were defined by at least 50 percent and at least 70 percent improvement.
The results showed that golimumab was efficacious and generally well tolerated. An ACR20 response was achieved at week 14 by 51 percent of patients receiving 50mg and 45 percent of those receiving 100mg, compared with 9 percent of placebo-treated patients. In addition, significantly more golimumab-treated patients than placebo-treated patients achieved ACR50 and ACR70 responses and those who initially showed little improvement and switched from placebo to golimumab or increased their dosage also showed improvement. Patients treated with the drug had significant improvement in physical function and health-related quality of life, as well as significant improvement in enthesitis, an inflammation where muscles attach to bones. In addition to improving arthritic symptoms, golimumab also improved psoriasis symptoms: 40 percent of the 50 mg group and 58 percent of the 100 mg group had at least 75 percent improvement in psoriasis symptoms, compared with 3 percent of the placebo group. "The safety profile of golimumab in psoriatic arthritis was similar to other anti-TNF agents that have been studied in this disease. Subcutaneous administrations were well tolerated. Only a small number of patients had injection site reactions, which were mostly mild.
This was also the first placebo-controlled study evaluating the effect of an anti-TNF?± on nail psoriasis, which affected about 70 percent of the patients involved in the study. Significant improvements in nail symptoms were seen in those treated with golimumab as early as week 14 and were maintained or improved through the end of the study period.
The authors conclude that "subcutaneous golimumab (at doses of 50 mg and 100 mg) administered every 4 weeks significantly improved active psoriatic arthritis and associated skin disease." Longer-term data on golimumab's efficacy and safety will be reported in the future.
Notes:
Article: Golimumab, a New Human Tumor Necrosis Factor ?± Antibody, Administered Every Four Weeks as a Subcutaneous Injection in Psoriatic Arthritis," Arthur Kavanaugh, Iain McInnes, Philip Mease, Gerald G. Krueger, Dafna Gladman, Juan Gomez-Reino, Kim Papp, Julie Zrubek, Surekha Mudivarthy, Michael Mack, Sudha Visvanathan, Anna Beutler, Arthritis & Rheumatism, April 2009.
Source:
Sean Wagner
Wiley-Blackwell
Led by Arthur Kavanaugh of the University of California San Diego in La Jolla, CA the study involved 405 patients with active psoriatic arthritis even after having taken disease-modifying antirheumatic drugs or nonsteroidal anti-inflammatory drugs. Patients were randomized to receive subcutaneous injections of placebo, golimumab 50 mg, or golimumab 100 mg every four weeks for 24 weeks. Patients with less than 10 percent improvement in swollen and tender joints at week 16 were switched from placebo to 50 mg golimumab or from 50 mg to 100 mg. The primary end point of the study was the proportion of patients who met the American College of Rheumatology 20 percent improvement criteria (ACR20 response) at week 14. This response included at least a 20 percent improvement in swollen and tender joint counts and other measures such as pain, disease activity, physical function, and C-reactive protein. ACR50 and ACR70 responses were defined by at least 50 percent and at least 70 percent improvement.
The results showed that golimumab was efficacious and generally well tolerated. An ACR20 response was achieved at week 14 by 51 percent of patients receiving 50mg and 45 percent of those receiving 100mg, compared with 9 percent of placebo-treated patients. In addition, significantly more golimumab-treated patients than placebo-treated patients achieved ACR50 and ACR70 responses and those who initially showed little improvement and switched from placebo to golimumab or increased their dosage also showed improvement. Patients treated with the drug had significant improvement in physical function and health-related quality of life, as well as significant improvement in enthesitis, an inflammation where muscles attach to bones. In addition to improving arthritic symptoms, golimumab also improved psoriasis symptoms: 40 percent of the 50 mg group and 58 percent of the 100 mg group had at least 75 percent improvement in psoriasis symptoms, compared with 3 percent of the placebo group. "The safety profile of golimumab in psoriatic arthritis was similar to other anti-TNF agents that have been studied in this disease. Subcutaneous administrations were well tolerated. Only a small number of patients had injection site reactions, which were mostly mild.
This was also the first placebo-controlled study evaluating the effect of an anti-TNF?± on nail psoriasis, which affected about 70 percent of the patients involved in the study. Significant improvements in nail symptoms were seen in those treated with golimumab as early as week 14 and were maintained or improved through the end of the study period.
The authors conclude that "subcutaneous golimumab (at doses of 50 mg and 100 mg) administered every 4 weeks significantly improved active psoriatic arthritis and associated skin disease." Longer-term data on golimumab's efficacy and safety will be reported in the future.
Notes:
Article: Golimumab, a New Human Tumor Necrosis Factor ?± Antibody, Administered Every Four Weeks as a Subcutaneous Injection in Psoriatic Arthritis," Arthur Kavanaugh, Iain McInnes, Philip Mease, Gerald G. Krueger, Dafna Gladman, Juan Gomez-Reino, Kim Papp, Julie Zrubek, Surekha Mudivarthy, Michael Mack, Sudha Visvanathan, Anna Beutler, Arthritis & Rheumatism, April 2009.
Source:
Sean Wagner
Wiley-Blackwell
среда, 5 октября 2011 г.
Rheumatologists Are Eager To Use Roche-Genentech's ACTEMRA, According To New Study By BioTrends
BioTrends is pleased to announce the publication of a new syndicated report, LaunchTrends®: ACTEMRA. Actemra (tocilizumab), marketed by Roche-Genentech, is the first IL-6 receptor inhibitor agent approved for rheumatoid arthritis. This report is the first in a three wave series and is derived from on-line survey responses from 77 rheumatologists and qualitative interviews with 20 rheumatologists.
At one month post launch, more than one-third of the survey respondents had already started to use Actemra in their patients and although the majority of respondents have the product slated as a third line (or later) option, many reported an expectation that Actemra could quickly advance to second line therapy following a single TNF failure. Even though most rheumatologists indicated that Actemra would likely replace Orencia or Rituxan in their practice, initial patient origination was largely from TNF failures. Overall, rheumatologists view the unique mechanism of action as Actemra's greatest attribute. Concerns with long term safety, certain side effects and managed care access could be potential obstacles to rapid adoption. In the next six months, more than 80% of the rheumatologists expect to be using Actemra in their practices.
LaunchTrends: Actemra is a three wave primary market research study that consists of a quantitative on-line survey and qualitative telephone interviews. In total, 300 rheumatologists will participate in the research. This report will capture launch effectiveness at one month, three months, and six months post launch. The reports are designed to assess trial and use of Actemra, obstacles to use, typical patient types, product perceptions, promotional efforts/messages, and satisfaction with the product relative to other agents. The next wave of the study will field in mid-April with the results available in early May 2010.
About BioTrends Research Group, Inc.
BioTrends Research Group, Inc. provides syndicated market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
Source: BioTrends Research Group, Inc
View drug information on Actemra; Orencia; Rituxan.
At one month post launch, more than one-third of the survey respondents had already started to use Actemra in their patients and although the majority of respondents have the product slated as a third line (or later) option, many reported an expectation that Actemra could quickly advance to second line therapy following a single TNF failure. Even though most rheumatologists indicated that Actemra would likely replace Orencia or Rituxan in their practice, initial patient origination was largely from TNF failures. Overall, rheumatologists view the unique mechanism of action as Actemra's greatest attribute. Concerns with long term safety, certain side effects and managed care access could be potential obstacles to rapid adoption. In the next six months, more than 80% of the rheumatologists expect to be using Actemra in their practices.
LaunchTrends: Actemra is a three wave primary market research study that consists of a quantitative on-line survey and qualitative telephone interviews. In total, 300 rheumatologists will participate in the research. This report will capture launch effectiveness at one month, three months, and six months post launch. The reports are designed to assess trial and use of Actemra, obstacles to use, typical patient types, product perceptions, promotional efforts/messages, and satisfaction with the product relative to other agents. The next wave of the study will field in mid-April with the results available in early May 2010.
About BioTrends Research Group, Inc.
BioTrends Research Group, Inc. provides syndicated market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
Source: BioTrends Research Group, Inc
View drug information on Actemra; Orencia; Rituxan.
воскресенье, 2 октября 2011 г.
ACTEMRA(TM) (tocilizumab) Third Phase III Study Results Show Significant Improvement In Symptoms Of Patients With Rheumatoid Arthritis
Roche today announced that
results from the ACTEMRA(TM) RADIATE (RheumAtoiD ArthritIs Study in
Anti-TNF FailurEs) trial successfully met its primary endpoint in patients
with moderate to severe rheumatoid arthritis (RA) who failed to respond to
anti-tumor necrosis factor treatments (anti-TNFs).
The trial - the third multinational Phase III study of ACTEMRA outside
of Japan - showed that a greater proportion of patients treated with
ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) achieved a significant
reduction in the signs and symptoms of RA as evaluated by ACR20 following
24 weeks of treatment, compared to those who were treated with placebo plus
methotrexate.
ACTEMRA was generally well tolerated; the most common adverse events
reported more frequently in the ACTEMRA arms of the RADIATE trial were
nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract
infection.
"The study results reconfirm the findings from the previous
multinational trials that interleukin-6 receptor inhibition is a novel
mechanism for reducing inflammation caused by RA," said Lars Birgerson,
M.D., Ph.D., Global Head Medical Affairs, Roche. "The data demonstrate that
ACTEMRA can potentially offer an effective approach in reducing the signs
and symptoms of RA, particularly when therapies such as anti-TNFs prove
insufficient."
Data from this trial will be submitted for presentation at upcoming
national scientific meetings. In addition, other Phase III trials exploring
ACTEMRA in RA are ongoing with another study scheduled to report in 2007.
About the RADIATE Study
The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) study is
a three-arm, randomized, double-blind, placebo-controlled study designed to
evaluate the safety and efficacy of ACTEMRA plus methotrexate (4 mg/kg or 8
mg/kg) compared to placebo plus methotrexate in RA patients who had an
inadequate response to anti-TNFs alone. Patients received either ACTEMRA
intravenously (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate
weekly or placebo infusions every four weeks plus methotrexate weekly.
Data from the study were analyzed to determine patients' response to
treatment by using three standard assessments: ACR score (1), developed by
the American College of Rheumatology (ACR), DAS28 (2), a measurement of RA
disease activity, and EULAR response criteria (3), a measurement of
treatment response. The study included 498 patients at 128 trial sites in
13 countries, including the United States.
The RADIATE trial is one of five Phase III clinical studies designed to
investigate ACTEMRA as a potential new treatment for RA. Roche and Chugai
have initiated the collaborative clinical development program that has
enrolled a total of more than 4,000 patients in 41 countries including the
United States and several European countries.
About ACTEMRA (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody and represents a novel mechanism of action to treat RA.
Studies suggest that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, may reduce inflammation of
the joints. The global ACTEMRA Phase III clinical development program is
designed to evaluate this clinical finding. The compound is not currently
approved in the United States.
The most common adverse events reported in ACTEMRA global clinical
studies are upper respiratory tract infections, headache, nasopharyngitis
and hypertension. As with other biological disease modifying anti-rheumatic
drugs (DMARDs), serious infections have been reported in some patients
treated with ACTEMRA.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain, and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin and
osteoporosis and may contribute to shortening life expectancy by affecting
major organ systems. After 10 years, less than 50% of patients can continue
to work or function normally on a daily basis. RA affects more than 21
million people worldwide with approximately 2.1 million people affected in
the United States.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2006, Roche was named
one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to
Sell For (Selling Power), and one of AARP's Top Companies for Older
Workers, and in 2005, Roche was named one of Fortune magazine's Best
Companies to Work For in America. For additional information about the U.S.
pharmaceuticals business, visit our websites: rocheusa or
roche.us.
References
(1) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%, 50%
or 70%) in certain RA symptoms and measures the number of tender
and swollen joints, pain, patient's and physician's global assessments
and certain laboratory markers. An ACR70 response is considered
exceptional and represents a significant improvement in a patient's
condition.
(2) The Disease Activity Score (DAS)28 is a combined index that measures
disease activity in patients with RA. It combines information from 28
tender and swollen joints (range 0-28), erythrocyte sedimentation rate,
and a general health assessment on a visual analog scale. The level of
disease activity is interpreted as low (DAS28 less than or equal to
3.2), moderate (3.2 < DAS28 less than or equal to 5.1) or high (DAS28
>5.1). DAS28
results from the ACTEMRA(TM) RADIATE (RheumAtoiD ArthritIs Study in
Anti-TNF FailurEs) trial successfully met its primary endpoint in patients
with moderate to severe rheumatoid arthritis (RA) who failed to respond to
anti-tumor necrosis factor treatments (anti-TNFs).
The trial - the third multinational Phase III study of ACTEMRA outside
of Japan - showed that a greater proportion of patients treated with
ACTEMRA plus methotrexate (4 mg/kg or 8 mg/kg) achieved a significant
reduction in the signs and symptoms of RA as evaluated by ACR20 following
24 weeks of treatment, compared to those who were treated with placebo plus
methotrexate.
ACTEMRA was generally well tolerated; the most common adverse events
reported more frequently in the ACTEMRA arms of the RADIATE trial were
nausea, headache, nasopharyngitis, diarrhea and upper respiratory tract
infection.
"The study results reconfirm the findings from the previous
multinational trials that interleukin-6 receptor inhibition is a novel
mechanism for reducing inflammation caused by RA," said Lars Birgerson,
M.D., Ph.D., Global Head Medical Affairs, Roche. "The data demonstrate that
ACTEMRA can potentially offer an effective approach in reducing the signs
and symptoms of RA, particularly when therapies such as anti-TNFs prove
insufficient."
Data from this trial will be submitted for presentation at upcoming
national scientific meetings. In addition, other Phase III trials exploring
ACTEMRA in RA are ongoing with another study scheduled to report in 2007.
About the RADIATE Study
The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) study is
a three-arm, randomized, double-blind, placebo-controlled study designed to
evaluate the safety and efficacy of ACTEMRA plus methotrexate (4 mg/kg or 8
mg/kg) compared to placebo plus methotrexate in RA patients who had an
inadequate response to anti-TNFs alone. Patients received either ACTEMRA
intravenously (4 mg/kg or 8 mg/kg) every four weeks plus methotrexate
weekly or placebo infusions every four weeks plus methotrexate weekly.
Data from the study were analyzed to determine patients' response to
treatment by using three standard assessments: ACR score (1), developed by
the American College of Rheumatology (ACR), DAS28 (2), a measurement of RA
disease activity, and EULAR response criteria (3), a measurement of
treatment response. The study included 498 patients at 128 trial sites in
13 countries, including the United States.
The RADIATE trial is one of five Phase III clinical studies designed to
investigate ACTEMRA as a potential new treatment for RA. Roche and Chugai
have initiated the collaborative clinical development program that has
enrolled a total of more than 4,000 patients in 41 countries including the
United States and several European countries.
About ACTEMRA (tocilizumab)
ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting
monoclonal antibody and represents a novel mechanism of action to treat RA.
Studies suggest that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, may reduce inflammation of
the joints. The global ACTEMRA Phase III clinical development program is
designed to evaluate this clinical finding. The compound is not currently
approved in the United States.
The most common adverse events reported in ACTEMRA global clinical
studies are upper respiratory tract infections, headache, nasopharyngitis
and hypertension. As with other biological disease modifying anti-rheumatic
drugs (DMARDs), serious infections have been reported in some patients
treated with ACTEMRA.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain, and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, decreased hemoglobin and
osteoporosis and may contribute to shortening life expectancy by affecting
major organ systems. After 10 years, less than 50% of patients can continue
to work or function normally on a daily basis. RA affects more than 21
million people worldwide with approximately 2.1 million people affected in
the United States.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2006, Roche was named
one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to
Sell For (Selling Power), and one of AARP's Top Companies for Older
Workers, and in 2005, Roche was named one of Fortune magazine's Best
Companies to Work For in America. For additional information about the U.S.
pharmaceuticals business, visit our websites: rocheusa or
roche.us.
References
(1) ACR20, ACR50 and ACR70 represent the percentage of reduction (20%, 50%
or 70%) in certain RA symptoms and measures the number of tender
and swollen joints, pain, patient's and physician's global assessments
and certain laboratory markers. An ACR70 response is considered
exceptional and represents a significant improvement in a patient's
condition.
(2) The Disease Activity Score (DAS)28 is a combined index that measures
disease activity in patients with RA. It combines information from 28
tender and swollen joints (range 0-28), erythrocyte sedimentation rate,
and a general health assessment on a visual analog scale. The level of
disease activity is interpreted as low (DAS28 less than or equal to
3.2), moderate (3.2 < DAS28 less than or equal to 5.1) or high (DAS28
>5.1). DAS28
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