For patients with rheumatoid arthritis, combining one well-known, lower cost synthetic drug with one of six biologic medications often works best to reduce joint swelling or tenderness, according to a new report funded by the Agency for Healthcare Research and Quality, part of the U.S. Department of Health and Human Services. An article based on the report will be posted on-line Monday in the Annals of Internal Medicine.
Researchers reviewed published evidence to compare the benefits and harms of three classes of medications: synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, and corticosteroids. Synthetic DMARDs include hydroxychloroquine, leflunomide, methotrexate and sulfasalazine; biologic DMARDs include abatacept, adalimumab, anakinra, etanercept, infliximab and rituximab; and corticosteroids include drugs such as prednisone.
The report concluded that combining methotrexate, a synthetic DMARD, with one of the biologic DMARDs works better than using methotrexate or a biologic DMARD alone. The report also found that methotrexate works as effectively as the biologic DMARDs adalimumab and etanercept for patients who have early rheumatoid arthritis. Adalimumab and etanercept, however, show better short-term results as measured by X-rays of joints. The report also emphasized that biologic DMARDs and methotrexate increase the risk of serious infection, including a reoccurrence of tuberculosis.
"Rheumatoid arthritis is a painful, degenerative disease that affects people of all ages and can profoundly impact quality of life," said AHRQ Director Carolyn M. Clancy, M.D. "This report establishes a clear, unbiased summary of what is known about current treatments. It also identifies areas where more research is needed."
About 2 million Americans have rheumatoid arthritis, a long-term illness that causes joint and tissue inflammation. Rheumatoid arthritis is an autoimmune disease, meaning that the body confuses healthy tissue for foreign substances and attacks itself. The cause is unknown. The disease often begins with fatigue, morning stiffness, weakness and muscle aches. Eventually, joint pain appears. Pain may affect the wrists, knees, elbows, fingers, toes, ankles or neck. Other symptoms may include anemia, eye burning, limited range of motion, skin redness and swollen glands. Joint destruction may occur within 1 to 2 years after the disease appears. Some cases cause deformities. Treatment typically begins with medications but may include physical therapy and surgery.
Among other findings in the report:
- Combining prednisone with the synthetic DMARD hydroxychloroquine, methotrexate or sulfasalazine works better than using only a synthetic DMARD to reduce joint swelling and tenderness and to improve function.
- No meaningful clinical differences can be found between methotrexate and either leflunomide or sulfasalazine.
- Combining the synthetic DMARDs methotrexate and sulfasalazine is no more effective than using just one of the medications for patients with early rheumatoid arthritis.
- Not enough evidence exists to determine whether combining two biologic DMARDs is more effective than using one biologic DMARD.
- About 17 of every 1,000 people taking a biologic DMARD for 3 to 12 months have a serious infection. Combining two biologic DMARDs can increase the risk.
- Among biologic DMARDs, rates of painful injection site reactions are more common for anakinra (67 percent) than for etanercept (22 percent) or adalimumab (18 percent).
- More long-term research is needed on rheumatoid arthritis medications, including how the outcomes of these drugs vary among patients with different health conditions and demographic characteristics. More comparative studies on various combinations of drugs are critical. Also important is investigating whether taking the medications earlier (especially biologic DMARDs) is better for long-term outcomes.
The report, Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis in Adults, was authored by the AHRQ-funded RTI International-University of North Carolina Evidence-based Practice Center in Chapel Hill, NC. It is the newest analysis from AHRQ's Effective Health Care Program. That program represents an important federal effort to compare alternative treatments for significant health conditions and make the findings public. The program is intended to help patients, doctors, nurses and others choose the most effective treatments. Information on the program, including full reports and plain-language summary guides, can be found at effectivehealthcare.ahrq.
ahrq
вторник, 30 августа 2011 г.
суббота, 27 августа 2011 г.
FDA Accepts Application Approval Request of REMICADE(reg) for Psoriatic Arthritis
Supporting Data Show Significant Reduction of Joint and Skin Symptoms in Psoriatic Arthritis -
Centocor, Inc, announced today that the U.S. Food and Drug Administration (FDA) has accepted its filing of a supplemental
Biologics Licensee Application (sBLA) for REMICADE(reg) (infliximab) for the treatment of psoriatic arthritis (PsA) in patients
with active disease. PsA is a chronic, potentially debilitating disease, which affects approximately one million people and
causes joint inflammation frequently associated with active psoriasis.
"We are pleased that the FDA has accepted this application for REMICADE(reg) in the treatment of psoriatic arthritis," said
Cynthia Guzzo, senior director, Clinical Research, Centocor, Inc. "The results we have seen are extremely encouraging and we
hope to gain approval for patients impacted by this disease."
The filing is based on the results of two double-blind, placebo-controlled trials, IMPACT and IMPACT 2. The study results
were presented in October 2004 at the American College of Rheumatology Annual Scientific Meeting and in June 2004 at the
European League Against Rheumatism's Annual European Congress of Rheumatology.
IMPACT 2 is a Phase III, multi-center, randomized, double-blind, placebo-controlled trial that demonstrated that treatment
with REMICADE(reg) 5 mg/kg resulted in marked improvements in patients with PsA and significant improvement in both joint and
skin disease was evident as early as week two. These data showed that at week 14, more than half of the patients in the
REMICADE(reg) treatment group achieved significant improvements in the signs and symptoms of PsA as measured by the proportion of
patients achieving ACR 20 (58 percent of the REMICADE(reg) patient group versus 11 percent placebo, p less than 0.001) and 75
percent improvement in PASI (63.9 percent of the REMICADE(reg) treatment group versus 2.3 percent placebo, p less than 0.001).
The ACR 20 and PASI 75 responses were achieved regardless of concomitant methotrexate use or level of joint involvement at
baseline.
Furthermore, compared to placebo, significantly more subjects in the REMICADE(reg) treatment group achieved ACR 70 or PASI 90 as
early as week six and improved or maintained these results at later points in the study. At week 24, results showed that 27
percent of patients treated with REMICADE(reg) exhibited a 70 percent improvement in symptoms of arthritis (as measured by ACR
70) compared with two percent in the placebo group (p less than 0.001).
Thirty-nine percent of patients showed a 90 percent improvement in psoriasis (as measured by PASI 90) compared with zero
percent in the placebo group (p less than 0.001). In the first study, IMPACT, 104 people were randomized to REMICADE(reg) (5
mg/kg) or placebo. At week 16, 65 percent (n=34) of people on REMICADE(reg) therapy achieved ACR 20. Additionally, of the 38
people with evaluable psoriasis, 68 percent (n=15) achieved a 75 percent or greater improvement from baseline (PASI 75)
indicating clinically meaningful improvement in psoriasis. Significant improvements were maintained through one year.
REMICADE(reg) was generally well tolerated in these studies, with similar numbers of patients experiencing adverse events (AE) in
each group. No deaths, cases of tuberculosis or other opportunistic infections were reported and serious infections and
infusion reactions were uncommon. Also, with the exception of one case of basal cell carcinoma in the placebo group, no
malignancies were reported. In general, the AE observed in these studies were consistent with those reported in other
indications, and most common AE included events that commonly occur in the general population. Significant laboratory
abnormalities were unusual, with an elevation in liver function tests during the IMPACT 2 trial being the most common
abnormality. Overall, there were slightly more patients with serious AE in the REMICADE(reg) group than in placebo. See Important
Information below.
About Psoriatic Arthritis
PsA involves joint pain and swelling that can lead to debilitation coupled with inflamed, scaly, red patches of psoriasis.
Symptoms may include stiffness and tenderness of the joints and surrounding tissue, reduced range of motion, nail changes and
redness and pain of the eye. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected.
Approximately one million Americans have PsA, and the disease affects both men and women equally, most commonly between the
ages 30 and 50.
About REMICADE(reg)
REMICADE(reg) is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent
approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union
and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE(reg) is
indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological
markers of inflammatory activity and who have responded inadequately to conventional therapy.
In September, the European Commission gave approval for expanded labeling for REMICADE(reg), in combination with methotrexate,
for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease
modifying anti-rheumatic drugs.
REMICADE(reg) is the only biologic indicated for the treatment of patients with moderately-to-severely active Crohn's disease who
have had an inadequate response to conventional therapy. REMICADE(reg) is also indicated for reducing the number of draining
enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.
REMICADE(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to
inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or
office setting. In RA and CD patients, REMICADE(reg) is a two-hour infusion administered every eight weeks, following a standard
induction regimen that requires treatment at weeks zero, two and six.
As a result, REMICADE(reg) patients may require as few as six treatments each year. The safety and efficacy of REMICADE(reg) have
been well established in clinical trials over the past 12 years and through commercial experience with more than a half
million patients treated worldwide.
Important Information
Many people with heart failure should not take REMICADE(reg); so prior to treatment discussion of any heart condition with a
doctor is necessary. A doctor should be informed right away of new or worsening symptoms of heart failure (such as shortness
of breath or swelling of your ankles or feet.)
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal.
Tell your doctor if you have had recent or past exposure to people with TB.
Evaluation for TB should be performed. If latent (inactive) TB exists, a doctor should begin TB treatment before starting
REMICADE(reg). REMICADE(reg) can lower one's ability to fight infections, so if prone to or if a history of infection(s) exists, or
one develops any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE(reg), tell a doctor right
away. Also tell a doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. Blood disorders
have been reported, some fatal. Tell a doctor if you develop possible signs of blood disorders such as persistent fever,
bruising, bleeding or paleness while taking REMICADE(reg). Nervous system disorders have also been reported.
Tell a doctor if there is a history of a disease(s) that affects the nervous system, or if one experiences any numbness,
weakness, tingling or visual disturbances while taking REMICADE(reg). Reports of lymphoma (a type of cancer) in patients on
REMICADE(reg) and other TNF blockers are rare but occur more often than in the general population; tell a doctor if there exists
a history of cancer.
Serious infusion reactions have been reported with REMICADE(reg), including hives, difficulty breathing and low blood pressure.
Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side
effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild
reactions to infusion such as rash or itchy skin.
About Centocor, Inc.
Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield
long-term benefits for patients and the health care community. The company is dedicated to the research and development of
treatments for a wide range of Immune-Mediated Inflammatory Disorders (IMID), such as arthritis and inflammatory skin
diseases and for cancer. Centocor's products, developed primarily through monoclonal antibody technology, help physicians
deliver innovative treatments to improve human health and restore patients' quality of life. Centocor, Inc., is a wholly
owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.
Centocor, Inc., has exclusive marketing rights to REMICADE(reg) in the United States. Schering-Plough Corporation has rights to
market REMICADE(reg) in all other countries throughout the world, except in Japan and parts of the Far East where Tanabe Seiyaku,
Ltd., markets the product.
Centocor, Inc, announced today that the U.S. Food and Drug Administration (FDA) has accepted its filing of a supplemental
Biologics Licensee Application (sBLA) for REMICADE(reg) (infliximab) for the treatment of psoriatic arthritis (PsA) in patients
with active disease. PsA is a chronic, potentially debilitating disease, which affects approximately one million people and
causes joint inflammation frequently associated with active psoriasis.
"We are pleased that the FDA has accepted this application for REMICADE(reg) in the treatment of psoriatic arthritis," said
Cynthia Guzzo, senior director, Clinical Research, Centocor, Inc. "The results we have seen are extremely encouraging and we
hope to gain approval for patients impacted by this disease."
The filing is based on the results of two double-blind, placebo-controlled trials, IMPACT and IMPACT 2. The study results
were presented in October 2004 at the American College of Rheumatology Annual Scientific Meeting and in June 2004 at the
European League Against Rheumatism's Annual European Congress of Rheumatology.
IMPACT 2 is a Phase III, multi-center, randomized, double-blind, placebo-controlled trial that demonstrated that treatment
with REMICADE(reg) 5 mg/kg resulted in marked improvements in patients with PsA and significant improvement in both joint and
skin disease was evident as early as week two. These data showed that at week 14, more than half of the patients in the
REMICADE(reg) treatment group achieved significant improvements in the signs and symptoms of PsA as measured by the proportion of
patients achieving ACR 20 (58 percent of the REMICADE(reg) patient group versus 11 percent placebo, p less than 0.001) and 75
percent improvement in PASI (63.9 percent of the REMICADE(reg) treatment group versus 2.3 percent placebo, p less than 0.001).
The ACR 20 and PASI 75 responses were achieved regardless of concomitant methotrexate use or level of joint involvement at
baseline.
Furthermore, compared to placebo, significantly more subjects in the REMICADE(reg) treatment group achieved ACR 70 or PASI 90 as
early as week six and improved or maintained these results at later points in the study. At week 24, results showed that 27
percent of patients treated with REMICADE(reg) exhibited a 70 percent improvement in symptoms of arthritis (as measured by ACR
70) compared with two percent in the placebo group (p less than 0.001).
Thirty-nine percent of patients showed a 90 percent improvement in psoriasis (as measured by PASI 90) compared with zero
percent in the placebo group (p less than 0.001). In the first study, IMPACT, 104 people were randomized to REMICADE(reg) (5
mg/kg) or placebo. At week 16, 65 percent (n=34) of people on REMICADE(reg) therapy achieved ACR 20. Additionally, of the 38
people with evaluable psoriasis, 68 percent (n=15) achieved a 75 percent or greater improvement from baseline (PASI 75)
indicating clinically meaningful improvement in psoriasis. Significant improvements were maintained through one year.
REMICADE(reg) was generally well tolerated in these studies, with similar numbers of patients experiencing adverse events (AE) in
each group. No deaths, cases of tuberculosis or other opportunistic infections were reported and serious infections and
infusion reactions were uncommon. Also, with the exception of one case of basal cell carcinoma in the placebo group, no
malignancies were reported. In general, the AE observed in these studies were consistent with those reported in other
indications, and most common AE included events that commonly occur in the general population. Significant laboratory
abnormalities were unusual, with an elevation in liver function tests during the IMPACT 2 trial being the most common
abnormality. Overall, there were slightly more patients with serious AE in the REMICADE(reg) group than in placebo. See Important
Information below.
About Psoriatic Arthritis
PsA involves joint pain and swelling that can lead to debilitation coupled with inflamed, scaly, red patches of psoriasis.
Symptoms may include stiffness and tenderness of the joints and surrounding tissue, reduced range of motion, nail changes and
redness and pain of the eye. Joints of the hands, wrists, knees, ankles, feet, lower back and neck are commonly affected.
Approximately one million Americans have PsA, and the disease affects both men and women equally, most commonly between the
ages 30 and 50.
About REMICADE(reg)
REMICADE(reg) is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent
approved for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD) in North America, the European Union
and Japan, and was the first biologic approved for ankylosing spondylitis in the European Union. In the EU, REMICADE(reg) is
indicated for the treatment of ankylosing spondylitis in patients who have severe axial symptoms, elevated serological
markers of inflammatory activity and who have responded inadequately to conventional therapy.
In September, the European Commission gave approval for expanded labeling for REMICADE(reg), in combination with methotrexate,
for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease
modifying anti-rheumatic drugs.
REMICADE(reg) is the only biologic indicated for the treatment of patients with moderately-to-severely active Crohn's disease who
have had an inadequate response to conventional therapy. REMICADE(reg) is also indicated for reducing the number of draining
enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.
REMICADE(reg) is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to
inject themselves frequently, REMICADE(reg) is the only anti-TNF biologic administered directly by caregivers in the clinic or
office setting. In RA and CD patients, REMICADE(reg) is a two-hour infusion administered every eight weeks, following a standard
induction regimen that requires treatment at weeks zero, two and six.
As a result, REMICADE(reg) patients may require as few as six treatments each year. The safety and efficacy of REMICADE(reg) have
been well established in clinical trials over the past 12 years and through commercial experience with more than a half
million patients treated worldwide.
Important Information
Many people with heart failure should not take REMICADE(reg); so prior to treatment discussion of any heart condition with a
doctor is necessary. A doctor should be informed right away of new or worsening symptoms of heart failure (such as shortness
of breath or swelling of your ankles or feet.)
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal.
Tell your doctor if you have had recent or past exposure to people with TB.
Evaluation for TB should be performed. If latent (inactive) TB exists, a doctor should begin TB treatment before starting
REMICADE(reg). REMICADE(reg) can lower one's ability to fight infections, so if prone to or if a history of infection(s) exists, or
one develops any signs of an infection such as fever, fatigue, cough or the flu while taking REMICADE(reg), tell a doctor right
away. Also tell a doctor if you have lived in a region where histoplasmosis or coccidioidomycosis is common. Blood disorders
have been reported, some fatal. Tell a doctor if you develop possible signs of blood disorders such as persistent fever,
bruising, bleeding or paleness while taking REMICADE(reg). Nervous system disorders have also been reported.
Tell a doctor if there is a history of a disease(s) that affects the nervous system, or if one experiences any numbness,
weakness, tingling or visual disturbances while taking REMICADE(reg). Reports of lymphoma (a type of cancer) in patients on
REMICADE(reg) and other TNF blockers are rare but occur more often than in the general population; tell a doctor if there exists
a history of cancer.
Serious infusion reactions have been reported with REMICADE(reg), including hives, difficulty breathing and low blood pressure.
Reactions have occurred during or after infusions. In clinical studies, some people experienced the following common side
effects: respiratory infections (that may include sinus infections and sore throat), coughing and stomach pain or mild
reactions to infusion such as rash or itchy skin.
About Centocor, Inc.
Centocor, Inc., is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield
long-term benefits for patients and the health care community. The company is dedicated to the research and development of
treatments for a wide range of Immune-Mediated Inflammatory Disorders (IMID), such as arthritis and inflammatory skin
diseases and for cancer. Centocor's products, developed primarily through monoclonal antibody technology, help physicians
deliver innovative treatments to improve human health and restore patients' quality of life. Centocor, Inc., is a wholly
owned subsidiary of Johnson & Johnson, the worldwide manufacturer of health care products.
Centocor, Inc., has exclusive marketing rights to REMICADE(reg) in the United States. Schering-Plough Corporation has rights to
market REMICADE(reg) in all other countries throughout the world, except in Japan and parts of the Far East where Tanabe Seiyaku,
Ltd., markets the product.
среда, 24 августа 2011 г.
Abbott's Humira(R) (Adalimumab) Recommended By NICE For The Treatment Of Rheumatoid Arthritis, UK
The National Institute for Health and Clinical Excellence (NICE) recommended Humira (adalimumab) as an option for the treatment of adults with rheumatoid arthritis (RA). It is the second positive opinion for adalimumab for rheumatological conditions in as many months, having been recommended by NICE for the treatment of psoriatic arthritis in August of this year.[1]
Adalimumab, licensed in the UK since 2003, is indicated for the treatment of active RA in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Today's announcement by NICE underscores the clinical value of the use of adalimumab as an effective option for the management of adults who have both:
- Active rheumatoid arthritis as measured by disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.
- Undergone trials of two DMARDs, including methotrexate (unless contraindicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at standard dose, unless significant toxicity has limited the dose or duration of treatment.
Primary Care Trusts have a statutory duty to fund NICE technology appraisals within three months of publication.
"The recommendation of adalimumab in NICE's guidance is an important milestone for clinicians and patients alike," noted Dr Bruce Kirkham, Consultant Rheumatologist, Guy's & St Thomas' NHS Foundation Trust, London. "The efficacy of treatments such as adalimumab has long been recognised, and NICE's recommendation acknowledges this efficacy, while confirming both the clinical and economic rationale for their use."
RA is a chronic and progressive disabling condition characterised by inflammation of the synovial tissue of the joints. It causes tenderness and stiffness of joints leading to progressive destruction, and other symptoms such as pain and fatigue. It affects approximately 400,000 people in England and Wales. Of these, approximately 15% have severe disease.[2]
"People living with rheumatoid arthritis will welcome today's recommendation from NICE," commented Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society. "In order to effectively manage RA, it is crucial that those of us with the disease have access to the right treatment at the right time. NICE's decision means there are more options - and fewer barriers - to people with RA having access to treatments that work."
About RA
Up to 600,000 people in the UK suffer from RA.[3],[4],[5] Unlike osteoarthritis, the most common form of arthritis, RA is an inflammatory disease of the joints, which can result in eventual destruction of the joints' interior and the surrounding bone, leading to disability. The joints most commonly affected during the beginning of the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can be affected, but less often. Although there is no cure for RA, people continue to seek treatments that not only alleviate the pain and inflammation but also slow disease progression, thereby inhibiting the joint damage that can hinder patients from performing daily activities.
About HUMIRA® (adalimumab)
Adalimumab, in combination with methotrexate (MTX), is indicated for:
- The treatment of moderate to severe active RA in adults (aged 18 and over) when the response to DMARDs including MTX has been inadequate.
- The treatment of severe, active and progressive RA in adults not previously treated with MTX.
Adalimumab is also indicated for the treatment of adults with:
- Severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
- Active and progressive psoriatic arthritis (PsA) when the response to previous DMARD therapy has been inadequate.
- Severe, active Crohn's disease (CD), in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
For the RA, AS and PsA indications, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection using a pre-filled pen. The recommended dosing in CD is 80mg adalimumab at week 0 followed by 40mg at week 2 and 40 mg every other week thereafter.
Adalimumab has been shown to reduce the rate of joint damage in RA as measured by X-ray and improve physical function, when given in combination with MTX. Adalimumab can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.[6]
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 65,000 people and markets its products in more than 130 countries.
References:
[1]. National Institute for Clinical Excellence. Adalimumab for the treatment of moderate-to-severe psoriatic arthritis - Guidance. August 2007 nice.uk .
[2]. National Institute for Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis. Guidance October 2007. nice.uk .
[3].Funding anti-TNF Therapies for Severe Resistant Rheumatoid Arthritis. Birmingham University 2004
[4]. Simpson C et al. The Patient's journey: rheumatoid arthritis. BMJ 2005; 331;887-889
[5]. Government Actuary's Department.
UK Base Population Estimates for mid-2003 accessed April 2007
[6]. Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics emc.medicines.uk/
View drug information on Humira.
Adalimumab, licensed in the UK since 2003, is indicated for the treatment of active RA in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Today's announcement by NICE underscores the clinical value of the use of adalimumab as an effective option for the management of adults who have both:
- Active rheumatoid arthritis as measured by disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.
- Undergone trials of two DMARDs, including methotrexate (unless contraindicated). A trial of a DMARD is defined as being normally of 6 months, with 2 months at standard dose, unless significant toxicity has limited the dose or duration of treatment.
Primary Care Trusts have a statutory duty to fund NICE technology appraisals within three months of publication.
"The recommendation of adalimumab in NICE's guidance is an important milestone for clinicians and patients alike," noted Dr Bruce Kirkham, Consultant Rheumatologist, Guy's & St Thomas' NHS Foundation Trust, London. "The efficacy of treatments such as adalimumab has long been recognised, and NICE's recommendation acknowledges this efficacy, while confirming both the clinical and economic rationale for their use."
RA is a chronic and progressive disabling condition characterised by inflammation of the synovial tissue of the joints. It causes tenderness and stiffness of joints leading to progressive destruction, and other symptoms such as pain and fatigue. It affects approximately 400,000 people in England and Wales. Of these, approximately 15% have severe disease.[2]
"People living with rheumatoid arthritis will welcome today's recommendation from NICE," commented Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society. "In order to effectively manage RA, it is crucial that those of us with the disease have access to the right treatment at the right time. NICE's decision means there are more options - and fewer barriers - to people with RA having access to treatments that work."
About RA
Up to 600,000 people in the UK suffer from RA.[3],[4],[5] Unlike osteoarthritis, the most common form of arthritis, RA is an inflammatory disease of the joints, which can result in eventual destruction of the joints' interior and the surrounding bone, leading to disability. The joints most commonly affected during the beginning of the disease are the smaller joints of the fingers, feet and wrists. The elbows, knees, ankles and hips can be affected, but less often. Although there is no cure for RA, people continue to seek treatments that not only alleviate the pain and inflammation but also slow disease progression, thereby inhibiting the joint damage that can hinder patients from performing daily activities.
About HUMIRA® (adalimumab)
Adalimumab, in combination with methotrexate (MTX), is indicated for:
- The treatment of moderate to severe active RA in adults (aged 18 and over) when the response to DMARDs including MTX has been inadequate.
- The treatment of severe, active and progressive RA in adults not previously treated with MTX.
Adalimumab is also indicated for the treatment of adults with:
- Severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.
- Active and progressive psoriatic arthritis (PsA) when the response to previous DMARD therapy has been inadequate.
- Severe, active Crohn's disease (CD), in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
For the RA, AS and PsA indications, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection using a pre-filled pen. The recommended dosing in CD is 80mg adalimumab at week 0 followed by 40mg at week 2 and 40 mg every other week thereafter.
Adalimumab has been shown to reduce the rate of joint damage in RA as measured by X-ray and improve physical function, when given in combination with MTX. Adalimumab can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.[6]
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 65,000 people and markets its products in more than 130 countries.
References:
[1]. National Institute for Clinical Excellence. Adalimumab for the treatment of moderate-to-severe psoriatic arthritis - Guidance. August 2007 nice.uk .
[2]. National Institute for Clinical Excellence. Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis. Guidance October 2007. nice.uk .
[3].Funding anti-TNF Therapies for Severe Resistant Rheumatoid Arthritis. Birmingham University 2004
[4]. Simpson C et al. The Patient's journey: rheumatoid arthritis. BMJ 2005; 331;887-889
[5]. Government Actuary's Department.
UK Base Population Estimates for mid-2003 accessed April 2007
[6]. Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics emc.medicines.uk/
View drug information on Humira.
воскресенье, 21 августа 2011 г.
Array BioPharma Announces Top-Line Results In Two Phase 1 Clinical Trials
Array BioPharma Inc. (NASDAQ: ARRY) announced top-line results from its Phase 1 seven-day dose escalation trial up to 1,200 mg daily of p38 inhibitor, ARRY-797, in healthy volunteers. In addition, the top-line results were announced in a second study, where ARRY-797 was evaluated in a 28-day Phase 1b trial in stable rheumatoid arthritis (RA) patients taking methotrexate. This study compared two doses of ARRY-797 to placebo.
A preliminary analysis of both trials indicates that ARRY-797 was well tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients' assessment of pain (VAS score) over the course of the study.
"In the 28-day RA study, ARRY-797 demonstrated a transient inhibition of the inflammatory biomarker CRP and a trend towards analgesic efficacy in the pain endpoint," said Kevin Koch, Ph.D., President and Chief Scientific Officer. "Since these results are similar to other p38 inhibitors evaluated in rheumatoid arthritis, these findings have led us to discontinue testing of ARRY-797 in chronic inflammatory diseases. We continue to believe that a p38 inhibitor holds promise in treating patients with cancer and sub-chronic pain."
The Company continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from both studies. Array anticipates that complete results from the studies will be presented at a medical conference in 2010. Based on these preliminary results, Array plans to cease the enrollment of new patients in its current clinical trial of ARRY-797 in ankylosing spondylitis patients.
Phase 1b Dose Escalation Trial in Healthy Volunteers: Clinical Study Design and Results
This Phase 1b dose escalation trial was a randomized, double-blind, placebo-controlled study in healthy volunteers and was designed to evaluate the safety and pharmacokinetics of ARRY-797 after single-day and multiple-day administration of ARRY-797. Single ascending-doses of 900 mg (once) and 1,200 mg/day (800 mg followed by 400 mg 12 hours later), and multiple-day, ascending-doses of 200, 300 and 400 mg/day TID (every eight hours) for eight consecutive days were explored.
Safety, Tolerability and Pharmacokinetics: Overall, ARRY-797 was well-tolerated after single-day and multiple-day administration of total daily doses of 600 mg, 900 mg, and 1,200 mg. In the multiple-day cohorts up to 400 mg TID, no adverse event (AE) was reported by more than one subject in any treatment group and all AEs were considered mild in intensity. In the single-day cohorts, mild dizziness was reported by two of the 6 subjects receiving a 900 mg dose of ARRY-797 and moderate dizziness by one of the 6 subjects receiving 800 mg followed by 400 mg ARRY-797. Approximately dose-proportional increases in mean total and peak exposures were observed with increasing dose following single- and multiple-dose administration. Mean plasma concentrations of ARRY-797 reached steady-state on day two after repeat-dose administration with modest accumulation.
Phase 1b 28-day Study in Patients with RA: Clinical Study Design and Results
This Phase 1b trial was a randomized, double-blind, placebo-controlled design that enrolled 29 patients with RA. Twenty eight patients completed four weeks of treatment. The trial was conducted at six sites in the United States. Patients received either 100 mg or 200 mg ARRY-797 twice daily, or placebo. In addition, all patients were on a background of methotrexate and could receive certain NSAIDs (including COX-2 inhibitors), corticosteroids (low-dose), opioids/analgesics, aspirin, or acetaminophen. Patients were evaluated every seven days for improvement in clinical signs and symptoms according three measures: CRP levels (marker of inflammation), patient's assessment of arthritis pain (VAS score), and NTx levels (marker of bone remodeling).
Effects on Signs and Symptoms of Rheumatoid Arthritis: The CRP levels at the 200 mg BID dose of ARRY-797 showed a statistically significant decrease during the first three weeks of the study but returned to baseline on week four. Also, the patient's assessment of pain (VAS score) showed trends to decrease in the 200 mg BID arm. The NTx levels for both active arms separated from placebo by as much as 30 percent in the 100 mg arm and 50 percent in the 200 mg arm.
Safety, Tolerability and Pharmacokinetics: ARRY-797 was well-tolerated through 29 days of dosing. There were no premature discontinuations for serious AEs in any of the study arms. The most common AEs were generally mild or moderate and were not significantly different than placebo. Based upon a preliminary assessment, the exposure of ARRY-797 was consistent with previous studies in healthy volunteers, there were no apparent drug-drug interactions between methotrexate and ARRY-797, and no apparent food effect was observed.
ARRY-797 in Acute Pain
The efficacy of ARRY-797 previously was evaluated in two acute inflammatory pain trials in patients with post-surgical dental pain. ARRY-797 achieved its primary and secondary endpoints for analgesic efficacy and was well-tolerated in both trials.
In the first trial, the analgesic effect of 400 mg of ARRY-797, compared to placebo, was statistically significant based upon the primary endpoint of total pain relief over six hours post dose (p
A preliminary analysis of both trials indicates that ARRY-797 was well tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients' assessment of pain (VAS score) over the course of the study.
"In the 28-day RA study, ARRY-797 demonstrated a transient inhibition of the inflammatory biomarker CRP and a trend towards analgesic efficacy in the pain endpoint," said Kevin Koch, Ph.D., President and Chief Scientific Officer. "Since these results are similar to other p38 inhibitors evaluated in rheumatoid arthritis, these findings have led us to discontinue testing of ARRY-797 in chronic inflammatory diseases. We continue to believe that a p38 inhibitor holds promise in treating patients with cancer and sub-chronic pain."
The Company continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from both studies. Array anticipates that complete results from the studies will be presented at a medical conference in 2010. Based on these preliminary results, Array plans to cease the enrollment of new patients in its current clinical trial of ARRY-797 in ankylosing spondylitis patients.
Phase 1b Dose Escalation Trial in Healthy Volunteers: Clinical Study Design and Results
This Phase 1b dose escalation trial was a randomized, double-blind, placebo-controlled study in healthy volunteers and was designed to evaluate the safety and pharmacokinetics of ARRY-797 after single-day and multiple-day administration of ARRY-797. Single ascending-doses of 900 mg (once) and 1,200 mg/day (800 mg followed by 400 mg 12 hours later), and multiple-day, ascending-doses of 200, 300 and 400 mg/day TID (every eight hours) for eight consecutive days were explored.
Safety, Tolerability and Pharmacokinetics: Overall, ARRY-797 was well-tolerated after single-day and multiple-day administration of total daily doses of 600 mg, 900 mg, and 1,200 mg. In the multiple-day cohorts up to 400 mg TID, no adverse event (AE) was reported by more than one subject in any treatment group and all AEs were considered mild in intensity. In the single-day cohorts, mild dizziness was reported by two of the 6 subjects receiving a 900 mg dose of ARRY-797 and moderate dizziness by one of the 6 subjects receiving 800 mg followed by 400 mg ARRY-797. Approximately dose-proportional increases in mean total and peak exposures were observed with increasing dose following single- and multiple-dose administration. Mean plasma concentrations of ARRY-797 reached steady-state on day two after repeat-dose administration with modest accumulation.
Phase 1b 28-day Study in Patients with RA: Clinical Study Design and Results
This Phase 1b trial was a randomized, double-blind, placebo-controlled design that enrolled 29 patients with RA. Twenty eight patients completed four weeks of treatment. The trial was conducted at six sites in the United States. Patients received either 100 mg or 200 mg ARRY-797 twice daily, or placebo. In addition, all patients were on a background of methotrexate and could receive certain NSAIDs (including COX-2 inhibitors), corticosteroids (low-dose), opioids/analgesics, aspirin, or acetaminophen. Patients were evaluated every seven days for improvement in clinical signs and symptoms according three measures: CRP levels (marker of inflammation), patient's assessment of arthritis pain (VAS score), and NTx levels (marker of bone remodeling).
Effects on Signs and Symptoms of Rheumatoid Arthritis: The CRP levels at the 200 mg BID dose of ARRY-797 showed a statistically significant decrease during the first three weeks of the study but returned to baseline on week four. Also, the patient's assessment of pain (VAS score) showed trends to decrease in the 200 mg BID arm. The NTx levels for both active arms separated from placebo by as much as 30 percent in the 100 mg arm and 50 percent in the 200 mg arm.
Safety, Tolerability and Pharmacokinetics: ARRY-797 was well-tolerated through 29 days of dosing. There were no premature discontinuations for serious AEs in any of the study arms. The most common AEs were generally mild or moderate and were not significantly different than placebo. Based upon a preliminary assessment, the exposure of ARRY-797 was consistent with previous studies in healthy volunteers, there were no apparent drug-drug interactions between methotrexate and ARRY-797, and no apparent food effect was observed.
ARRY-797 in Acute Pain
The efficacy of ARRY-797 previously was evaluated in two acute inflammatory pain trials in patients with post-surgical dental pain. ARRY-797 achieved its primary and secondary endpoints for analgesic efficacy and was well-tolerated in both trials.
In the first trial, the analgesic effect of 400 mg of ARRY-797, compared to placebo, was statistically significant based upon the primary endpoint of total pain relief over six hours post dose (p
четверг, 18 августа 2011 г.
Serious deficiencies in the healthcare provision for people with arthritis / rheumatism Europe
Serious deficiencies in the healthcare provision for people with arthritis / rheumatism were exposed today in the results of a new European survey.[1]
More than 100 million people in Europe are affected by arthritis / rheumatism, making it Europe's most widespread chronic disease.[2] The condition can have serious consequences, ranging from severe pain to loss of mobility, and delays in diagnosis and treatment have been shown to increase the risk of further joint damage.[3]
However, the survey showed that a third of people with arthritis / rheumatism had to wait over a year before receiving the correct diagnosis, while 15 per cent had to wait up to three years.1
In addition, although over half of the respondents in the survey said their condition had a major impact on their ability to work,1 only 34 per cent said they had convenient access to occupational therapy and 44 per cent to rehabilitation.1
Undertaken by the People with Arthritis / Rheumatism in Europe (PARE) Manifesto Steering Group, a body representing the EULAR Social Leagues (patient groups), the survey also showed a significant impact on quality of life, with more than 50 per cent of people stating it had a moderate or major impact on relationships with family and friends.1
In addition, although arthritis / rheumatism is a long-term condition, less than two out of ten people with arthritis / rheumatism questioned in the survey thought that they were very well-informed about it, while four out of ten people felt fairly well-informed.1
Speaking at the European League Against Rheumatism (EULAR) medical congress, Dr Neil Betteridge, Chair of the PARE Manifesto Steering Group, said that the results of the survey revealed a need to improve access to information and healthcare provision.
"The pain and disability of arthritis / rheumatism affects every aspect of life and it has serious consequences for society, but despite this, many people do not have access to appropriate treatment and support," he said.
Dissatisfaction with treatment was also a problem - a quarter of those surveyed were dissatisfied with the treatment their doctor prescribed and only a quarter were very or extremely satisfied. Poor pain relief (59 per cent) and unpleasant side-effects (43 per cent) were the major reasons for lack of contentment.1 Gastrointestinal (GI) side-effects were cited as by far the most common side-effect (32 per cent).1 GI side-effects are commonly associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), a common treatment for arthritis / rheumatism.
The survey involved 617 people with arthritis / rheumatism from seven European countries, (France, Germany, Hungary, Italy, The Netherlands, Sweden and the UK).
- ends -
Notes for Editors
PARE Manifesto Survey
The survey was carried out by the PARE Manifesto Steering Group, a body representing the EULAR Social Leagues (patient groups) with the support of Double Helix Development, an independent market research company. The PARE Manifesto Steering Group partnered with AstraZeneca to investigate the impact on quality of life of arthritis / rheumatism. The international survey was carried out in seven European countries, (France, Germany, Hungary, Italy, The Netherlands, Sweden and the UK) between Friday, 26th March and Friday 6th May, 2004. 617 patients contributed to the results.
The study was initially conducted as an online survey via the PARE Manifesto web site, paremanifesto, and with the support of PARE Manifesto's national patient groups. Respondents were screened to make sure that they could only complete the survey once.
A telephone line was also set up in each country for people with arthritis / rheumatism who did not have access to the internet or who could not type for long periods of time. This meant that they could be interviewed by telephone and their views included in the results.
The telephone number was advertised through media releases and patient flyers distributed by general practitioners, rheumatologists, pharmacists and in outpatient clinics in hospitals.
250 of the 617 people who completed the survey, were interviewed by telephone.
PARE Manifesto Steering Group
The PARE Manifesto Steering Group is a body representing the EULAR Social Leagues (patient groups). It addresses the most important key objectives in the "European Manifesto". The European Manifesto is a document focusing on ten calls to action in order to ensure a better quality of life for people living with arthritis / rheumatism in Europe. For more information please go to paremanifesto.
For further enquiries please contact:
Carrie Monaghan
Hill & Knowlton (UK) Ltd
+44 20 7413 3788 (direct)
+44 7764 487 460 (mobile)
cmonaghanhillandknowlton
Birte Gl?sing
PARE Manifesto Secretariat
+ 44 207 380 6567 (direct)
+ 44 7778 554 367 (mobile)
secretariatparemanifesto
--------------------------------------------------------------------------------
References:
[1]. People with Arthritis and Rheumatism in Europe (PARE) Manifesto Steering Group. European patient survey 2004. Data on file, PARE.
[2]. PARE Manifesto Steering Group; The PARE Manifesto: A call to action; paremanifesto/home.htm. Last accessed 16.04.04.
[3]. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and answers about arthritis and rheumatic diseases. niams.nih/hi/topics/arthritis/arthpain.htm#1. Last accessed 16.04.04.
More than 100 million people in Europe are affected by arthritis / rheumatism, making it Europe's most widespread chronic disease.[2] The condition can have serious consequences, ranging from severe pain to loss of mobility, and delays in diagnosis and treatment have been shown to increase the risk of further joint damage.[3]
However, the survey showed that a third of people with arthritis / rheumatism had to wait over a year before receiving the correct diagnosis, while 15 per cent had to wait up to three years.1
In addition, although over half of the respondents in the survey said their condition had a major impact on their ability to work,1 only 34 per cent said they had convenient access to occupational therapy and 44 per cent to rehabilitation.1
Undertaken by the People with Arthritis / Rheumatism in Europe (PARE) Manifesto Steering Group, a body representing the EULAR Social Leagues (patient groups), the survey also showed a significant impact on quality of life, with more than 50 per cent of people stating it had a moderate or major impact on relationships with family and friends.1
In addition, although arthritis / rheumatism is a long-term condition, less than two out of ten people with arthritis / rheumatism questioned in the survey thought that they were very well-informed about it, while four out of ten people felt fairly well-informed.1
Speaking at the European League Against Rheumatism (EULAR) medical congress, Dr Neil Betteridge, Chair of the PARE Manifesto Steering Group, said that the results of the survey revealed a need to improve access to information and healthcare provision.
"The pain and disability of arthritis / rheumatism affects every aspect of life and it has serious consequences for society, but despite this, many people do not have access to appropriate treatment and support," he said.
Dissatisfaction with treatment was also a problem - a quarter of those surveyed were dissatisfied with the treatment their doctor prescribed and only a quarter were very or extremely satisfied. Poor pain relief (59 per cent) and unpleasant side-effects (43 per cent) were the major reasons for lack of contentment.1 Gastrointestinal (GI) side-effects were cited as by far the most common side-effect (32 per cent).1 GI side-effects are commonly associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs), a common treatment for arthritis / rheumatism.
The survey involved 617 people with arthritis / rheumatism from seven European countries, (France, Germany, Hungary, Italy, The Netherlands, Sweden and the UK).
- ends -
Notes for Editors
PARE Manifesto Survey
The survey was carried out by the PARE Manifesto Steering Group, a body representing the EULAR Social Leagues (patient groups) with the support of Double Helix Development, an independent market research company. The PARE Manifesto Steering Group partnered with AstraZeneca to investigate the impact on quality of life of arthritis / rheumatism. The international survey was carried out in seven European countries, (France, Germany, Hungary, Italy, The Netherlands, Sweden and the UK) between Friday, 26th March and Friday 6th May, 2004. 617 patients contributed to the results.
The study was initially conducted as an online survey via the PARE Manifesto web site, paremanifesto, and with the support of PARE Manifesto's national patient groups. Respondents were screened to make sure that they could only complete the survey once.
A telephone line was also set up in each country for people with arthritis / rheumatism who did not have access to the internet or who could not type for long periods of time. This meant that they could be interviewed by telephone and their views included in the results.
The telephone number was advertised through media releases and patient flyers distributed by general practitioners, rheumatologists, pharmacists and in outpatient clinics in hospitals.
250 of the 617 people who completed the survey, were interviewed by telephone.
PARE Manifesto Steering Group
The PARE Manifesto Steering Group is a body representing the EULAR Social Leagues (patient groups). It addresses the most important key objectives in the "European Manifesto". The European Manifesto is a document focusing on ten calls to action in order to ensure a better quality of life for people living with arthritis / rheumatism in Europe. For more information please go to paremanifesto.
For further enquiries please contact:
Carrie Monaghan
Hill & Knowlton (UK) Ltd
+44 20 7413 3788 (direct)
+44 7764 487 460 (mobile)
cmonaghanhillandknowlton
Birte Gl?sing
PARE Manifesto Secretariat
+ 44 207 380 6567 (direct)
+ 44 7778 554 367 (mobile)
secretariatparemanifesto
--------------------------------------------------------------------------------
References:
[1]. People with Arthritis and Rheumatism in Europe (PARE) Manifesto Steering Group. European patient survey 2004. Data on file, PARE.
[2]. PARE Manifesto Steering Group; The PARE Manifesto: A call to action; paremanifesto/home.htm. Last accessed 16.04.04.
[3]. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and answers about arthritis and rheumatic diseases. niams.nih/hi/topics/arthritis/arthpain.htm#1. Last accessed 16.04.04.
понедельник, 15 августа 2011 г.
Relationship Between Bone Density And Erosion In Arthritis
Rheumatoid arthritis (RA), the most common form of inflammatory arthritis, affects almost three percent of people over age 65. RA patients experience pain, functional limitations and two forms of disabling bone disease: focal erosions and osteoporosis. After five years of disease, up to 50 percent of RA patients show evidence of focal erosions and RA doubles the risk of osteoporosis and fractures. A new study examined the relationship between these two RA-related processes, in the hopes of providing insight into the underlying pathophysiology of RA-related bone disease. The study was published in the June issue of Arthritis & Rheumatism.
Led by Daniel H. Solomon of Brigham and Women's Hospital in Boston , the study involved 163 postmenopausal women with RA, none of whom were taking osteoporosis medications. Participants underwent bone density scans of the hip and spine, as well as X-rays of the hand to determine if they had bone erosions.
The results showed that hip bone mineral density (BMD) correlated with bone erosion, but the relationship was not statistically significant after adjusting for clinical factors such as age, BMI and use of oral glucocorticoids used to treat RA. The relationship did appear stronger, however, in patients with early RA. "Our findings suggest that the relationship between focal erosions and generalized osteoporosis is complicated and modified by many aspects of RA and other factors," the authors state. They point out that with longer disease duration, other variables such as the use of disease-modifying antirheumatic drugs (DMARDs), disease activity and markers of inflammation may dilute the relationship between focal erosions and hip BMD.
As to why there was a stronger relationship between hip BMD and erosions than with spine BMD, there are several possible explanations. It's possible that the inflammation underlying RA affects the hip more than the spine or that the effects are more apparent at the hip, which may more closely relate to joint mobility and overall functional status.
Several prior studies have examined the bone manifestations of RA, but the current study is one of the only ones to date that has focused on the relationship between two skeletal manifestations of the disease. The authors note that almost all participants were taking DMARDs, which may blunt the relationship between erosions and BMD. Also, patients were not currently taking glucocorticoids or osteoporosis medications but may have in the past, which might have had an effect on the results. Supplemental vitamin D use may also have had an unforeseen effect.
"It may be that the presumed association between erosions and BMD is most relevant with regard to patients with severe or early untreated RA," the authors conclude. This could become increasingly important as more bone-directed treatments become part of RA treatment protocols. For example, data from trials of a monoclonal antibody directed at a molecule important in bone metabolism suggest that it may be effective at improving BMD and reducing progression of erosion. Since focal erosions and osteoporosis may be manifestations of a similar inflammatory response, further studies may clarify important roles of inflammation in both of these processes in RA.
Article: "The Relationship Between Focal Erosions and Generalized Osteoporosis in Postmenopausal Women with Rheumatoid Arthritis," Daniel H. Solomon, Joel S. Finkelstein, Nancy Shadick, Meryl S. LeBoff, Carl S. Winalski, Margaret Stedman, Roberta Glass, M. Alan Brookhart, Michael E. Weinblatt, Ellen M. Gravallese, Arthritis & Rheumatism, June 2009.
Source:
Sean Wagner
Wiley-Blackwell
Led by Daniel H. Solomon of Brigham and Women's Hospital in Boston , the study involved 163 postmenopausal women with RA, none of whom were taking osteoporosis medications. Participants underwent bone density scans of the hip and spine, as well as X-rays of the hand to determine if they had bone erosions.
The results showed that hip bone mineral density (BMD) correlated with bone erosion, but the relationship was not statistically significant after adjusting for clinical factors such as age, BMI and use of oral glucocorticoids used to treat RA. The relationship did appear stronger, however, in patients with early RA. "Our findings suggest that the relationship between focal erosions and generalized osteoporosis is complicated and modified by many aspects of RA and other factors," the authors state. They point out that with longer disease duration, other variables such as the use of disease-modifying antirheumatic drugs (DMARDs), disease activity and markers of inflammation may dilute the relationship between focal erosions and hip BMD.
As to why there was a stronger relationship between hip BMD and erosions than with spine BMD, there are several possible explanations. It's possible that the inflammation underlying RA affects the hip more than the spine or that the effects are more apparent at the hip, which may more closely relate to joint mobility and overall functional status.
Several prior studies have examined the bone manifestations of RA, but the current study is one of the only ones to date that has focused on the relationship between two skeletal manifestations of the disease. The authors note that almost all participants were taking DMARDs, which may blunt the relationship between erosions and BMD. Also, patients were not currently taking glucocorticoids or osteoporosis medications but may have in the past, which might have had an effect on the results. Supplemental vitamin D use may also have had an unforeseen effect.
"It may be that the presumed association between erosions and BMD is most relevant with regard to patients with severe or early untreated RA," the authors conclude. This could become increasingly important as more bone-directed treatments become part of RA treatment protocols. For example, data from trials of a monoclonal antibody directed at a molecule important in bone metabolism suggest that it may be effective at improving BMD and reducing progression of erosion. Since focal erosions and osteoporosis may be manifestations of a similar inflammatory response, further studies may clarify important roles of inflammation in both of these processes in RA.
Article: "The Relationship Between Focal Erosions and Generalized Osteoporosis in Postmenopausal Women with Rheumatoid Arthritis," Daniel H. Solomon, Joel S. Finkelstein, Nancy Shadick, Meryl S. LeBoff, Carl S. Winalski, Margaret Stedman, Roberta Glass, M. Alan Brookhart, Michael E. Weinblatt, Ellen M. Gravallese, Arthritis & Rheumatism, June 2009.
Source:
Sean Wagner
Wiley-Blackwell
пятница, 12 августа 2011 г.
Abbott Study Examines Rates Of Uveitis (Inflammation Of The Eye) In Ankylosing Spondylitis Patients Treated With HUMIRA(R) (adalimumab)
A study of
ankylosing spondylitis (AS) patients treated with Abbott's HUMIRA(R) showed
a decrease in the rate of uveitis flares by approximately half compared to
patients treated with placebo. Ankylosing spondylitis is an inflammatory
disease of the spine, and may also be associated with other inflammatory
diseases of the skin, eyes, and intestines. Uveitis, or inflammation of the
eye, occurs in up to 40 percent of people with AS, and can lead to severe
and painful symptoms, including eye damage and blindness. These data were
presented today at the American College of Rheumatology Annual Scientific
Meeting in Boston.
The RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) trial was designed to examine
the effectiveness of HUMIRA in treating the signs and symptoms of AS in
patients with active disease despite previous standard treatment. The 1,250
patient trial also included a subset of patients (n=274) with uveitis.
Results of the trial suggested that the number of uveitis flares was
reduced in patients with active AS treated with HUMIRA.
In the prospective, multi-national, open-label trial, adult patients
with active AS who had insufficient responses to prior non-steroidal
anti-inflammatory drug (NSAID) therapy received open-label HUMIRA 40 mg
subcutaneously every other week for 12 weeks. Patients with symptomatic
uveitis at baseline and/or in the previous year received the same regimen
for a total of 20 weeks. Evaluations of treatment effects were measured at
weeks 2, 6, 12 and week 20, if applicable.
This analysis measured the number of acute flares during treatment with
HUMIRA both for all patients in the trial and for patients with pre-known
history of uveitis. The rate was calculated as flares per 100-patient-years
(100-PYs), which represent the number of flares that would occur in 100
patients observed or treated for one year. The rate of uveitis flares was
reduced by approximately half during treatment with HUMIRA compared with
the rate prior to the trial (15 flares/100-PY to 7.4 flares/100-PY in the
entire trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the
subset with a history of uveitis).
Overall, 27 adverse events of uveitis were reported for 25/1,250
patients. Two of the 25 patients experienced an attack of uveitis for the
first time. In both patients, the general AS disease activity was high at
time of the anterior uveitis episode.
"Uveitis is a fairly common and potentially serious complication of
ankylosing spondylitis," said Martin Rudwaleit, M.D., of the Charite
University Hospital in Germany and lead author of the trial. "This study is
an example of the research needed to better understand this condition and
the impact it has on these patients."
About RHAPSODY
RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) is a prospective,
multi-national, open-label trial designed to examine the effectiveness of
HUMIRA in treating the signs and symptoms of the disease in a large number
of patients (n=1,250) with active AS despite previous standard treatment,
including patients with uveitis (n=274), in real-life clinical practices.
About Uveitis
There are three different types of uveitis based on the part of the eye
involved, including anterior, posterior or intermediate. Acute anterior
uveitis occurs in up to 40 percent of patients with AS. Symptoms include
pain, light sensitivity, blurry vision or reduced vision; severe
complications may include high eye pressure, cataracts, or glaucoma, which
can lead to permanent loss of vision.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a type of arthritis that primarily
causes inflammation of the spine. Ankylosing means "stiff or rigid" and
spondylitis means "inflammation of the spine." Advanced AS can lead to new
bone formation on the spine causing the spine to fuse in a fixed position.
Typically, the first symptoms of AS are gradual and can include frequent
pain and stiffness in the lower back and buttocks. In addition to back
pain, other symptoms can include inflammation of joints or tendons, weight
loss, fatigue, and eye inflammation (uveitis).
AS affects an estimated 129 out of 100,000 people in the United States
and commonly develops between the ages of 15 and 40. Men are three times
more likely than women to develop AS. Although the course and severity of
AS varies from person to person, some patients with progressive AS can
develop spinal deformities leading to significant disability.
The cause of AS is not known, though genetics may play a role: 90
percent of people with AS share a common genetic marker, but having this
genetic marker does not mean a person will develop the disease.
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and opportunistic
infections, including fatalities, have been reported with the use of
TNF-blocking agents, including HUMIRA. Many of these serious infections
have occurred in patients also taking other immunosuppressive agents that
in addition to their underlying disease could predispose them to
infections. Infections have also been reported in patients receiving HUMIRA
alone. Treatment with HUMIRA should not be initiated in patients with
active infections. TNF-blocking agents, including HUMIRA, have been
associated with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus. Some cases have been fatal. Patients at
risk for HBV infections should be evaluated for prior evidence of HBV
infections before initiating HUMIRA. The combination of HUMIRA and anakinra
is not recommended and patients using HUMIRA should not receive live
vaccines.
More cases of malignancies have been observed among patients receiving
TNF blockers, including HUMIRA, compared to control patients in clinical
trials. These malignancies, other than lymphoma and non-melanoma skin
cancer, were similar in type and number to what would be expected in the
general population. There was an approximately 3.5 fold higher rate of
lymphoma in combined controlled and uncontrolled open-label portions of
HUMIRA clinical trials. The potential role of TNF-blocking therapy in the
development of malignancies is not known. TNF-blocking agents, including
HUMIRA, have been associated in rare cases with demyelinating disease and
severe allergic reactions. Infrequent reports of serious blood disorders
have been reported with TNF-blocking agents.
Worsening congestive heart failure (CHF) has been observed with
TNF-blocking agents, including HUMIRA, and new onset CHF has been reported
with TNF-blocking agents. Treatment with HUMIRA may result in the formation
of autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled
clinical trials in adults with 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.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic
arthritis and Crohn's disease, the safety profile for adult patients
treated with HUMIRA was similar to the safety profile seen in adult
patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is approved for the treatment of adults with rheumatoid
arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and
Crohn's disease in the United States and in Europe. HUMIRA resembles
antibodies normally found in the body. It works by blocking tumor necrosis
factor alpha (TNF-alpha), an inflammatory protein that, when produced in
excess, plays a key role in the inflammatory responses of autoimmune
diseases.
Earlier this year, HUMIRA received FDA approval of data in the Clinical
section of the label regarding the long-term maintenance of efficacy to 5
years with respect to clinical response, physical function and radiographic
response in patients with rheumatoid arthritis. To date, HUMIRA has been
approved in 67 countries and more than 190,000 people worldwide are
currently being treated with HUMIRA. Clinical trials are currently under
way evaluating the potential of HUMIRA in other immune-mediated diseases.
In the U.S., HUMIRA is approved by the FDA for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult patients with
moderately to severely active RA. HUMIRA is indicated for reducing the
signs and symptoms of active arthritis, inhibiting the progression of
structural damage and improving physical function in patients with
psoriatic arthritis. HUMIRA can be used alone or in combination with
methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is also approved for reducing signs and symptoms in patients with
active AS.
Earlier this year, HUMIRA was approved for reducing the signs and
symptoms and inducing and maintaining clinical remission in adults with
moderately to severely active Crohn's disease who have had an inadequate
response to conventional therapy, and reducing the signs and symptoms and
inducing clinical remission in these patients if they have also lost
response to or are intolerant to infliximab.
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, Mass., United States, is a world-class discovery and
basic research facility supporting research and development of biologic
treatments. Abbott Biotechnology Limited, which opened April 10, 2007, in
Barceloneta, Puerto Rico, is the main production facility for HUMIRA.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals and devices. The company
employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at abbott.
Abbott
abbott
View drug information on Humira.
ankylosing spondylitis (AS) patients treated with Abbott's HUMIRA(R) showed
a decrease in the rate of uveitis flares by approximately half compared to
patients treated with placebo. Ankylosing spondylitis is an inflammatory
disease of the spine, and may also be associated with other inflammatory
diseases of the skin, eyes, and intestines. Uveitis, or inflammation of the
eye, occurs in up to 40 percent of people with AS, and can lead to severe
and painful symptoms, including eye damage and blindness. These data were
presented today at the American College of Rheumatology Annual Scientific
Meeting in Boston.
The RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) trial was designed to examine
the effectiveness of HUMIRA in treating the signs and symptoms of AS in
patients with active disease despite previous standard treatment. The 1,250
patient trial also included a subset of patients (n=274) with uveitis.
Results of the trial suggested that the number of uveitis flares was
reduced in patients with active AS treated with HUMIRA.
In the prospective, multi-national, open-label trial, adult patients
with active AS who had insufficient responses to prior non-steroidal
anti-inflammatory drug (NSAID) therapy received open-label HUMIRA 40 mg
subcutaneously every other week for 12 weeks. Patients with symptomatic
uveitis at baseline and/or in the previous year received the same regimen
for a total of 20 weeks. Evaluations of treatment effects were measured at
weeks 2, 6, 12 and week 20, if applicable.
This analysis measured the number of acute flares during treatment with
HUMIRA both for all patients in the trial and for patients with pre-known
history of uveitis. The rate was calculated as flares per 100-patient-years
(100-PYs), which represent the number of flares that would occur in 100
patients observed or treated for one year. The rate of uveitis flares was
reduced by approximately half during treatment with HUMIRA compared with
the rate prior to the trial (15 flares/100-PY to 7.4 flares/100-PY in the
entire trial population, 68.4 flares/100-PY to 28.9 flares/100-PY in the
subset with a history of uveitis).
Overall, 27 adverse events of uveitis were reported for 25/1,250
patients. Two of the 25 patients experienced an attack of uveitis for the
first time. In both patients, the general AS disease activity was high at
time of the anterior uveitis episode.
"Uveitis is a fairly common and potentially serious complication of
ankylosing spondylitis," said Martin Rudwaleit, M.D., of the Charite
University Hospital in Germany and lead author of the trial. "This study is
an example of the research needed to better understand this condition and
the impact it has on these patients."
About RHAPSODY
RHAPSODY (Review of safety and effectiveness witH Adalimumab in
Patients with active ankylosing SpOnDYlitis) is a prospective,
multi-national, open-label trial designed to examine the effectiveness of
HUMIRA in treating the signs and symptoms of the disease in a large number
of patients (n=1,250) with active AS despite previous standard treatment,
including patients with uveitis (n=274), in real-life clinical practices.
About Uveitis
There are three different types of uveitis based on the part of the eye
involved, including anterior, posterior or intermediate. Acute anterior
uveitis occurs in up to 40 percent of patients with AS. Symptoms include
pain, light sensitivity, blurry vision or reduced vision; severe
complications may include high eye pressure, cataracts, or glaucoma, which
can lead to permanent loss of vision.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS) is a type of arthritis that primarily
causes inflammation of the spine. Ankylosing means "stiff or rigid" and
spondylitis means "inflammation of the spine." Advanced AS can lead to new
bone formation on the spine causing the spine to fuse in a fixed position.
Typically, the first symptoms of AS are gradual and can include frequent
pain and stiffness in the lower back and buttocks. In addition to back
pain, other symptoms can include inflammation of joints or tendons, weight
loss, fatigue, and eye inflammation (uveitis).
AS affects an estimated 129 out of 100,000 people in the United States
and commonly develops between the ages of 15 and 40. Men are three times
more likely than women to develop AS. Although the course and severity of
AS varies from person to person, some patients with progressive AS can
develop spinal deformities leading to significant disability.
The cause of AS is not known, though genetics may play a role: 90
percent of people with AS share a common genetic marker, but having this
genetic marker does not mean a person will develop the disease.
Important Safety Information
Serious infections, sepsis, tuberculosis (TB) and opportunistic
infections, including fatalities, have been reported with the use of
TNF-blocking agents, including HUMIRA. Many of these serious infections
have occurred in patients also taking other immunosuppressive agents that
in addition to their underlying disease could predispose them to
infections. Infections have also been reported in patients receiving HUMIRA
alone. Treatment with HUMIRA should not be initiated in patients with
active infections. TNF-blocking agents, including HUMIRA, have been
associated with reactivation of hepatitis B (HBV) in patients who are
chronic carriers of this virus. Some cases have been fatal. Patients at
risk for HBV infections should be evaluated for prior evidence of HBV
infections before initiating HUMIRA. The combination of HUMIRA and anakinra
is not recommended and patients using HUMIRA should not receive live
vaccines.
More cases of malignancies have been observed among patients receiving
TNF blockers, including HUMIRA, compared to control patients in clinical
trials. These malignancies, other than lymphoma and non-melanoma skin
cancer, were similar in type and number to what would be expected in the
general population. There was an approximately 3.5 fold higher rate of
lymphoma in combined controlled and uncontrolled open-label portions of
HUMIRA clinical trials. The potential role of TNF-blocking therapy in the
development of malignancies is not known. TNF-blocking agents, including
HUMIRA, have been associated in rare cases with demyelinating disease and
severe allergic reactions. Infrequent reports of serious blood disorders
have been reported with TNF-blocking agents.
Worsening congestive heart failure (CHF) has been observed with
TNF-blocking agents, including HUMIRA, and new onset CHF has been reported
with TNF-blocking agents. Treatment with HUMIRA may result in the formation
of autoantibodies and rarely, in development of a lupus-like syndrome.
The most frequent adverse events seen in the placebo-controlled
clinical trials in adults with 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.
In HUMIRA clinical trials for ankylosing spondylitis, psoriatic
arthritis and Crohn's disease, the safety profile for adult patients
treated with HUMIRA was similar to the safety profile seen in adult
patients with rheumatoid arthritis.
About HUMIRA
HUMIRA is approved for the treatment of adults with rheumatoid
arthritis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and
Crohn's disease in the United States and in Europe. HUMIRA resembles
antibodies normally found in the body. It works by blocking tumor necrosis
factor alpha (TNF-alpha), an inflammatory protein that, when produced in
excess, plays a key role in the inflammatory responses of autoimmune
diseases.
Earlier this year, HUMIRA received FDA approval of data in the Clinical
section of the label regarding the long-term maintenance of efficacy to 5
years with respect to clinical response, physical function and radiographic
response in patients with rheumatoid arthritis. To date, HUMIRA has been
approved in 67 countries and more than 190,000 people worldwide are
currently being treated with HUMIRA. Clinical trials are currently under
way evaluating the potential of HUMIRA in other immune-mediated diseases.
In the U.S., HUMIRA is approved by the FDA for reducing signs and
symptoms, inducing major clinical response, inhibiting the progression of
structural damage, and improving physical function in adult patients with
moderately to severely active RA. HUMIRA is indicated for reducing the
signs and symptoms of active arthritis, inhibiting the progression of
structural damage and improving physical function in patients with
psoriatic arthritis. HUMIRA can be used alone or in combination with
methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).
HUMIRA is also approved for reducing signs and symptoms in patients with
active AS.
Earlier this year, HUMIRA was approved for reducing the signs and
symptoms and inducing and maintaining clinical remission in adults with
moderately to severely active Crohn's disease who have had an inadequate
response to conventional therapy, and reducing the signs and symptoms and
inducing clinical remission in these patients if they have also lost
response to or are intolerant to infliximab.
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, Mass., United States, is a world-class discovery and
basic research facility supporting research and development of biologic
treatments. Abbott Biotechnology Limited, which opened April 10, 2007, in
Barceloneta, Puerto Rico, is the main production facility for HUMIRA.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals and devices. The company
employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the
company's Web site at abbott.
Abbott
abbott
View drug information on Humira.
вторник, 9 августа 2011 г.
Actemra: New Data Confirms Significant Improvement Of Disease Signs And Symptoms In Patients With Rheumatoid Arthritis
Second multinational phase III study provides further evidence of the significant role of IL-6 receptor inhibition in the treatment of rheumatoid arthritis
Roche announced today that TOWARD1, the second multinational phase III Actemra (tocilizumab) study, successfully reached its primary endpoint and showed that a greater proportion of patients treated with Actemra in combination with traditional disease modifying drugs (DMARDs) achieved a significant improvement in disease signs and symptoms at week 24, compared to the those treated with DMARDs alone. The patients' symptoms were measured using the standard ACR score2 assessment method. The patients enrolled in the study had active, moderate to severe rheumatoid arthritis (RA) and had experienced an inadequate response to DMARDs.
"The TOWARD trial data further documents the efficacy and safety of Actemra and the value of its IL-6 receptor inhibition. We look forward to further results from this extensive multinational Phase III development programme," commented William Burns, CEO Division Roche Pharmaceuticals.
The TOWARD trial included approximately 40% of patients from the United States and data from this trial will be submitted for presentation at international scientific meetings later this year and in 2008. TOWARD is the second of a programme of five phase III clinical trials running on Actemra, with two other trials due to report later in 2007. In January 2007 Roche reported that OPTION3, the first of the phase III trials outside Japan, had successfully met its primary endpoint in patients who had an inadequate response to methorexate.
About the TOWARD study
The TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) study was an international study treating 1216 patients with moderate to severe RA. The study was conducted at 130 study sites in 18 countries, including the USA. In this 2 arm, randomized, double-blind study, patients received either 8mg/kg Actemra intravenously every 4 weeks or placebo in combination with stable anti-rheumatic therapy, including traditional DMARDs but excluding biologics. A greater proportion of patients treated with Actemra in combination with traditional DMARDs achieved a significant improvement in disease signs and symptoms at week 24, compared to those treated with DMARDs alone. The study also explored pharmacokinetics, immune response and pharmacodynamic parameters of Actemra in this patient population.
About Actemra
Actemra is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. Roche and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera® (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs approximately 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at roche.
All trademarks used or mentioned in this release are protected by law.
References:
1) TOWARD refers to Tocilizumab in Combination With traditional DMARD therapy
2) The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20 or 50% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.
3) OPTION refers to the Tocilizumab Pivotal Trial in Methotrexate Inadequate respONders
View drug information on Actemra.
Roche announced today that TOWARD1, the second multinational phase III Actemra (tocilizumab) study, successfully reached its primary endpoint and showed that a greater proportion of patients treated with Actemra in combination with traditional disease modifying drugs (DMARDs) achieved a significant improvement in disease signs and symptoms at week 24, compared to the those treated with DMARDs alone. The patients' symptoms were measured using the standard ACR score2 assessment method. The patients enrolled in the study had active, moderate to severe rheumatoid arthritis (RA) and had experienced an inadequate response to DMARDs.
"The TOWARD trial data further documents the efficacy and safety of Actemra and the value of its IL-6 receptor inhibition. We look forward to further results from this extensive multinational Phase III development programme," commented William Burns, CEO Division Roche Pharmaceuticals.
The TOWARD trial included approximately 40% of patients from the United States and data from this trial will be submitted for presentation at international scientific meetings later this year and in 2008. TOWARD is the second of a programme of five phase III clinical trials running on Actemra, with two other trials due to report later in 2007. In January 2007 Roche reported that OPTION3, the first of the phase III trials outside Japan, had successfully met its primary endpoint in patients who had an inadequate response to methorexate.
About the TOWARD study
The TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) study was an international study treating 1216 patients with moderate to severe RA. The study was conducted at 130 study sites in 18 countries, including the USA. In this 2 arm, randomized, double-blind study, patients received either 8mg/kg Actemra intravenously every 4 weeks or placebo in combination with stable anti-rheumatic therapy, including traditional DMARDs but excluding biologics. A greater proportion of patients treated with Actemra in combination with traditional DMARDs achieved a significant improvement in disease signs and symptoms at week 24, compared to those treated with DMARDs alone. The study also explored pharmacokinetics, immune response and pharmacodynamic parameters of Actemra in this patient population.
About Actemra
Actemra is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. Roche and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera® (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche's second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs approximately 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at roche.
All trademarks used or mentioned in this release are protected by law.
References:
1) TOWARD refers to Tocilizumab in Combination With traditional DMARD therapy
2) The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20 or 50% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.
3) OPTION refers to the Tocilizumab Pivotal Trial in Methotrexate Inadequate respONders
View drug information on Actemra.
суббота, 6 августа 2011 г.
Ibuprofen Puts High Risk Cardiac Patients At Risk--Drug Interaction May Cause Heart Attacks
Doctors who treat the painful condition of osteoarthritis in patients with increased cardiovascular risk need to be cautious. A team lead by researchers at Mount Sinai School of Medicine, are the first to study outcomes in high cardiovascular risk patients with osteoarthritis. The researchers compared combination treatments of low-dose aspirin with the drugs ibuprofen, naproxen and the cox-2 inhibitor lumiracoxib. They have found that high cardiovascular risk patients taking ibuprofen and aspirin combined are nine times more likely suffer a heart attack. This new study, published in Annals of the Rheumatic Diseases, suggests that ibuprofen interferes with the blood thinning properties of aspirin in patients at high risk for cardiovascular disease.
Past evidence suggests that both selective cox-2 inhibitors and non-selective non-steroidal anti-inflammatory drugs or NSAIDs increase the risk of cardiovascular events. However, research has been lacking in the high cardiovascular risk population of patients taking aspirin, in-combination with these pain medicines used for osteoarthritis. Mount Sinai researchers are among the first to study this area and have found that the common painkiller ibuprofen used for osteoarthritis, may boost the likelihood of heart problems in high cardiovascular risk patients who are already taking aspirin.
"Ibuprofen has a significantly higher rate of major cardiovascular events, mostly heart attacks, when compared to a COX-2 inhibitor," said Dr. Michael E. Farkouh, M.D., of Mount Sinai Heart, lead investigator of Therapeutic Arthritis Research and Gastrointestinal Event Trial ???" High Risk (TARGET- HR) and Associate Professor of Medicine and Cardiology at Mount Sinai School of Medicine. "The findings underscore the importance of not only considering the class of NSAIDs used in high risk cardiac patients with osteoarthritis but also making physicians aware of the interaction of NSAIDs with aspirin, diminishing any beneficial effects."
The cardiovascular health of 18, 523 patients over 50 years age with osteoarthritis were compared by researchers in the TARGET trial. Patients were taking high doses of lumiracoxib (Cox-2 inhibitor), or either of the NSAIDs- ibuprofen or naproxen. In patients with osteoarthritis at high cardiovascular risk not taking low-dose aspirin treatment, the rate of heart attacks was higher for those on lumiracoxib than it was for patients on naproxen. It was no higher for patients on ibuprofen. However, in patients at high cardiovascular risk taking low dose aspirin, ibuprofen was associated with a higher incidence of cardiovascular events than lumiracoxib and naproxen. The findings show interference of ibuprofen on the effects of aspirin in high cardiovascular risk patients.
"This is the first randomized trial evidence to show risk of interaction between ibuprofen and aspirin to be real," said Dr. Farkouh. "Doctors should not give high risk cardiovascular patients ibuprofen for pain while they are taking aspirin for their heart. Cardiologists, rheumatologists and gastroenterologists need to work together to fully evaluate the evidence at hand to make proper recommendations to primary care physicians."
Mount Sinai Heart
Mount Sinai Heart, under the creative leadership of Dr. Valentin Fuster, takes an integrated approach to clinical care, basic research and clinical research to dramatically improve the heart health of individuals globally. Mount Sinai Heart encompasses The Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Jos?©e and Henry R. Kravis Center for Cardiovascular Health at The Mount Sinai Medical Center, preeminent resources for the study and treatment of heart and blood vessel diseases. Committed to finding new and improved methods of diagnosis, treatment and prevention, they comprise a multidisciplinary effort that brings together the expertise of Mount Sinai School of Medicine and The Mount Sinai Hospital in cardiology, cardiovascular surgery, medical education, research and community service, with state-of-the-art facilities for patient care, advanced laboratories for scientific research and leading programs for postgraduate education of clinician-scientists.
About The Mount Sinai Hospital
The Mount Sinai Hospital is one of the nation's oldest, largest and most-respected voluntary hospitals. Founded in 1852, Mount Sinai today is a 1,171-bed tertiary-care teaching facility that is internationally acclaimed for excellence in clinical care.
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2005 of $174.1 million in research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
Mount Sinai Medical Center
One Gustave Levy Place
New York, NY 10029
United States
Mount Sinai Medical Center
Past evidence suggests that both selective cox-2 inhibitors and non-selective non-steroidal anti-inflammatory drugs or NSAIDs increase the risk of cardiovascular events. However, research has been lacking in the high cardiovascular risk population of patients taking aspirin, in-combination with these pain medicines used for osteoarthritis. Mount Sinai researchers are among the first to study this area and have found that the common painkiller ibuprofen used for osteoarthritis, may boost the likelihood of heart problems in high cardiovascular risk patients who are already taking aspirin.
"Ibuprofen has a significantly higher rate of major cardiovascular events, mostly heart attacks, when compared to a COX-2 inhibitor," said Dr. Michael E. Farkouh, M.D., of Mount Sinai Heart, lead investigator of Therapeutic Arthritis Research and Gastrointestinal Event Trial ???" High Risk (TARGET- HR) and Associate Professor of Medicine and Cardiology at Mount Sinai School of Medicine. "The findings underscore the importance of not only considering the class of NSAIDs used in high risk cardiac patients with osteoarthritis but also making physicians aware of the interaction of NSAIDs with aspirin, diminishing any beneficial effects."
The cardiovascular health of 18, 523 patients over 50 years age with osteoarthritis were compared by researchers in the TARGET trial. Patients were taking high doses of lumiracoxib (Cox-2 inhibitor), or either of the NSAIDs- ibuprofen or naproxen. In patients with osteoarthritis at high cardiovascular risk not taking low-dose aspirin treatment, the rate of heart attacks was higher for those on lumiracoxib than it was for patients on naproxen. It was no higher for patients on ibuprofen. However, in patients at high cardiovascular risk taking low dose aspirin, ibuprofen was associated with a higher incidence of cardiovascular events than lumiracoxib and naproxen. The findings show interference of ibuprofen on the effects of aspirin in high cardiovascular risk patients.
"This is the first randomized trial evidence to show risk of interaction between ibuprofen and aspirin to be real," said Dr. Farkouh. "Doctors should not give high risk cardiovascular patients ibuprofen for pain while they are taking aspirin for their heart. Cardiologists, rheumatologists and gastroenterologists need to work together to fully evaluate the evidence at hand to make proper recommendations to primary care physicians."
Mount Sinai Heart
Mount Sinai Heart, under the creative leadership of Dr. Valentin Fuster, takes an integrated approach to clinical care, basic research and clinical research to dramatically improve the heart health of individuals globally. Mount Sinai Heart encompasses The Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Jos?©e and Henry R. Kravis Center for Cardiovascular Health at The Mount Sinai Medical Center, preeminent resources for the study and treatment of heart and blood vessel diseases. Committed to finding new and improved methods of diagnosis, treatment and prevention, they comprise a multidisciplinary effort that brings together the expertise of Mount Sinai School of Medicine and The Mount Sinai Hospital in cardiology, cardiovascular surgery, medical education, research and community service, with state-of-the-art facilities for patient care, advanced laboratories for scientific research and leading programs for postgraduate education of clinician-scientists.
About The Mount Sinai Hospital
The Mount Sinai Hospital is one of the nation's oldest, largest and most-respected voluntary hospitals. Founded in 1852, Mount Sinai today is a 1,171-bed tertiary-care teaching facility that is internationally acclaimed for excellence in clinical care.
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai's leadership in scientific investigation is its receipt during fiscal year 2005 of $174.1 million in research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
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среда, 3 августа 2011 г.
First Actemra Multinational Phase III Trial Demonstrates Significant Improvement In Signs And Symptoms Of Rheumatoid Arthritis
Roche announced today that 'OPTION'1, the first multinational phase III study of Actemra (tocilizumab) outside of Japan, successfully met its primary endpoint in the group of patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate. The study showed that a greater proportion of RA patients treated with Actemra achieved a significant improvement in disease signs and symptoms (ACR scores2) at week 24, compared to methotrexate control. Moreover, the preliminary analysis did not reveal any clinically important safety concerns with Actemra compared to control.
"We are pleased that this study confirms the favourable efficacy and safety profile of Actemra in the treatment of RA. Actemra, through its unique blockade of the interleukin-6 receptor, will provide a new treatment option for people afflicted by rheumatoid arthritis," commented William M. Burns, CEO Division Roche Pharmaceuticals.
Data from this trial will be submitted for presentation at upcoming international scientific meetings. In addition, four other phase III trials exploring Actemra in RA are ongoing with three of them scheduled to report in 2007.
About the OPTION study
The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) study was an international study which took place in 17 countries with 73 centres entering 623 patients with moderate to severe RA. In this 3 arm, randomized, double-blind study, patients received Actemra intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly.
The study found that patients treated with Actemra had a significant reduction in the signs and symptoms of rheumatoid arthritis over 6 months of treatment. Moreover, the preliminary analysis did not reveal any clinically important safety concerns with Actemra compared to control. The study also explored pharmacokinetics and mechanisms of the effect of IL-6 receptor blockade on the immune response in RA patients.
About Actemra
Actemra (tocilizumab) is a new humanised interleukin-6 (IL-6) receptor monoclonal antibody with a novel mechanism of action providing a unique treatment option for RA, a disease with a high unmet medical need. Roche and Chugai have initiated a collaborative phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra (tocilizumab) is another 'first-in-class' medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, blocking the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III development.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).
References:
1) OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate responders
2) The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20 or 50% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.
All trademarks used or mentioned in this release are legally protected.
Roche
roche
View drug information on Actemra.
"We are pleased that this study confirms the favourable efficacy and safety profile of Actemra in the treatment of RA. Actemra, through its unique blockade of the interleukin-6 receptor, will provide a new treatment option for people afflicted by rheumatoid arthritis," commented William M. Burns, CEO Division Roche Pharmaceuticals.
Data from this trial will be submitted for presentation at upcoming international scientific meetings. In addition, four other phase III trials exploring Actemra in RA are ongoing with three of them scheduled to report in 2007.
About the OPTION study
The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) study was an international study which took place in 17 countries with 73 centres entering 623 patients with moderate to severe RA. In this 3 arm, randomized, double-blind study, patients received Actemra intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly.
The study found that patients treated with Actemra had a significant reduction in the signs and symptoms of rheumatoid arthritis over 6 months of treatment. Moreover, the preliminary analysis did not reveal any clinically important safety concerns with Actemra compared to control. The study also explored pharmacokinetics and mechanisms of the effect of IL-6 receptor blockade on the immune response in RA patients.
About Actemra
Actemra (tocilizumab) is a new humanised interleukin-6 (IL-6) receptor monoclonal antibody with a novel mechanism of action providing a unique treatment option for RA, a disease with a high unmet medical need. Roche and Chugai have initiated a collaborative phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 41 countries including several European countries and the USA. In Japan, Actemra was launched in June 2005 as a therapy for Castleman's disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
About rheumatoid arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by chronic inflammation of multiple joints and fatigue as well as the possibility of osteoporosis, anaemia, and lung, skin and liver effects. This inflammation causes pain, stiffness and swelling, resulting in loss of joint function due to destruction of the bone and cartilage, often leading to progressive disability. Further, as chronic inflammation continues, there may be shortening of life expectancy as a result of effects on major organ systems. After 10 years, less than 50% of patients can continue to work or function normally on a day to day basis. RA affects more than 21 million people worldwide.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company's emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra (tocilizumab) is another 'first-in-class' medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, blocking the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a fully humanised anti-CD20 antibody, is just entering phase III development.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (roche).
References:
1) OPTION refers to the TOcilizumab Pivotal Trial in Methotrexate Inadequate responders
2) The ACR response is a standard assessment used to measure patients' responses to anti-rheumatic therapies, devised by the American College of Rheumatology (ACR). It requires a patient to have a defined percentage reduction in a number of symptoms and measures of their disease. For example, a 20 or 50% level of reduction (the percentage of reduction of RA symptoms) is represented as ACR20, ACR50 or ACR70. An ACR70 response is exceptional for existing treatments and represents a significant improvement in a patient's condition.
All trademarks used or mentioned in this release are legally protected.
Roche
roche
View drug information on Actemra.
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