 |
|
New Actemra data shows significant benefit for patients suffering from rheumatoid arthritis
November 09, 2007TOWARD study, presented at major US congress ACR, confirms IL-6 receptor inhibition plays a key role in the treatment of RA
The innovative new rheumatoid arthritis drug Actemra (tocilizumab) has been shown to significantly improve the signs and symptoms of rheumatoid arthritis (RA) in patients who failed to achieve an adequate response to traditional disease modifying agents (DMARDs). Exciting new data from the TOWARD1 study, being presented as a late breaker, at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, November 6-11, reinforce the benefit of tackling RA through the inhibition of the IL-6 pathway.
In the TOWARD trial, 61% of patients in the Actemra plus DMARD group achieved a 20% reduction in RA symptoms (ACR202 response) compared with only 25% of patients in the control group. Around one in three patients achieved clinical remission in the Actemra group, as assessed using DAS28 <2.63 .These results are consistent with the results of another Actemra trial, the OPTION4 study, which were previously reported and which will be the subject of further presentations at ACR. The OPTION study showed that 59% of patients in the Actemra treatment arm experienced a 20% reduction in RA symptoms (ACR20 response) versus only 27% of patients in the control group.
"We are very encouraged by the findings of this new TOWARD data which suggest that Actemra plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Mark C. Genovese, M.D., lead study investigator of the TOWARD trial and associate Professor of Medicine at Stanford University School of Medicine. "These data further establish the efficacy of Actemra and confirm that inhibiting the interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms."
"These results show that remission rates achieved with Actemra compare favourably with current RA therapies indicating the medicine's potential to become a very effective new treatment option," said Dr. Urs Schleuniger, Head of Inflammatory Diseases, Roche. "Findings from the TOWARD and OPTION studies will be part of the application to Regulatory Authorities that we intend to submit by the end of the year."
About TOWARD Study
Patients were randomized to receive either Actemra intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The multicentre study treated 1,216 patients at 130 trial sites in 18 countries, including the U.S. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28 <2.6) compared with 3% of patients treated with only DMARDs.
About OPTION Study
In the OPTION trial, 623 patients were randomized to receive Actemra intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries, outside the United States. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus methotrexate compared to the control arm. Fifty nine per cent, 44% and 22%, respectively, of patients treated with Actemra (8mg/kg) plus methotrexate achieved ACR20, ACR50 and ACR70 compared with 27%, 11% and 2%, respectively, in the control group. Disease remission was demonstrated in 28% of Actemra patients (DAS28 <2.6) compared with 1% of patients treated with methotrexate alone.
Other parameters measured in both studies included levels of C-reactive protein (CRP), a marker of inflammation, fatigue and haemoglobin. Patients on Actemra showed a rapid normalisation of the CPR levels within two weeks and a rapid improvement in haemoglobin levels. According to both studies, patients treated with Actemra plus DMARDs experienced greater improvements in quality of life and function measures, including fatigue and physical and mental functions compared to placebo plus DMARDs.
Actemra generally well tolerated in both TOWARD and OPTION
Actemra was generally well tolerated in both studies. The most common adverse events reported more frequently in the Actemra arm were upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other disease modifying anti-rheumatic drugs, serious infections have been reported in some patients treated with Actemra.
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. The overall safety profile observed in the global studies of Actemra is consistent and Actemra is generally well tolerated.
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.
Cohn & Wolfe, London
"We are very encouraged by the findings of this new TOWARD data which suggest that Actemra plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Mark C. Genovese, M.D., lead study investigator of the TOWARD trial and associate Professor of Medicine at Stanford University School of Medicine. "These data further establish the efficacy of Actemra and confirm that inhibiting the interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms."
"These results show that remission rates achieved with Actemra compare favourably with current RA therapies indicating the medicine's potential to become a very effective new treatment option," said Dr. Urs Schleuniger, Head of Inflammatory Diseases, Roche. "Findings from the TOWARD and OPTION studies will be part of the application to Regulatory Authorities that we intend to submit by the end of the year."
About TOWARD Study
Patients were randomized to receive either Actemra intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The multicentre study treated 1,216 patients at 130 trial sites in 18 countries, including the U.S. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28 <2.6) compared with 3% of patients treated with only DMARDs.
About OPTION Study
In the OPTION trial, 623 patients were randomized to receive Actemra intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries, outside the United States. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus methotrexate compared to the control arm. Fifty nine per cent, 44% and 22%, respectively, of patients treated with Actemra (8mg/kg) plus methotrexate achieved ACR20, ACR50 and ACR70 compared with 27%, 11% and 2%, respectively, in the control group. Disease remission was demonstrated in 28% of Actemra patients (DAS28 <2.6) compared with 1% of patients treated with methotrexate alone.
Other parameters measured in both studies included levels of C-reactive protein (CRP), a marker of inflammation, fatigue and haemoglobin. Patients on Actemra showed a rapid normalisation of the CPR levels within two weeks and a rapid improvement in haemoglobin levels. According to both studies, patients treated with Actemra plus DMARDs experienced greater improvements in quality of life and function measures, including fatigue and physical and mental functions compared to placebo plus DMARDs.
Actemra generally well tolerated in both TOWARD and OPTION
Actemra was generally well tolerated in both studies. The most common adverse events reported more frequently in the Actemra arm were upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other disease modifying anti-rheumatic drugs, serious infections have been reported in some patients treated with Actemra.
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. The overall safety profile observed in the global studies of Actemra is consistent and Actemra is generally well tolerated.
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.
Cohn & Wolfe, London
Rheumatoid Arthritis Current Events and Rheumatoid Arthritis News RSSResearchers find new way to attack inflammation in Graves' eye disease
A small group of patients with severe Graves' eye disease experienced rapid improvement of their symptoms - and improved vision - following treatment with the drug rituximab.
Pain thresholds linked to inflammation and sleep problems in arthritis patients
Despite recent advances in anti-inflammatory therapy, many rheumatoid arthritis (RA) patients continue to suffer from pain.
New therapy for vasculitis will help patients avoid infertility and cancer
Researchers have identified that Rituxan, a drug previously approved for the treatment of non-Hodgkin's B cell lymphoma and rheumatoid arthritis, can treat severe ANCA-associated vasculitis as effectively as cyclophosphamide, the current standard therapy.
Strategy for mismatched stem cell transplants triggers protection against graft-vs.-host disease
A new technique being tested in stem-cell transplants from imperfectly matched donors has revealed a striking, unforeseen response that can suppress graft-versus-host disease, a common and dangerous complication of mismatched transplants, report scientists from Dana-Farber Cancer Institute.
Grains and lamb offer new sources of omega-3
CSIRO research on grains and lamb aimed at developing new dietary sources of long-chain omega-3 oils will be presented at the World Congress on Oils and Fats in Sydney this week.
Visionary concept earns La Jolla Institute scientist prestigious NIH Pioneer Award
A scientist at the La Jolla Institute for Allergy & Immunology has received one of the National Institutes of Health (NIH)'s top awards -- the 2009 NIH Director's Pioneer Award.
Experimental approach may reverse rheumatoid arthritis and osteoporosis
Researchers have identified a mechanism that may keep a well known signaling molecule from eroding bone and inflaming joints, according to an early study published online today in the Journal of Clinical Investigation.
Promising new target emerges for autoimmune diseases
University of Michigan scientists say they have uncovered a fundamentally new mechanism that holds in check aggressive immune cells that can attack the body's own cells.
New 'biofactories' produce rare healing substances in the endangered Devil's claw plant
Deep in Africa's Kalahari Desert lies the "Devil's claw," a plant that may hold the key to effective treatments for arthritis, tendonitis and other illnesses that affect millions each year.
Abnormal Brain Circuits May Prevent Movement Disorder
Most people who carry a genetic mutation for a movement disorder called dystonia will never develop symptoms, a phenomenon that has puzzled scientists since the first genetic mutation was identified in the 1990's.
More Rheumatoid Arthritis Current Events and Rheumatoid Arthritis News Articles
 |
The First Year: Rheumatoid Arthritis: An Essential Guide for the Newly Diagnosed (First Year, The) by M.E.A. McNeil (Author), Kenneth Sack MD (Foreword) Rheumatoid arthritis (RA), a disease characterized by inflammation of the joints, is one of the most disabling forms of arthritis and affects over two million people in the United States. Without proper treatment it can lead to long-term joint damage, chronic pain, loss of function, and disability. From the first moment of her diagnosis, author M.E.A. McNeil took charge and educated herself on every aspect of her condition. Now, as a "patient-expert," she guides those newly diagnosed step-by-step through their first year with RA. McNeil provides crucial information about the nature of the disease, treatment options, diet, exercise, social concerns, emotional issues, networking with others, and much more. The First Year—Rheumatoid Arthritis is an essential resource for everyone who wants... |
 |
The New Arthritis Breakthrough: The Only Medical Therapy Clinically Proven to Produce Long-term Improvement and Remission of RA, Lupus, Juvenile RS, Fibromyalgia, ... & Other Inflammatory Forms of Arthritis by Henry Scammell (Author) "...can be miraculous for rheumatoid arthritis sufferers."-- Health & Healing, Tomorrow's Medicine Today |
 |
Living with Rheumatoid Arthritis (Johns Hopkins Press Health Book) by Tammi L. Shlotzhauer MD (Author), James L. McGuire MD (Author), Carol M. Ziminski MD (Foreword) Already a trusted guide and an invaluable resource, Living with Rheumatoid Arthritis offers practical advice for the millions of people who live with this painful disease. Now thoroughly revised and expanded, this second edition brings readers up to date with the latest methods of diagnosis and treatment. Building on their accessible explanation of the disease and its causes, the authors describe the essential components of care: medication, joint protection, physical activity, and good nutrition. They provide a wealth of new information on medications, including biologic response–modifiers, alternative and complementary approaches, and treatments for osteoporosis (which often accompanies rheumatoid arthritis), and they describe safe and effective ways to cope with pain,... |
 |
Freedom from Rheumatoid Arthritis: The amazing story of one woman's recovery by Sonia St. Claire (Author) Freedom from Rheumatoid Arthritis is an inspirational book about survival. It tells the story of how one woman went from being a bed ridden cripple on and off for a year and a half, to reclaiming her health, happiness and quality of life stolen from her by this insidious disease. It is the story of a journey, a journey of discovery undertaken by one fiercely determined woman. A woman who has been to the depths and healed herself, and now with consummate compassion and grace, offers to share that process with you. This book includes a seven day menu, recovery and maintenance diet and recipes. |
 |
The Arthritis Foundation's Guide to Good Living with Rheumatoid Arthritis, 3rd Edition by Dorothy Foltz-Gray (Author) From the Arthritis Foundation, a trusted source of health information and guidance for more than 50 years, Good Living With Rheumatoid Arthritis, 3rd Edition, explains new research and treatments in clear, simple language. Readers will learn how to be proactive patients, how to stretch daily to reduce pain and increase flexibility, and how to judge the many over-the-counter drugs and supplements on the market today. |
 |
Synova Total Joint Care with Glucosamine, Chondroitin, MSM for Osteo and Rheumatoid Arthritis - 60 Coated Caplets by Next Nutraceuticals Synova Total Joint Care provides the latest clinically tested ingredients for the body's moveable joints, called synovial joints. The shoulder, elbow, wrist, fingers, hip, knee, ankle and toes are synovial joints. Synova Total Joint Care works to support joint health as well as joint flare-ups.* *Glucosamine HCl - a precursor for glycosaminoglycans, the primary component of joint cartilage. Glucosamine can help rebuild, renew and strengthen synovial joint cartilage.* *Joint Serum (Hyaluronic Acid) - HA is a natural component of synovial fluid found to increase joint viscosity, naturally helping to lubricate and re-hydrate joints.* *Methylsulfonylmethane (MSM) - a naturally occuring sulfur needed to form collagen, which is the protein found in all synovial connective... |
 |
Rheumatoid Arthritis: The Infection Connection {Targeting and Treating the Cause of Chronic Illness} by Katherine M. Poehlmann (Author) Foreword by Dr. Harold W. Clark, author of "Why Arthritis?" Appendices by Dr. Joseph Mercola (mercola.com) and Dr. Garth Nicolson (Institute for Molecular Medicine) Definitions of terms ****************************** EVERYTHING YOU NEED TO KNOW BEFORE CONSULTING YOUR DOCTOR! ****************************** A research scientist and former arthritis sufferer outlines a proven treatment that could banish your arthritis pain forever. This well-documented study presents evidence that rheumatoid arthritis (RA) and other chronic illnesses are caused by microbial infection. When the infection triggers allergic reactions, it appears that the body's immune system has turned on itself. Once the cause of the infection and allergies are identified and removed,... |
 |
Conquering Arthritis: What Doctors Don't Tell You Because They Don't Know: 9 Secrets I Learned the Hard Way by Barbara D. Allan (Author) This book provides hard-earned, practical, detailed information that is critical for successful healing of arthritis, but that has never before been collected in one book. Without this information many people with arthritis will not get well. The information is organized into a well-researched, easy-to-follow plan for getting well again and includes case histories of people with dramatic and lasting recoveries. It focuses not just on coping with the symptoms of arthritis, but on correcting its underlying causes using proven alternative medicine and pain management techniques. Anyone who is serious about healing from arthritis needs this book. |
 |
What To Do When The Doctor Says It's Rheumatoid Arthritis: Stop Your Pain, Become More Active, and Learn How to Talk to Your Doctors by Winnie Yu (Author), Harry D. Fischer (Author) Rheumatoid arthritis is a painful, incurable connective-tissue disease that attacks the hands, feet, and joints and may lead to deformities and permanent disabilities. This book, written by a doctor and health journalist will offer comprehensive medical advice and lifestyle information for the nearly three million Americans who suffer from this disease. The book uses mind-body techniques and alternative medicine to cope with the pain and discomfort, including information on: Pain relief Exercise Nutrition Managing your relationship with your doctors |
 |
Rheumatoid Arthritis, 2nd Edition by John J. Cush (Author), Michael E. Weinblatt (Author), Arthur Kavanaugh (Author) Emphasizes the importance of early intervention in Rheumatoid Arthritis with focus on pharmacologic treatments of RA. Detailed information on the various medications employed in treatment, including corticosteroids, NSAIDs, DMARDs, biologic agents, and combination therapy, is reviewed, including evidence based data on efficacy, safety, side effects, and monitoring requirements. Clinical evaluation is presented, including lab findings, joint scoring, diagnostic criteria, and radiographic outcomes. Surgical options and the management of advanced RA are discussed. |
| © 2009 BrightSurf.com |