Study Showed Half of Patients Treated with Enbrel (etanercept) Plus Methotrexate Can Achieve DAS Clinical Remission and 80 Percent Had No Progression of Joint Damage in Active Early Rheumatoid ArthritisCOLLEGEVILLE, Pa. & THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Jul 15, 2008 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Amgen (NASDAQ:AMGN) today announced the publication of data from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) trial demonstrating that half of patients treated with the combination of ENBREL and methotrexate achieved Disease Activity Score (DAS) clinical remission and nearly all had no progression of joint damage. These findings were published online on July 15 by The Lancet, a leading global medical journal.
According to study results at one year, 50 percent of patients (n = 265) with active early moderate-to-severe rheumatoid arthritis who received a combination of ENBREL and methotrexate therapy achieved DAS clinical remission (DAS28 less than 2.6) versus 28 percent (n = 263) of those treated with methotrexate alone. DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a modified measure of the DAS44, which is a validated tool used in clinical trials and serves as the basis for the European League Against Rheumatism (EULAR) response criteria.
"We hope that these data encourage physicians to use clinical remission as a new standard for evaluating symptom control in the treatment of early RA," said Paul Emery, M.D., lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK. "Clinical remission is highly relevant to patients' daily lives as they cope with their symptoms."
Additionally, at one year, 80 percent of patients (n = 246) receiving ENBREL and methotrexate had no evidence of progression of joint damage as seen on x-ray, compared to 59 percent (n = 230) of those treated with methotrexate alone.
Combination therapy with ENBREL plus methotrexate also helped patients remain more functionally active. Based on the Health Assessment Questionnaire (used to assess certain daily life activities), 61 percent (n = 256) of patients treated with combination therapy demonstrated improvement in their functionality versus 44 percent (n = 241) of those treated with only methotrexate. Further, the COMET trial showed that patients who were treated with combination therapy had a nearly three-fold reduction in work stoppage compared with those who received methotrexate alone.
"It's important for people living with a chronic disease like moderate to severe rheumatoid arthritis to be able to continue with their daily life activities," said Dr. Emery. "These data show that if patients receive combination treatment early, they are more likely to be able to continue with their daily activities, including going to work, than those treated with methotrexate alone."
American College of Rheumatology (ACR) scores were also assessed in the COMET study and were comparable to the DAS clinical remission data. Nearly half of patients receiving ENBREL plus methotrexate achieved an ACR 70 score, versus 28 percent of the methotrexate-only group. The percentage of patients who achieve an ACR 70 score represent those who achieve a 70 percent improvement in select RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician disease assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
The COMET study is a 24-month, double-blind, randomized, parallel group, multicenter, outpatient study. The data published in The Lancet represent the results of the first year of treatment, in which patients were randomly assigned to receive combination ENBREL 50 mg plus methotrexate therapy, or methotrexate alone, once a week for 52 weeks. The population under study had less than two years (median seven months) of moderately to severely active disease.
At one year, there were no differences in rates of serious infections or malignancies among patients in the ENBREL plus methotrexate group compared with the methotrexate-only group. No cases of tuberculosis or demyelinating disease were reported. No new safety signals were identified.
In other RA clinical trials of ENBREL, the most common adverse events were injection site reaction, infection, and headache. Rare cases of tuberculosis and demyelinating diseases have been reported in post-marketing surveillance.
To view the abstract of this manuscript, please visit the following Web site: www.thelancet.com/journals/lancet.
ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor and has 16 years of collective clinical experience with an established safety profile. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severe plaque psoriasis in adults.
ENBREL indications in the U.S.:
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
-- ENBREL is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
-- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
-- ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Important Safety Information
What important safety information do I need to know about taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with advanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
-- Think you have, are being treated for, have signs of, or are prone to infection
-- Have any open sores
-- Have or have had TB or hepatitis B
-- Have ever been treated for heart failure
-- Have ever had or develop a serious nervous system disorder
-- Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reaction, infection and headache.
In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious adverse reactions were reported, including serious infection and depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please visit www.enbrel.com or call 1-888-4ENBREL to request additional information, including the full U.S. Prescribing Information and Medication Guide.
About Amgen and Wyeth
Amgen and Wyeth Pharmaceuticals, a division of Wyeth, market ENBREL in North America. Wyeth markets ENBREL outside of North America. Immunex Corporation, a wholly owned subsidiary of Amgen, manufactures ENBREL.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. To learn more, visit www.wyeth.com.
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Posted: July 2008