Early treatment the best for patients with moderate to severe rheumatoid arthritis

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) 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 < 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 TB 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.

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