Amgen and Wyeth Pharmaceuticals, a division of Wyeth has announced that data from a multicenter, randomized, double-blind trial of ENBREL plus methotrexate showed that 50 per cent of patients with active early rheumatoid arthritis achieved clinical remission at one year. In contrast, 28 per cent of patients achieved clinical remission who were treated with methotrexate alone.

The population under study had less than two years (median seven months) of moderately to severely active disease. Results from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) trial will be presented at the American College of Rheumatology (ACR) Scientific Meeting in Boston, Massachusetts.

COMET marks the first major rheumatoid arthritis (RA) clinical trial with ENBREL to use clinical remission as a primary endpoint, as measured by disease activity score (DAS28 less than 2.6). 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.

"Clinical remission, as measured by DAS28, is an important goal in clinical practice, and is perhaps the most relevant to patients' daily lives as they struggle with their symptoms," said Paul Emery, professor of Rheumatology, University of Leeds, UK. "We hope that both patients and physicians are encouraged by these findings as they set a new standard for earlier treatment of RA".

The COMET study's secondary endpoints included proportions of patients achieving ACR 20, ACR 50 and ACR 70 scores at week 52 following treatment with ENBREL plus methotrexate, compared to methotrexate alone. The study showed 48 per cent of patients receiving ENBREL plus methotrexate achieved an ACR 70 score, versus 28 per cent of the methotrexate-only group. Additionally, 71 per cent of patients receiving combination therapy achieved an ACR 50 score, versus 49 per cent of patients treated with methotrexate alone. The percentage of patients who achieve an ACR 50 or ACR 70 score represent those who achieve a 50 per cent or 70 per cent 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.

More than two million Americans suffer from RA, which can cause stiffness, swelling, and limitation in the motion and function of multiple joints. If RA is left untreated, patients can become disabled from irreversible joint damage caused by the disease, limiting their ability to function.

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, the most common adverse events were injection site reaction, infection, and headache.

ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 and has since been used in more than 460,000 patients worldwide across indications.