To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Etanercept Plus Methotrexate Prevents Joint Damage in Early Active Rheumatoid Arthritis: Presented at EULAR URL: http://www.pslgroup.com/dg/223B5A.htm Doctor's Guide June 17, 2008
By Genie Benoist PARIS -- June 17, 2008 -- Early treatment with etanercept plus methotrexate can halt disease progression in patients with moderate to severe rheumatoid arthritis (RA) and help patients resume their routine activities, according to study results reported here at EULAR 2008, the Annual Congress of the European Union League Against Rheumatism. The Combination of Methotrexate and Etanercept in Active Early Rheumatoid Arthritis (COMET) study is the first major trial to use remission as its primary endpoint in patients with early active RA treated with a biologic therapy. In a presentation on June 13, lead investigator Paul Emery, MD, University of Leeds, Leeds, United Kingdom, reported 52-week clinical data in 528 randomised patients treated with etanercept plus methotrexate or methotrexate alone. He also presented findings in 476 patients evaluated for radiographic efficacy. Participants in the trial had RA for up to 2 years, were methotrexate-naive, and had active RA, defined as a Disease Activity Score (DAS) 28 of 3.2 or greater, with either elevated levels of erythrocyte sedimentation rate (ESR, >=28 mm/hr) or C-reactive protein (>=20 mg/L). Methotrexate was titrated starting at week 4 to a maximum of 20 mg/week at week 8. Primary efficacy endpoints were the proportion of patients achieving DAS28 remission and the change from baseline in modified Total Sharp Score (mTSS) at week 52. Other endpoints included low disease activity, radiographic nonprogression, and the percentage of patients achieving a Health Assessment Questionnaire (HAQ) score within the norm. Baseline demographics and disease characteristics were similar for both groups. Of the overall group, 21% had used disease-modifying antirheumatic drugs and 92% had severe disease (DAS28 >5.1). Results showed that 80% of patients treated with etanercept and 59% of those treated with methotrexate alone achieved radiographic remission or nonprogression, defined as a change in TSS (<=0.5) at 52 weeks (P < .001). In addition, 50% of patients on combination treatment achieved clinical remission (DAS28 <2.6) and nearly 55% achieved functional remission (HAQ <0.5) versus 28% and 39%, respectively, of patients treated with methotrexate alone (P < .001). "Until recently, we did not know whether remission was a realistic or even achievable goal," said Dr. Emery. "We now have results which show that not only is clinical remission achievable in a significant number of patients, but radiographic and functional remissions are also achievable." Combination therapy resulted in significantly lower radiographic progression than methotrexate monotherapy, with mean mTSS changes from baseline of 0.27 with the combination and 2.44 with monotherapy (P < .001) at week 52. The proportion of patients achieving HAQ scores within the norm was significantly greater in the combination therapy group (55% vs 39%, P < .001). Serious adverse events were reported by about 12% of patients in both groups. There were no differences in the frequency of serious infections or malignancies and no cases of tuberculosis or demyelinating disease. "The results demonstrate that remission is a realistic therapeutic goal when combination therapy is initiated early in the rheumatoid arthritis disease process," Dr. Emery and colleagues concluded. Funding for the study was provided by Wyeth Pharmaceuticals Inc. [Presentation title: Clinical Remission, Radiographic Non-Progression, and Normalized Function With the Combination of Etanercept and Methotrexate in the Treatment of Early Active Rheumatoid Arthritis: 1-Year Results of the COMET Trial. Abstract OP-0008] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.