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EULAR: Enbrel (Etanercept) Plus Methotrexate Show Significant Benefits In Rheumatoid Arthritis Treatment By Thomas Buckingham PRAGUE, CZECH REPUBLIC -- June 15, 2001 -- There is a significant and sustained long-term clinical benefit from the combination of Enbrel and methotrexate (MTX) in the treatment of rheumatoid arthritis (RA), according to researchers. Dr. R.M. Fleischmann of Dallas, Texas, presented this finding at the European League Against Rheumatism (EULAR) Congress, Prague, Czech Republic, June 13-16. The goal of this study was to observe the safety and clinical benefit of Enbrel plus MTX. The original trial was a six month, double-blind, placebo-controlled trial comparing MTX plus placebo or Enbrel, conducted at seven centers in the United States. This previous study showed a significant benefit of the Enbrel/MTX combination (p<0.001). The results of the open label extension study of up to three years were presented here. Disease activity or RA was evaluated using ACR criteria and adverse events were compared with data from a previous controlled study. Seventy-nine patients entered the long-term extension trial: 70 continued on therapy, three withdrew due to lack of efficacy, two desired to conceive, one began commercially available Enbrel, two stopped due to adverse events and one stopped prior to total knee replacement. The duration of exposure was one year in 76 patients, two years in 63 and three years in 41. Compared to baseline, the Health Assessment Questionnaire (HAQ) disability index improved from 1.5 to 0.8 (p<0.0001), the mean dose of MTX was reduced from 18 to 10.5 mg (p<0.0001). Adverse events were lower in the extension trial than in the original six-month double blind trial (1.35 infections/year compared to 2.62/year for placebo/MTX or 2.07/year for Enbrel/MTX). No evidence of autoimmunity was seen. Enbrel plus MTX is safe and well tolerated. Improvement of disease activity is sustained even when treatment with MTX or steroids is reduced or discontinued. SOURCE: PeerView Press E-mail this page to a friend or colleague! To print, use this version