A Trial of Etanercept, a Recombinant Tumor Necrosis Factor Receptor:Fc Fusion Protein, in Patients with Rheumatoid Arthritis Receiving Methotrexate
Michael E. Weinblatt, M.D., Joel M. Kremer, M.D., Arthur D. Bankhurst, M.D., Ken J. Bulpitt, M.D., Roy M. Fleischmann, M.D., Robert I. Fox, M.D., Christopher G. Jackson, M.D., Mary Lange, M.S., and Daniel J. Burge, M.D.
Background Patients treated with methotrexate for rheumatoidarthritis often improve but continue to have active disease.This study was undertaken to determine whether the additionof etanercept, a soluble tumor necrosis factor receptor (p75):Fcfusion protein (TNFR:Fc), to methotrexate therapy would provideadditional benefit to patients who had persistent rheumatoidarthritis despite receiving methotrexate.
Methods In a 24-week, double-blind trial, we randomly assigned89 patients with persistently active rheumatoid arthritis despiteat least 6 months of methotrexate therapy at a stable dose of15 to 25 mg per week (or as low as 10 mg per week for patientsunable to tolerate higher doses) to receive either etanercept(25 mg) or placebo subcutaneously twice weekly while continuingto receive methotrexate. The primary measure of clinical responsewas the American College of Rheumatology criteria for a 20 percentimprovement in measures of disease activity (ACR 20) at 24 weeks.
Results The addition of etanercept to methotrexate therapy resultedin rapid and sustained improvement. At 24 weeks, 71 percentof the patients receiving etanercept plus methotrexate and 27percent of those receiving placebo plus methotrexate met theACR 20 criteria (P<0.001); 39 percent of the patients receivingetanercept plus methotrexate and 3 percent of those receivingplacebo plus methotrexate met the ACR 50 criteria (for a 50percent improvement) (P<0.001). Patients receiving etanerceptplus methotrexate had significantly better outcomes accordingto all measures of disease activity. The only adverse eventsassociated with etanercept were mild injection-site reactions,and no patient withdrew from the study because of adverse eventsassociated with etanercept.
Conclusions In patients with persistently active rheumatoidarthritis, the combination of etanercept and methotrexate wassafe and well tolerated and provided significantly greater clinicalbenefit than methotrexate alone.
Source Information
From Brigham and Women's Hospital, Boston (M.E.W.); Albany Medical College, Albany, N.Y. (J.M.K.); the University of New Mexico School of Medicine, Albuquerque (A.D.B.); the University of California at Los Angeles, Los Angeles (K.J.B.); Metroplex Clinical Research Center, Dallas (R.M.F.); Scripps Clinic, La Jolla, Calif. (R.I.F.); the University of Utah Medical Center, Salt Lake City (C.G.J.); and Immunex Corporation, Seattle (M.L., D.J.B.).
Address reprint requests to Dr. Weinblatt at Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115.
Etanercept in Rheumatoid Arthritis
Cook D. A., Dimick J. B., Gallagher D. C., Escalante A., del Rincón I., Ferraccioli G.F., Di Poi E., Weinblatt M. E., Burge D. J.
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N Engl J Med 1999;
340:2000-2001, Jun 24, 1999.
Correspondence
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