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Volume 340:253-259 January 28, 1999 Number 4 Next

	Full Text PDF Editorial by O'Dell, J. R. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Patients treated with methotrexate for rheumatoid arthritis often improve but continue to have active disease. This study was undertaken to determine whether the addition of etanercept, a soluble tumor necrosis factor receptor (p75):Fc fusion protein (TNFR:Fc), to methotrexate therapy would provide additional benefit to patients who had persistent rheumatoid arthritis despite receiving methotrexate.

Methods In a 24-week, double-blind trial, we randomly assigned 89 patients with persistently active rheumatoid arthritis despite at least 6 months of methotrexate therapy at a stable dose of 15 to 25 mg per week (or as low as 10 mg per week for patients unable to tolerate higher doses) to receive either etanercept (25 mg) or placebo subcutaneously twice weekly while continuing to receive methotrexate. The primary measure of clinical response was the American College of Rheumatology criteria for a 20 percent improvement in measures of disease activity (ACR 20) at 24 weeks.

Results The addition of etanercept to methotrexate therapy resulted in rapid and sustained improvement. At 24 weeks, 71 percent of the patients receiving etanercept plus methotrexate and 27 percent of those receiving placebo plus methotrexate met the ACR 20 criteria (P<0.001); 39 percent of the patients receiving etanercept plus methotrexate and 3 percent of those receiving placebo plus methotrexate met the ACR 50 criteria (for a 50 percent improvement) (P<0.001). Patients receiving etanercept plus methotrexate had significantly better outcomes according to all measures of disease activity. The only adverse events associated with etanercept were mild injection-site reactions, and no patient withdrew from the study because of adverse events associated with etanercept.

Conclusions In patients with persistently active rheumatoid arthritis, the combination of etanercept and methotrexate was safe and well tolerated and provided significantly greater clinical benefit 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.

Full Text of this Article

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Etanercept in Rheumatoid Arthritis
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Extract | Full Text  
N Engl J Med 1999; 340:2000-2001, Jun 24, 1999. Correspondence

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