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A correction has been published: N Engl J Med 2001;344(3):240.

Volume 343:1586-1593 November 30, 2000 Number 22 Next

	Full Text PDF Editorial by Klippel, J. H. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article Related Article PubMed Citation

ABSTRACT

Background Etanercept, which blocks the action of tumor necrosis factor, reduces disease activity in patients with long-standing rheumatoid arthritis. Its efficacy in reducing disease activity and preventing joint damage in patients with active early rheumatoid arthritis is unknown.

Methods We treated 632 patients with early rheumatoid arthritis with either twice-weekly subcutaneous etanercept (10 or 25 mg) or weekly oral methotrexate (mean, 19 mg per week) for 12 months. Clinical response was defined as the percent improvement in disease activity according to the criteria of the American College of Rheumatology. Bone erosion and joint-space narrowing were measured radiographically and scored with use of the Sharp scale. On this scale, an increase of 1 point represents one new erosion or minimal narrowing.

Results As compared with patients who received methotrexate, patients who received the 25-mg dose of etanercept had a more rapid rate of improvement, with significantly more patients having 20 percent, 50 percent, and 70 percent improvement in disease activity during the first six months (P<0.05). The mean increase in the erosion score during the first 6 months was 0.30 in the group assigned to receive 25 mg of etanercept and 0.68 in the methotrexate group (P= 0.001), and the respective increases during the first 12 months were 0.47 and 1.03 (P=0.002). Among patients who received the 25-mg dose of etanercept, 72 percent had no increase in the erosion score, as compared with 60 percent of patients in the methotrexate group (P=0.007). This group of patients also had fewer adverse events (P=0.02) and fewer infections (P= 0.006) than the group that was treated with methotrexate.

Conclusions As compared with oral methotrexate, intravenous etanercept acted more rapidly to decrease symptoms and slow joint damage in patients with early active rheumatoid arthritis.

Source Information

From Johns Hopkins University, Baltimore (J.M.B.); Michigan State University, Grand Rapids (R.W.M.); Metroplex Clinical Research Center, Dallas (R.M.F.); Phoenix Center for Clinical Research, Phoenix, Ariz. (J.R.T.); Denver Arthritis Clinic, Denver (M.H.S.); Mount Sinai Hospital, Toronto (E.C.K.); Stanford University, Stanford, Calif. (M.C.G.); University of Pittsburgh Medical Center, Pittsburgh (M.C.W.); University of Alabama at Birmingham, Birmingham (L.W.M.); Arthritis Center for Nebraska, Lincoln (A.L.W.); Hospital for Special Surgery, New York (J.M.); and Immunex, Seattle (B.K.F.).

Address reprint requests to Dr. Bathon at Johns Hopkins Asthma and Allergy Center, Johns Hopkins University, 5501 Hopkins Bayview Cir., Rm. 5A24, Baltimore, MD 21224.

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