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Previous Volume 342:1627-1632 June 1, 2000 Number 22 Next

	Full Text PDF Editorial by Sartor, R. B. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Patients with Crohn's disease often have relapses. Better treatments are needed for the maintenance of remission. Although methotrexate is an effective short-term treatment for Crohn's disease, its role in maintaining remissions is not known.

Methods We conducted a double-blind, placebo-controlled, multicenter study of patients with chronically active Crohn's disease who had entered remission after 16 to 24 weeks of treatment with 25 mg of methotrexate given intramuscularly once weekly. Patients were randomly assigned to receive either methotrexate at a dose of 15 mg intramuscularly once weekly or placebo for 40 weeks. No other treatments for Crohn's disease were permitted. We compared the efficacy of treatment by analyzing the proportion of patients who remained in remission at week 40. Remission was defined as a score of 150 or less on the Crohn's Disease Activity Index.

Results Forty patients received methotrexate, and 36 received placebo. At week 40, 26 patients (65 percent) were in remission in the methotrexate group, as compared with 14 (39 percent) in the placebo group (P=0.04; absolute reduction in the risk of relapse, 26.1 percent; 95 percent confidence interval, 4.4 percent to 47.8 percent). Fewer patients in the methotrexate group than in the placebo group required prednisone for relapse (11 of 40 [28 percent] vs. 21 of 36 [58 percent], P=0.01). None of the patients who received methotrexate had a severe adverse event; one patient in this group withdrew because of nausea.

Conclusions In patients with Crohn's disease who enter remission after treatment with methotrexate, a low dose of methotrexate maintains remission.

Source Information

From the London Clinical Trials Research Group, the John P. Robarts Research Institute, London, Ont. (B.G.F., C.J.W.); the Departments of Medicine (B.G.F., M.H., J.W.D.M.) and Epidemiology and Biostatistics (B.G.F., J.K.), University of Western Ontario, London; the Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton (R.N.F.); the Department of Medicine, Division of Gastroenterology, McMaster University, Hamilton, Ont. (E.J.I.); the Department of Medicine, Division of Gastroenterology, McGill University, Montreal (G.W.); the Department of Medicine, Division of Gastroenterology, University of Calgary, Calgary, Alta. (L.S.); the Department of Medicine, Division of Gastroenterology, University of Toronto, Toronto (A.H.S., G.R.G.) — all in Canada; and the Department of Medicine, Section of Gastroenterology, University of Chicago, Chicago (S.B.H.).

Address reprint requests to Dr. Feagan at the London Clinical Trials Research Group, John P. Robarts Research Institute, 100 Perth Dr., London, ON N6A 5K8, Canada, or at feagan{at}lctrg.com.

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