Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators.

@article{citeulike:2989098, abstract = {BACKGROUND. Although corticosteroids are highly effective in improving symptoms of Crohn's disease, they may have substantial toxicity. In some patients, attempts to discontinue corticosteroids are unsuccessful. METHODS. We conducted a double-blind, placebo-controlled multicenter study of weekly injections of methotrexate in patients who had chronically active Crohn's disease despite a minimum of three months of prednisone therapy. Patients were randomly assigned to treatment with intramuscular methotrexate (25 mg once weekly) or placebo for 16 weeks. The patients also received prednisone (20 mg once a day), which was tapered over 10 weeks unless their condition worsened. The primary outcome measure was clinical remission at the end of the 16-week trial. Remission was defined by the discontinuation of prednisone and a score of < or = 150 points on the Crohn's Disease Activity Index. RESULTS. A total of 141 patients were randomly assigned in a 2:1 ratio to methotrexate (94 patients) or placebo (47 patients). After 16 weeks, 37 patients (39.4 percent) were in clinical remission in the methotrexate group, as compared with 9 patients (19.1 percent) in the placebo group (P = 0.025; relative risk, 1.95; 95 percent confidence interval, 1.09 to 3.48). The patients in the methotrexate group received less prednisone overall than those in the placebo group (P = 0.026). The mean (+/- SE) score on the Crohn's Disease Activity Index after 16 weeks of treatment was significantly lower in the methotrexate group (162 +/- 12) than in the placebo group (204 +/- 17, P = 0.002). The changes in quality-of-life scores and serum orosomucoid concentrations were similar. In the methotrexate group, 16 patients (17 percent) withdrew from treatment because of adverse events (including asymptomatic elevation of serum aminotransferase in 7 and nausea in 6), as compared with 1 patient (2 percent) in the placebo group. CONCLUSIONS. In a group of patients with chronically active Crohn's disease, methotrexate was more effective than placebo in improving symptoms and reducing requirements for prednisone.}, address = {Department of Medicine, University of Calgary, Alta., Canada.}, author = {Feagan, B. G. and Rochon, J. and Fedorak, R. N. and Irvine, E. J. and Wild, G. and Sutherland, L. and Steinhart, A. H. and Greenberg, G. R. and Gillies, R. and Hopkins, M. }, citeulike-article-id = {2989098}, issn = {0028-4793}, journal = {The New England journal of medicine}, keywords = {ibd}, month = {February}, number = {5}, pages = {292--297}, posted-at = {2008-07-11 18:08:56}, priority = {2}, title = {Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators.}, url = {http://view.ncbi.nlm.nih.gov/pubmed/7816064}, volume = {332}, year = {1995} }

TY - JOUR ID - citeulike:2989098 L3 - citeulike-article-id:2989098 TI - Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators. JF - The New England journal of medicine VL - 332 IS - 5 SP - 292 EP - 297 AD - Department of Medicine, University of Calgary, Alta., Canada. SN - 0028-4793 N2 - BACKGROUND. Although corticosteroids are highly effective in improving symptoms of Crohn's disease, they may have substantial toxicity. In some patients, attempts to discontinue corticosteroids are unsuccessful. METHODS. We conducted a double-blind, placebo-controlled multicenter study of weekly injections of methotrexate in patients who had chronically active Crohn's disease despite a minimum of three months of prednisone therapy. Patients were randomly assigned to treatment with intramuscular methotrexate (25 mg once weekly) or placebo for 16 weeks. The patients also received prednisone (20 mg once a day), which was tapered over 10 weeks unless their condition worsened. The primary outcome measure was clinical remission at the end of the 16-week trial. Remission was defined by the discontinuation of prednisone and a score of < or = 150 points on the Crohn's Disease Activity Index. RESULTS. A total of 141 patients were randomly assigned in a 2:1 ratio to methotrexate (94 patients) or placebo (47 patients). After 16 weeks, 37 patients (39.4 percent) were in clinical remission in the methotrexate group, as compared with 9 patients (19.1 percent) in the placebo group (P = 0.025; relative risk, 1.95; 95 percent confidence interval, 1.09 to 3.48). The patients in the methotrexate group received less prednisone overall than those in the placebo group (P = 0.026). The mean (+/- SE) score on the Crohn's Disease Activity Index after 16 weeks of treatment was significantly lower in the methotrexate group (162 +/- 12) than in the placebo group (204 +/- 17, P = 0.002). The changes in quality-of-life scores and serum orosomucoid concentrations were similar. In the methotrexate group, 16 patients (17 percent) withdrew from treatment because of adverse events (including asymptomatic elevation of serum aminotransferase in 7 and nausea in 6), as compared with 1 patient (2 percent) in the placebo group. CONCLUSIONS. In a group of patients with chronically active Crohn's disease, methotrexate was more effective than placebo in improving symptoms and reducing requirements for prednisone. KW - ibd AU - Feagan, BG AU - Rochon, J AU - Fedorak, RN AU - Irvine, EJ AU - Wild, G AU - Sutherland, L AU - Steinhart, AH AU - Greenberg, GR AU - Gillies, R AU - Hopkins, M PY - 1995/02/02/ UR - http://view.ncbi.nlm.nih.gov/pubmed/7816064 ER -