TY - JOUR
T1 - A comparison of methotrexate with placebo for the maintenance of remission in Crohn's disease
AU - Feagan, Brian G.
AU - Fedorak, Richard N.
AU - Irvine, E. Jan
AU - Wild, Gary
AU - Sutherland, Lloyd
AU - Steinhart, A. Hillary
AU - Greenberg, Gordon R.
AU - Koval, John
AU - Wong, Cindy J.
AU - Hopkins, Marybeth
AU - Hanauer, Stephen B.
AU - Mcdonald, John W D
N1 - Funding Information:
Brian G. Feagan, Richard N. Fedorak, E. Jan Irvine, Gary E. Wild, Lloyd R. Sutherland, A. Hillary Steinhart, Gordon Greenberg, John Koval, Cindy 1. Wong, Marybeth Hopkins, Stephen B. Hanauer, John Wd McDonald, Univ of Westem Ontario, London, ON, Canada; Univ of Alberta, Edmon ton, AB, Canada; McMaster Univ, Hamilton, ON, Canada; McGill Univ, Montreal, PQ; Univ of Calgary, Calgary, AB, Canada; Univ of Toronto, Toronto, ON, Canada; London Clin Trials Research Group, London, ON, Canada; Univ of Chicago, Chicago, IL, Canada. Background. remission in chronically active double-blind, placebo-controlled multi-center study in patients with chron ically active weeks of treatment with methotrexate, 25 mg I.M. once weekly. Patients were randomly assigned to receive continued methotrexate at a reduced dose (15 mg I.M.) or placebo for 40 weeks. No other therapies were permitted. The efficacy of treatment was compared by analyzing the proportion of patients who remained in remission (CDAI nisone) at week forty. were given placebo. The baseline characteristics of the patients were similar in the two treatment groups. At week 40, 26 patients (65.0%) remained in remission in the methotrexate group, compared to 14 patients (38.9%) in the placebo group percent confidence interval, 4.4 to 47.8%). Patients assigned to methotrex ate were less likely to require prednisone than those treated with placebo (11 of 40 patients, 27.5% compared to 21 The Crohn's who continued methotrexate (mean ::':SEweek 40 score 135::':16compared with 196::':18; of-life. Twenty-two of the 36 patients who relapsed were retreated with 25 mg of methotrexate plus prednisone; 12 (54.5%) of these reentered remis sion as compared with only 4 of 14 (14.3%) who received other treatments. No patient who received methotrexate experienced a severe adverse event compared with two patients in the placebo group. No patients experienced leukopenia, or clinically important abnormalities of liver enzymes. clusions. A low dose of methotrexate was safe and effective for maintaining clinical remission in patients who had previously responded to meth otrexate therapy for active disease. Moreover, retreatrnent with a higher drug dose was able to reinduce remission in the majority of patients who relapsed. Supported by the Crohn' s and Colitis Foundations of Canada and America and the Medical Research Council of Canada.
PY - 2000/6/1
Y1 - 2000/6/1
N2 - 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 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.
AB - 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 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.
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U2 - 10.1056/NEJM200006013422202
DO - 10.1056/NEJM200006013422202
M3 - Article
C2 - 10833208
AN - SCOPUS:0034214336
SN - 0028-4793
VL - 342
SP - 1627
EP - 1632
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 22
ER -