METHOTREXATE IN CHRONIC ACTIVE ULCERATIVE-COLITIS - A DOUBLE-BLIND, RANDOMIZED, ISRAELI MULTICENTER TRIAL

Background & Aims:Uncontrolled studies have suggested that methotrexat e may be effective in patients with active ulcerative colitis, The aim of this study was to evaluate the effectiveness of oral methotrexate in chronic steroid-dependent ulcerative colitis in a randomized, doubl e-blind multicenter trial, Methods: Patients with active ulcerative co litis who have received steroids and/or immunosuppressives for at leas t 4 months during the preceding 12 months with a current Mayo Clinic s core of greater than or equal to 7 were included in the study. Methotr exate (12.5 mg) or placebo was added to their treatment once weekly fo r 9 months, Results: Sixty-seven patients were included (methotrexate, 30 patients; placebo, 37 patients), The proportion of patients enteri ng first remission (methotrexate, 46.7%; placebo, 48.6%), the time to reach first remission (methotrexate, 4.1 +/- 1.9 months; placebo, 3.4 +/- 1.7 months), as well as the proportions of patients having a relap se after first remission (methotrexate, 64.3%; placebo, 44.4%) were no t significantly different between the two groups. The mean Mayo Clinic score, the mean monthly steroid dose, and the proportion of abnormal laboratory results during the study were also similar. Conclusions: Me thotrexate at a weekly oral dose of 12.5 mg was not found to be better than placebo in the induction or maintenance of remission in patients with chronic active ulcerative colitis.