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Methotrexate is effective in Crohn disease, but its benefits in ulcerative colitis are less clear.
In a multicenter European study, 111 patients with steroid-dependent ulcerative colitis were randomized 1:1 to receive parenteral methotrexate (25 mg) or placebo once weekly for 24 weeks. The primary endpoint was steroid-free remission (Mayo score ≤2 and no item >1) and complete steroid withdrawal at week 16; this rate was 31.7% for methotrexate and 19.6% for placebo (P=0.15). Secondary endpoints were clinical remission (Mayo clinical subscore ≤2 and no item >1), which reached statistical significance in favor of methotrexate (41.7% vs. 23.5%; P=0.04), and steroid-free endoscopic healing, which did not reach significance (35.5% for methotrexate…