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In two multisite, randomized, double-blind, placebo-controlled, manufacturer-supported trials (Active Ulcerative Colitis Trials [ACT] 1 and 2), researchers evaluated the efficacy of infliximab for induction and maintenance therapy in ulcerative colitis (UC) patients. In each trial, 362 adults with moderate-to-severe active UC were randomized to receive intravenous placebo or infliximab (5 or 10 mg/kg body weight) at weeks 0, 2, and 6 and then every 8 weeks through week 46 in ACT 1 or week 22 in ACT 2.
Patients had Mayo disease activity scores of 6 or higher (scale range, 0–12) and active disease on sigmoidoscopy, despite concurrent treatment (steroids alone or in combination with azathioprine or mercaptopurine in ACT 1; corticosteroids alone…