Randomised controlled trials (RCTs) that compared infliximab with placebo were eligible for inclusion. In the included studies, infliximab was given at doses of 5, 10 or 20 mg/kg between one and three times over a 7-week period. The included studies also employed one or more of the following concomitant therapies: glucocorticoids, 5-aminosalicylates, immunosuppressants, azathioprine, antibiotics. Studies of patients with active ulcerative colitis of any age and both sexes were eligible for inclusion. The mean age of the patients in the included studies ranged from 36.9 to 41.9 years, and the majority were male. Inclusion criteria for the outcomes were not stated, but the primary outcome of the review was clinical improvement. The included studies evaluated clinical response using the Mayo score or the Truelove and Witt's score, and clinical remission using the ulcerative colitis symptom score, the Baron score, the Seo index or the Mayo score. Time to clinical response was also assessed in the review.
Three reviewers independently assessed studies for inclusion. Any differences were resolved through consensus.