A Cochrane review [Abstract] 1 included one study on infliximab with a total of 108 subjects. In the intervention group, 83 patients received a single 2-hour intravenous infusion of infliximab (either 5 mg, 10 mg or 20 mg per kg). Four weeks after the infusion, 27 of 83 patients in the infliximab group vs 1 of 25 patients in the placebo group were in remission [RR 8.1, 95% CI 1.2-56.9; NNT 4 (95% CI, 3-9)]. Fifty four of 83 patients in the infliximab group vs 4 of 25 in the placebo achieved clinical response (RR 4.1, 95% CI 1.6-10.1). Clinical response was defined as a reduction of 70 points or more in the CDAI score at 4 weeks after the infusion, and clinical remission defined as a CDAI less than 150. No dose-response relation was seen at 4 weeks. There was no difference in the proportions of adverse events between the intervention and placebo groups.
Comment: The quality of evidence is downgraded by sparse data and limitations in study quality.
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