The Active Ulcerative Colitis Trials (ACT) 1 and 2 found that the drug infliximab may prompt remission in patients with moderate-to-severe active ulcerative colitis. Currently, the drug is used to treat Crohn's disease, and its effectiveness in treating ulcerative colitis still is unknown. Both trials included 364 patients randomly assigned to receive intravenous treatments of 5 mg/kg of infliximab, 10 mg/kg of infliximab, or a placebo at the start of the study, at weeks 2 and 6, and then every 8 weeks until week 46 for ACT 1, or week 22 for ACT 2. Both studies yielded results that showed a better clinical response among the infliximab groups. At week 8, 70% of the 5-mg/kg group and 62% of the 10- mg/kg group showed a positive clinical response, compared with only 37% in the placebo group (ACT 1). In the ACT 2 groups, corresponding results were 65%, 70%, and 29%. Participants began to show improvements as soon as week 2, regardless of their response to steroid treatment. In fact, more patients in the infliximab group were able to discontinue their steroid treatment. Although the rates of side effects were similar among all treatment groups, however, the number of serious complicationssuch as serious infections, lupus-like reactions, and neurologic complicationswas higher among the infliximab groups.
Ms. Farley is a freelance medical writer based in Wakefield, RI.