The safety and efficacy of infliximab in patients with active ulcerative colitis in China

Abstract

Objective Infliximab is effective and safe for the treatment of ulcerative colitis in Western populations. The aim of this study was to evaluate the efficacy and safety of infliximab in patients with moderate-to-severe active ulcerative colitis in multiple centers in China. Methods This was a randomized, double-blind, placebo-controlled trial comprising a 26 week study period. Patients with moderate-to-severe active ulcerative colitis received intravenous infliximab 5 mg/kg or placebo in a 1∶1 ratio. Results Across 12 centers in China, participants (n=99) were randomized to receive either infliximab (n=50) or placebo (n=49). Significantly more patients in the infliximab group achieved clinical response [n=32 (64%)] than placebo [n=16 (33%); P=0.002 1] and mucosal healing [n=17 (34%)] than placebo [n=8 (16%); P=0.045 1]at Week 8 with infliximab, while at Week 26 more infliximab patients [n=14 (28%)] achieved clinical remission than placebo [n=5 (10%); P=0.028 1]. There were no drug-related serious adverse events during the study. Conclusions Infliximab 5 mg/kg was safe and efficacious in Chinese patients with moderate-to-severe ulcerative colitis. Key words: Ulcerative colitis; Infliximab; Chinese