The efficacy of CT-P13, a biosimilar of infliximab, in inflammatory bowel diseases: a systematic review and meta-analysis

Abstract Background Since 2015, an infliximab biosimilar, CT-P13, has been approved for commercial use in many countries, easing the economic burden borne by society and patients. Many clinical trials investigating CT-P13 for the treatment of IBD have been conducted and reported that it may be a substitute for infliximab. However, the differences between the efficacy of CT-P13 and infliximab-originator require further elucidation. Methods Data on the rates of clinical response, clinical remission, and mucosal healing of IBD were pooled for random-effects model meta-analysis using Stata MP 17. A total of 30 studies were included. Results The pooled risk of clinical remission rate of patients with Crohn’s disease and ulcerative colitis who were naïve to biologics at 08–14 weeks were 0.66 (95% CI, 0.58–0.75) and 0.48 (95% CI, 0.43–0.54), respectively, and at 100–104 weeks were 0.66 (95% CI, 0.49 to 0.84) and 0.71 (95% CI, 0.62 to 0.79) respectively. The pooled risk of clinical remission rate of patients with Crohn’s disease and ulcerative colitis who were transitioned from the original agent at 24–32 weeks were 0.84 (95% CI, 0.77–0.92) and 0.78 (95% CI, 0.63–0.93), respectively, and at 48–54 weeks were 0.72 (95% CI, 0.62 to 0.82) and 0.78 (95% CI, 0.71 to 0.86) respectively. The pooled rates for mucosal healing in ulcerative colitis were 0.56 (95% CI: 0.46 to 0.67) at 08–14 weeks, and 0.64 (95% CI: 0.42 to 0.85) at 48–54 weeks. RCT studies showed no significant change in efficacy after switching, whether Crohn’s disease or ulcerative colitis. Conclusions CT-P13 is effective in short and long-term periods. The application of CT-P13 for the management of IBD was promising.