Systematic review with meta-analysis: the efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-alpha agent (infliximab), in inflammatory bowel diseases

作者：Komaki Y; Yamada A; Komaki F; Micic D; Ido A; Sakuraba A^*

来源：Alimentary Pharmacology and Therapeutics, 2017, 45(8): 1043-1057.

DOI：10.1111/apt.13990

Background
Biosimilars of anti-tumour necrosis factor (TNF)- agents have now become clinically available for the treatment of inflammatory bowel diseases (IBD).
Aim
To perform a systematic review and meta-analysis to evaluate the efficacy and safety of biosimilars of anti-TNF- agents in patients with IBD.
Methods
Electronic databases were searched. The outcomes were the pooled rates of clinical response or remission, sustained clinical response or remission, and adverse events in patients with IBD induced with or switched to biosimilars of anti-TNF- agents.
Results
Eleven observational studies reporting outcomes in 829 patients treated with biosimilar of infliximab (CT-P13) were identified. The pooled rates of clinical response among Crohn's disease (CD) and ulcerative colitis (UC) at 8-14 weeks were 0.79 (95% confidence interval (CI) = 0.65-0.88) and 0.74 (95% CI = 0.65-0.82), respectively, and at 24-30 weeks were 0.77 (95% CI = 0.63-0.86) and 0.77 (95% CI = 0.67-0.85) respectively. Adverse events were rare (CD, 0.08 (95% CI = 0.02-0.26); UC, 0.08 (95% CI = 0.03-0.17)). The pooled rates of sustained clinical response among CD and UC after switching from infliximab to CT-P13 at 30-32 weeks were 0.85 (95% CI = 0.71-0.93) and 0.96 (95% CI = 0.58-1.00), respectively, and at 48-63 weeks were 0.75 (95% CI = 0.44-0.92) and 0.83 (95% CI = 0.19-0.99) respectively. Adverse events were rare (CD, 0.10, 95% CI = 0.02-0.31; UC, 0.22, 95% CI = 0.04-0.63).
Conclusions
CT-P13 was associated with excellent clinical efficacy and safety profile, supporting its use in the treatment of IBD.

• 出版日期2017-4
• 单位西北大学