Komaki Y, Yamada A, Komaki F, Micic D, Ido A, Sakuraba A
Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, The University of Chicago Medicine, Chicago, USA.
Division of Gastroenterology and Hepatology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA.
Aliment Pharmacol Ther. 2017 Apr;45(8):1043-1057. doi: 10.1111/apt.13990. Epub 2017 Feb 26.
Biosimilars of anti-tumour necrosis factor (TNF)-α agents have now become clinically available for the treatment of inflammatory bowel diseases (IBD).
To perform a systematic review and meta-analysis to evaluate the efficacy and safety of biosimilars of anti-TNF-α agents in patients with IBD.
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-α agents.
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).
CT-P13 was associated with excellent clinical efficacy and safety profile, supporting its use in the treatment of IBD.
抗肿瘤坏死因子（TNF）-α 制剂的生物类似药现已在临床上可用于治疗炎症性肠病（IBD）。
进行系统评价和荟萃分析，以评估抗 TNF-α 制剂生物类似药在 IBD 患者中的疗效和安全性。
检索电子数据库。结局指标为使用或换用抗 TNF-α 制剂生物类似药诱导的 IBD 患者的临床缓解率、持续临床缓解率及不良事件发生率。
共纳入 11 项观察性研究，涉及 829 例接受英夫利昔单抗生物类似药（CT-P13）治疗的患者。克罗恩病（CD）和溃疡性结肠炎（UC）患者在 8 - 14 周时的临床缓解合并率分别为 0.79（95%置信区间（CI）= 0.65 - 0.88）和 0.74（95%CI = 0.65 - 0.82），在 24 - 30 周时分别为 0.77（95%CI = 0.63 - 0.86）和 0.77（95%CI = 0.67 - 0.85）。不良事件少见（CD，0.08（95%CI = 0.02 - 0.26）；UC，0.08（95%CI = 0.03 - 0.17））。CD 和 UC 患者从英夫利昔单抗换用 CT-P13 后，在 30 - 32 周时的持续临床缓解合并率分别为 0.85（95%CI = 0.71 - 0.93）和 0.96（95%CI = 0.58 - 1.00），在 48 - 63 周时分别为 0.75（95%CI = 0.44 - 0.92）和 0.83（95%CI = 0.19 - 0.99）。不良事件少见（CD，0.10，95%CI = 0.02 - 0.31；UC，0.22，95%CI = 0.04 - 0.63）。
CT-P13 具有良好的临床疗效和安全性，支持其用于治疗 IBD。
