系统评价与荟萃分析：抗肿瘤坏死因子-α药物（英夫利昔单抗）的生物类似药CT-P13在炎症性肠病中的疗效与安全性
Systematic review with meta-analysis: the efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases.
作者信息
Komaki Y, Yamada A, Komaki F, Micic D, Ido A, Sakuraba A
机构信息
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.
出版信息
Aliment Pharmacol Ther. 2017 Apr;45(8):1043-1057. doi: 10.1111/apt.13990. Epub 2017 Feb 26.
BACKGROUND
Biosimilars of anti-tumour necrosis factor (TNF)-α 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-α 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-α 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.
背景
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）。
目的
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。
方法
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。
结果
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）。
结论
CT-P13 具有良好的临床疗效和安全性，支持其用于治疗 IBD。
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