Moćko Paweł, Kawalec Paweł, Pilc Andrzej
Drug Management Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.
Drug Management Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.
Pharmacol Rep. 2016 Dec;68(6):1237-1243. doi: 10.1016/j.pharep.2016.07.013. Epub 2016 Aug 1.
Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD.
A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD. The network meta-analysis (NMA) was conducted for an induction phase (6-10 weeks) and maintenance phase (52-56 weeks) with a Bayesian hierarchical random effects model in the ADDIS software. The PROSPERO registration number was CRD42016032606.
Ten RCTs were included in the systematic review with NMA. In the case of the induction phase, the NMA could be conducted for the assessment of the relative safety profile of adalimumab, vedolizumab, certolizumab pegol, and ustekinumab, and in the case of the maintenance phase-of infliximab, adalimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with biologics. Statistical analysis revealed that vedolizumab had the greatest probability of being the safest treatment in most endpoints in the induction phase and adalimumab-in the maintenance phase.
No significant differences between the biologics in the relative safety profile analysis were observed. Further studies are needed to confirm our findings, including head-to-head comparisons between the analyzed biologics.
克罗恩病（CD）是一种炎症性肠病，尤其在西欧和北美的发达国家较为常见。本研究旨在比较生物制剂在克罗恩病患者中的安全性。
使用PubMed、Embase和CENTRAL数据库进行系统文献检索，截至2016年4月27日。我们纳入了比较生物制剂（英夫利昔单抗、阿达木单抗、维多珠单抗、赛妥珠单抗聚乙二醇化修饰物和优特克单抗）在克罗恩病患者中彼此之间或与安慰剂安全性的随机对照试验（RCT）。在ADDIS软件中，采用贝叶斯分层随机效应模型对诱导期（6 - 10周）和维持期（52 - 56周）进行网络荟萃分析（NMA）。PROSPERO注册号为CRD42016032606。
系统评价及NMA纳入了10项RCT。在诱导期，可进行NMA以评估阿达木单抗、维多珠单抗、赛妥珠单抗聚乙二醇化修饰物和优特克单抗的相对安全性；在维持期，可评估英夫利昔单抗、阿达木单抗和维多珠单抗的相对安全性。接受生物制剂治疗的患者不良事件发生率无显著差异。统计分析显示，在诱导期的大多数终点中，维多珠单抗最有可能是最安全的治疗药物；在维持期，阿达木单抗最有可能是最安全的治疗药物。
在相对安全性分析中，未观察到生物制剂之间存在显著差异。需要进一步研究来证实我们的发现，包括所分析生物制剂之间的直接比较。
