Moćko Paweł, Kawalec Paweł, Pilc Andrzej
Drug Management Department, Faculty of Health Sciences, Institute of Public Health, Jagiellonian University, ul. Grzegórzecka 20, 31-531, Kraków, Poland.
Department of Neurobiology, Institute of Pharmacology, Polish Academy of Sciences, Kraków, Poland.
Clin Drug Investig. 2017 Jan;37(1):25-37. doi: 10.1007/s40261-016-0459-y.
Biologic drugs are used in innovative therapies for the management of inflammatory bowel diseases (IBDs). The aim of this study was to compare the safety profile of biologic drugs in patients with IBD.
A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, up to 22 August 2016. We included randomized, placebo-controlled, or head-to-head clinical trials that compared the safety of different biologics in patients with IBDs. Two reviewers independently conducted the search and selection of studies and rated each trial's risk of bias. The network meta-analysis (NMA) was conducted for a mid-term (20-30 weeks) and long-term (≥52 weeks) follow-up with a Bayesian hierarchical random effects model using the ADDIS software. The PROSPERO registration number was CRD42015029884.
Sixteen randomized controlled trials were included in the systematic review with NMA. In the case of the mid-term follow-up, it was possible to conduct the NMA for assessing the relative safety profile of certolizumab pegol and infliximab, and in the case of the long-term follow-up, of infliximab, adalimumab, golimumab, and vedolizumab. There were no significant differences in the rate of adverse events in patients treated with all analyzed biologic drugs for IBD. The analysis of probability for being the safest treatment showed that infliximab was the best option in most analyzed endpoints both in mid-term and in long-term follow-ups.
We showed no significant differences in the relative safety profile of the analyzed biologic drugs. Further studies are needed to confirm our findings, including head-to-head comparisons between these drugs.
生物制剂用于炎症性肠病（IBD）创新治疗。本研究旨在比较生物制剂在IBD患者中的安全性。
利用PubMed、Embase和CENTRAL数据库进行系统文献检索，截至2016年8月22日。我们纳入了比较不同生物制剂在IBD患者中安全性的随机、安慰剂对照或头对头临床试验。两名研究者独立进行文献检索和研究筛选，并对每个试验的偏倚风险进行评分。使用ADDIS软件，采用贝叶斯分层随机效应模型对中期（20 - 30周）和长期（≥52周）随访进行网络荟萃分析（NMA）。PROSPERO注册号为CRD42015029884。
系统评价及NMA纳入了16项随机对照试验。中期随访时，可进行NMA以评估聚乙二醇化赛妥珠单抗和英夫利昔单抗的相对安全性；长期随访时，可评估英夫利昔单抗、阿达木单抗、戈利木单抗和维得利珠单抗的相对安全性。所有分析的用于IBD的生物制剂治疗患者的不良事件发生率无显著差异。最安全治疗概率分析表明，在中期和长期随访的大多数分析终点中，英夫利昔单抗是最佳选择。
我们发现所分析的生物制剂相对安全性无显著差异。需要进一步研究来证实我们的发现，包括这些药物之间的头对头比较。
