Safety Profile of Biologic Drugs in the Treatment of Inflammatory Bowel Diseases: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.

BACKGROUND AND OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.