Biological agents have proven clinical efficacy in the treatment of ulcerative colitis (UC). Their adverse effects have also been studied in a substantial number of primary studies and meta-analyses. Given the large volume of information that has been published, the aim of this umbrella review was to effectively summarize the accumulated evidence from randomized controlled trials (RCTs) on the safety of biological therapies for UC into one accessible and usable document. Pubmed and Scopus databases were systematically searched through November 2017 to identify meta-analyses of RCTs that have investigated potential harms of biological agents (adalimumab, golimumab, infliximab, and vedolizumab) in patients with UC. Ten eligible meta-analyses were included. The body of available evidence supports the safety of biologic therapies in UC. Further research is needed to clarify the risk of any infection with biologics, for elderly and high-risk groups, for longer-term effects, and for head-to-head comparisons between the different biologics.
Keywords: Adverse effect; Anti-TNF; Anti-integrin; Anti-α4β7 antibody; Inflammatory bowel disease; Meta-analysis; Side effect; Systematic review; Ulcerative colitis; Umbrella review.
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