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Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta‐Analysis
Author(s) -
Moćko Paweł,
Kawalec Paweł,
Pilc Andrzej
Publication year - 2016
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/phar.1785
Subject(s) - vedolizumab , golimumab , medicine , adalimumab , infliximab , ulcerative colitis , adverse effect , meta analysis , placebo , cochrane library , randomized controlled trial , disease , alternative medicine , pathology
Objectives We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis ( UC ). Methods A systematic literature search was performed using Medline (PubMed), Embase, and Cochrane Central Register of Controlled Trials ( CENTRAL ) databases through February 9, 2016. We included randomized controlled trials ( RCT s) that compared the safety of biologic drugs (infliximab, adalimumab, golimumab, and vedolizumab) with one another or with placebo in patients with UC . Two reviewers independently conducted the search and selection of studies and rated the risk of bias in each trial. The network meta‐analysis ( NMA ) was conducted for an induction phase (6–8 weeks) and maintenance phase (52–54 weeks) with a Bayesian hierarchical random effects model in Aggregate Data Drug Information System ( ADDIS) software. The PROSPERO registration number was CRD 42016032607. Results Seven RCT s 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, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCT s was evaluated as low risk of bias, but high risk of bias in the case of attrition bias (incomplete outcome data) according to the Cochrane criteria. No significant differences were found in the rate of adverse events in patients treated with the reviewed biologics. Vedolizumab was most likely to have the most favorable safety profile in the induction phase as was infliximab for the maintenance phase. Conclusions The assessment of the relative safety profile revealed no significant differences between the biologic drugs. Further studies are needed to confirm our findings including head‐to‐head comparisons between the analyzed biologics.