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Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis

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Abstract

Background

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.

Methodology

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.

Results

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.

Conclusions

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.

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Authors and Affiliations

  1. Drug Management Department, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland

    Paweł Moćko & Paweł Kawalec

  2. Department of Neurobiology, Institute of Pharmacology, Polish Academy of Sciences, 31-343, Kraków, Smętna street 12, Poland

    Andrzej Pilc

Authors
  1. Paweł Moćko
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  2. Paweł Kawalec
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  3. Andrzej Pilc
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Correspondence to Paweł Kawalec.

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Moćko, P., Kawalec, P. & Pilc, A. Safety profile of biologic drugs in the therapy of Crohn disease: A systematic review and network meta-analysis. Pharmacol. Rep 68, 1237–1243 (2016). https://doi.org/10.1016/j.pharep.2016.07.013

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