Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis.
We compared the safety profile of biologic drugs in patients with moderately to severely active ulcerative colitis (UC).



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 (RCTs) 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 CRD42016032607.



Seven 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, golimumab, and vedolizumab, and in the case of the maintenance phase of infliximab, adalimumab, golimumab, and vedolizumab. The methodological quality of the included RCTs 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.



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.
Department of Drug Management, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Kraków, Poland.
Paweł
P
Moćko
Department of Drug Management, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Kraków, Poland.
Paweł
P
Kawalec
Department of Drug Management, Institute of Public Health, Faculty of Health Sciences, Jagiellonian University, Kraków, Poland.|Department of Neurobiology, Institute of Pharmacology, Polish Academy of Sciences, Kraków, Poland.
Andrzej
A
Pilc
D006801:Humans; D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000188:drug therapy; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
D000068879:Adalimumab; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D001688:Biological Products; C529000:golimumab; D000069285:Infliximab; C543529:vedolizumab
biologic drugs; network meta-analysis; safety profile; systematic review; ulcerative colitis