Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system

PLoS One. 2019 Dec 4;14(12):e0225572. doi: 10.1371/journal.pone.0225572. eCollection 2019.

Abstract

Vedolizumab is the first gut-selective integrin blocker indicated for patients with Crohn's disease (CD) and ulcerative colitis (UC). This study aimed to examine the adverse events (AEs) profile of vedolizumab compared to anti-tumor necrosis factors (anti-TNFs) indicated for CD and UC using the FDA Adverse Event Reporting System (FAERS) database. AE reports with vedolizumab (5/20/2014-6/30/2015) and CD/UC-indicated anti-TNF drugs (adalimumab, infliximab, certolizumab pegol, and golimumab, during 8/1/1998-6/30/2015) as primary suspects were extracted from the FAERS database. AEs associated with vedolizumab were compared for signals of disproportionate reporting against anti-TNF drugs and all other drugs (1969-6/30/2015), using the proportional reporting ratio (PRR) and the empirical Bayesian geometric mean (EBGM) algorithms. The search retrieved 499 reports for vedolizumab and 119,620 reports for anti-TNFs, with 35.9% and 32.1% of these, respectively, being serious AEs. With the PRR approach, vedolizumab-associated reports had signals for 22 groups of AEs (9 were associated with serious outcomes) relative to anti-TNFs and had 34 signals relative to all other drugs. Signals detected included those reported as warnings in prescribing information and new AEs related to cardiovascular disease. Due to the voluntary nature of FAERS, this finding should be considered hypothesis generating (rather than hypothesis testing). Longer-term observational studies are required to evaluate the safety of vedolizumab.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems*
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Female
  • Humans
  • Male
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / metabolism
  • United States
  • United States Food and Drug Administration*

Substances

  • Antibodies, Monoclonal, Humanized
  • Tumor Necrosis Factor-alpha
  • vedolizumab

Grants and funding

Funding for this research was provided by AbbVie Inc. The study sponsor, AbbVie Inc., was involved in some stages of the study research (study design, collection, analysis of data) and manuscript preparation, but the interpretation of the results and the decision to submit the final paper were made by each author independently. AbbVie Inc. provided support in the form of salaries for authors [JC, AW], but did not have any additional role in the decision to publish or preparation of the manuscript. Groupe d’analyse provided support in the form of salaries for authors [FV, YX] but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. Analysis Group, Inc., provided support in the form of salaries for authors [EW], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.