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Assessment of the Real-World Safety Profile of Vedolizumab Using the United States Food and Drug Administration Adverse Event Reporting System
UMB Dataset

UID: 102

Author(s): Raymond K. Cross*, Michael Chiorean, Francis Vekeman, Yongling Xiao, Eric Wu, Jingdong Chao, Anthony W. Wang * Corresponding Author
For two decades the standard drug therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC) has been anti-tumor necrosis factor agents (anti-TNFs) such as adalimumab (Humira), certolizumab pegol (Cimzia), infliximab (Remicade) and several others. More recently, vedolizumab (Entyvio) has entered the market as the first gut-selective integrin blocker that offers an alternative treatment for inflammatory bowel disease (IBD). Using the FDA Adverse Event Reporting System (FAERS) database, this study compared adverse event reports (AE) for the two types of therapies. The search retrieved 499 reports for vedolizumab and 119,620 for anti-TNFs for the years 1998 through 2015. Using the proportional reporting ratio (PPR) and the empirical Bayesian geometric mean (EBGM) algorithms, AE data were reviewed for signals of disproportionate reporting for the two types of drugs. This dataset includes statistical summary tables of characteristics (demographic) and a variety of adverse event comparisons of vedolizumab, anti-TNFs, and all other medications. Cleaned FAERS data was provided with permission by DrugLogic, Inc. Interested researchers may contact DrugLogic Inc. (Reston, VA) by calling 800-393-1313 or emailing
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Summary data available within the article and supplementary file
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Software Used
R 3.2.2
SAS 9.3
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Grant Support
Fully funded by AbbVie, Inc./AbbVie, Inc.
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