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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

    Raymond K. Cross
    Michael Chiorean
    Francis Vekeman
    Yongling Xiao
    3 more author(s)...

    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

    Colitis, Ulcerative/drug therapy
    Crohn Disease/drug therapy
    Drug-Related Side Effects and Adverse Reactions
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