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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


Autoři: Raymond K. Cross aff001;  Michael Chiorean aff002;  Francis Vekeman aff003;  Yongling Xiao aff003;  Eric Wu aff004;  Jingdong Chao aff005;  Anthony W. Wang aff005
Působiště autorů: University of Maryland School of Medicine, Baltimore, Maryland, United States of America aff001;  Virginia Mason Medical Center, Seattle, Washington, United States of America aff002;  Groupe d’analyse, Ltée, Montréal, Québec, Canada aff003;  Analysis Group, Inc., Boston, Massachusetts, United States of America aff004;  AbbVie Inc., North Chicago, Illinois, United States of America aff005
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0225572

Souhrn

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.

Klíčová slova:

Adverse events – Drug discovery – Drug information – Drug therapy – Gastrointestinal infections – Immune receptor signaling – Ulcerative colitis – Upper respiratory tract infections


Zdroje

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