ArticlePloS one2019
Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system.
Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 26 citations in OpenAlex.
- Arterial Thrombosis in Severe Ulcerative Colitis: A Case-Based Narrative Review of Current Evidence.Biomedicines · 2026Review
- Vedolizumab Versus Other Biologics and the Risk of Venous Thromboembolism in Patients with Pediatric-Onset Inflammatory Bowel Diseases: A Target Trial Emulation Study.Paediatric drugs · 2025Article
- The Cardiovascular Effects of Inflammatory Bowel Disease Therapy with Biologics and Small Molecules: A Comprehensive Review.Journal of clinical medicine · 2025Review
- Residual Traditional Risk in Non-Traditional Atherosclerotic Diseases.International journal of molecular sciences · 2025Review
- New Adverse Drug Reaction Signals from 2017 to 2021-Genuine Alerts or False Alarms?Pharmacy (Basel, Switzerland) · 2024Review
- Long-term outcomes and predictors of vedolizumab persistence in ulcerative colitis.Therapeutic advances in gastroenterology · 2024Article
- Cardiovascular implications of inflammatory bowel disease: An updated review.World journal of cardiology · 2023Review
- Vedolizumab-Induced Acute Interstitial Nephritis in Ulcerative Colitis.ACG case reports journal · 2022Article
- Identification of Risk Factors for Coexisting Sinusitis and Inflammatory Bowel Disease.Crohn's & colitis 360 · 2021Article
- Systemic quinolones and risk of acute liver failure I: Analysis of data from the US FDA adverse event reporting system.JGH open : an open access journal of gastroenterology and hepatology · 2021Article
- Factors influencing the outcome of vedolizumab treatment: Real-life data with objective outcome measurements.United European gastroenterology journal · 2021Observational
- Thromboembolic and atherosclerotic cardiovascular events in inflammatory bowel disease: epidemiology, pathogenesis and clinical management.Therapeutic advances in gastroenterology · 2021Review
- Venous Thromboembolism in Patients with Inflammatory Bowel Disease: The Role of Pharmacological Therapy and Surgery.Journal of clinical medicine · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.