The Safety of Vedolizumab for Ulcerative Colitis and Crohn's Disease

Overview

Journal Gut

Specialty Gastroenterology

Date 2016 Feb 20

PMID 26893500

Citations 314

Authors

Jean-Frederic Colombel

Bruce E Sands

Paul Rutgeerts

William Sandborn

Silvio Danese

Geert DHaens

Remo Panaccione

Edward V Loftus Jr

Serap Sankoh

Irving Fox

Asit Parikh

Catherine Milch

Brihad Abhyankar

Brian G Feagan

Affiliations

Soon will be listed here.

Abstract

Objective: Vedolizumab is a gut-selective antibody to αβ integrin for the treatment of ulcerative colitis (UC) and Crohn's disease (CD). We report an integrated summary of the safety of vedolizumab.

Design: Safety data (May 2009-June 2013) from six trials of vedolizumab were integrated. Adverse events were evaluated in patients who received ≥1 dose of vedolizumab or placebo and were reported as exposure-adjusted incidence rates as the number of patients experiencing the event per 100 person-years (PYs) of exposure. Predictors of serious infection were assessed using a Cox proportional hazards model.

Results: In total, 2830 patients had 4811 PYs of vedolizumab exposure (median exposure range, 1-1977 days). No increased risk of any infection or serious infection was associated with vedolizumab exposure. Serious clostridial infections, sepsis and tuberculosis were reported infrequently (≤0.6% of patients). No cases of progressive multifocal leucoencephalopathy were observed. Independent risk factors for serious infection in UC were prior failure of a tumour necrosis factor α antagonist (HR, 1.99; 95% CIs 1.16 to 3.42; p=0.0122) and narcotic analgesic use (HR, 2.68; 95% CI 1.57 to 4.58; p=0.0003), and in CD were younger age (HR, 0.97; 95% CI 0.95 to 0.98; p<0.0001), corticosteroid (HR, 1.88; 95% CI 1.35 to 2.63; p=0.0002) or narcotic analgesic use (HR, 2.72; 95% CI 1.90 to 3.89; p<0.0001). Investigator-defined infusion-related reactions were reported for ≤5% of patients in each study. Eighteen vedolizumab-exposed patients (<1%) were diagnosed with a malignancy.

Conclusions: Vedolizumab has a favourable safety profile with low incidence rates of serious infections, infusion-related reactions and malignancies over an extended treatment period.

Trial Registration Number: NCT01177228, NCT00619489, NCT00783718, NCT00783692, NCT01224171, NCT00790933.

Citing Articles

Anaphylaxis to a Vedolizumab Infusion following Drug Holiday in a Patient with Ulcerative Colitis: A Case Report.

Karp J, Shen H, Goodwin T, Sparrow M Case Rep Gastroenterol. 2025; 19(1):62-66.

PMID: 39981168 PMC: 11820661. DOI: 10.1159/000543387.

Risk factors and clinical characteristics of colonization and infection in patients with inflammatory bowel disease exposed to Vedolizumab: a multicenter retrospective study.

Li Q, Song X, Su P, Lv X, Liu X, Chen X Therap Adv Gastroenterol. 2025; 18:17562848251321707.

PMID: 39975482 PMC: 11837063. DOI: 10.1177/17562848251321707.

Exploring Dual-Targeted Therapy in the Management of Moderate to Severe Inflammatory Bowel Disease: A Retrospective Study.

Bhaskar S, Makovich Z, Mhaskar R, Coughlin E, Seminerio-Diehl J Crohns Colitis 360. 2025; 7(1):otae057.

PMID: 39877297 PMC: 11772558. DOI: 10.1093/crocol/otae057.

Live Typhoid and Yellow Fever Vaccines Administered to a Patient With Ulcerative Colitis on Vedolizumab.

Hegde Y, Hayney M, Caldera F ACG Case Rep J. 2025; 11(10):e01507.

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Application of Chinese Medicine in Treatment of Ulcerative Colitis and Elucidation of Relevant Mechanisms.

Zhu J, Wang H, Aisikaer M, Zhou W, Yang T, Aximujiang K Chin J Integr Med. 2025; .

PMID: 39821880 DOI: 10.1007/s11655-025-3824-y.

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