ArticleGut2017
The safety of vedolizumab for ulcerative colitis and Crohn's disease.
Article in Gut, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 390 papers, 9 of them syntheses that pooled it.
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.
Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease
A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Who cites it
390 citing papers in PubMed, 9 syntheses or guidelines pooled it, 793 citations in OpenAlex.
- Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- Pharmacological management of spondyloarthritis associated with inflammatory bowel disease: a systematic review of efficacy, safety, and emerging therapies.BMC rheumatology · 2025Pooled it
- North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition position paper on the therapeutic drug monitoring in pediatric inflammatory bowel disease.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- Association between vedolizumab and risk of clostridium difficile infection in patients with ulcerative colitis: A systematic review and meta-analysis.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024Pooled it
- Risk of Clostridioides difficile infection in inflammatory bowel disease patients undergoing vedolizumab treatment: a systematic review and meta-analysis.BMC gastroenterology · 2024Pooled it
- Pooled it
- Efficacy and safety of biologics in primary sclerosing cholangitis with inflammatory bowel disease: A systematic review and meta-analysis.Hepatology communications · 2024Pooled it
- The Relationship Between Opioid Use and Healthcare Utilization in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.Inflammatory bowel diseases · 2022Pooled it
- Efficacy and safety of vedolizumab for pediatrics with inflammatory bowel disease: a systematic review.BMC pediatrics · 2022Pooled it
- Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease.Digestive diseases and sciences · 2024Trial
- Efficacy and Safety of the Anti-mucosal Addressin Cell Adhesion Molecule-1 Antibody Ontamalimab in Patients with Moderate-to-Severe Ulcerative Colitis or Crohn's Disease.Journal of Crohn's & colitis · 2024Trial
- Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial.Journal of Crohn's & colitis · 2022Trial
- Long-term Safety and Efficacy of the Anti-MAdCAM-1 Monoclonal Antibody Ontamalimab [SHP647] for the Treatment of Ulcerative Colitis: The Open-label Study TURANDOT II.Journal of Crohn's & colitis · 2021Trial
- The gut microbiota-tryptophan metabolism-immune axis in inflammatory bowel disease: Mechanisms and therapeutic prospects.Human vaccines & immunotherapeutics · 2026Review
- Inflammatory bowel disease treatment: Mechanisms to clinical translation (Review).International journal of molecular medicine · 2026Review
- Comparative Real-World Effectiveness of Anti-TNF, Ustekinumab and Vedolizumab in Crohn's Disease Over 24 Months: A Pooled Analysis From the Prospective UMBRELLA-IBD Registry in Germany.Alimentary pharmacology & therapeutics · 2026Article
- Physiologically Based Pharmacokinetic Modeling of Vedolizumab in Healthy Adults and Patients with Inflammatory Bowel Disease.Clinical pharmacokinetics · 2026Article
- Postoperative Complications Associated with Advanced Therapies in Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.Advances in therapy · 2026Article
- Rhoifolin Alleviates Ulcerative Colitis by Targeting NMNAT1 and Activating SIRT1-FOXO1 Signaling to Enhance ILC3s Effector Function.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Application of Chinese Medicine in Treatment of Ulcerative Colitis and Elucidation of Relevant Mechanisms.Chinese journal of integrative medicine · 2026Review
330 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 5 countries.
Funding
Abstract
objectiveVedolizumab is a gut-selective antibody to α
designSafety 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.
resultsIn 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.
conclusionsVedolizumab 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.
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.