Trial reportAlimentary pharmacology & therapeutics2020
Long-term safety of vedolizumab for inflammatory bowel disease.
Trial report in Alimentary pharmacology & therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00790933 (A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab), which is not on this map. Cited by 109 papers, 4 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.
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
Who cites it
109 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- Second United Arab Emirates consensus guidance on the diagnosis and management of inflammatory bowel disease.World journal of gastroenterology · 2025Pooled it
- Systematic review and bayesian network meta-analysis: comparative efficacy and safety of six commonly used biologic therapies for moderate-to-severe Crohn's disease.Frontiers in pharmacology · 2024Pooled it
- Vedolizumab for acute gastrointestinal graft-versus-host disease: A systematic review and meta-analysis.Frontiers in immunology · 2022Pooled it
- Safety, Pharmacokinetics, Food effect, and Pharmacodynamics of AJM347, a Selective α4β7 Integrin Antagonist: A First-in-Human Single- and Multiple-Ascending Dose Study in Healthy Male Volunteers.Journal of clinical pharmacology · 2026Trial
- Vedolizumab and ART in recent HIV-1 infection unveil the role of α4β7 in reservoir size.JCI insight · 2024Trial
- Ozanimod Differentially Impacts Circulating Lymphocyte Subsets in Patients with Moderately to Severely Active Crohn's Disease.Digestive diseases and sciences · 2024Trial
- Long-term safety of vedolizumab for inflammatory bowel disease.Alimentary pharmacology & therapeutics · 2020Trial
- IBD and Immune-Mediated Inflammatory Diseases: What Is the Optimal Management?Journal of clinical medicine · 2026Review
- Clinical combination therapy for IBD and promising co-delivery strategies.Inflammopharmacology · 2026Review
- [Advanced Combination Therapy in Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2026Review
- Efficacy and Safety of Switching From Intravenous to Subcutaneous Vedolizumab in Japanese Patients With Ulcerative Colitis: A Study Focusing on Injection-Site Reactions.JGH open : an open access journal of gastroenterology and hepatology · 2026Article
- Predictive model for vedolizumab efficacy in moderate-to-severe ulcerative colitis based on computed tomography-derived body compositions and nutritional inflammatory markers.World journal of radiology · 2026Article
- Takayasu and Giant Cell Arteritis Unmasked by Vedolizumab as Paradoxical Reactions: Two Case Reports.ACR open rheumatology · 2026Article
- Cost-Consequences Analysis of Biologic Treatments for Moderate-to-Severe Crohn's Disease Using Real-World Transition Probability and Cost Data in Thailand.Clinical drug investigation · 2026Article
- A case of autoimmune hepatitis in a patient with inflammatory bowel disease and significant lymphadenopathy in the porta hepatis.JPGN reports · 2026Article
- Challenges and Treatment Strategies in Elderly Patients with Inflammatory Bowel Disease: A Systematic Review and Narrative Synthesis.Journal of personalized medicine · 2026Review
- Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study.Intestinal research · 2026Article
- A decade of clinical data with vedolizumab: the past, present, and future.Therapeutic advances in gastroenterology · 2026Review
- Long-Term Safety of Ontamalimab in Patients with Moderate to Severe Inflammatory Bowel Disease.Clinical and experimental gastroenterology · 2026Article
49 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVedolizumab, a gut-selective α
aimTo report the final results from the vedolizumab GEMINI long-term safety (LTS) study.
methodsThe phase 3, open-label GEMINI LTS study (initiated May 2009) enrolled patients with UC or CD from four prior clinical trials and vedolizumab-naïve patients. Vedolizumab LTS was evaluated; efficacy and patient-reported outcomes were exploratory endpoints.
resultsEnrolled patients (UC, n = 894; CD, n = 1349) received vedolizumab 300 mg IV every 4 weeks; median cumulative exposure was 42.4 months (range: 0.03-112.2) for UC and 31.5 months (range: 0.03-100.3) for CD. Over 8 years, adverse events (AEs) occurred in 93% (UC) and 96% (CD) of patients, with UC (36%) and CD (35%) exacerbations most frequent. Serious AEs were reported for 31% (UC) and 41% (CD) of patients. Vedolizumab discontinuation due to AEs occurred in 15% (UC) and 17% (CD) of patients. There were no new trends for infections, malignancies, infusion-related reactions, or hepatic events, and no cases of progressive multifocal leukoencephalopathy. Of the ten deaths (UC, n = 4; CD, n = 6), two were considered drug-related by local investigators (West Nile virus infection-related encephalitis and hepatocellular carcinoma). Continuous vedolizumab maintained clinical response long-term, with 33% (UC) and 28% (CD) of patients in clinical remission at 400 treatment weeks.
conclusionsThe safety profile of vedolizumab remains favourable with no unexpected or new safety concerns. These results further establish the safety of vedolizumab and support its long-term use (NCT00790933/EudraCT 2008-002784-14).
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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.