Trial reportAlimentary pharmacology & therapeutics2021
Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme.
Trial report in Alimentary pharmacology & therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02743806 (Entyvio), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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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.
Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- Effectiveness and Treatment Persistence of Vedolizumab Compared to Anti-Tumour Necrosis Factor-α in Patients With Crohn's Disease: A Systematic Literature Review and Meta-Analysis.United European gastroenterology journal · 2025Pooled it
- Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme.Alimentary pharmacology & therapeutics · 2021Trial
- Ulcerative colitis: signaling pathways, therapeutic targets and interventional strategies.Signal transduction and targeted therapy · 2026Review
- Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety.Therapeutic advances in gastroenterology · 2026Article
- 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
- Vedolizumab for Crohn's disease: Real-world efficacy through a meta-analytical lens.United European gastroenterology journal · 2025Article
- Access to High-Cost Biological Agents: Perceptions of Brazilian Patients with Inflammatory Bowel Diseases.Journal of clinical medicine · 2023Article
- The Efficacy of Currently Licensed Biologics for Treatment of Ulcerative Colitis: A Literature Review.Cureus · 2023Review
- Real-World Study on Vedolizumab Serum Concentration, Efficacy, and Safety after the Transition from Intravenous to Subcutaneous Vedolizumab in Inflammatory Bowel Disease Patients: Single-Center Experience.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Pharmacokinetic-Pharmacodynamic Model of Vedolizumab for Targeting Endoscopic Remission in Patients With Crohn Disease: Posthoc Analysis of the LOVE-CD Study.Inflammatory bowel diseases · 2022Article
Corrections and comments
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Authors and funding
7 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVedolizumab was shown to be effective and safe for patients with ulcerative colitis (UC) or Crohn's disease (CD) in the GEMINI phase 3 and long-term safety (LTS) studies.
aimTo report treatment persistence and safety results up to 2 years after enrolment in the vedolizumab extended access programme (XAP)
methodsVedolizumab XAP is a phase 3b/4, prospective, open-label, multinational, interventional study. At rollover from GEMINI LTS, patients who were experiencing continued clinical benefit with vedolizumab received reduced dosing frequency from every 4 weeks (Q4W) to every 8 weeks (Q8W). Patient persistence on Q8W dosing, incidence of relapse, and safety 2 years after enrolment were investigated.
resultsWe enrolled 311 patients (142 UC and 169 CD). At baseline, 93.7% (UC) and 89.3% (CD) of patients were in clinical remission; 93.0% (UC) and 84.6% (CD) reduced dosing frequency to Q8W at enrolment. Of those who reduced dosing frequency to Q8W at enrolment, 93.9% (UC) and 91.6% (CD) remained on Q8W dosing; 6.1% (UC) and 8.4% (CD) re-escalated to Q4W dosing. Relapse was reported in 9.1% (UC) and 14.0% (CD) of patients who reduced dosing to Q8W. Adverse events related to vedolizumab were infrequent; no new events were reported.
conclusionWe observed high patient persistence on vedolizumab Q8W in the first 2 years after the reduction of dosing frequency in the XAP along with low rates of Q4W dose re-escalation and relapse. The safety profile was consistent with previous reports. ClinicalTrials.gov: NCT02743806.
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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.