ArticleTherapeutic advances in gastroenterology2026
Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety.
Article in Therapeutic advances in gastroenterology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 1 paper.
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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.
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
An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV
Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease
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1 citing paper in PubMed.
- Comment on: Final results from the vedolizumab extended access program multinational study demonstrate long-term treatment persistence and safety.Therapeutic advances in gastroenterology · 2026Article
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8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
Background: Vedolizumab is a gut-selective, anti-α Objectives: Long-term vedolizumab treatment persistence and safety were evaluated in patients who completed GEMINI LTS (NCT00790933) or VERSIFY (NCT02425111) clinical trials and continued treatment in the open-label vedolizumab extended access program (XAP). Design: A phase IIIb/IV clinical study. Methods: This phase IIIb/IV, prospective, multinational study (NCT02743806) was conducted from August 2016 to January 2023 in adults with UC/CD treated with vedolizumab 300 mg intravenous every 8/4 weeks (Q8W/Q4W). Results: Of 331 (UC, 142; CD, 189) patients enrolled, 311 from GEMINI LTS (UC, 142; CD, 169) and 20 with CD from VERSIFY, most (295/331) started the XAP study on Q8W dosing (UC, 93% (132/142); CD, 86% (163/189)). The mean (SD) disease duration at XAP study baseline was 14 (7) years for UC and 3 (7) years for CD. Vedolizumab Q8W treatment persistence for ⩾6 months without relapse was 98% (129/132) for UC and 95% (154/163) for CD. Twenty-seven patients (9%) were re-escalated from Q8W to Q4W dosing: UC, 8% (11/132); CD, 10% (16/163). The mean (SD) vedolizumab treatment duration in the XAP was 3.5 (1.6) years for UC and 3.6 (1.7) years for CD. In the UC and CD groups, 13% and 16% of patients had serious adverse events (SAEs), respectively (1% per group was treatment related); two (1%) and four (2%) had serious infections, respectively, none related to treatment. One patient died from chronic obstructive pulmonary disease. Conclusion: In this prospective longitudinal study, patients had high persistence with vedolizumab Q8W. SAE, relapse, and reescalation to Q4W dosing rates were low. Trial registration: The study protocol was registered at ClinicalTrials.gov (https://clinicaltrials.gov/; NCT02743806).
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