ArticleGastro hep advances2026
Impact of Vedolizumab on Bowel Urgency in Ulcerative Colitis: Post Hoc Analysis of the GEMINI 1, VISIBLE 1, and VARSITY Trials.
Article in Gastro hep advances, 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. Not yet cited in PubMed.
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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, 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 Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
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4 authors.
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Abstract
Background and Aims: Bowel urgency is a particularly burdensome symptom for adults with ulcerative colitis. This post hoc analysis of 3 phase 3 studies evaluated the effects of vedolizumab on bowel urgency using selected items from the Inflammatory Bowel Disease Questionnaire (IBDQ). Methods: Data were pooled from 3 phase 3 randomized trials: GEMINI 1 (NCT00783718), VISIBLE 1 (NCT02611830), and VARSITY (NCT02497469). Adults with moderate to severe ulcerative colitis who received vedolizumab or placebo and completed the IBDQ were included. Items Q11, Q16, and Q26 from the IBDQ were combined to create a bowel urgency composite score. Bowel urgency resolution was defined as the absence of symptoms across all 3 items. Primary outcomes were the change in bowel urgency composite score and the proportion of patients with bowel urgency resolution at week 52. Exploratory outcomes included change in bowel urgency composite score and bowel urgency resolution stratified by anti-tumor necrosis factor-α exposure status, disease activity, and treatment arm (intravenous vedolizumab once every 8 weeks vs placebo), and the relationship between bowel urgency and clinical and endoscopic outcomes. Results: Overall, 1225 patients were included. Patients receiving vedolizumab had greater changes in bowel urgency composite scores than placebo overall and when stratified into subgroups. A greater proportion of patients in the vedolizumab group (44%) attained bowel urgency resolution than the placebo group (22%). Bowel urgency resolution at week 6 was significantly associated with attaining all clinical and endoscopic outcomes at week 6, and with attaining clinical remission, endoscopic improvement, and symptomatic remission at week 52 (all Conclusion: Bowel urgency-related symptoms, assessed by the IBDQ, were improved in patients receiving vedolizumab vs placebo.
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