Trial reportJournal of Crohn's & colitis2018
Efficacy of Vedolizumab in Fistulising Crohn's Disease: Exploratory Analyses of Data from GEMINI 2.
Trial report in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00783692 (A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab), which is not on this map. Cited by 56 papers, 1 of them a synthesis 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, 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
Who cites it
56 citing papers in PubMed, 1 synthesis or guideline pooled 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
- Medical Therapies Beyond Infliximab for Perianal Fistulizing Crohn's Disease: Current Evidence and Future Perspectives.Journal of clinical medicine · 2026Review
- Exclusive enteral nutrition improves radiological outcomes in adults with perianal fistulizing Crohn's disease: A real-world retrospective cohort study.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2026Article
- Clinical Trial Endpoints for Perianal Fistulizing Crohn's Disease.The American journal of gastroenterology · 2026Review
- Perianal Fistulizing Crohn's Disease: Outcomes of Surgical Repairs and Current State of Stem Cell-Based Therapies.Clinics in colon and rectal surgery · 2025Review
- Management of Complicated Crohn's Disease.Gastroenterology & hepatology · 2025Article
- How to Approach the Difficult Perineum in Crohn's Disease.Clinics in colon and rectal surgery · 2025Review
- Outcomes of medical and surgical treatment for intestinal fistulizing Crohn's disease.PloS one · 2025Article
- Management of Anal Fistula with Crohn's Disease.Journal of the anus, rectum and colon · 2025Review
- Management and Treatment of Perianal Fistulizing Crohn's Disease.Clinical and experimental gastroenterology · 2025Review
- Navigating the complexities of perianal Crohn's disease: Diagnostic strategies, treatment approaches, and future perspectives.World journal of gastroenterology · 2024Article
- Perianal disease in inflammatory bowel disease: Broadening treatment and surveillance strategies for anal cancer.World journal of gastroenterology · 2024Review
- Ustekinumab or Vedolizumab after Failure of Anti-TNF Agents in Crohn's Disease: A Review of Comparative Effectiveness Studies.Journal of clinical medicine · 2024Review
- Review
- Hyperbaric Oxygen Therapy for Refractory Perianal Crohn's Disease: A Case Report.Gastroenterology & hepatology · 2024Article
- Perianal Fistulas in Patients With Crohn's Disease.Gastroenterology & hepatology · 2024Article
- Perianal fistulizing Crohn's disease: Current perspectives on diagnosis, monitoring and management with a focus on emerging therapies.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024Review
- Comparative Effectiveness of Biologic Therapies in Preventing Penetrating Complications in Patients With Crohn's Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024Article
- Current and emerging therapeutic strategies for perianal fistula in Crohn's disease patients.Advances in pharmacology (San Diego, Calif.) · 2024Review
- Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
BACKGROUND AND
aimsMedical management of fistulising Crohn's disease [CD] is constrained by the limited number of available therapies. We evaluated the efficacy of vedolizumab, a gut-selective α4β7 integrin antagonist approved for treating moderately to severely active CD, in a subpopulation of patients with fistulising CD who participated in the GEMINI 2 trial [NCT00783692].
methodsExploratory analyses of data from the GEMINI 2 trial were conducted in 461 responders to 6-week vedolizumab induction therapy who received maintenance placebo [VDZ/PBO, N = 153] or vedolizumab [VDZ/VDZ, N = 308]. Fistula closure rates were assessed at Weeks 14 and 52, and the time to fistula closure was analysed by the Cox proportional hazards model with adjustments for significant covariates.
resultsAt entry into the maintenance period, 153 [33%] patients had a history of fistulising disease and 57 [12%] patients had ≥1 active draining fistula. By Week 14, 28% of VDZ/VDZ-treated patients compared with 11% of VDZ/PBO-treated patients (95% confidence interval [CI], -11.4 to 43.9) achieved fistula closure. Corresponding rates at Week 52 were 31% and 11% (absolute risk reduction [ARR]: 19.7%; 95% CI, -8.9 to 46.2). Similarly, VDZ/VDZ-treated patients had faster time to fistula closure and were more likely to have fistula closure at Week 52 [33% vs 11%; HR: 2.54; 95% CI, 0.54-11.96]. Prior failure of antibiotic therapy was a negative predictor of fistula closure [HR: 0.217; 95% CI, 0.059-0.795; p = 0.021], whereas trough vedolizumab concentrations did not affect closure rates.
conclusionsOur findings are consistent with the beneficial effect of vedolizumab treatment for fistulising CD.
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Registered trials
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