Trial reportJournal of Crohn's & colitis2019
Deep Remission With Vedolizumab in Patients With Moderately to Severely Active Ulcerative Colitis: A GEMINI 1 post hoc Analysis.
Trial report in Journal of Crohn's & colitis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00783718 (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), which is not on this map. Cited by 20 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 MLN0002 in Patients With Moderate to Severe Ulcerative Colitis
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis.BMC gastroenterology · 2022Pooled it
- Ulcerative colitis: from molecular pathophysiology to management and the emerging role of natural and pharmacological drug candidates.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- 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
- Ulcerative colitis: signaling pathways, therapeutic targets and interventional strategies.Signal transduction and targeted therapy · 2026Review
- Novel outcomes in inflammatory bowel disease.Journal of Crohn's & colitis · 2025Review
- Evaluation of the clinical utility of measuring serum infliximab and vedolizumab concentrations during monitoring of biologic therapy in patients with inflammatory bowel disease.Przeglad gastroenterologiczny · 2025Article
- Ulcerative colitis: molecular insights and intervention therapy.Molecular biomedicine · 2024Review
- Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn's disease and ulcerative colitis included in randomised controlled trials.BMC gastroenterology · 2024Article
- Single-cell atlas of the human neonatal small intestine affected by necrotizing enterocolitis.PLoS biology · 2023Article
- Emergency colectomy for massive rectal bleeding in a patient with well-controlled ulcerative colitis receiving Vedolizumab.Archive of clinical cases · 2023Article
- Early Clinical Remission Is a Predictor of Long-Term Remission with the Use of Vedolizumab for Ulcerative Colitis.Biomedicines · 2022Article
- Proactive versus Reactive Therapeutic Drug Monitoring: Why, When, and How?Inflammatory intestinal diseases · 2022Review
- Efficacy and Safety of Vedolizumab in Management of Moderate to Severe Ulcerative Colitis: A Systematic Review.Cureus · 2021Review
- Faecal Calprotectin in Assessment of Mucosal Healing in Adults with Inflammatory Bowel Disease: A Meta-Analysis.Journal of clinical medicine · 2021Review
- Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020Article
- Positioning Biologic Therapies in the Management of Pediatric Inflammatory Bowel Disease.Gastroenterology & hepatology · 2020Article
- Circulating α4β7Clinical and experimental gastroenterology · 2020Article
- Achieving Mucosal Healing in Inflammatory Bowel Diseases: Which Drug Concentrations Need to Be Targeted?Clinical pharmacology and therapeutics · 2019Review
- Therapeutic drug monitoring in inflammatory bowel disease: for every patient and every drug?Current opinion in gastroenterology · 2019Review
- Mucosal healing in inflammatory bowel disease: Expanding horizon.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2019Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsThis GEMINI 1 post hoc analysis evaluated vedolizumab efficacy for inducing deep remission in patients with ulcerative colitis and correlation between vedolizumab trough concentrations and deep remission rates.
methodsWeek 6 vedolizumab responders were re-randomized to placebo or vedolizumab every 8 or 4 weeks. Deep remission at Week 52 was measured using four different definitions [from most to least stringent]: [1] Mayo Clinic endoscopic score = 0, rectal bleeding score = 0 and decrease or no change from baseline in stool frequency score; [2] endoscopic score ≤1, rectal bleeding score = 0 and stool frequency score = 0; [3] endoscopic score ≤1, rectal bleeding score = 0, decrease or no change from baseline stool frequency score, and total score [endoscopic score + rectal bleeding score + stool frequency score] ≤1; and [4] endoscopic score ≤1, rectal bleeding score = 0 and stool frequency score ≤1. Steady-state trough vedolizumab serum concentrations were evaluated.
resultsAt Week 6, 373 vedolizumab responders were re-randomized to maintenance placebo [n = 126] or vedolizumab every 8 [n = 122] or 4 [n = 125] weeks. Significantly more vedolizumab patients achieved deep remission at Week 52 for the most (placebo 8.7%, every 8 weeks 27.0% [p = 0.0001], every 4 weeks 28.0% [p < 0.0001]) and least (placebo 15.9%, every 8 weeks 43.4% [p < 0.0001], every 4 weeks 43.2% [p < 0.0001]) stringent definitions. Patients with higher vedolizumab trough concentration quartiles had higher deep remission rates [all definitions] compared with those with the lowest quartile or who received placebo.
conclusionVedolizumab was associated with significantly higher deep remission rates than placebo at Week 52, regardless of deep remission definition [NCT00783718].
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Registered trials
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.