Trial reportAlimentary pharmacology & therapeutics2017
Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial.
Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
30 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- A systematic review of minimum important changes for generic multi-attribute utility instruments and recommendations for their estimation.The European journal of health economics : HEPAC : health economics in prevention and care · 2025Pooled it
- Systematic Literature Review: Ability of the IBDQ-32 to Detect Meaningful Change in Ulcerative Colitis Health Indicators.Inflammatory bowel diseases · 2024Pooled it
- Risk of Multiple Sclerosis Among Users of Antitumor Necrosis Factor α in 4 Canadian Provinces: A Population-Based Study.Neurology · 2023Pooled it
- Psychometric validation of the SF-36Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2018Pooled it
- Induction and Maintenance Treatment With Upadacitinib Improves Health-Related Quality of Life in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 Study Results.Inflammatory bowel diseases · 2023Trial
- Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study.PloS one · 2019Trial
- A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease.Journal of Crohn's & colitis · 2018Trial
- Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies.Journal of Crohn's & colitis · 2018Trial
- Fatigue in inflammatory bowel disease: Mechanisms, assessment, and management strategies.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026Article
- The UK vedolizumab real-life experience study in inflammatory bowel disease (VEST): patient characteristics, drug persistence and patient-centred outcomes.Therapeutic advances in gastroenterology · 2026Article
- Efficacy and health-related quality of life associated with second-line vedolizumab after first-line treatment with one anti-TNF in patients with ulcerative colitis: a meta-analysis of the GEMINI-1 and VISIBLE-1 trials.Therapeutic advances in gastroenterology · 2026Article
- Clinical Response and Improvement of the Quality of Life, Fatigue, Mood, and Sleep Disturbances During Vedolizumab Induction Therapy in Polish Patients With Moderate-to-Severe Ulcerative Colitis or Crohn's Disease.Canadian journal of gastroenterology & hepatology · 2026Observational
- Health-related quality of life outcomes among vedolizumab-treated patients with inflammatory bowel disease in the UK and Ireland: a 52-week observational study (OCTAVO).Journal of patient-reported outcomes · 2025Observational
- Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies.Crohn's & colitis 360 · 2023Article
- Quality of Life (QoL) in Patients with Chronic Inflammatory Bowel Diseases: How Much Better with Biological Drugs?Journal of personalized medicine · 2023Article
- Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study.Advances in therapy · 2023Article
- Can we change the natural course of inflammatory bowel disease?Therapeutic advances in gastroenterology · 2023Review
- Early Clinical Remission Is a Predictor of Long-Term Remission with the Use of Vedolizumab for Ulcerative Colitis.Biomedicines · 2022Article
- Quality of Life in Newly Diagnosed Moderate-to-Severe Ulcerative Colitis: Changes in the MOSAIK Cohort Over 1 Year.Gut and liver · 2022Article
- Potential benefits of immunomodulator use with vedolizumab for maintenance of remission in ulcerative colitis.Journal of gastroenterology and hepatology · 2022Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHealth-related quality of life (HRQL) is often diminished in patients with ulcerative colitis.
aimTo evaluate the effects of vedolizumab on HRQL in patients with ulcerative colitis.
methodsUsing maintenance phase data from the GEMINI 1 study, an analysis of covariance model was used to calculate mean differences between the vedolizumab and placebo groups in changes from baseline to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D. Proportions of patients meeting minimal clinically important difference (MCID) thresholds for changes on these instruments were compared between treatment groups for the overall population and for clinically important subgroups. Concordance between clinical remission and remission defined using IBDQ scores was examined.
resultsCompared with placebo-treated patients, vedolizumab-treated patients had greater improvements (152-201%) in IBDQ, EQ-5D visual analogue scale (VAS), and EQ-5D utility scores. Greater proportions (6.9-19.9%) of vedolizumab-treated patients than placebo-treated patients met MCID thresholds for all the instruments. Vedolizumab-treated patients with lower baseline disease activity and those without prior tumour necrosis factor (TNF) antagonist failure had greater HRQL improvements. Among 127 patients with clinical remission based on complete Mayo Clinic scores, >80% also had IBDQ remission; >70% of the 150 patients with IBDQ remission demonstrated clinical remission.
conclusionsVedolizumab therapy was associated with significant improvements in HRQL measures compared with placebo. Benefits were greater in patients with lower disease activity and no prior TNF antagonist failure.
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