Trial reportJournal of gastroenterology2020
Effects of vedolizumab in Japanese patients with Crohn's disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses.
Trial report in Journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02038920 (Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002), which is not on this map. Cited by 28 papers, 9 of them syntheses 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.
Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease
Who cites it
28 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Infection risk in inflammatory bowel disease patients treated with vedolizumab: a systematic review and meta-analysis.Frontiers in medicine · 2026Pooled it
- AGA Living Clinical Practice Guideline on the Pharmacologic Management of Moderate-to-Severe Crohn's Disease.Gastroenterology · 2025Guideline
- Comparative Efficacy of Subcutaneous and Intravenous Infliximab and Vedolizumab for Maintenance Treatment of TNF-naive Adult Patients with Inflammatory Bowel Disease: A Systematic Literature Review and Network Meta-analysis.Digestive diseases and sciences · 2024Pooled it
- Systematic review and bayesian network meta-analysis: comparative efficacy and safety of six commonly used biologic therapies for moderate-to-severe Crohn's disease.Frontiers in pharmacology · 2024Pooled it
- Vedolizumab for induction and maintenance of remission in Crohn's disease.The Cochrane database of systematic reviews · 2023Pooled it
- Has the therapeutical ceiling been reached in Crohn's disease randomized controlled trials? A systematic review and meta-analysis.United European gastroenterology journal · 2023Pooled it
- Model-Based Meta-Analysis on the Efficacy of Biologics and Small Targeted Molecules for Crohn's Disease.Frontiers in immunology · 2022Pooled it
- Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis.The lancet. Gastroenterology & hepatology · 2021Pooled it
- Predictive value of blood concentration of biologics on endoscopic inactivity in inflammatory bowel disease: A systematic review.World journal of gastroenterology · 2021Pooled it
- Vedolizumab for prevention of lower-GI acute GVHD in the Japanese subgroup analysis of the phase 3 GRAPHITE study.International journal of hematology · 2025Trial
- A Comparative Study of Different Biological Drugs in First-Line Therapy in Crohn's Disease: A Multicenter Descriptive Analysis.Medicina (Kaunas, Lithuania) · 2026Article
- Ustekinumab versus vedolizumab in patients with Crohn's disease refractory to anti-tumour necrosis factor: A systematic review and meta-analysis.Pakistan journal of medical sciences · 2025Review
- Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis.Therapeutic advances in gastroenterology · 2025Article
- Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024Review
- Comparing the Efficacy and Safety of Adalimumab and Vedolizumab in Treating Moderate to Severe Crohn's Disease and Ulcerative Colitis.Gastroenterology research · 2023Article
- Comparison of treatment effect between phase 2 and phase 3 trials in patients with inflammatory bowel disease.United European gastroenterology journal · 2023Review
- Efficacy and safety of vedolizumab in the treatment of patients with inflammatory bowel disease: A systematic review and meta‑analysis of randomized controlled trials.Experimental and therapeutic medicine · 2023Article
- Defining the Failure of Medical Therapy for Inflammatory Bowel Disease in the Era of Advanced Therapies: A Systematic Review.Biomedicines · 2023Review
- Korean clinical practice guidelines on biologics for moderate to severe Crohn's disease.Intestinal research · 2023Review
- Early Clinical Remission Is a Predictor of Long-Term Remission with the Use of Vedolizumab for Ulcerative Colitis.Biomedicines · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVedolizumab is a gut-selective humanized antibody that binds the α
methodsIn this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance.
resultsAt Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research.
conclusionVedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated.
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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.