Evidence map›Paper›PMID 30807613›Full record

Trial reportPloS one2019

Vedolizumab in Japanese patients with ulcerative colitis: A Phase 3, randomized, double-blind, placebo-controlled study.

Satoshi Motoya, Kenji Watanabe, Haruhiko Ogata, Takanori Kanai, Toshiyuki Matsui, Yasuo Suzuki, Mitsuhiro Shikamura, Kenkichi Sugiura, Kazunori Oda, Tetsuharu Hori and 3 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02039505 (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 67 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 12 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT02039505 phase3completednot on this map

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 Ulcerative Colitis

TypeinterventionalSponsorTakedaRan2014 to 2018Enrolled292ConditionsUlcerative ColitisArmsVedolizumab, Vedolizumab placebo
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 12 syntheses or guidelines pooled it.

  1. Differential Efficacy of Advanced Therapies in Inducing Remission in Ulcerative Colitis Based on Prior Exposure to TNF Antagonists.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
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  11. First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2020
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  20. Practical guidelines on medical management of adults with moderate-to-severe inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2026
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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

Satoshi MotoyaIBD Center, Hokkaido Prefectural Welfare Federation of Agricultural Cooperative, Sapporo-Kosei General Hospital, Sapporo, Japan.
Kenji WatanabeDepartment of Intestinal Inflammation Research, Hyogo College of Medicine, Hyogo, Japan.
Haruhiko OgataEndoscopic Center, Keio University School of Medicine, Tokyo, Japan.
Takanori KanaiDivision of Gastroenterology & Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Toshiyuki MatsuiDepartment of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.
Yasuo SuzukiDepartment of Internal Medicine, Toho University Medical Center Sakura Hospital, Chiba, Japan.
Mitsuhiro ShikamuraTakeda Development Center Japan, Takeda Pharmaceutical Company, Osaka, Japan.
Kenkichi SugiuraTakeda Development Center Japan, Takeda Pharmaceutical Company, Osaka, Japan.
Kazunori OdaRegenerative Medicine Unit, Takeda Pharmaceutical Company, Kanagawa, Japan.
Tetsuharu HoriTakeda Development Center Japan, Takeda Pharmaceutical Company, Osaka, Japan.
Takahiro ArakiTakeda Development Center Japan, Takeda Pharmaceutical Company, Osaka, Japan.
Mamoru WatanabeDepartment of Gastroenterology and Hepatology, Tokyo Medical and Dental University, Tokyo, Japan.
Toshifumi HibiCenter for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.ORCID 0000-0002-6256-1204

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVedolizumab safety and efficacy have been established in many populations all over the world, but have never been studied in Japan. We report results from a Phase 3, randomized, double-blind, placebo-controlled study of vedolizumab in Japanese patients with active ulcerative colitis (UC).

methodsPatients with moderate-to-severe UC were enrolled into Cohort 1 (double-blinded) or Cohort 2 (open-label) in the induction phase. Cohort 1 was randomized 2:1 to receive 300 mg vedolizumab or placebo, while Cohort 2 received vedolizumab 300 mg only, at Weeks 0, 2, and 6. Patients from Cohorts 1 and 2 showing a clinical response to vedolizumab at Week 10 were randomized 1:1 to receive vedolizumab or placebo (double-blinded) at Week 14 and then every 8 weeks up to Week 54 as the maintenance phase. The primary endpoint was clinical response at Week 10, for the induction phase, and clinical remission at Week 60, for the maintenance phase.

resultsA total of 292 patients were enrolled into the induction phase (246 in Cohort 1, 46 in Cohort 2); 83 patients achieved response to vedolizumab and were subsequently enrolled into the maintenance phase. Clinical response rates at Week 10 were 39.6% (65/164) and 32.9% (27/82) in the vedolizumab and placebo groups in Cohort 1, respectively (adjusted odds ratio [AOR] = 1.37, 95% CI 0.779-2.399; p = 0.2722). In the maintenance phase, clinical remission rate at Week 60 was significantly higher in the vedolizumab group, at 56.1% (23/41), versus 31.0% (13/42) for placebo (AOR = 2.88, 95% CI 1.168-7.108; p = 0.0210). Most adverse events were mild to moderate in intensity, and no deaths occurred during the study period.

conclusionsVedolizumab showed numerically greater efficacy compared with placebo as induction therapy, but the difference was not statistically significant. Vedolizumab was significantly superior to placebo as maintenance therapy in Japanese patients with UC. Vedolizumab has favourable safety and tolerability in these patients.

trial registrationClinicalTrials.gov: NCT02039505.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeDouble-Blind MethodGastrointestinal AgentsHumansJapanPlacebosAntibodies, Monoclonal, HumanizedGastrointestinal AgentsPlacebosvedolizumab

Identifiers

PMID30807613
PMCPMC6391030

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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.