Evidence map›Paper›PMID 34409654›Full record

ArticleJournal of gastroenterology and hepatology2022

Potential benefits of immunomodulator use with vedolizumab for maintenance of remission in ulcerative colitis.

Makoto Naganuma, Kenji Watanabe, Satoshi Motoya, Haruhiko Ogata, Toshiyuki Matsui, Yasuo Suzuki, Lyann Ursos, Shigeru Sakamoto, Mitsuhiro Shikamura, Tetsuharu Hori and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Journal of gastroenterology and hepatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Combination of vedolizumab and immunomodulators in ulcerative colitis.Journal of gastroenterology and hepatology · 2021
    Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Makoto NaganumaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4244-3243
Kenji WatanabeDepartment of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Japan.ORCID https://orcid.org/0000-0002-3781-4724
Satoshi MotoyaIBD Center, Hokkaido Prefectural Welfare Federation of Agricultural Cooperative, Sapporo-Kosei General Hospital, Sapporo, Japan.
Haruhiko OgataEndoscopic Center, Keio University School of Medicine, Tokyo, Japan.
Toshiyuki MatsuiDepartment of Gastroenterology, Fukuoka University Chikushi Hospital, Chikushino, Japan.
Yasuo SuzukiDepartment of Internal Medicine, Toho University Medical Center Sakura Hospital, Sakura, Japan.
Lyann UrsosUS Medical, Takeda Pharmaceuticals USA, Inc., Deerfield, Illinois, USA.
Shigeru SakamotoJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1818-2194
Mitsuhiro ShikamuraTakeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Tetsuharu HoriTakeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.
Jovelle FernandezJapan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Mamoru WatanabeAdvanced Research Institute, Tokyo Medical and Dental University, Tokyo, Japan.
Toshifumi HibiCenter for Advanced Inflammatory Bowel Disease Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Takanori KanaiDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.

Funding

Takeda Pharmaceutical Company
6 · The paper itself

Abstract

BACKGROUND AND

aimThis study aimed to determine the efficacy and safety of vedolizumab treatment with or without concomitant immunomodulator use in Japanese patients with moderate-to-severe ulcerative colitis.

methodsAmong enrolled patients in a phase 3 study conducted in Japan (clinicaltrials.gov, NCT02039505), data from patients allocated to 300-mg intravenous vedolizumab for induction and maintenance phases were used for this exploratory analysis. Efficacy endpoints were clinical response, clinical remission, and mucosal healing at week 10 and clinical remission and mucosal healing at week 60, and disease worsening and treatment failure during the maintenance phase.

resultsAt week 10, the differences in clinical response, clinical remission, and mucosal healing rates between the subgroups (those with concomitant immunomodulator use minus those without) were 0.7 (95% confidence interval: -14.3, 15.7), 3.3 (95% confidence interval: -8.5, 15.2), and 1.8 (95% confidence interval: -13.0, 16.5), respectively. At week 60, the differences in clinical remission and mucosal healing between the subgroups with and without concomitant immunomodulator use were 26.1 (95% confidence interval: -3.5, 55.6) and 29.9 (95% confidence interval: 1.4, 58.4), respectively. The proportions of patients without treatment failure at day 330 of the maintenance phase were 90.7% with concomitant immunomodulator use and 73.7% without. No marked differences in incidence of infections were observed between subgroups.

conclusionsThis study suggested the possibility that concomitant immunomodulator use may be beneficial to maintain the clinical efficacy of vedolizumab.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeClinical Trials, Phase III as TopicHumansImmunologic FactorsJapanRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedImmunologic FactorsvedolizumabImmunomodulationUlcerative colitisVedolizumab

Identifiers

PMID34409654
PMCPMC9293068

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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.