Evidence map›Paper›PMID 39883201›Full record

Trial reportJournal of gastroenterology2025

First-line biologics as a treatment for ulcerative colitis: a multicenter randomized control study.

Makoto Naganuma, Hisashi Shiga, Masayuki Shimoda, Minoru Matsuura, Kento Takenaka, Toshimitsu Fujii, Shojiro Yamamoto, Mao Matsubayashi, Taku Kobayashi, Nobuo Aoyama and 24 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. 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

34 authors.

Makoto NaganumaThird Department of Internal Medicine, Kansai Medical University, 2-5-1 Shinmachi, Hirakata, Osaka, 573-1010, Japan. naganuma@hirakata.kmu.ac.jp.ORCID 0000-0002-4244-3243
Hisashi ShigaDivision of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Masayuki ShimodaDepartment of Pathology, The Jikei University School of Medicine, Tokyo, Japan.
Minoru MatsuuraDepartment of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
Kento TakenakaDepartment of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan.
Toshimitsu FujiiDepartment of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan.
Shojiro YamamotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Mao MatsubayashiInflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
Taku KobayashiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Nobuo AoyamaGastrointestinal Endoscopy and Inflammatory Bowel Disease Center, Aoyama Medical Clinic, Hyogo, Japan.
Daisuke SaitoDepartment of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
Kaoru YokoyamaDepartment of Gastroenterology, Kitasato University School of Medicine Sagamihara, Tokyo, Japan.
Kei MoriyaDepartment of Gastroenterology, Nara Prefecture General Medical Center, Nara, Japan.
Kiichiro TsuchiyaDepartment of Gastroenterology, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.
Shunsuke ShibuiInflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
Ami KawamotoDepartment of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan.
Hiromichi ShimizuDepartment of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan.
Ryuichi OkamotoDepartment of Gastroenterology and Hepatology, Institute of Science Tokyo, Tokyo, Japan.
Kazuki SakamotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan.
Katsuki YaguchiInflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
Reiko KunisakiInflammatory Bowel Disease Center, Yokohama City University Medical Center, Yokohama, Japan.
Shintaro AkiyamaDepartment of Gastroenterology, Institute of Medicine, University of Tsukuba, Tsukuba, Japan.
Ryohei HayashiDepartment of Gastroenterology, Hiroshima University Hospital, Hiroshima, Japan.
Keisuke HasuiDepartment of Gastroenterology, Hematology and Clinical Immunology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Shuji KanmuraDepartment of Gastroenterology and Hepatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Shigeki BambaDivision of Digestive Endoscopy, Shiga University of Medical Science, Otsu, Japan.
Yoshiyuki MishimaDepartment of Internal Medicine II, Faculty of Medicine, Shimane University, Izumo, Japan.
Kazuki KakimotoSecond Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Shinya SugimotoDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Atsushi NakazawaDepartment of Gastroenterology, Saiseikai Central Hospital, Tokyo, Japan.
Takayuki AbeFaculty of Data Science, Kyoto Women's University, Kyoto, Japan.
Haruhiko OgataFujita Health University Haneda Clinic, Tokyo, Japan.
Tadakazu HisamatsuDepartment of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
Collaborators of the Study

Funding

the Japan Agency for Medical Research and Development JP20ek0109463
6 · The paper itself

Abstract

backgroundDespite the availability of several biologics for ulcerative colitis (UC), there remains a critical need to identify first-line treatment biologics. The superiority of infliximab (IFX) over vedolizumab (VED) and ustekinumab (UST) was evaluated as initial UC treatments in patients with biologic-naïve UC.

methodsThis multicenter, randomized control trial was conducted across 20 Japanese medical institutions. An independent center randomly allocated patients with UC (Mayo score ≥ 6) who had not previously used biologics to three treatment groups (IFX, VED, UST). The primary endpoint was the clinical remission (CR) rate at week 12, with other endpoints including the treatment continuation rate at week 26 and adverse events (AEs).

resultsFrom May 2021 to June 2023, 107 cases were registered, including 104 for safety and 97 for efficacy evaluation. CR rate at week 12 was 36.4% (95%CI:20.4-54.9), 32.4% (95%CI:17.4-50.5) and 43.3% (95%CI:25.5-62.6) in IFX, VED, and UST group, respectively. Continuation rates at week 26 were 50.0%(IFX), 58.3% (VED), and 82.4% (UST). AEs related to study medication were 14.7% (IFX), 16.7% (VED), and 5.9% (UST). Predictors for CR at week 12 were thiopurine use in IFX (p = 0.04), lower baseline Mayo score (p = 0.007), and lower Patient report outcome 2 (p = 0.003) at week 2 in VED.

conclusionDue to small sample size, it is challenging to make conclusions for main endpoints from this study while our study suggested that use of thiopurines in IFX group and lower activity at enrollment in VED group may enhance treatment efficacy. (jRCT1031200329; available at https://jrct.niph.go.jp/ ).

Indexed as

Antibodies, Monoclonal, HumanizedBiological ProductsColitis, UlcerativeGastrointestinal AgentsInfliximabUstekinumabAdultAgedFemaleHumansJapanMaleMiddle AgedRemission InductionTreatment OutcomeAntibodies, Monoclonal, HumanizedBiological ProductsGastrointestinal AgentsInfliximabUstekinumabvedolizumabClinical remissionInfliximabRandomized control trialUstekinumabVedolizumab

Identifiers

PMID39883201

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.