Evidence map›Paper›PMID 24363029›Full record

Trial reportJournal of gastroenterology2014

Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis.

Yasuo Suzuki, Satoshi Motoya, Hiroyuki Hanai, Takayuki Matsumoto, Toshifumi Hibi, Anne M Robinson, Nael M Mostafa, Jingdong Chao, Vipin Arora, Anne Camez and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 27 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 27 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

84 citing papers in PubMed, 27 syntheses or guidelines pooled it.

  1. Major cardiovascular event risk of advanced therapies in inflammatory bowel diseases: systematic review and meta-analysis.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2026
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  15. 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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24 more citing papers are in PubMed but not listed here.

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

12 authors.

Yasuo SuzukiToho University Medical Center Sakura Hospital, Chiba, Japan.
Satoshi Motoya
Hiroyuki Hanai
Takayuki Matsumoto
Toshifumi Hibi
Anne M Robinson
Nael M Mostafa
Jingdong Chao
Vipin Arora
Anne Camez
Roopal B Thakkar
Mamoru Watanabe

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdalimumab is a fully human, monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis (UC).

methodsThis 52-week, phase 2/3, randomized, double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids, immunomodulators, or both. Patients received placebo, adalimumab 80/40 (80 mg at week 0, then 40 mg every other week), or adalimumab 160/80 (160/80 mg at weeks 0/2, then 40 mg every other week) in addition to background UC therapy.

resultsAt week 8, remission rates were similar among treatment arms, but more patients treated with adalimumab 160/80 achieved response (placebo, 35 %; 80/40, 43 %; 160/80, 50 %; P = 0.044 for 160/80 vs placebo) and mucosal healing (placebo, 30 %; 80/40, 39 %; 160/80, 44 %; P = 0.045 for 160/80 vs placebo) compared with placebo. At week 52, more patients receiving adalimumab 40 mg every other week achieved response (18 vs 31 %; P = 0.021), remission (7 vs 23 %; P = 0.001), and mucosal healing (16 vs 29 %; P = 0.015) compared with placebo. Week 8 response to adalimumab was associated with greater rates of response (61 %), remission (46 %), and mucosal healing (57 %) at week 52 relative to the overall population. Rates of serious adverse events were similar between treatment arms.

conclusionsInduction with adalimumab 160/80 mg led to early response and mucosal healing. Maintenance adalimumab had greater rates of long-term response, remission, and mucosal healing compared with placebo. No new safety signals were identified.

Indexed as

AdalimumabAdrenal Cortex HormonesAdultAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsColitis, UlcerativeDouble-Blind MethodDrug ResistanceFemaleHumansImmunosuppressive AgentsJapanMaintenance ChemotherapyMaleMiddle AgedRemission InductionAdalimumabAdrenal Cortex HormonesAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsImmunosuppressive Agents

Identifiers

PMID24363029
PMCPMC3925299

What OpenQuestion holds

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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.