Evidence map›Paper›PMID 39368474›Full record

Trial reportMed (New York, N.Y.)2025

Responsiveness of different disease activity indices in moderate-to-severe ulcerative colitis.

Virginia Solitano, Remo Panaccione, Bruce E Sands, Zhongya Wang, Malcolm Hogan, Guangyong Zou, Laurent Peyrin-Biroulet, Silvio Danese, Linda J Cornfield, Brian G Feagan and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Med (New York, N.Y.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02407236 (A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT02407236 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2015 to 2021Enrolled961ConditionsColitis, Ulcerative, Inflammatory Bowel DiseasesArmsPlacebo IV, Placebo SC, Ustekinumab IV, Ustekinumab SC
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

13 authors.

Virginia SolitanoDepartment of Medicine, Division of Gastroenterology, Western University, London, ON, Canada; Alimentiv, Inc., London, ON, Canada; Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
Remo PanaccioneDivision of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Bruce E SandsIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Zhongya WangAlimentiv, Inc., London, ON, Canada.
Malcolm HoganAlimentiv, Inc., London, ON, Canada.
Guangyong ZouAlimentiv, Inc., London, ON, Canada; Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
Laurent Peyrin-BirouletDepartment of Gastroenterology and INSERM NGERE U1256, University Hospital of Nancy, University of Lorraine, Nancy, France.
Silvio DaneseGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy.
Linda J CornfieldAlimentiv, Inc., London, ON, Canada.
Brian G FeaganDepartment of Medicine, Division of Gastroenterology, Western University, London, ON, Canada; Alimentiv, Inc., London, ON, Canada; Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
Siddharth SinghDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Vipul JairathDepartment of Medicine, Division of Gastroenterology, Western University, London, ON, Canada; Alimentiv, Inc., London, ON, Canada; Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.
Christopher MaAlimentiv, Inc., London, ON, Canada; Division of Gastroenterology and Hepatology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada. Electronic address: christopher.ma@ucalgary.ca.

Funding

Comparative effectiveness research in Hispanic patients with inflammatory bowel diseasesR01DK135937 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Siddharth Singh · 2024 to 2026
$1.9M
NIDDK NIH HHS R01 DK135937
6 · The paper itself

Abstract

backgroundClinical, endoscopic, histological, and composite instruments are currently used to measure disease activity in patients with ulcerative colitis (UC). We compared the responsiveness of the Mayo Clinic score (MCS), modified MCS (mMS; excluding physician global assessment), partial MCS (pMS; MCS without endoscopic subscore), Robart's Histopathology Index (RHI), and UC-100 score to change after ustekinumab treatment in patients with moderately to severely active UC.

methodsPost hoc analysis of the phase 3 UNIFI induction trial (ClinicalTrials.gov: NCT02407236) was conducted. Participants with moderately to severely active UC were randomized to receive ustekinumab or placebo. Treatment assignment was the criterion to assess responsiveness, which was quantified using the probability of a treated participant having a larger change in score than a placebo participant, termed the win probability (WinP), and estimated using nonparametric methods.

findingsThe UC-100 score demonstrated large responsiveness (WinP 0.72 [95% confidence interval: 0.66-0.78]), and the MCS (0.68 [0.62-0.73]), mMS (0.69 [0.63-0.75]), and pMS (0.65 [0.59-0.71]) demonstrated similar effect sizes. Of the component items of the Mayo score, the endoscopic subscore (WinP 0.76 [0.69-0.82]) and the stool frequency subscore (WinP 0.74 [0.69-0.79]) were the most responsive. The Inflammatory Bowel Disease Questionnaire (IBDQ) quality-of-life questionnaire was also responsive (WinP 0.78 [0.72-0.82]).

conclusionsUC disease activity indices are similarly responsive. Depending on the treatment setting, time point of evaluation, and feasibility of measurement, different scores may be used to demonstrate response. These results support the use of mMS as a composite primary endpoint, incorporating both patient-reported and endoscopic outcome measures. The UC-100 score may be more appropriate in settings that also routinely incorporate histological evaluation.

fundingThere is no funding for this study.

Indexed as

Colitis, UlcerativeSeverity of Illness IndexUstekinumabAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeUstekinumabdisease activity indexendoscopyhistologyMayo Clinic scoremodified Mayo scorepatient-reported outcomeRHITranslation to patientsUC-100ulcerative colitis

Identifiers

PMID39368474
PMCPMC12239942

What OpenQuestion holds

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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.