Evidence map›Paper›PMID 39414161›Full record

SynthesisGastroenterology2025

Placebo Rates in Crohn's Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis.

Virginia Solitano, Malcolm Hogan, Siddharth Singh, Silvio Danese, Laurent Peyrin-Biroulet, Guangyong Zou, Yuhong Yuan, Bruce E Sands, Brian G Feagan, Parambir S Dulai and 3 more

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 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

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
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 SolitanoDivision of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Division of Gastroenterology and Gastrointestinal Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
Malcolm HoganAlimentiv Inc, London, Ontario, Canada.
Siddharth SinghDivision of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California.
Silvio DaneseDivision of Gastroenterology and Gastrointestinal Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Università Vita-Salute San Raffaele, Milan, Italy.
Laurent Peyrin-BirouletDepartment of Gastroenterology, Nancy University Hospital, Vandœuvre-lès-Nancy, France; INFINY Institute, Nancy University Hospital, Vandœuvre-lès-Nancy, France; Groupe Hospitalier privé Ambroise Paré-Hartmann Paris IBD Center, Neuilly sur Seine, France.
Guangyong ZouDepartment of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Alimentiv Inc, London, Ontario, Canada.
Yuhong YuanLawson Health Research Institute, London, Ontario, Canada.
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Brian G FeaganDivision of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Alimentiv Inc, London, Ontario, Canada.
Parambir S DulaiDivision of Gastroenterology, Northwestern University, Chicago, Illinois.
Neeraj NarulaDivision of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
Christopher MaAlimentiv Inc, London, Ontario, Canada; Division of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.
Vipul JairathDivision of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada; Alimentiv Inc, London, Ontario, Canada. Electronic address: vjairath@uwo.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

BACKGROUND &

aimsUnderstanding placebo rates is critical for efficient clinical trial design. We assessed placebo rates and associated factors using individual patient data from Crohn's disease trials.

methodsWe conducted a meta-analysis of phase 2/3 placebo-controlled trials evaluating advanced therapies in moderate to severe Crohn's disease (2010-2021). Deidentified individual patient data were obtained through Vivli Inc and the Yale University Open Data Access Project. Primary outcomes were clinical response and remission. Pooled placebo rates and 95% confidence intervals (CIs) were estimated using 1- and 2-stage meta-analytic approaches. Regression analyses identified patient-level factors associated with placebo rates.

resultsAnalysis of individual patient data from 8 induction (n = 1147) and 4 maintenance (n = 524) trials showed overall placebo clinical response and remission rates for induction were 27% (95% CI, 23%-32%) and 10% (95% CI, 8%-14%), respectively, and 32% (95% CI, 23%-42%) and 22% (95% CI, 14%-33%) for maintenance, respectively. Among biologic (bio)-naïve patients, placebo response and remission rates during induction were 29% (95% CI, 24%-35%) and 11% (95% CI, 8%-15%) respectively, and 26% (95% CI, 20%-33%) and 10% (95% CI, 8%-14%) for biologic (bio)-exposed patients, respectively. During maintenance, biologic-naïve response and remission rates were 41% (95% CI, 34%-48%) and 32% (95% CI, 24%-40%), respectively, and 29% (95% CI, 24%-34%) and 16% (95% CI, 13%-21%) for bio-exposed, respectively. Higher baseline C-reactive protein concentration predicted lower placebo rates, whereas higher baseline albumin levels and body mass index increased the odds of placebo outcomes. Increased baseline Crohn's Disease Activity Index and 2-item patient-reported outcome scores predicted higher response rates in induction, lower response rates in maintenance, and lower remission rates in induction and maintenance.

conclusionsPatient- and trial-level characteristics influence placebo rates in Crohn's disease trials. Careful implementation of eligibility criteria, outcome definitions, and patient stratification may reduce placebo rates.

Indexed as

Crohn DiseaseGastrointestinal AgentsPlacebo EffectClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicHumansRandomized Controlled Trials as TopicRemission InductionSeverity of Illness IndexTreatment OutcomeGastrointestinal AgentsCrohn’s DiseaseMeta-analysisPlacebo ResponseTrial Design

Identifiers

PMID39414161
PMCPMC12186694

What OpenQuestion holds

Textmetadata
LicenceTDM
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.