Evidence map›Paper›PMID 35366313›Full record

SynthesisInflammatory bowel diseases2023

Gender-Based Differences in Response to Tumor Necrosis Factor Inhibitor Therapies for Ulcerative Colitis: Individual Participant Data Meta-Analyses of Clinical Trials.

Manasi Agrawal, Francesca Petralia, Adam Tepler, Laura Durbin, Walter Reinisch, Jean-Frederic Colombel, Shailja C Shah

Open access · bronzeAbstract readMeta-Analysis
In one paragraph

Synthesis in Inflammatory bowel diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.0field-weighted citation impact, top 8% of its field
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, 16 citations in OpenAlex.

  1. Observational
  2. Influence of biological sex in inflammatory bowel diseases.Nature reviews. Gastroenterology & hepatology · 2025
    Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. Sex- and gender-related differences in inflammatory bowel diseases.Frontiers in gastroenterology (Lausanne, Switzerland) · 2023
    Review
  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

7 authors at 6 institutions in 3 countries.

Manasi AgrawalThe Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0003-4729-1485
Francesca PetraliaDepartment of Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Adam TeplerDivision of General Internal Medicine, Department of Medicine, NYU Grossman School of Medicine, New York, NY, USA.
Laura DurbinKantar, Health Division, New York, NY, USA.
Walter ReinischDepartment Internal Medicine III, Division Gastroenterology & Hepatology, Medical University of Vienna, Vienna, Austria.
Jean-Frederic ColombelThe Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0001-6472-249X
Shailja C ShahGastroenterology Section, VA San Diego Healthcare System, La Jolla, CA, USA.
Icahn School of Medicine at Mount Sinai · USAalborg University · DKKantar Health (United States) · USMedical University of Vienna · ATNew York University · USUniversity of California San Diego · US

Funding

Early-life Risk Factors for Inflammatory Bowel DiseaseK23DK129762 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI AGRAWAL, MANASI · 2021 to 2025
$951k
Optimization of Helicobacter pylori-related Disease Outcomes in VeteransIK2CX002027 · VA · VETERANS HEALTH ADMINISTRATION · PI SHAILJA C SHAH · 2020 to 2026
–
CSRD VA IK2 CX002027NIDDK NIH HHS K23 DK129762
6 · The paper itself

Abstract

backgroundGender-based differences are reported in inflammatory bowel diseases (IBD) pathogenesis, but their impacts on IBD outcomes are not well known. We determined gender-based differences in response to treatment with tumor necrosis factor inhibitor (TNFi) therapies in individuals with ulcerative colitis (UC).

methodsWe used the Yale University Open Data Access (YODA) platform to abstract individual participant data from randomized clinical trials to study infliximab and golimumab as induction and maintenance therapies in moderately to severely active UC. Using multivariable logistic regression, we examined associations between gender and the endpoints of clinical remission, mucosal healing, and clinical response for each study individually and in a meta-analysis.

resultsOf 1639 patients included in induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment-Subcutaneous [PURSUIT-SC], active ulcerative colitis trials [ACT] 1 and 2) and 1280 patients included in maintenance trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment-Maintenance [PURSUIT-IM], ACT 1 and 2), 696 (42.5%) and 534 (41.7%) were women, respectively. In a meta-analysis of induction trials, the adjusted odds ratios (aORs) of clinical remission (aOR, 0.55; 95% CI, 0.31-0.97), mucosal healing (aOR, 0.47; 95% CI, 0.27-0.83), and clinical response (aOR, 0.51; 95% CI, 0.29-0.90) in the treatment arm and of clinical remission in the placebo arm (aOR, 0.34; 95% CI, 0.15-0.82) were lower in men compared to women. There were no differences in outcomes by gender in the treatment and placebo arms in the meta-analysis of maintenance trials.

conclusionsMen are less likely to achieve clinical remission, mucosal healing, and clinical response compared to women during induction treatment with TNFi for UC, but not during the maintenance phase. Future studies delineating the mechanisms underlying these observations would be informative.

Indexed as

Colitis, UlcerativeInflammatory Bowel DiseasesFemaleHumansInfliximabMaleRemission InductionTreatment OutcomeTumor Necrosis Factor InhibitorsInfliximabTumor Necrosis Factor Inhibitorsclinical trial datagenderindividual participant datameta-analysissex-basedtherapytumor necrosis factor inhibitorulcerative colitis

Identifiers

PMID35366313
PMCPMC10091488
OpenAlexW4225894179

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.