Evidence map›Paper›PMID 39302135›Full record

ArticleJournal of Crohn's & colitis2025

Outcomes of Patients With Prior Biologic Intolerance Are Better Than Those With Biologic Failure in Clinical Trials of Inflammatory Bowel Disease.

Sunil Samnani, Emily C L Wong, Hasan Hamam, Parambir S Dulai, John K Marshall, Vipul Jairath, Walter Reinisch, Neeraj Narula

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of Crohn's & colitis, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

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

8 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

8 authors.

Sunil SamnaniDepartment of Medicine, Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.ORCID 0000-0003-4741-3542
Emily C L WongDepartment of Medicine, Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.ORCID 0000-0001-9472-201X
Hasan HamamDepartment of Medicine, Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.ORCID 0009-0000-6999-3125
Parambir S DulaiDivision of Gastroenterology, Northwestern University, Chicago, IL, USA.
John K MarshallDepartment of Medicine, Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.
Vipul JairathDivision of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.
Walter ReinischDepartment of Internal Medicine III, Division of Gastroenterology and Hepatology, Medical University of Vienna, Währinger Gürtel 18-20, Vienna, Austria.ORCID 0000-0002-2088-091X
Neeraj NarulaDepartment of Medicine, Division of Gastroenterology, McMaster University, Hamilton, ON, Canada.ORCID 0000-0002-1536-8436

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsInflammatory bowel disease (IBD) trials often stratify patients by prior biologic exposure, including prior biologic failure or intolerance. This study aimed to assess clinical outcomes in IBD patients with prior biologic failure vs intolerance treated with ustekinumab or vedolizumab.

methodsA post-hoc analysis of ulcerative colitis (UC) and Crohn's disease (CD) clinical trials for ustekinumab (UNITI and UNIFI) and vedolizumab (GEMINI-1 and GEMINI-2) was performed. Clinical response, clinical remission, and endoscopic improvement (for UC) were compared among biologic naïve, biologic failure, and biologic intolerant patients. Statistical analyses, including chi-square tests and logistic regression, were performed.

resultsA total of 1178 UC and 1439 CD patients received either ustekinumab or vedolizumab. In UC, biologic intolerant patients exhibited higher clinical response (54.7% vs 38.8%, aOR 1.87 [95% CI, 0.93-3.73]), clinical remission (25.0% vs 11.0%, aOR 2.84 [95% CI, 1.47-5.49]), and endoscopic improvement (40.6% vs 24.8%, aOR 2.76 [95% CI, 1.28-5.94]) compared to biologic failure, with outcomes similar to biologic naïve patients. In biologic intolerant CD patients, clinical response was similar between prior biologic failure and intolerance (34.2% vs 32.8%), but after adjustment for potential confounders, biologic intolerance was associated with higher odds of clinical response (aOR: 1.67, 95% CI, 1.09-2.55), with no significant difference observed for clinical remission (aOR: 1.48, 95% CI, 0.88-2.49).

conclusionsImproved treatment outcomes were generally observed in patients with biologic intolerance compared to failure, especially in UC, where outcomes were similar to biologic naïve patients. Future clinical trials should meticulously differentiate prior biologic failure vs intolerance to mitigate potential bias.

Indexed as

Antibodies, Monoclonal, HumanizedBiological ProductsColitis, UlcerativeCrohn DiseaseGastrointestinal AgentsUstekinumabAdultFemaleHumansMaleMiddle AgedRemission InductionTreatment FailureTreatment OutcomeAntibodies, Monoclonal, HumanizedBiological ProductsGastrointestinal AgentsUstekinumabvedolizumabbiologic failurebiologic intoleranceclinical outcomesInflammatory bowel disease

Identifiers

PMID39302135
PMCPMC11945295

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.