Evidence map›Paper›PMID 40708501›Full record

ArticleInflammatory bowel diseases2025

Efficacy and Safety of Ustekinumab and Vedolizumab for Crohn's Disease of the Pouch.

Sunhee Park, Kian Keyashian, Andrew Ho, David Limsui, Spencer Frost, Raul Vazquez, Eleanor Yang, Joseph Ebriani, Laura Maas, Alyssa Parian and 4 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Inflammatory bowel diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Managing Refractory Pouchitis: Which Biologic Is Best?Digestive diseases and sciences · 2026
    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

14 authors.

Sunhee ParkDepartment of Gastroenterology, University of California, Irvine, Orange, CA, USA.ORCID 0009-0003-3987-2463
Kian KeyashianDepartment of Gastroenterology, Stanford University, Palo Alto, CA, USA.
Andrew HoDepartment of Gastroenterology, Santa Clara Valley Medical Center, San Jose, CA, USA.
David LimsuiDepartment of Gastroenterology, Stanford University, Palo Alto, CA, USA.
Spencer FrostDepartment of Gastroenterology, Stanford University, Palo Alto, CA, USA.
Raul VazquezDepartment of Gastroenterology, Stanford University, Palo Alto, CA, USA.
Eleanor YangDepartment of Gastroenterology, University of California, Irvine, Orange, CA, USA.
Joseph EbrianiDepartment of Gastroenterology, University of California Los Angele, Los Angeles, CA, USA.
Laura MaasDepartment of Gastroenterology, Johns Hopkins University, Baltimore, MD, USA.
Alyssa ParianDepartment of Gastroenterology, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0001-9995-7942
Mark LazarevDepartment of Gastroenterology, Johns Hopkins University, Baltimore, MD, USA.
Nimisha ParekhDepartment of Gastroenterology, University of California, Irvine, Orange, CA, USA.
Jenny S SaukDepartment of Gastroenterology, University of California Los Angele, Los Angeles, CA, USA.
Berkeley LimketkaiDepartment of Gastroenterology, University of California Los Angele, Los Angeles, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsMedically refractory ulcerative colitis may require colectomy with ileal pouch-anal anastomosis. Complications of the J-pouch include pouchitis, occurring in 50%-80% of patients, and Crohn's disease (CD) of the pouch, occurring in 3%-17%. Our aim was to evaluate the efficacy and safety of ustekinumab (UST) and vedolizumab (VDZ) in patients with CD of the pouch.

methodsThis was a retrospective, multicenter cohort study of adults with CD of the pouch treated with UST or VDZ. The primary outcome was clinical response at 3 or 6 months. Secondary outcomes included clinical remission, endoscopic response, histologic response, pouch failure or surgery, and adverse effects of therapy. Multivariable logistic regression evaluated the efficacy and safety of UST versus VDZ, adjusted for age, smoking status, disease duration, corticosteroid use, and antibiotic use. Kaplan-Meier survival analysis evaluated the durability of UST versus VDZ for CD of the pouch.

resultsOne hundred and four patients were included in this analysis. Seventy-seven patients were treated with UST and 57 patients were treated with VDZ between 2011 and 2021. A total of 64/77 (83%) UST-treated patients and 45/57 (79%) VDZ-treated patients had prior biologic exposure. Clinical response occurred in 62% UST-treated patients and 53% VDZ-treated patients at 3 months, and in 56% and 46% at 6 months, respectively. Clinical remission occurred in 32% UST-treated patients and 18% VDZ-treated patients at 3 months and 29% and 21% at 6 months, respectively. Among those treated with UST, 41% achieved endoscopic response, 10% achieved endoscopic remission, 46% achieved histologic response, and 7% achieved histologic remission. Among those treated with VDZ, 27% achieved endoscopic response, 16% achieved endoscopic remission, 26% achieved histologic response, and 8% achieved histologic remission. Over a follow-up period of 3 years, 5% UST-treated patients had inflammatory bowel disease (IBD)-related hospitalization, and 9% required pouch-failure surgery. In total, 3% VDZ-treated patients had IBD-related hospitalization and 5% required pouch-failure surgery. Reported adverse effects were uncommon, including arthralgias (1), hair loss (1), syncope (1), and upper respiratory infection (1) for UST and wrist edema (1) and elevated transaminases (1) for VDZ. In multivariable analyses, patients on UST were more likely to have a clinical response compared to VDZ at 3 months (OR 2.73, 95% [CI] 1.13-6.56, P = .025) and 6 months (OR 2.53, 95% CI: 1.01-6.29, P = .046). UST had significantly longer durability of treatment than VDZ (log-rank P < .005).

conclusionsIn one of the largest cohorts evaluating UST and VDZ for CD of the pouch thus far, these biologics were found to be safe and effective treatments for CD of the pouch.

Indexed as

Antibodies, Monoclonal, HumanizedColonic PouchesCrohn DiseaseGastrointestinal AgentsPouchitisUstekinumabAdultFemaleFollow-Up StudiesHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeYoung AdultAntibodies, Monoclonal, HumanizedGastrointestinal AgentsUstekinumabvedolizumabCD of the pouchclinical responsedurabilityendoscopic responseustekinumabvedolizumab

Identifiers

PMID40708501
PMCPMC12638055

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Registered trials

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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.