Evidence map›Paper›PMID 40956538›Full record

ArticleDigestive diseases and sciences2026

Safety and Efficacy of Ustekinumab and Vedolizumab Among Older Adults with Inflammatory Bowel Disease.

Moniyka Sachar, Pakdee Rojanasopondist, William Beaty, Cristina Fernandez, Olivia Delau, Alice Li, Nicole Werner, Polly Kirsch, Rebecca Minerva Ortiz, Xinyu Wang and 9 more

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Digestive diseases and sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  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

19 authors.

Moniyka SacharDepartment of Medicine, New York University Langone Medical Center, New York, NY, USA.
Pakdee RojanasopondistNew York University Grossman School of Medicine, New York, NY, USA.
William BeatyNew York University Grossman School of Medicine, New York, NY, USA.
Cristina FernandezDepartment of Medicine, New York University Langone Medical Center, New York, NY, USA.
Olivia DelauDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Alice LiDepartment of Biostatistics, New York University School of Public Health, New York, NY, USA.
Nicole WernerNew York University Grossman School of Medicine, New York, NY, USA.
Polly KirschNew York University Grossman School of Medicine, New York, NY, USA.
Rebecca Minerva OrtizDepartment of Medicine, New York University Langone Medical Center, New York, NY, USA.
Xinyu WangDepartment of Biostatistics, New York University School of Public Health, New York, NY, USA.
Megan MurphyDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Jordan Eric AxelradDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Simon HongDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Ariela HolmerDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Shannon ChangDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
David HudesmanDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Seymour KatzDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Lisa MalterDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA.
Adam S FayeDirector of Clinical Research, NYU IBD Center, NYU Langone Division of Gastroenterology, New York University, 303 East 33Rd Street, New York, NY, 10016, USA. adam.faye@nyulangone.org.

Funding

Optimal Preoperative Care for Older Adults with Inflammatory Bowel Disease (K76) - Resubmission - 1K76AG083286 · NIA · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Adam Scotte Faye · 2024 to 2026
$729k
NIH HHS K76AG083286
6 · The paper itself

Abstract

purposeThere is a lack of safety and efficacy data for newer biologic agents among adults ≥ 60 years old with inflammatory bowel disease (IBD) given their limited inclusion in clinical trials. We conducted a retrospective cohort study comparing the safety and efficacy of ustekinumab (UST) or vedolizumab (VDZ) use in older adults as compared to younger adults with IBD.

methodsThis single-center retrospective study compared individuals 18 to 59 years old to individuals ≥ 60 years old with a confirmed diagnosis of IBD who began VDZ or UST treatment between 2014 and 2022. The primary efficacy and safety outcomes were endoscopic remission and serious infection, respectively. Secondary outcomes included endoscopic response, clinical remission, and non-severe adverse events. Multivariable regression was used to identify factors independently associated with safety and efficacy.

resultsOverall, 948 individuals were included, with 779 (82.2%) < 60 years-old. In total, 548 (57.8%) had Crohn's disease, 367 (38.7%) had ulcerative colitis, 33 (3.5%) had indeterminate colitis, and a total of 403 individuals (42.5%) initiated VDZ whereas 545 (57.5%) initiated UST. When assessing efficacy, younger and older individuals had comparable rates of endoscopic remission (< 60 years-old 27.5% vs 29.0% ≥ 60 years-old, p = 0.69) as well as clinical remission (< 60 years-old 26.4% vs 26.6% ≥ 60 years-old, p = 0.96). When assessing safety, serious infection rates (< 60 years-old 8.9% vs 8.9% ≥ 60 years-old, p  = 0.99) and non-severe adverse event rates (< 60 years-old 12.3% vs 8.9% ≥ 60 years-old, p = 0.21) were not significantly different. On multivariable analysis, measures of disease severity (prior advanced therapy use, prior corticosteroid use, severe disease) significantly decreased the odds of endoscopic and clinical remission. Additionally, prior advanced therapy use and the presence of comorbidities increased the odds of serious infections.

conclusionThe use of UST and VDZ had similar efficacy and safety outcomes in older adults as compared to younger individuals with IBD. Decisions to utilize these biologics should be driven by overall disease burden and comorbidities, and not be deferred due to advanced chronological age alone.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeGastrointestinal AgentsInflammatory Bowel DiseasesUstekinumabAdolescentAdultAgedAge FactorsFemaleHumansMaleMiddle AgedRemission InductionRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsUstekinumabvedolizumabBiologic therapyCrohn’s diseaseUlcerative colitisUstekinumabVedolizumab

Identifiers

PMID40956538

What OpenQuestion holds

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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.