Evidence map›Paper›PMID 41766590›Full record

Observational studyJournal of pediatric gastroenterology and nutrition2026

Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study.

Steven J Steiner, Jeremy Adler, Shehzad A Saeed, Richard S Strauss, Kristin M Howe, Anna Sheahan, Renping Zhang, Kimberly R Keihn, Katharine Harrow, Kelly K Olano and 7 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of pediatric gastroenterology and nutrition, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05242458 (Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease), which is not on this 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.

NCT05242458 completednot on this map

Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease: A Retrospective Cohort Study Using the ImproveCareNow Registry Data

TypeobservationalSponsorJanssen Research & Development, LLCRan2022 to 2023Enrolled545ConditionsCrohn's DiseaseArmsUstekinumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Observational
  3. 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

17 authors.

Steven J SteinerRiley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0002-7461-3905
Jeremy AdlerC.S. Mott Children's Hospital, Michigan Medicine, University of Michigan, Ann Arbor, Michigan, USA.
Shehzad A SaeedDayton Children's Hospital/Wright State University Boonshoft School of Medicine, Dayton, Ohio, USA.
Richard S StraussJohnson & Johnson, Spring House, Pennsylvania, USA.
Kristin M HoweImproveCareNow, Essex Junction, Vermont, USA.
Anna SheahanJohnson & Johnson, Horsham, Pennsylvania, USA.
Renping ZhangJohnson & Johnson, La Jolla, California, USA.
Kimberly R KeihnRiley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Katharine HarrowCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Kelly K OlanoCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
David A EvansResearch Data Corporation, Gibbsboro, New Jersey, USA.
Kim Hung LoJohnson & Johnson, Spring House, Pennsylvania, USA.
Nanhua ZhangCincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Lilianne KimJohnson & Johnson, Spring House, Pennsylvania, USA.
Richard B CollettiUniversity of Vermont Children's Hospital, Burlington, Vermont, USA.
Sheri VolgerJohnson & Johnson, Spring House, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-1689-1173
ImproveCareNow Learning Health Network

Funding

Johnson & Johnson
6 · The paper itself

Abstract

objectivesFew approved treatments exist for children with Crohn's disease (CD). The REALITI study retrospectively assessed the effectiveness and safety of ustekinumab in real-world clinical settings for children with CD.

methodsData were collected from the prospective ImproveCareNow (ICN) registry for pediatric patients (≥ 2 to <18 years old) and young adult patients (≥ 18 to <26 years old), regardless of baseline CD severity. Additional analyses were conducted for a subset of patients who had moderately-to-severely active CD (short pediatric CD activity index [sPCDAI] ≥30). Key Week-52 endpoints included clinical remission (sPCDAI ≤10) and corticosteroid-free (CF) clinical remission. Safety events of interest were assessed at Week 52.

resultsOverall, 479 patients with CD were treated with ustekinumab, 348 pediatric patients and 131 young adults; most were biologic-exposed (pediatric, 98.9%; young adult, 95.4%). At Week 52 (observed case; excluding patients without Week 52 data), clinical remission was achieved by 47.3% (125/264) of pediatric patients and 44.8% (39/87) of young adults, and CF clinical remission by 41.3% (109/264) and 39.1% (34/87), respectively. At Week 52 (observed case), among patients with moderately-to-severely active CD, clinical remission was achieved by 36.9% (41/111) of pediatric patients and 34.3% (12/35) of young adults, and CF clinical remission by 31.5% (35/111) and 28.6% (10/35), respectively. Ustekinumab was well tolerated, with no new safety signals identified.

conclusionsIn the REALITI study of real-world data from the ICN registry, the effectiveness and safety of ustekinumab treatment through 52 weeks were similar in pediatric and young adult patients with CD.

trial registrationClinicalTrials.gov identifier: NCT05242458; https://clinicaltrials.gov/study/NCT05242458.

Indexed as

Crohn DiseaseUstekinumabAdolescentAdultChildChild, PreschoolFemaleHumansMaleRegistriesRemission InductionRetrospective StudiesSeverity of Illness IndexTreatment OutcomeYoung AdultUstekinumabbiologic productchildreninflammatory bowel diseasereal‐worldregistries

Identifiers

PMID41766590
PMCPMC13150951

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.