Evidence map›Paper›PMID 40289770›Full record

ArticleJournal of Crohn's & colitis2025

A multicenter study of the real-world effectiveness and safety of risankizumab in Crohn's disease.

Amanda M Johnson, Manar Askar, Seema Belani, Abdul Khan, Anthony A Xu, Blake Kassmeyer, Hyder Said, Michael Santiago-Castro, Jalpa Devi, Katherine Huang and 11 more

Erratum issuedAbstract readMulticenter Study
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. An erratum has been issued. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing 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

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

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Amanda M JohnsonDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States.
Manar AskarDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States.
Seema BelaniDivision of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, United States.
Abdul KhanDivision of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA, United States.
Anthony A XuSection of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, United States.
Blake KassmeyerDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States.
Hyder SaidDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Michael Santiago-CastroDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, United States.ORCID 0009-0007-0179-3136
Jalpa DeviDivision of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, United States.ORCID 0000-0001-8710-2381
Katherine HuangDivision of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, United States.
Fnu JaipradaDivision of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, United States.
Nickhil SethDivision of Gastroenterology and Hepatology, Brooke Army Medical Center, San Antonio, TX, United States.
David DulaneyDivision of Gastroenterology and Hepatology, Brooke Army Medical Center, San Antonio, TX, United States.
Edward V LoftusDivision of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, United States.
Marc FensterDivision of Gastroenterology, Montefiore Medical Center, Bronx, NY, United States.
Anish PatelDivision of Gastroenterology and Hepatology, Brooke Army Medical Center, San Antonio, TX, United States.
Shrinivas BishuDivision of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, United States.ORCID 0000-0003-4823-5805
Ryan C UngaroDivision of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.ORCID 0000-0001-8687-3758
Richa ShuklaSection of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, United States.
Andres J YarurDivision of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA, United States.
Parakkal DeepakDivision of Gastroenterology, Washington University School of Medicine, Saint Louis, MO, United States.ORCID 0000-0002-3436-9784

Funding

Research Training in GastroenterologyT32DK083266 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Hashem B El-Serag, FASIHA KANWAL · 2010 to 2026
$2.3M
Mayo Clinic Department of Medicine Catalyst GrantNIDDK NIH HHS T32 DK083266
6 · The paper itself

Abstract

backgroundWe aimed to evaluate the effectiveness and safety of risankizumab (RZB) for Crohn's disease (CD) in routine clinical practice.

methodsWe performed a retrospective review of a multicenter consortium of CD patients treated with RZB. Co-primary outcomes were week 12 clinical remission (Harvey Bradshaw Index [HBI] score of ≤4 or physician global assessment in those without HBI or with ileostomy) and 6-month endoscopic remission (Simplified Endoscopic Mucosal Assessment for Crohn's Disease of 0-1 or absence of ulcers). Secondary outcomes included steroid-free clinical remission, clinical response, radiographic response, cumulative clinical and endoscopic remission rates at 6 and 12 months, and adverse events.

resultsA total of 309 patients were included (median disease duration 14 years [IQR, 6-24]; median follow-up 7.1 months [IQR, 4.1-10.3]). Most patients (85.8%) were advanced therapy (AT)-exposed, and 169 (54.7%) had prior ustekinumab (UST) exposure. Week 12 clinical remission rates were 49.7% (98/197) overall, and 44.2% (50/113) vs 57.1% (48/84) in UST-exposed vs naïve patients (P = .073). Among those with active disease on baseline endoscopy (n = 122) who had an available follow-up at 6 months, 52.4% (22/42) achieved endoscopic remission. Cumulative rates of clinical and endoscopic remission at 12 months were 65.0% and 49.5%, respectively. Cumulative 12-month endoscopic remission was 33.9% (19/56) in UST-exposed and 68.1% (32/47) in UST-naïve patients (P < .001). Risankizumab was well-tolerated with no new safety signals identified.

conclusionsIn this large multicenter cohort of patients with CD, RZB was well-tolerated and effective in achieving favorable clinical and endoscopic outcomes in both AT-exposed and naïve populations, including those with exposure to UST.

Indexed as

Antibodies, MonoclonalCrohn DiseaseGastrointestinal AgentsAdultFemaleHumansMaleMiddle AgedRemission InductionRetrospective StudiesSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, MonoclonalGastrointestinal AgentsrisankizumabCrohn’s disease (CD)interleukinrisankizumab (RZB)

Identifiers

PMID40289770
PMCPMC13032034

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.