ArticleJournal of pediatric gastroenterology and nutrition2025
Ustekinumab is safe and effective in pediatric patients with Crohn's disease.
Article in Journal of pediatric gastroenterology and nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Meta-analysis: safety and efficacy of ustekinumab in pediatric inflammatory bowel disease patients with anti-TNF failure.BMC gastroenterology · 2026Pooled it
- Ustekinumab therapy for moderately to severely active pediatric Crohn's disease: UNITI Jr study safety and efficacy results in patients weighing at least 40 kg.Journal of Crohn's & colitis · 2026Trial
- Refractory Chronic Inflammatory Bowel Disease in Childhood and Adolescence: Options in Primary Non-Response or Secondary Treatment Failure.Deutsches Arzteblatt international · 2026Review
- Real-World Experience of Risankizumab in Refractory Pediatric Inflammatory Bowel Disease.ACG case reports journal · 2026Article
- Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study.Journal of pediatric gastroenterology and nutrition · 2026Observational
- Early proactive therapeutic drug monitoring with ustekinumab therapy in pediatric Crohn's disease: data from the prospective Canadian children IBD network.Crohn's & colitis 360 · 2026Article
- Exploratory transcriptomic analysis suggests candidate genes associated with loss of response to ustekinumab in Crohn's disease.Frontiers in genetics · 2026Article
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
objectivesReal-world data on ustekinumab for the treatment of pediatric Crohn's disease (CD) are limited. This study sought to evaluate the effectiveness, long-term durability, and safety of ustekinumab in the treatment of children with CD.
methodsA retrospective longitudinal cohort study of children with CD treated with ustekinumab from two large centers between 2015 and 2020 was performed. The primary outcome was frequency of steroid-free clinical remission at 1 year. Secondary outcomes included time to steroid-free clinical remission, frequency of clinical and biochemical remission, drug escalation and discontinuation, serum level data, and adverse events. Standard descriptive and comparative statistics were performed. Logistic regression was used to identify factors associated with steroid-free remission at 1 year. Kaplan-Meier curves were used to visualize time-to-event relationships for outcomes.
resultsA total of 101 patients were included. Median follow-up time on ustekinumab was 16.6 months (interquartile range [IQR]: 8.71-31.2) with drug failure in 28% at 1 year. Fifty-nine patients were in steroid-free clinical remission at 1 year. Higher baseline disease activity (odds ratio [OR]: 0.91 (95% confidence interval [CI]: 0.84-0.97), p = 0.01) and stricturing/penetrating disease phenotype (OR: 0.14 (95% CI: 0.03-0.65), p = 0.02) were associated with decreased likelihood of steroid-free clinical remission at 1-year. Ustekinumab drug escalation occurred in 70% of patients, and after escalation, 50 (70%) achieved clinical remission, and 49 (69%) achieved steroid-free remission at the last follow-up. Adverse events were rare and did not require therapy discontinuation.
conclusionsUstekinumab is effective and safe in the treatment of children with CD. Escalation of therapy occurs frequently but results in sustained durability.
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