ArticlePaediatric drugs2024
Effectiveness and Safety of Ustekinumab in Pediatric Ulcerative Colitis: A Multi-center Retrospective Study from the Pediatric IBD Porto Group of ESPGHAN.
Article in Paediatric drugs, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.
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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.
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
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Reshaping study design for faster extrapolation-based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN-NASPGHAN position paper.Journal of pediatric gastroenterology and nutrition · 2026Pooled it
- Management of paediatric ulcerative colitis, part 1: Ambulatory care-An updated evidence-based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organisation.Journal of pediatric gastroenterology and nutrition · 2025Guideline
- How Organ Manifestations Beyond the Bone May Guide Risk Stratification and Treatment Decisions in Chronic Nonbacterial Osteomyelitis.Paediatric drugs · 2026Review
- Reactive Therapeutic Drug Monitoring Guides Optimal Management of Adalimumab Failure in Pediatric Crohn's Disease: A Real-World Single-Center Experience.Pediatric gastroenterology, hepatology & nutrition · 2026Article
- Real-world outcomes of ustekinumab, vedolizumab, and tumor necrosis factor inhibitors in very-early-onset inflammatory bowel disease: a multi-center cohort study.Journal of gastroenterology · 2026Article
- Advances in the Management of Pediatric Inflammatory Bowel Disease: From Biologics to Small Molecules.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Switching Between Anti-TNFs and Other Biologic Drugs in Paediatric Inflammatory Bowel Disease: A Narrative Review and Practical Clinical Guide.Journal of inflammation research · 2026Review
- Association of Serum Levels of Ustekinumab, Vedolizumab, and Faecal Calprotectin in Paediatric Patients with Inflammatory Bowel Diseases: A Prospective Observational Study.Paediatric drugs · 2025Observational
- Upadacitinib for Induction of Remission in Pediatric Ulcerative Colitis: An International Multicenter Study.Journal of Crohn's & colitis · 2025Article
- [Position paper of the Society for Paediatric Gastroenterology and Nutrition (GPGE) on the off-label use of biologics and signal inhibitors in children and adolescents with IBD that have already been approved for adults].Zeitschrift fur Gastroenterologie · 2025Article
- Bibliometric analysis of Crohn's disease in children, 2014-2024.Frontiers in pediatrics · 2025Review
Corrections and comments
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Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesCurrent data on ustekinumab therapy in children with ulcerative colitis (UC) or unclassified inflammatory bowel disease (IBDU) are limited. We aimed to evaluate the effectiveness and safety of ustekinumab in pediatric UC and IBDU.
methodsThis multicenter retrospective study included 16 centers affiliated with the IBD Interest and Porto groups of ESPGHAN. Children with UC or IBDU treated with ustekinumab were enrolled. Demographic, clinical, laboratory, endoscopic, and imaging data as well as adverse events were recorded. Analyses were all based on the intention-to-treat principle.
resultsFifty-eight children (39 UC and 19 IBDU, median age 14.5 [IQR 11.5-16.5] years) were included. All had failed biologic therapies, and 38 (66%) had failed two or more biologics. Corticosteroid-free clinical remission (CFR) was observed in 27 (47%), 33 (57%), and 37 (64%) children at 16, 26, and 52 weeks, respectively. Normalization of C-reactive protein and calprotectin < 150 μg/g were achieved in 60% and 52%, respectively, by 52 weeks. Endoscopic and radiologic remissions were reached in 8% and 23%, respectively. The main predictors of CFR were diagnosis of UC compared with IBDU (hazard ratio [HR] 2.2, 95% CI 1.03-4.85; p = 0.041) and no prior vedolizumab therapy (HR 2.1, 95% CI 1.11-4.27; p = 0.023). Ustekinumab serum levels were not associated with disease activity. Adverse events were recorded in six (10%) children, leading to discontinuation of the drug in three.
conclusionBased on these findings, ustekinumab appears as an effective therapy for pediatric refractory UC and IBDU. The potential efficacy should be weighed against the risks of serious adverse events.
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