ArticleEuropean journal of pediatrics2024
STEP-CD study: ustekinumab use in paediatric Crohn's disease-a multicentre retrospective study from paediatric IBD Porto group of ESPGHAN.
Article in European journal of pediatrics, 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 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.
- Meta-analysis: safety and efficacy of ustekinumab in pediatric inflammatory bowel disease patients with anti-TNF failure.BMC gastroenterology · 2026Pooled 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
- 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
- How Organ Manifestations Beyond the Bone May Guide Risk Stratification and Treatment Decisions in Chronic Nonbacterial Osteomyelitis.Paediatric drugs · 2026Review
- Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study.Journal of pediatric gastroenterology and nutrition · 2026Observational
- Off-Label Ustekinumab and Vedolizumab in Pediatric Anti-TNFα Refractory IBD: Therapeutic Drug Monitoring Insights from a Case Series.Pharmaceuticals (Basel, Switzerland) · 2026Article
- 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
- [Research progress on biologics and therapeutic drug monitoring in pediatric inflammatory bowel disease].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025Review
- Association of Serum Levels of Ustekinumab, Vedolizumab, and Faecal Calprotectin in Paediatric Patients with Inflammatory Bowel Diseases: A Prospective Observational Study.Paediatric drugs · 2025Observational
- [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
33 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Ustekinumab is an effective therapy for adult Crohn's disease (CD), but data in paediatric CD patients are scarce. The aim of the study was to describe the real-life effectiveness and safety of ustekinumab in paediatric CD. This is a multicentre review of children with Crohn's disease treated with ustekinumab. The aim of our study was to describe the effectiveness and safety of ustekinumab in paediatric real-life practice. This is a study of the Paediatric IBD (inflammatory bowel disease) Porto group of ESPGHAN. Corticosteroid (CS)- and exclusive enteral nutrition (EEN)-free remission, defined as weighted Paediatric Crohn's Disease Activity Index (wPCDAI) < 12.5, and physician global assessment (PGA) were determined at weeks 12 and 52. A total of 101 children were included at a median age of 15.4 years (IQR 12.7-17.2) with a median follow-up of 7.4 months (IQR 5.6-11.8). Ninety-nine percent had received prior anti-TNF, 63% ≥ 2 anti-TNFα therapies and 22% vedolizumab. Baseline median wPCDAI was 39 (IQR 25-57.5) (71 (70%) patients with moderate-severe activity). Weeks 12 and 52 CS- and EEN-free remission were both 40.5%. Clinical response at week 6, iv induction route and older age at onset of ustekinumab treatment were predictive factors associated with clinical remission at week 12. Seven minor adverse events probably related to ustekinumab were reported. One patient died from an unrelated cause. Conclusion: Our results suggest that ustekinumab is effective and safe in children with chronically active or refractory CD. What is Known: • Ustekinumab is an effective therapy for adult moderate to severe Crohn's disease (CD). • Off-label use of ustekinumab in children is increasing especially in anti-TNF refractory CD. What is New: • Is the largest cohort of real-world use of ustekinumab in paediatric CD to date. • Clinical response at week 6, iv induction and older age at onset of ustekinumab were predictive factors associated with clinical response at week 12.
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