| Title: | Effectiveness and safety of Ustekinumab in pediatric ulcerative colitis : a multicenter retrospective study from the pediatric ibd porto group of ESPGHAN |
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| Authors: | ID Cohen, Shlomi (Author)
ID Rolandsdotter, Helena (Author)
ID Kolho, Kaija-Leena (Author)
ID Turner, Dan (Author)
ID Tzivinikos, Christos (Author)
ID Bramuzzo, Matteo (Author)
ID Pujol-Muncunill, Gemma (Author)
ID Urlep Žužej, Darja (Author), et al. |
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| Files: |  PDF - Presentation file, download (662,99 KB)
MD5: 72446F05A9C9CCCBD4357AC438E7A7B5
 URL - Source URL, visit https://link.springer.com/article/10.1007/s40272-024-00631-z
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| Language: | English |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: |  UKC LJ - Ljubljana University Medical Centre
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| Abstract: | Background and Objectives Current 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. Methods This 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. Results Fifty-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. Conclusion Based 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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| Keywords: | Ustekinumab, pediatric ulcerative colitis, effectiveness |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2024 |
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| Number of pages: | str. 609–617 |
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| Numbering: | Vol. 26 |
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| PID: | 20.500.12556/DiRROS-27852  |
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| UDC: | 61 |
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| ISSN on article: | 1174-5878 |
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| DOI: | 10.1007/s40272-024-00631-z |
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| COBISS.SI-ID: | 228474627 |
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| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 10. 3. 2025;
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| Publication date in DiRROS: | 26.02.2026 |
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| Views: | 132 |
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| Downloads: | 53 |
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