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Upadacitinib for Induction of Remission in Pediatric Ulcerative Colitis: An International Multicenter Study
A. Yerushalmy-Feler, EA. Spencer, MT. Dolinger, DL. Suskind, K. Mitrova, O. Hradsky, MA. Conrad, JR. Kelsen, HH. Uhlig, C. Tzivinikos, S. Ancona, M. Wlazlo, L. Hackl, DS. Shouval, M. Bramuzzo, D. Urlep, C. Olbjorn, G. D'Arcangelo, G....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, multicentrická studie
PubMed
39605286
DOI
10.1093/ecco-jcc/jjae182
Knihovny.cz E-zdroje
- MeSH
- C-reaktivní protein analýza MeSH
- dítě MeSH
- heterocyklické sloučeniny tricyklické * terapeutické užití škodlivé účinky MeSH
- indukce remise metody MeSH
- indukční chemoterapie metody MeSH
- leukocytární L1-antigenní komplex analýza MeSH
- lidé MeSH
- mladiství MeSH
- retrospektivní studie MeSH
- ulcerózní kolitida * farmakoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
BACKGROUND AND AIMS: Data on upadacitinib therapy in children with ulcerative colitis (UC) or unclassified inflammatory bowel disease (IBD-U) are scarce. We aimed to evaluate the effectiveness and safety of upadacitinib as an induction therapy in pediatric UC or IBD-U. METHODS: In this multicenter retrospective study, children treated with upadacitinib for induction of remission of active UC or IBD-U from 30 centers worldwide were enrolled. Demographic, clinical, and laboratory data, as well as adverse events (AEs), were recorded at Week 8 post-induction. RESULTS: One hundred children were included (90 UC and 10 IBD-U, median age 15.6 [interquartile range 13.3-17.1] years). Ninety-eight were previously treated with biologic therapies, and 76 were treated with ≥2 biologics. At the end of the 8-week induction period, clinical response, clinical remission, and corticosteroid-free clinical remission (CFR) were observed in 84%, 62%, and 56% of the children, respectively. Normal C-reactive protein and fecal calprotectin (FC) <150 mcg/g were achieved in 75% and 50%, respectively. Combined CFR and FC remission was observed in 18/46 (39%) children with available data at 8 weeks. Adverse events were recorded in 37 children, including 1 serious AE of an appendiceal neuroendocrine tumor. The most frequent AEs were hyperlipidemia (n = 13), acne (n = 12), and infections (n = 10, 5 of whom with herpes viruses). CONCLUSIONS: Upadacitinib is an effective induction therapy for refractory pediatric UC and IBD-U. Efficacy should be weighed against the potential risks of AEs.
Al Jalila Children's Specialty Hospital Dubai United Arab Emirates
Biomedical Research Centre University of Oxford Oxford UK
Centre of Human Genetics University of Oxford Oxford UK
Children's Hospital Zagreb University of Zagreb Medical School Zagreb Croatia
Department of Paediatric and Adolescent Medicine Akershus University Hospital Lørenskog Norway
Department of Paediatrics University of Oxford Oxford UK
Department of Pediatrics 1 Medical University Innsbruck Innsbruck Austria
Department of Pediatrics School of Medicine Kyungpook National University Daegu Korea
Faculty of Medical and Health Sciences Tel Aviv University Tel Aviv Israel
Faculty of Medicine Tel Aviv University Tel Aviv Israel
Gastroenterology and Nutrition Unit Meyer Children's Hospital Florence Italy
Institute for Maternal and Child Health IRCCS Burlo Garofolo Trieste Italy
Pediatric Department Children's Hospital Vittore Buzzi University of Milan Milan Italy
Pediatric Hepatology Gastroenterology and Transplantation ASST Papa Giovanni XXIII Bergamo Italy
Seattle Children's Hospital IBD Center Seattle WA USA
Translational Gastroenterology Unit University of Oxford Oxford UK
Citace poskytuje Crossref.org
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- $a BACKGROUND AND AIMS: Data on upadacitinib therapy in children with ulcerative colitis (UC) or unclassified inflammatory bowel disease (IBD-U) are scarce. We aimed to evaluate the effectiveness and safety of upadacitinib as an induction therapy in pediatric UC or IBD-U. METHODS: In this multicenter retrospective study, children treated with upadacitinib for induction of remission of active UC or IBD-U from 30 centers worldwide were enrolled. Demographic, clinical, and laboratory data, as well as adverse events (AEs), were recorded at Week 8 post-induction. RESULTS: One hundred children were included (90 UC and 10 IBD-U, median age 15.6 [interquartile range 13.3-17.1] years). Ninety-eight were previously treated with biologic therapies, and 76 were treated with ≥2 biologics. At the end of the 8-week induction period, clinical response, clinical remission, and corticosteroid-free clinical remission (CFR) were observed in 84%, 62%, and 56% of the children, respectively. Normal C-reactive protein and fecal calprotectin (FC) <150 mcg/g were achieved in 75% and 50%, respectively. Combined CFR and FC remission was observed in 18/46 (39%) children with available data at 8 weeks. Adverse events were recorded in 37 children, including 1 serious AE of an appendiceal neuroendocrine tumor. The most frequent AEs were hyperlipidemia (n = 13), acne (n = 12), and infections (n = 10, 5 of whom with herpes viruses). CONCLUSIONS: Upadacitinib is an effective induction therapy for refractory pediatric UC and IBD-U. Efficacy should be weighed against the potential risks of AEs.
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