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Safety and Potential Efficacy of Escalating Dose of Ustekinumab in Pediatric Crohn Disease (the Speed-up Study): A Multicenter Study from the Pediatric IBD Porto Group of ESPGHAN
A. Yerushalmy-Feler, G. Pujol-Muncunill, J. Martin-de-Carpi, KL. Kolho, A. Levine, C. Olbjørn, M. Granot, M. Bramuzzo, H. Rolandsdotter, N. Mouratidou, O. Hradsky, L. Scarallo, M. Matar, RM. Rimon, F. Rinawi, T. Shalem, H. Najajra, T. de Meij, M....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu multicentrická studie, časopisecké články
- MeSH
- Crohnova nemoc * farmakoterapie MeSH
- dítě MeSH
- dospělí MeSH
- hojení ran MeSH
- indukce remise MeSH
- lidé MeSH
- mladiství MeSH
- retrospektivní studie MeSH
- ustekinumab * škodlivé účinky MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
OBJECTIVES: Escalation of the ustekinumab (UST) maintenance dosage was effective in adults with Crohn disease (CD), but no data are available for children. We evaluated the effectiveness and safety of dose escalation of UST in pediatric CD. METHODS: This was a retrospective multicenter study from 25 centers affiliated with the IBD Interest and Porto groups of ESPGHAN. We included children with CD who initiated UST at a standard dosing and underwent either dose escalation to intervals shorter than 8 weeks or re-induction of UST due to active disease. Demographic, clinical, laboratory, endoscopic, imaging, and safety data were collected up to 12 months of follow-up. RESULTS: Sixty-nine children were included (median age 15.8 years, interquartile range 13.8-16.9) with median disease duration of 4.3 years (2.9-6.3). Most children were biologic (98.6%)- and immunomodulator (86.8%)- experienced. Clinical response and remission were observed at 3 months after UST escalation in 46 (67%) and 29 (42%) children, respectively. The strongest predictor for clinical remission was lower weighted Pediatric Crohn Disease Activity Index (wPCDAI) at escalation ( P = 0.001). The median C-reactive protein level decreased from 14 (3-28.03) to 5 (1.1-20.5) mg/L ( P = 0.012), and the fecal calprotectin level from 1100 (500-2300) to 515 (250-1469) μg/g ( P = 0.012) 3 months post-escalation. Endoscopic and transmural healing were achieved in 3 of 19 (16%) and 2 of 15 (13%) patients, respectively. Thirteen patients (18.8%) discontinued therapy due to active disease. No serious adverse events were reported. CONCLUSIONS: Two-thirds of children with active CD responded to dose escalation of UST. Milder disease activity may predict a favorable outcome following UST dose escalation.
the Department of Paediatric and Adolescent Medicine Akershus University Hospital Lørenskog Norway
the Department of Paediatrics Hospital Universitario de Fuenlabrada Madrid Spain
the Department of Pediatrics Paracelsus Medical University Salzburg Austria
the Gastroenterology and Nutrition Unit Meyer Children's Hospital Florence Italy
the Paediatric Gastroenterology Hepatology and Nutrition Hospital Niño Jesús Madrid Spain
the Pediatric Gastroenterology Unit Department of Pediatrics Maggiore Hospital Bologna Italy
the Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel
Citace poskytuje Crossref.org
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- $a Yerushalmy-Feler, Anat $u From the Pediatric Gastroenterology Institute, "Dana-Dwek" Children's Hospital, Tel Aviv Sourasky Medical Center and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
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- $a Safety and Potential Efficacy of Escalating Dose of Ustekinumab in Pediatric Crohn Disease (the Speed-up Study): A Multicenter Study from the Pediatric IBD Porto Group of ESPGHAN / $c A. Yerushalmy-Feler, G. Pujol-Muncunill, J. Martin-de-Carpi, KL. Kolho, A. Levine, C. Olbjørn, M. Granot, M. Bramuzzo, H. Rolandsdotter, N. Mouratidou, O. Hradsky, L. Scarallo, M. Matar, RM. Rimon, F. Rinawi, T. Shalem, H. Najajra, T. de Meij, M. Aloi, MV. Rodríguez-Belvís, P. Alvisi, AM. Schneider, P. van Rheenen, VM. Navas-López, F. Kiparissi, J. Barrio, D. Turner, S. Cohen
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- $a OBJECTIVES: Escalation of the ustekinumab (UST) maintenance dosage was effective in adults with Crohn disease (CD), but no data are available for children. We evaluated the effectiveness and safety of dose escalation of UST in pediatric CD. METHODS: This was a retrospective multicenter study from 25 centers affiliated with the IBD Interest and Porto groups of ESPGHAN. We included children with CD who initiated UST at a standard dosing and underwent either dose escalation to intervals shorter than 8 weeks or re-induction of UST due to active disease. Demographic, clinical, laboratory, endoscopic, imaging, and safety data were collected up to 12 months of follow-up. RESULTS: Sixty-nine children were included (median age 15.8 years, interquartile range 13.8-16.9) with median disease duration of 4.3 years (2.9-6.3). Most children were biologic (98.6%)- and immunomodulator (86.8%)- experienced. Clinical response and remission were observed at 3 months after UST escalation in 46 (67%) and 29 (42%) children, respectively. The strongest predictor for clinical remission was lower weighted Pediatric Crohn Disease Activity Index (wPCDAI) at escalation ( P = 0.001). The median C-reactive protein level decreased from 14 (3-28.03) to 5 (1.1-20.5) mg/L ( P = 0.012), and the fecal calprotectin level from 1100 (500-2300) to 515 (250-1469) μg/g ( P = 0.012) 3 months post-escalation. Endoscopic and transmural healing were achieved in 3 of 19 (16%) and 2 of 15 (13%) patients, respectively. Thirteen patients (18.8%) discontinued therapy due to active disease. No serious adverse events were reported. CONCLUSIONS: Two-thirds of children with active CD responded to dose escalation of UST. Milder disease activity may predict a favorable outcome following UST dose escalation.
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