Matteo Bramuzzo1, Serena Arrigo2, Claudio Romano3, Maria Chiara Filardi4, Paolo Lionetti5, Anna Agrusti6, Valeria Dipasquale3, Monica Paci5, Giovanna Zuin7, Marina Aloi8, Caterina Strisciuglio9, Erasmo Miele10, Maria Pastore11, Stefano Martelossi12, Patrizia Alvisi13. 1. Gastroenterology, Digestive Endoscopy and Nutrition Unit, Institute for Maternal and Child Health, IRCCS, 'Burlo Garofolo', Trieste, Italy. 2. Pediatric Gastroenterology and Endoscopy Unit, Institute 'Giannina Gaslini', Genoa, Italy. 3. Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood 'G. Barresi', University of Messina, Messina, Italy. 4. Unit of Translational Physiology and Nutrition, Department of Biological, Geological and Environmental Sciences, University of Bologna, Bologna, Italy. 5. Department of Neuroscience, Psychology, Pharmacology and Child's Health, University of Florence, Meyer Hospital, Florence, Italy. 6. Department of Medicine, Surgery and Health Sciences, University of Trieste, Trieste, Italy. 7. Pediatric Department, University of Milano-Bicocca, Fondazione MBBM, San Gerardo Hospital, Monza, Italy. 8. Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy. 9. Department of Woman, Child and General and Specialist Surgery, University of Campania 'Luigi Vanvitelli', Naples, Italy. 10. Department of Translational Medical Science, Section of Pediatrics, 'Federico II', University of Naples, Italy. 11. Pediatric Department, 'Casa Sollievo della Sofferenza' Hospital, IRCCS, San Giovanni Rotondo, Italy. 12. Pediatric Department, Ca' Foncello Hospital, Treviso, Italy. 13. Gastroenterology Unit, Pediatric Department, Maggiore Hospital, Bologna, Italy.
Abstract
Background: Very few data regarding the use of infliximab in children with very early-onset inflammatory bowel disease (VEO-IBD) have been reported. Objective: We aimed to assess the efficacy and the safety of infliximab in children with VEO-IBD compared with older children. Methods: Children treated with infliximab were identified within the Italian IBD registry. The primary outcome was the rate of clinical remission at weeks 14 and 54. Secondary outcomes included the proportion of partial clinical response, treatment duration, and incidence of adverse events. Results: Forty-two children with VEO-IBD were compared with 130 children with IBD. Despite significantly higher infliximab withdrawals in VEO-IBD patients during induction (42.9% vs 7.7% p < 0.01), remission rates at week 14 were similar (28.6% vs 43.8%, p = 0.10). At week 54 fewer VEO-IBD children were in remission (15.8% vs 54.3%, p < 0.01). The treatment duration was shorter in VEO-IBD (median 12.0 vs 18.4 months, p < 0.01). During the induction phase, adverse events were more common in the VEO-IBD group (p < 0.01). Conclusion: Compared with older children, VEO-IBD patients have higher rates of infliximab failures, lower remission rates at one year, and more often experience adverse events during induction.
Background: Very few data regarding the use of infliximab in children with very early-onset inflammatory bowel disease (VEO-IBD) have been reported. Objective: We aimed to assess the efficacy and the safety of infliximab in children with VEO-IBD compared with older children. Methods:Children treated with infliximab were identified within the Italian IBD registry. The primary outcome was the rate of clinical remission at weeks 14 and 54. Secondary outcomes included the proportion of partial clinical response, treatment duration, and incidence of adverse events. Results: Forty-two children with VEO-IBD were compared with 130 children with IBD. Despite significantly higher infliximab withdrawals in VEO-IBD patients during induction (42.9% vs 7.7% p < 0.01), remission rates at week 14 were similar (28.6% vs 43.8%, p = 0.10). At week 54 fewer VEO-IBD children were in remission (15.8% vs 54.3%, p < 0.01). The treatment duration was shorter in VEO-IBD (median 12.0 vs 18.4 months, p < 0.01). During the induction phase, adverse events were more common in the VEO-IBD group (p < 0.01). Conclusion: Compared with older children, VEO-IBD patients have higher rates of infliximab failures, lower remission rates at one year, and more often experience adverse events during induction.
Entities:
Keywords:
Children; inflammatory bowel disease; infliximab; very early onset
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