2026-04-13T14:21:28Zhttps://recercat.cat/oai/request
oai:recercat.cat:11351/125252025-10-24T10:35:13Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT author PADULLES-ZAMORA, NURIA author García García, Sonia author Clemente, Susana author Segarra, Oscar author Álvarez Beltran, Marina author Cabañas Poy, Mª José author Sanz Martínez, María Teresa author Gorgas, Maria Queralt author Miarons, Marta author Larrosa, María Nieves 2025-10-24T10:35:13Z 2025-10-24T10:35:13Z 2025-02-03T13:51:26Z2025-02-03T13:51:26Z2024-12-10 http://hdl.handle.net/11351/12525 Children; Inflammatory bowel diseases; Therapeutic drug monitoringNiños; Enfermedades inflamatorias intestinales; Monitorización terapéutica de medicamentosNens; Malalties inflamatòries intestinals; Monitoratge terapèutica de medicamentsBackground: This study evaluated the long-term effectiveness and safety of a multidisciplinary early proactive therapeutic drug monitoring (TDM) program combined with Bayesian forecasting for infliximab (IFX) dose adjustment in a real-world dataset of paediatric patients with inflammatory bowel disease (IBD). Methods: A descriptive, ambispective, single-centre study of paediatric patients with IBD who underwent IFX serum concentration measurements between September 2015 and September 2023. The patients received reactive TDM before September 2019 (n = 17) and proactive TDM thereafter (n = 21). We analysed for clinical, biological, and endoscopic remission; treatment failure; hospitalisations; emergency visits; and adverse drug reactions. The IFX doses were adjusted to maintain trough concentrations ≥ 5 µg/mL, with specific targets for proactive TDM. Results: Of the 38 patients, 21 had Crohn’s disease (CD), 16 ulcerative colitis (UC), and 1 undetermined IBD. The mean (standard deviation) IFX trough concentrations were 6.83 (5.66) µg/mL (reactive) and 12.38 (9.24) µg/mL (proactive) (p = 0.08). No statistically significant differences between groups were found in remission rates or treatment failure. The proactive group had fewer hospitalisations (14.29% vs. 23.53%; p = 0.47) and shorter median hospitalisation days (6 vs. 19; p = 0.50), although the difference was not statistically significant. The number of patients with adverse reactions (infusion related reactions and infections) was higher in the proactive group (38.10% vs. 23.53%; p = 0.34) but the difference was not significantly different. Conclusions: Proactive TDM showed no significant differences in treatment outcomes compared to reactive TDM. However, the results in both the reactive and proactive TDM groups were not worse than those reported in other studies. Further studies with larger samples are needed to optimize the treatment strategies for pediatric IBD patients.This study was funded by a grant for research in the field of Hospital Pharmacy of the Fundación Española de Farmacia Hospitalaria (FEFH) in the 2021–2022 call for proposals. Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Avaluació de resultats (Assistència sanitària) Aparell digestiu - Malalties - Tractament Medicaments gastrointestinals - Ús terapèutic Medicaments - Monitoratge Crohn, Malaltia de - Tractament Infants ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Gastroenteritis::Inflammatory Bowel Diseases Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Monitoring, Physiologic::Drug Monitoring CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Gastrointestinal Agents Other subheadings::Other subheadings::/therapeutic use NAMED GROUPS::Persons::Age Groups::Child TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::gastroenteritis::enfermedad inflamatoria intestinal Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::monitorización fisiológica::monitorización de medicamentos COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos gastrointestinales Otros calificadores::Otros calificadores::/uso terapéutico DENOMINACIONES DE GRUPOS::personas::Grupos de Edad::niño Long-Term Effectiveness and Safety of Proactive Therapeutic Drug Monitoring of Infliximab in Paediatric Inflammatory Bowel Disease: A Real-World Study info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion