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Infliximab in paediatric inflammatory bowel disease: External evaluation of population pharmacokinetic models.

التفاصيل البيبلوغرافية
العنوان: Infliximab in paediatric inflammatory bowel disease: External evaluation of population pharmacokinetic models.
المؤلفون: Heikal OS; Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen and University of Groningen, Groningen, The Netherlands., van Rheenen PF; Department of Paediatric Gastroenterology, Hepatology and Nutrition, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands., Touw DJ; Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen and University of Groningen, Groningen, The Netherlands.; Department of Pharmaceutical Analysis, Groningen Research Institute for Pharmacy, University of Groningen, Groningen, The Netherlands., Kosterink JGW; Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen and University of Groningen, Groningen, The Netherlands.; Groningen Research Institute of Pharmacy, Pharmacotherapy, Epidemiology & Economics, University of Groningen, Groningen, The Netherlands., Maurer M; Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen and University of Groningen, Groningen, The Netherlands., Koomen JV; Department of Anaesthesiology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.; Department of Pharmacology, Toxicology and Kinetics, Dutch Medicines Evaluation Board, Utrecht, The Netherlands., Chelle P; School of Pharmacy, University of Waterloo, Waterloo, Ontario, Canada., Mian P; Department of Clinical Pharmacy and Pharmacology, University Medical Centre Groningen and University of Groningen, Groningen, The Netherlands.
المصدر: British journal of clinical pharmacology [Br J Clin Pharmacol] 2024 Jun 06. Date of Electronic Publication: 2024 Jun 06.
Publication Model: Ahead of Print
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 7503323 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2125 (Electronic) Linking ISSN: 03065251 NLM ISO Abbreviation: Br J Clin Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: Oxford : Wiley-Blackwell
Original Publication: London, Macmillan Journals Ltd.
مستخلص: Aims: Use of infliximab (IFX) has improved outcomes in children with inflammatory bowel disease (IBD). However, a proportion of patients does not respond to IFX or loses response over time. Population pharmacokinetic (PopPK) modelling is a promising approach for IFX dose optimization, but with the increasing number of PopPK models in literature, model evaluation is essential. The aims of this study are: (i) to validate the predictive performance of existing IFX PopPK models using a cohort of children with IBD; and (ii) to perform a Bayesian estimation of the most suitable model to predict the next IFX concentrations.
Methods: PubMed was searched for IFX PopPK models in children. Selected models were rebuilt and analysed using R. Model performance was assessed through goodness-of-fit-plots, residuals against time, prediction error and prediction-corrected visual predictive checks. The validation cohort consisted of 73 children with IBD who were treated with IFX in our centre between 2017 and 2023 (340 IFX measurements).
Results: We identified 9 PopPK models. Model bias for individual predicted values ranged from -9.29% to 8.01% compared to bias for population predicted values. The model by Vande Casteele et al. demonstrated superior performance (individual predicted bias 2.13, population predicted bias -6.11); upon Bayesian estimation, it predicted induction trough levels with median error of 12.95% but had a median error of -69% predicting maintenance concentrations.
Conclusion: The model by Vande Casteele et al. displayed superior performance in initial evaluations but had a high error in estimating next IFX levels and can only be used in practice to predict induction levels.
(© 2024 The Author(s). British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.)
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فهرسة مساهمة: Keywords: IBD; PopPK; TDM; children; gastroenterology; infliximab; tumour necrosis factor‐α
تواريخ الأحداث: Date Created: 20240607 Latest Revision: 20240607
رمز التحديث: 20240607
DOI: 10.1111/bcp.16126
PMID: 38845210
قاعدة البيانات: MEDLINE
الوصف
تدمد:1365-2125
DOI:10.1111/bcp.16126