دورية أكاديمية
Infliximab in paediatric inflammatory bowel disease: External evaluation of population pharmacokinetic models.
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.) |
References: | Bouhuys M, Lexmond WS, van Rheenen PF. Pediatric inflammatory bowel disease. Pediatrics. 2023;151(1). doi:10.1542/peds.2022‐058037. Chung A, Carroll M, Almeida P, et al. Early infliximab clearance predicts remission in children with Crohn's disease. Dig Dis Sci. 2023;68(5):1995‐2005. doi:10.1007/S10620‐022‐07783‐3. Frymoyer A, Hoekman DR, Piester TL, et al. Application of population pharmacokinetic modeling for individualized infliximab dosing strategies in Crohn disease. J Pediatr Gastroenterol Nutr. 2017;65(6):639‐645. doi:10.1097/MPG.0000000000001620. Kelsen JR, Grossman AB, Pauly‐Hubbard H, Gupta K, Baldassano RN, Mamula P. Infliximab therapy in pediatric patients 7 years of age and younger. J Pediatr Gastroenterol Nutr. 2014;59(6):758‐762. doi:10.1097/MPG.0000000000000533. Bauman LE, Xiong Y, Mizuno T, et al. Improved population pharmacokinetic model for predicting optimized infliximab exposure in pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2020;26(3):429‐439. doi:10.1093/IBD/IZZ143. Funk RS, Shakhnovich V, Cho YK, et al. Factors associated with reduced infliximab exposure in the treatment of pediatric autoimmune disorders: a cross‐sectional prospective convenience sampling study. Pediatr Rheumatol. 2021;19(1):62. doi:10.1186/S12969‐021‐00548‐8. Gadsby J, Hall K, Shah F, Pattni S, Gethins S, Mulla H. Infliximab: a single‐centre, prospective, observational evaluation of TDM data in patients with IBD. Eur J Hosp Pharm. 2024;31(1):16‐20. doi:10.1136/ejhpharm‐2021‐003015. van Rheenen PF, Aloi M, Assa A, et al. The medical management of paediatric Crohn's disease: an ECCO‐ESPGHAN guideline update. J Crohns Colitis. 2021;15(2):171‐194. doi:10.1093/ECCO‐JCC/JJAA161. Kelly OB, Donnell SO, Stempak JM, Steinhart AH, Silverberg MS. Therapeutic drug monitoring to guide infliximab dose adjustment is associated with better endoscopic outcomes than clinical decision making alone in active inflammatory bowel disease. Inflamm Bowel Dis. 2017;23(7):1202‐1209. doi:10.1097/MIB.0000000000001126. Li L, Sassen SDT, Ewoldt TMJ, et al. Meropenem model‐informed precision dosing in the treatment of critically ill patients: can we use it? Antibiotics. 2023;12(2):383. doi:10.3390/antibiotics12020383. De Cock RFW, Piana C, Krekels EHJ, Danhof M, Allegaert K, Knibbe CAJ. The role of population PK–PD modelling in paediatric clinical research. Eur J Clin Pharmacol. 2011;67(S1):5‐16. doi:10.1007/s00228‐009‐0782‐9. Admiraal R, van Kesteren C, Boelens JJ, Bredius RGM, Tibboel D, Knibbe CAJ. Towards evidence‐based dosing regimens in children on the basis of population pharmacokinetic pharmacodynamic modelling. Arch Dis Child. 2014;99(3):267‐272. doi:10.1136/archdischild‐2013‐303721. Whaley KG, Xiong Y, Karns R, et al. Multicenter cohort study of infliximab pharmacokinetics and therapy response in pediatric acute severe ulcerative colitis. Clin Gastroenterol Hepatol. 2022;21(5):1338‐1347. doi:10.1016/J.CGH.2022.08.016. Nassar‐Sheikh Rashid A, Schonenberg‐Meinema D, Berends SE, Van Den Berg JM, Mathôt RAA. Population pharmacokinetics of infliximab in children with juvenile idiopathic arthritis. Ther Drug Monit. 2022;44(2):301‐307. doi:10.1097/FTD.0000000000000914. Vande Casteele N, Oyamada J, Shimizu C, et al. Infliximab pharmacokinetics are influenced by intravenous immunoglobulin administration in patients with Kawasaki disease. Clin Pharmacokinet. 2018;57(12):1593‐1601. doi:10.1007/S40262‐018‐0653‐6. Fasanmade AA, Adedokun OJ, Blank M, Zhou H, Davis HM. Pharmacokinetic properties of infliximab in children and adults with Crohn's disease: a retrospective analysis of data from 2 phase III clinical trials. Clin Ther. 2011;33(7):946‐964. doi:10.1016/J.CLINTHERA.2011.06.002. Xiong Y, Mizuno T, Colman R, et al. Real‐world infliximab pharmacokinetic study informs an electronic health record‐embedded dashboard to guide precision dosing in children with Crohn's disease. Clin Pharmacol Ther. 2021;109(6):1639‐1647. doi:10.1002/CPT.2148. Wojciechowski J, Upton RN, Mould DR, Wiese MD, Foster DJR. Infliximab maintenance dosing in inflammatory bowel disease: an example for in silico assessment of adaptive dosing strategies. AAPS J. 2017;19(4):1136‐1147. doi:10.1208/s12248‐017‐0082‐8. Passot C, Mulleman D, Bejan‐Angoulvant T, et al. The underlying inflammatory chronic disease influences infliximab pharmacokinetics. MAbs. 2016;8(7):1407‐1416. doi:10.1080/19420862.2016.1216741. Dubinsky MC, Phan BL, Singh N, Rabizadeh S, Mould DR. Pharmacokinetic dashboard‐recommended dosing is different than standard of care dosing in infliximab‐treated pediatric IBD patients. AAPS J. 2017;19(1):215‐222. doi:10.1208/S12248‐016‐9994‐Y. Otten AT, van der Meulen HH, Steenhuis M, et al. Clinical validation of a capillary blood home‐based self‐sampling technique for monitoring of infliximab, vedolizumab, and C‐reactive protein concentrations in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2024;30(3):325‐335. doi:10.1093/ibd/izad103. Sanquin. Concentratie Infliximab (IFX) of biosimilar, indien lager dan verwacht ook antistoffen tegen. Sanquin. Accessed June 21, 2023. https://www.sanquin.org/nl/producten-en-diensten/diagnostiek/diagnostische-testen/index/name/j285-concentratie-infliximab-ifx-of-biosimilar-indien-lager-dan-verwacht-ook-antistoffen-tegen. R Core Team. R: a language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2023. Accessed May 1, 2023. Baron K. mrgsolve: simulate from ODE‐based models. R package. Metrum Research Group. 2023. Accessed June 1, 2023. https://github.com/metrumresearchgroup/mrgsolve. Le Louedec F. MAP‐Bayesian estimation of PK parameters. R package. 2021. Accessed June 1, 2023. https://github.com/FelicienLL/mapbayr. Nguyen THT, Mouksassi M, Holford N, et al. Model evaluation of continuous data pharmacometric models: metrics and graphics. CPT Pharmacometrics Syst Pharmacol. 2017;6(2):87‐109. doi:10.1002/psp4.12161. European Medicines Agency. Guideline on reporting the results of population pharmacokinetic analyses.2007. Accessed October 1, 2023. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-reporting-results-population-pharmacokinetic-analyses_en.pdf. Schatz LM, Brinkmann A, Röhr A, et al. Systematic evaluation of pharmacokinetic models for model‐informed precision dosing of meropenem in critically ill patients undergoing continuous renal replacement therapy. Antimicrob Agents Chemother. 2023;67(5):e0010423. doi:10.1128/aac.00104‐23. Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer‐controlled infusion pumps. J Pharmacokinet Biopharm. 1992;20(1):63‐94. doi:10.1007/BF01143186. Alexander SPH, Fabbro D, Kelly E, et al. The concise guide to pharmacology 2019/20: enzymes. Br J Pharmacol. 2019;176(S1):S297‐S396. doi:10.1111/bph.14752. Petitcollin A, Leuret O, Tron C, et al. Modeling immunization to infliximab in children with Crohn's disease using population pharmacokinetics: a pilot study. Inflamm Bowel Dis. 2018;24(9):1745‐1754. doi:10.1093/IBD/IZY129. Kevans D, Murthy S, Mould DR, Silverberg MS. Accelerated clearance of infliximab is associated with treatment failure in patients with corticosteroid‐refractory acute ulcerative colitis. J Crohns Colitis. 2018;12(6):662‐669. doi:10.1093/ECCO‐JCC/JJY028. Dubinsky MC, Mendiolaza ML, Phan BL, Moran HR, Tse SS, Mould DR. Dashboard‐driven accelerated infliximab induction dosing increases infliximab durability and reduces immunogenicity. Inflamm Bowel Dis. 2022;28(9):1375‐1385. doi:10.1093/IBD/IZAB285. Kimura K, Yoshida A, Katagiri F, Takayanagi R, Yamada Y. Prediction of treatment failure during infliximab induction therapy in inflammatory bowel disease patients based on pharmacokinetic and pharmacodynamic modeling. Eur J Pharm Sci. 2020;150:105317. doi:10.1016/J.EJPS.2020.105317. Démaris A, Widigson ESK, Ilvemark JFKF, et al. Ulcerative colitis and acute severe ulcerative colitis patients are overlooked in infliximab population pharmacokinetic models: results from a comprehensive review. Pharmaceutics. 2022;14(10):2095. doi:10.3390/pharmaceutics14102095. Konecki C, Feliu C, Cazaubon Y, et al. External evaluation of population pharmacokinetic models and Bayes‐based dosing of infliximab. Pharmaceutics. 2021;13(8):1191. doi:10.3390/pharmaceutics13081191. Bevers NC, Keizer RJ, Wong DR, et al. Performance of eight infliximab population pharmacokinetic models in a cohort of Dutch children with inflammatory bowel disease. Clin Pharmacokinet. 2024;63(4):529‐538. doi:10.1007/s40262‐024‐01354‐7. |
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 |
تدمد: | 1365-2125 |
---|---|
DOI: | 10.1111/bcp.16126 |