Population Pharmacokinetic Model

After a comprehensive predictive model performance evaluation [1], the popPK model of Fasanmade et al. 2011 [2] was selected as the most suitable model to predict serum infliximab concentrations for patients with Crohn's disease and ulcerative colitis in the clinical setting of the observational clinical study GUIDE-IBD.

[1] Schräpel C, Kovar L, Selzer D, Hofmann U, Tran F, Reinisch W, Schwab M, Lehr T. External Model Performance Evaluation of Twelve Infliximab Population Pharmacokinetic Models in Patients with Inflammatory Bowel Disease. Pharmaceutics. 2021 Aug 31;13(9):1368. doi: 10.3390/pharmaceutics13091368. PMID: 34575443; PMCID: PMC8468301.

[2] Fasanmade, A. A., Adedokun, O. J., Blank, M., Zhou, H., & Davis, H. M. (2011). Pharmacokinetic properties of infliximab in children and adults with Crohn's disease: a retrospective analysis of data from 2 phase III clinical trials. Clinical therapeutics, 33(7), 946–964. https://doi.org/10.1016/j.clinthera.2011.06.002

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About

The results should be used carefully and with the limitations mentioned in the report Predictive Model Performance Evaluation of Population Pharmacokinetic (popPK) and Physiologically Based Pharmacokinetic (PBPK) Models for Serum Infliximab Concentrations in mind. The provided information do not replace clinical judgement and therapeutic decisions should not solely rely on the dosing simulations.

Authors

Christina Kovar^1,2, Simeon Rüdesheim^1,2 Dominik Selzer¹, Matthias Schwab², and Thorsten Lehr¹

¹ Clinical Pharmacy, Saarland University, Germany
² Dr. Margarete Fischer-Bosch-Institute of Clinical Pharmacology, Stuttgart, Germany