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Use of population PK/PD approach to model the thrombin generation assay: assessment in haemophilia A plasma samples spiked by a TFPI antibody.

التفاصيل البيبلوغرافية
العنوان: Use of population PK/PD approach to model the thrombin generation assay: assessment in haemophilia A plasma samples spiked by a TFPI antibody.
المؤلفون: Crépin R; Mines Saint-Etienne, Univ Lyon, Univ Jean Monnet, INSERM, U1059 Sainbiose, Centre CIS, 42023, Saint-Étienne, France., Morin C; Mines Saint-Etienne, Univ Lyon, Univ Jean Monnet, INSERM, U1059 Sainbiose, Centre CIS, 42023, Saint-Étienne, France. claire.morin@emse.fr., Montmartin A; INSERM, U1059, SAINBIOSE, Université de Lyon, UJM Saint Etienne, Saint-Étienne, France., Tardy-Poncet B; INSERM, U1059, SAINBIOSE, Université de Lyon, UJM Saint Etienne, Saint-Étienne, France., Chelle P; School of Pharmacy, University of Waterloo, Kitchener, ON, Canada.
المصدر: Journal of pharmacokinetics and pharmacodynamics [J Pharmacokinet Pharmacodyn] 2021 Aug; Vol. 48 (4), pp. 563-580. Date of Electronic Publication: 2021 Apr 12.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Springer Country of Publication: United States NLM ID: 101096520 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-8744 (Electronic) Linking ISSN: 1567567X NLM ISO Abbreviation: J Pharmacokinet Pharmacodyn Subsets: MEDLINE
أسماء مطبوعة: Publication: New York : Springer
Original Publication: Bristol, England ; New York, N.Y. : Kluwer Academic/Plenum Publishers, c2001-
مواضيع طبية MeSH: Thrombin Time*, Hemophilia A/*drug therapy , Lipoproteins/*immunology , Thrombin/*analysis, Antibodies/immunology ; Case-Control Studies ; Hemophilia A/blood ; Humans ; Male ; Models, Statistical
مستخلص: The thrombin generation (TG) assay is a well-established tool to capture the clotting potential of any healthy or haemophiliac subject. It measures ex vivo the kinetics of thrombin activation throughout the coagulation. Clinical studies allowed to create two databases gathering the coagulation factor levels and the thrombin generation profile of 40 healthy and 40 haemophiliac A (HA) subjects. Besides, portions of all HA samples were spiked with increasing levels of a TFPI antibody (considered as a possible therapeutic target) and corresponding TG profiles were determined. The non-linear mixed-effect (NLME) modelling aims at describing and explaining the experimentally observed important variability of the TG curves between subjects and the individual effects of spiking with a TFPI antibody. The models consist of an empirical description of the TG kinetics, accounting for an additive residual error and between-subject variability on its parameters. Factor VIII and TFPI were found to significantly explain and reduce the variability of the TG of haemophilia A samples. Besides, the model is shown to correctly reproduce the variability in the response to the ex vivo spiking with the TFPI antibody, by combining the empirical description of TG to a simple Hill equation that accounts for the binding between TFPI and different doses of its antibody. Such models can be useful for clinical practice, with the analysis and comparison of the distributions of TG profiles in healthy and haemophilia populations; and also for research, with the analysis of the effect of TFPI and its neutralization on individual TG profiles.
References: Hemker H, Béguin S (2000) Phenotyping the clotting system. Thromb Haemost 84:747–751. https://doi.org/10.1055/s-0037-1614109. (PMID: 10.1055/s-0037-161410911127849)
Dargaud Y, Béguin S, Lienhart A et al (2005) Evaluation of thrombin generating capacity in plasma from patients with haemophilia A and B. Thromb Haemost 93:475–480. https://doi.org/10.1160/TH04-10-0706. (PMID: 10.1160/TH04-10-070615735797)
Beltran-Miranda CP, Khan A, Jaloma-Cruz AR, Laffan MA (2005) Thrombin generation and phenotypic correlation in haemophilia A. Haemophilia 11:326–334. https://doi.org/10.1111/j.1365-2516.2005.01107.x. (PMID: 10.1111/j.1365-2516.2005.01107.x16011583)
Santagostino E, Mancuso ME, Tripodi A et al (2010) Severe hemophilia with mild bleeding phenotype: molecular characterization and global coagulation profile. J Thromb Haemost 8:737–743. https://doi.org/10.1111/j.1538-7836.2010.03767.x. (PMID: 10.1111/j.1538-7836.2010.03767.x20102490)
Brummel-Ziedins KE, Whelihan MF, Gissel M et al (2009) Thrombin generation and bleeding in haemophilia A. Haemophilia 15:1118–1125. https://doi.org/10.1111/j.1365-2516.2009.01994.x. (PMID: 10.1111/j.1365-2516.2009.01994.x195635003395070)
Chelle P, Montmartin A, Piot M et al (2018) Prediction of individual factor VIII or IX level for the correction of thrombin generation in haemophilic patients. Haemophilia 24:995–1001. https://doi.org/10.1111/hae.13539. (PMID: 10.1111/hae.1353929957846)
Robert S, Ghiotto J, Pirotte B et al (2009) Is thrombin generation the new rapid, reliable and relevant pharmacological tool for the development of anticoagulant drugs? Pharmacol Res 59:160–166. https://doi.org/10.1016/j.phrs.2008.12.003. (PMID: 10.1016/j.phrs.2008.12.00319124079)
Delavenne X, Ollier E, Lienhart A, Dargaud Y (2020) A new paradigm for personalized prophylaxis for patients with severe haemophilia A. Haemophilia 26:228–235. https://doi.org/10.1111/hae.13935. (PMID: 10.1111/hae.13935321009507154752)
Dielis AWJH, Castoldi E, Spronk HMH et al (2007) Coagulation factors and the protein C system as determinants of thrombin generation in a normal population: combined TFPI and TM deficiency. J Thromb Haemost 6:125–131. https://doi.org/10.1111/j.1538-7836.2007.02824.x. (PMID: 10.1111/j.1538-7836.2007.02824.x17988231)
Lewis SJ, Stephens E, Florou G et al (2007) Measurement of global haemostasis in severe haemophilia A following factor VIII infusion. Br J Haematol 138:775–782. https://doi.org/10.1111/j.1365-2141.2007.06722.x. (PMID: 10.1111/j.1365-2141.2007.06722.x17672884)
Eichler H, Angchaisuksiri P, Kavakli K et al (2019) Concizumab restores thrombin generation potential in patients with haemophilia: pharmacokinetic/pharmacodynamic modelling results of concizumab phase 1/1b data. Haemophilia 25:60–66. https://doi.org/10.1111/hae.13627. (PMID: 10.1111/hae.1362730408848)
Hockin MF, Jones KC, Everse SJ, Mann KG (2002) A model for the stoichiometric regulation of blood coagulation. J Biol Chem 277:18322–18333. https://doi.org/10.1074/jbc.M201173200. (PMID: 10.1074/jbc.M20117320011893748)
Panteleev MA, Ovanesov MV, Kireev DA et al (2006) Spatial propagation and localization of blood coagulation are regulated by intrinsic and protein C pathways, respectively. Biophys J 90:1489–1500. https://doi.org/10.1529/biophysj.105.069062. (PMID: 10.1529/biophysj.105.06906216326897)
Chatterjee MS, Denney WS, Jing H, Diamond SL (2010) Systems biology of coagulation initiation: kinetics of thrombin generation in resting and activated human blood. PLoS Comput Biol 6:e1000950. https://doi.org/10.1371/journal.pcbi.1000950. (PMID: 10.1371/journal.pcbi.1000950209413872947981)
Hemker HC, Kerdelo S, Kremers RMW (2012) Is there value in kinetic modeling of thrombin generation? No (unless…): is there value in kinetic modeling of thrombin generation? J Thromb Haemost 10:1470–1477. https://doi.org/10.1111/j.1538-7836.2012.04802.x. (PMID: 10.1111/j.1538-7836.2012.04802.x22650179)
Chelle P, Morin C, Montmartin A et al (2018) Evaluation and calibration of in silico models of thrombin generation using experimental data from healthy and haemophilic subjects. Bull Math Biol 80:1989–2025. https://doi.org/10.1007/s11538-018-0440-4. (PMID: 10.1007/s11538-018-0440-429948884)
Mould DR, Upton RN (2013) Basic concepts in population modeling, simulation, and model-based drug development—Part 2: introduction to pharmacokinetic modeling methods. CPT Pharmacomet Syst Pharmacol 2:e38. https://doi.org/10.1038/psp.2013.14. (PMID: 10.1038/psp.2013.14)
Hemker HC, Giesen P, AlDieri R et al (2002) The Calibrated Automated Thrombogram (CAT): a universal routine test for hyper- and hypocoagulability. Pathophysiol Haemost Thromb 32:249–253. https://doi.org/10.1159/000073575. (PMID: 10.1159/00007357513679651)
Mandema JW, Verotta D, Sheiner LB (1992) Building population pharmacokinetic–pharmacodynamic models. I. Models for covariate effects. J Pharmacokinet Biopharm 20:511–528. https://doi.org/10.1007/BF01061469. (PMID: 10.1007/BF010614691287200)
Wagenvoord R, Hemker PW, Hemker HC (2006) The limits of simulation of the clotting system. J Thromb Haemost 4:1331–1338. https://doi.org/10.1111/j.1538-7836.2006.01967.x. (PMID: 10.1111/j.1538-7836.2006.01967.x16706979)
Bergstrand M, Hooker AC, Wallin JE, Karlsson MO (2011) Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J 13:143–151. https://doi.org/10.1208/s12248-011-9255-z. (PMID: 10.1208/s12248-011-9255-z213020103085712)
Papadopoulos KP, Gavaises M, Atkin C (2014) A simplified mathematical model for thrombin generation. Med Eng Phys 36:196–204. https://doi.org/10.1016/j.medengphy.2013.10.012. (PMID: 10.1016/j.medengphy.2013.10.01224238617)
Chelle P, Montmartin A, Damien P et al (2019) Tissue factor pathway inhibitor is the main determinant of thrombin generation in haemophilic patients. Haemophilia 25:343–348. https://doi.org/10.1111/hae.13679. (PMID: 10.1111/hae.1367930690836)
Lecompte T, Wahl D, Regnault V (2006) Thrombinographie. Hématologie 12:115–127.
Mohammed BM, Martin EJ, Salinas V et al (2014) Failure of corn trypsin inhibitor to affect the thrombin generation assay in plasma from severe hemophiliacs. J Thromb Haemost 12:1558–1561. https://doi.org/10.1111/jth.12659. (PMID: 10.1111/jth.1265925041427)
فهرسة مساهمة: Keywords: Coagulation; Empirical model; Non-linear mixed-effects modelling; PK/PD model; Thrombin generation assay
المشرفين على المادة: 0 (Antibodies)
0 (Lipoproteins)
0 (lipoprotein-associated coagulation inhibitor)
EC 3.4.21.5 (Thrombin)
تواريخ الأحداث: Date Created: 20210413 Date Completed: 20220128 Latest Revision: 20220128
رمز التحديث: 20221213
DOI: 10.1007/s10928-021-09752-1
PMID: 33846873
قاعدة البيانات: MEDLINE
الوصف
تدمد:1573-8744
DOI:10.1007/s10928-021-09752-1