ArticleResearch and practice in thrombosis and haemostasis2021
Extended half-life factor VIII concentrates in adults with hemophilia A: Comparative pharmacokinetics of two products.
Article in Research and practice in thrombosis and haemostasis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 8 citations in OpenAlex.
- A French Real-World Evidence Study Evaluating the Efficacy, Safety, and Pharmacokinetic Parameters of rVIII-SingleChain in Patients with Hemophilia A Receiving Prophylaxis.Thrombosis and haemostasis · 2023Article
- Current Understanding of Inherited Modifiers of FVIII Pharmacokinetic Variation.Pharmacogenomics and personalized medicine · 2023Review
- Comparison of Real-World Dose and Consumption for Two Extended Half-Life Recombinant Factor VIII Products for the Treatment of Hemophilia A in the United States.Journal of blood medicine · 2022Article
- Extended half-life factor VIII concentrates in adults with hemophilia A: Comparative pharmacokinetics of two products.Research and practice in thrombosis and haemostasis · 2021Article
- Turoctocog alfa pegol versus recombinant factor VIII-Fc fusion protein: a head-to-head pharmacokinetics comparison.Blood transfusion = Trasfusione del sangueArticle
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe use of pharmacokinetic (PK) studies to help design personalized prophylaxis regimens for factor VIII (FVIII) concentrate in individuals with hemophilia A has been recognized for many years but only became practical for routine clinical use with the availability of web-accessible population PK applications based on Bayesian analysis.
objectiveTo compare PK variables using population PK studies done on 2 extended half-life recombinant FVIII concentrates in 23 individuals with hemophilia A after switching from one product to the other.
methodsWe retrospectively analyzed PK parameters derived from the Web-Accessible Population Pharmacokinetic Service-Hemophilia (WAPPS-HEMO) application on 23 individuals with severe or moderately severe hemophilia A who were required to switch from recombinant FVIII Fc (Eloctate; Biogen, Cambridge, MA, USA) to recombinant antihemophilic factor PEGylated (Adynovate; Takeda Pharmaceutical Company, Osaka, Japan) between 2016 and 2017.
resultsThere were minor PK differences between Eloctate and Adynovate, but some parameters did reach statistical significance, namely in vivo recovery (mean, 2.73 IU/dL per IU/kg vs 2.41 IU/dL per IU/kg), clearance (mean, 0.163 mL/h vs 0.194 mL/h), and volume of distribution at steady state (mean, 42.5 ml/kg vs 49.8 mL/kg). Smaller nonsignificant trends toward higher values for Adynovate were seen in terminal half-life, area under the curve, and predicted times to 5% and 1% residual FVIII after infusion.
conclusionPopulation PK analysis revealed differences between the two extended half-life FVIII concentrates, reaching significance for in vivo recovery, clearance, and volume of distribution.
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