A Novel, Enriched Population Pharmacokinetic Model for Recombinant Factor VIII-Fc Fusion Protein Concentrate in Hemophilia A Patients.
Laura H BukkemsJessica M HeijdraMary MathiasPeter W CollinsCharles R M HayRobert C TaitSarah ManglesBethan MyersG EvansBenjamin BailiffNicola CurryJeanette PayneSteve AustinTine M H J GoedhartFrank W G LeebeekKarina MeijerKarin FijnvandraatPratima ChowdaryRon A A MathôtMarjon H Cnossennull nullPublished in: Thrombosis and haemostasis (2020)
We concluded that the existing rFVIII-Fc population PK model is valid for patients ≥ 12 years. However, it is not reliable in younger patients. Our alternative model, constructed from real world patient data including children, allows for better description of patients ≥5 years.