Limited sampling strategies for individualized BAX 855 prophylaxis in severe hemophilia A: in silico evaluation.

ABSTRACT:

Objective

Limited sampling strategies (LSS) lower the burden of pharmacokinetic (PK)-guided dosing, but an extensive evaluation of LSS for BAX 855 (Adynovi) is currently lacking. This study aimed to develop a LSS for BAX 855 and combine this with a LSS of a standard half-life (SHL) factor VIII (FVIII) concentrate in a clinical setting.

Methods

Individual PK parameters of BAX 855 were estimated for 10 000 virtual patients with severe hemophilia A using Monte Carlo simulations. Several LSS consisting of 2-6 samples were examined based on patient burden, bias and accuracy of clearance, elimination half-life, volume of distribution and trough levels at 72 h (C72). Analyses were performed separately for adults and children <12 years.

Results

The preferred LSS for BAX 855 c

SUBMITTER: Bukkems LH 

PROVIDER: S-EPMC10101132 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature