Benefix (one-stage)
We are pleased to announce the update of the Benefix model for use on the WAPPS-Hemo platform. This model was built on data from industry (24% of patients) along with data already collected through WAPPS-Hemo (76% of the patients). The two-compartment kinetic model uses fat-free mass as a covariate and involves data from 475 patients and 4511 one-stage assay factor activities. Patients were between 0.92 to 76.5 years and, based on model evaluations, the model is appropriate for use in estimating individual PK estimates on the WAPPS-Hemo platform. There is very good precision and almost no bias on estimates of terminal half-life (see figure) where three factor activities are provided.
We continuously update our population PK models using data submitted to WAPPS-Hemo along with trial data. Our goal is to ensure that individual PK estimates for patients are as precise as possible.
Adynovate (one-stage and chromogenic)
We are pleased to announce the update of the Adynovate one-stage and chromogenic models for use on the WAPPS-Hemo platform. These models are an update to the 2018 models to include more accurate predictions for younger WAPPS-Hemo patients (from 7 months old), which has been possible thanks to the HCT’s efforts to provide accurate input into the WAPPS-Hemo platform for over 6 years!
The two-compartment kinetic models use fat-free mass, age and (if provided) blood type as covariate; respectively involve 1992 one-stage and 888 chromogenic PK measurements from 698 and 233 hemophilia A patients. Based on model evaluations, the models are appropriate for use in Bayesian forecasting on the WAPPS-Hemo platform. There is very good precision and almost no bias on estimates of terminal half-life and time to 2% (see figure) where only 3 PK samples are provided.
Our goal is to ensure that individual PK estimates for patients from all ages are as precise as possible.
