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The small size of the patient cohort could be a potential limitation of this study.2

Study design for
crossover study comparing PK characteristics and PK assessment. Jivi. Adynovate.
  • PK, pharmaokinetic; AUC(0-tlast), area under the curve (from time 0 to last data point).
  • Adapted from Solms et al.
  • Area under the curve is the total amount of a drug that reaches the bloodstream, measured by plasma concentration, over time.

Potency-adjusted PK analyses of Jivi® and Adynovate®2*

The preplanned analysis was followed by a post hoc analysis

  • In the preplanned analysis, the 50 IU/kg doses administered in this study were calculated based on the 1000 IU nominal potencies provided on the vial labels of the 2 products
  • In this study, the actual potencies were 1030 IU/vial for Jivi® and 1141 IU/vial for Adynovate®. This resulted in actual administered doses which were approximately:
    • 3% higher than the planned 50 IU/kg dose for Jivi®
    • 14.1% higher than the planned 50 IU/kg dose for Adynovate®
  • A subsequent post hoc analysis of PK parameters was conducted using the actual potencies of the 2 products being compared
  • Adapted from Solms et al. (1355)

Comparative PK Results for Jivi® vs Adynovate®2

The small size of the patient cohort could be a potential limitation of this study.2

Graph representing comparative PK results, including mean AUC, clearance, and mean terminal half-life. Jivi. Adynovate
  • PK, pharmacokinetic; AUC(0-tlast), area under the curve (from 0 to last data point); AUCnorm, dose normalized area under the curve; CI, confidence interval
  • Half-life and CI are not weight-dependent parameters, so they are not normalized.
  • Area under the curve is the total amount of a drug that reaches the bloodstream, measured by plasma concentration over time.3
  • Clearance is the rate by which a drug is eliminated from the body.4
  • Half-life is the time it takes for the amount of drug in the blood to decrease by one half.5
  • Geometric least squares.2

Median time to target FV111 Threshold levels with Jivi® vs Adynovate®2

Estimated from a population PK model (N = 18) based on potency-adjusted results2*

Chart representing
Median time to target FVIII threshold levels. Jivi. Adynovate.
  • PK, pharmacokinetic.
  • Adapted from Solms et al. A population PK model was developed based on data obtained by a one-stage assay to simulate time to reach FVIII thresholds of 1%, 3%, 5%, and 10% FVIII.2