Table 2.
Comparison of the pharmacokinetic parameters of octocog alfa, rurioctocog alfa pegol, and efanesoctocog alfa.
| PK parametersa | Efanesoctocog alfa vs | Fold change | 90% CI |
|---|---|---|---|
| t1/2z (h) | Octocog alfa (SHL) | 3.94 | 3.47-4.48 |
| Rurioctocog alfa pegol (EHL) | 2.82 | 2.48-3.20 | |
| Cmax (IU/dL) | Octocog alfa (SHL) | 1.18 | 1.10-1.26 |
| Rurioctocog alfa pegol (EHL) | 0.94 | 0.88-1.01 | |
| AUCinf (IU × h/dL) | Octocog alfa (SHL) | 6.03 | 5.32-6.83 |
| Rurioctocog alfa pegol (EHL) | 3.57 | 3.15-4.05 | |
| CL (mL/h/dL) | Octocog alfa (SHL) | 0.17 | 0.15-0.19 |
| Rurioctocog alfa pegol (EHL) | 0.28 | 0.25-0.32 |
AUCinf, area under the activity-time curve extrapolated to infinity; CL, clearance; Cmax, maximum FVIII activity; EHL, extended half-life; PK, pharmacokinetic; SHL, standard half-life; t1/2z, elimination half-life.
a
PK sampling was performed over a period of 3, 5, and 14 days after the administration of octocog alfa, rurioctocog alfa pegol, and efanesoctocog alfa, respectively.