Table 1.
Pharmacokinetic results after single 50 IU/kg dose administration of BAY 81–8973, rFVIII-FS, and rAHF-PFM using the chromogenic assay
| BAY 81–8973 vs rFVIII-FS (N=26)
|
BAY 81–8973 vs rAHF-PFM (N=18)
|
|||||
|---|---|---|---|---|---|---|
| BAY 81–8973 | rFVIII-FS | P-value | BAY 81–8973 | rAHF-PFM | P-value | |
|
| ||||||
| AUC0–inf, IU⋅h/dL | 1,889.2 (36.1) | 1,583.9 (39.9) | 0.0003 | 2,440 (28.5) | 1,650 (31.0) | <0.0001 |
| Cmax, IU/dL | 130.1 (23.0) | 136.2 (23.8) | 0.45 | 151 (19.9) | 153 (17.1) | 0.32 |
| MRT, h | 19.3 (26.8) | 16.5 (27.4) | <0.0001 | 19.2 (27.4) | 15.0 (27.9) | <0.0001 |
| CL, dL/h/kg | 0.026 (36.1) | 0.032 (39.9) | 0.0003 | 0.021 (28.5) | 0.030 (31.0) | <0.0001 |
| Half-life, h | 13.8 (28.0) | 12.0 (28.2) | 0.002 | 13.9 (25.1) | 12.0 (23.3) | <0.0001 |
| Range | 7.7–23.7 | 6.4–20.5 | 9.95–22.2 | 9.06–17.9 | ||
| Arithmetic mean | 14.3 | 12.4 | NA | NA | ||
| Vss, IU/dL | 0.51 (31.0) | 0.52 (32.0) | 0.67 | 0.39 (19.1) | 0.46 (16.7) | <0.0001 |
Notes: Data are geometric mean (% coefficient of variation) unless otherwise indicated. Copyright ©2015. John Wiley & Sons Ltd. Adapted from Shah A, Delesen H, Garger S, Lalezari S. Pharmacokinetic properties of Bay 81-8973, a full-length recombinant factor VIII. Haemophilia. 2015;21(6):766–771. © 2015 John Wiley & Sons Ltd.16 Adapted by permission from Springer Nature under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/): Springer Nature:Clin Pharmacokinet. Improved pharmacokinetics with Bay 81-8973 versus antihemophilic factor (recombinant) plasma/albumin-free method: a randomized pharmacokinetic study in patients with severe hemophilia A. Shah A, Solms A, Garmann D, et al. 2017;56(9):1045–1055.17
Abbreviations: AUC0–inf, area under the curve from time 0 to infinity; CL, clearance; Cmax, maximum concentration; FVIII, factor VIII; MRT, mean residence time; NA, not available; Vss, volume of distribution at steady state; rAHF-PFM, antihemophilic factor (recombinant) plasma/albumin-free method; rFVIII-FS, sucrose-formulated recombinant factor VIII.