Table 5.
BAX 855 vs Advate PKs in the pivotal study
| Before prophylactic treatment, mean (SD) | After 6 mo of prophylaxis, mean (SD) | ||||
|---|---|---|---|---|---|
| Advate (N = 26) | BAX 855 initial (N = 26) | Ratio: BAX 855 initial/Advate | BAX 855 final (N = 22) | Ratio BAX 855 final/initial | |
| T1/2 , h | 10.4 (2.2) | 14.3 (3.8) | 1.4 (0.25) | 16.0 (4.9) | 1.2 (0.47) |
| MRT, h | 12.9 (3.0) | 19.6 (5.3) | 1.5 (0.18) | 20.7 (4.8) | 1.1 (0.26) |
| AUC0-∞, IU⋅h/dL | 1168 (425) | 2073 (778) | 1.9 (0.91) | 2009 (631.53) | 1.1 (0.5) |
| CL, dL/(kg⋅h) | 0.0455 (0.0217) | 0.0276 (0.0203) | 0.613 (0.28) | 0.0247 (0.00823) | 1.0 (0.27) |
| IR, (IU/dL)/(IU/kg) | 2.37 (0.536) | 2.49 0.694) | 1.1 (0.36) | 2.3 (0.64) | 1.0 (0.22) |
Mean (standard deviation [SD]) results from the 1-stage clotting assay are shown. Similar results were obtained with the chromogenic assay: T1/2 ratio for BAX 855 Initial/Advate was 1.5 (0.4622), and for BAX 855 final/initial was 1.1 (0.2906)