Table 3.
Relative Bioavailability of Emicizumab Between Drug Products and Among Sites of Subcutaneous Injection
| Relative Bioavailability (GMR [90% CI]) | |||
|---|---|---|---|
| New vs Old Drug Products | Upper Arm vs Abdomen | Thigh vs Abdomen | |
| (Group B vs Group A) | (Group C vs Group B) | (Group D vs Group B) | |
| Parameter | N = 23 | N = 21 | N = 23 |
| Cmax/Dose | 1.199 (1.060‐1.355) | 0.823 (0.718‐0.943) | 1.168 (1.030‐1.324) |
| AUClast/Dose | 1.085 (0.942‐1.250) | 0.931 (0.824‐1.051) | 1.077 (0.979‐1.184) |
| AUCinf/Dose | 1.083 (0.920‐1.275) | 0.926 (0.814‐1.053) | 1.073 (0.969‐1.189) |
AUCinf indicates area under the plasma concentration‐time curve extrapolated to infinity; AUClast, area under the plasma concentration‐time curve to the last measurable plasma concentration; CI, confidence interval; Cmax, maximum plasma concentration; GMR, geometric mean ratio.
Subjects who tested positive for antiemicizumab antibodies (1 in group B, 2 in group C, and 1 in group E) were excluded from the bioavailability estimation.