Table 5.
Dosing and consumption of rVIII-SingleChain, AsBR, ABR, and location of bleeds with rVIII-SingleChain in on-demand therapy and prophylaxis
| On-demand (N = 27) | Prophylaxis | |||
|---|---|---|---|---|
| All (N = 146) | Three times per week (N = 79) | Twice per week (N = 47) | ||
| Dose, IU/kg | ||||
| Median (Q1, Q3) | 30 (25, 40) | 31 (27, 40) | 30 (26, 38) | 35 (30, 41) |
| Consumption, IU/kg per year | ||||
| Median | — | 4283 | 4514 | 3669 |
| Mean (SD) | — | 4494 (1778.17) | 4769 (1237.42) | 3974 (2396.93) |
| AsBR | ||||
| Median (Q1, Q3) | 11.73 (2.8, 36.5) | 0.0 (0.0, 2.4) | 0.0 (0.0, 3.6) | 0.0 (0.0, 1.1) |
| Mean (SD) | 24.84 (33.84) | 2.10 (4.76) | 2.33 (3.87) | 2.33 (6.67) |
| N bleeds per year* (95% CI) | 19.5 (17.8-21.3) | 1.6 (1.3-1.8) | 1.9 (1.6-2.3) | 1.3 (1.0-1.8) |
| ABR | ||||
| Median (Q1, Q3) | 19.64 (6.2, 46.5) | 1.14 (0.0, 4.2) | 1.93 (0.0, 4.9) | 0.0 (0.0, 3.3) |
| Mean (SD) | 31.14 (35.56) | 3.11 (5.05) | 3.34 (4.26) | 3.27 (6.83) |
| N bleeds per year† (95% CI) | 24.9 (23.0-27.0) | 2.6 (2.3-2.9) | 2.9 (2.5-3.4) | 2.4 (1.9-3.0) |
| Location of spontaneous bleeds, N (%) | ||||
| Joint | 419 (91.1) | 147 (94.2) | 104 (97.2) | 39 (95.1) |
| Muscle | 55 (12.0) | 11 (7.1) | 7 (6.5) | 3 (7.3) |
| Other | 57 (12.4) | 12 (7.7) | 8 (7.5) | 1 (2.4) |
Q1, lower quartile; Q3, upper quartile.
*
Estimated number of spontaneous bleeds per subject per year based on a Poisson distribution.
†
Estimated number of bleeds per subject per year based on a Poisson distribution.