Baseline characteristics for the total population
| . | Phase 3 parent trial . | B-YOND (extension trial) . | ||
|---|---|---|---|---|
| B-LONG . | Kids B-LONG . | From B-LONG . | From Kids B-LONG . | |
| Subjects enrolled, n | 119∗ | 30 | 93 | 27 |
| Median (range) age at the enrollment into the parent or extension study, y | 30 (12-71) | 5 (1-11) | 29 (13-63) | 7 (3-12) |
| Race, n (%) | ||||
| White | 70 (58.8) | 22 (73.3) | 47 (50.5) | 19 (70.4) |
| Black | 10 (8.4) | 2 (6.7) | 9 (9.7) | 2 (7.4) |
| Asian | 28 (23.5) | 5 (16.7) | 27 (29.0) | 5 (18.5) |
| Other | 11 (9.2) | 1 (3.3) | 10 (10.8) | 1 (3.7) |
| Median (IQR) estimated ABR before the start of rFIXFc treatment (prestudy)† | ||||
| Prior prophylactic regimen | 2 (1-6); n = 41 | 2.5 (0-5); n = 30 | ||
| Prior on-demand regimen | 22 (12-33); n = 66 | N/A | ||
| rFIXFc regimen, n‡ | ||||
| WP | 63 | 30 | 51 | 23 |
| Individualized IP | 29 | N/A | 31 | 5 |
| Modified prophylaxis | N/A | N/A | 16 | 2 |
| On-demand treatment | 27 | N/A | 15 | N/A |
| . | Phase 3 parent trial . | B-YOND (extension trial) . | ||
|---|---|---|---|---|
| B-LONG . | Kids B-LONG . | From B-LONG . | From Kids B-LONG . | |
| Subjects enrolled, n | 119∗ | 30 | 93 | 27 |
| Median (range) age at the enrollment into the parent or extension study, y | 30 (12-71) | 5 (1-11) | 29 (13-63) | 7 (3-12) |
| Race, n (%) | ||||
| White | 70 (58.8) | 22 (73.3) | 47 (50.5) | 19 (70.4) |
| Black | 10 (8.4) | 2 (6.7) | 9 (9.7) | 2 (7.4) |
| Asian | 28 (23.5) | 5 (16.7) | 27 (29.0) | 5 (18.5) |
| Other | 11 (9.2) | 1 (3.3) | 10 (10.8) | 1 (3.7) |
| Median (IQR) estimated ABR before the start of rFIXFc treatment (prestudy)† | ||||
| Prior prophylactic regimen | 2 (1-6); n = 41 | 2.5 (0-5); n = 30 | ||
| Prior on-demand regimen | 22 (12-33); n = 66 | N/A | ||
| rFIXFc regimen, n‡ | ||||
| WP | 63 | 30 | 51 | 23 |
| Individualized IP | 29 | N/A | 31 | 5 |
| Modified prophylaxis | N/A | N/A | 16 | 2 |
| On-demand treatment | 27 | N/A | 15 | N/A |
N/A, not applicable.
Four of the 123 B-LONG subjects were enrolled in the surgery-only group and are not included here.
In the B-LONG study, 10 subjects had either missing prestudy ABR data or missing prestudy regimen, and 2 subjects received a prestudy sports prophylaxis regimen. Their prestudy ABRs were not included in this analysis.
Subjects were permitted to switch treatment regimens on enrollment and at any time during the B-YOND study and may appear in ≥1 treatment regimen.