Table 1.
Patient demographics and baseline characteristics
| Patients with inhibitors | Patients without inhibitors | Total | |
|---|---|---|---|
| Number of patients | 26 | 34 | 60 |
| Age, N (%) | |||
| 0‐<1 mo | 3 (11.5) | ‐ | 3 (5.0) |
| 1‐<6 mo | 5 (19.2) | 7 (20.6) | 12 (20.0) |
| 6‐<12 mo | 8 (30.8) | 19 (55.9) | 27 (45.0) |
| ≥12 mo | 10 (38.5) | 8 (23.5) | 18 (30.0) |
| Mean age at baseline (SD), months | 10.5 (8.86) | 10.0 (7.16) | 10.2 (7.88) |
| Ethnicity | |||
| Hispanic or Latino, N (%) | 1 (3.8) | 4 (11.8) | 5 (8.3) |
| Race (%) | |||
| White | 17 (65.4) | 27 (79.4) | 44 (73.3) |
| Asian | 7 (26.9) | 5 (14.7) | 12 (20.0) |
| Other | 2 (7.7) | 2 (5.9) | 4 (6.7) |
| Black/African descent | ‐ | ‐ | ‐ |
| Genotype—type of mutation,a N | |||
| High risk | 24 | 17 | 41 |
| Low risk | 1 | 14 | 15 |
| Genotype information missing | 1 | 1 | 2 |
| Family history of haemophilia, N (%) | 26 (100.0) | 34 (100.0) | 60 (100.0) |
| Yes | 13 (50.0) | 14 (41.2) | 27 (45.0) |
| Family history of inhibitor, N (%) | 13 (100.0) | 14 (100.0) | 27 (100.0) |
| Yes | 1 (7.7) | 4 (28.6) | 5 (18.5) |
| Unknown | 7 (53.8) | 4 (28.6) | 11 (40.7) |
| Previous exposure to blood componentsb (≤5 d), N (%) | |||
| Yes | 4 (15.4) | 7 (20.6) | 11 (18.3) |
Abbreviations: CI, confidence interval; d, days; mo, months; N, number of patients; SD, standard deviation.
a
FVIII gene mutation analysis was conducted post hoc.
b
Patients who had prior exposure (≤5 exposure days) to blood components, such as cryoprecipitate or fresh frozen plasma, were included in the trial.