Inhibitor subgroup risk: CVAD placement and IFE∗
| . | Inhibitor negative (n = 75) . | Inhibitor positive . | ||
|---|---|---|---|---|
| Total (n = 28) . | High-titer (n = 14)† . | Low-titer (n = 14) . | ||
| Patients with CVAD placement surgery,‡ n (%) | 24 (32.0) | 18 (64.3) | 10 (71.4) | 8 (57.1) |
| Patients with IFE,§,‖ n (%) | 35 (46.7) | 9 (32.1) | 2 (14.3) | 7 (50.0) |
| Median (range) dose of IFE,§,‖,¶ IU/kg per day | 51.1 (19.0-170.9) | 57.5 (21.8-131.2) | 65.6 (53.7-131.2) | 53.6 (21.8-84.5) |
| Patients with IFE§,‖ due to CVAD, n (%)# | 22 (62.9) | 5 (55.6) | 2 (100.0) | 3 (42.9) |
| Patients with IFE§,‖ due to CVAD within 10 EDs, n (%)¶ | 16 (45.7) | 5 (55.6) | 2 (100.0) | 3 (42.9) |
| Patients with IFE§,‖ due to CVAD within 20 EDs, n (%)¶ | 16 (45.7) | 5 (55.6) | 2 (100.0) | 3 (42.9) |
| . | Inhibitor negative (n = 75) . | Inhibitor positive . | ||
|---|---|---|---|---|
| Total (n = 28) . | High-titer (n = 14)† . | Low-titer (n = 14) . | ||
| Patients with CVAD placement surgery,‡ n (%) | 24 (32.0) | 18 (64.3) | 10 (71.4) | 8 (57.1) |
| Patients with IFE,§,‖ n (%) | 35 (46.7) | 9 (32.1) | 2 (14.3) | 7 (50.0) |
| Median (range) dose of IFE,§,‖,¶ IU/kg per day | 51.1 (19.0-170.9) | 57.5 (21.8-131.2) | 65.6 (53.7-131.2) | 53.6 (21.8-84.5) |
| Patients with IFE§,‖ due to CVAD, n (%)# | 22 (62.9) | 5 (55.6) | 2 (100.0) | 3 (42.9) |
| Patients with IFE§,‖ due to CVAD within 10 EDs, n (%)¶ | 16 (45.7) | 5 (55.6) | 2 (100.0) | 3 (42.9) |
| Patients with IFE§,‖ due to CVAD within 20 EDs, n (%)¶ | 16 (45.7) | 5 (55.6) | 2 (100.0) | 3 (42.9) |
Percentages for the main category are based on the n. Percentages for subcategories are based on the n of the main category. ITI regimen period was not considered for this analysis.
ITI, immune tolerance induction.
Safety analysis set.
Seven of these initially developed an LTI followed by subsequent HTI.
CVAD placement surgeries were counted at any time (pre- or postinhibitor development).
At least 1 infusion per day on ≥3 consecutive days.
For the inhibitor-positive group, data until inhibitor development have been included.
For median dose of IFE, the 2-sided Mann-Whitney U test was used to compare patients who were inhibitor-negative vs patients with HTIs (P = .0002) and inhibitor-negative vs patients with LTIs (P = .2656).
To derive IFE due to CVAD, the day of CVAD surgery is considered as the starting point.