Summary of inhibitor development as assessed by Nijmegen-modified Bethesda assay in the safety analysis set
| . | High-titer inhibitor (≥5.00 BU/mL) (n = 14) . | Low-titer inhibitor (≥0.60 and <5.00 BU/mL) (n = 14) . | All inhibitor subjects (n = 28) . |
|---|---|---|---|
| All treated subjects with an inhibitor test or inhibitor | 101 | 101 | 101 |
| Incidence of inhibitor formation, % (95% CI) | 13.86 (7.79-22.16) | 13.86 (7.79-22.16) | 27.72 (19.28-37.52) |
| Subjects with ≥10 EDs to rFVIIIFc* | 90 | 90 | 90 |
| Incidence of inhibitor formation, % (95% CI) | 15.56 (8.77-24.72) | 15.56 (8.77-24.72) | 31.11 (21.77-41.74) |
| Subjects with ≥20 EDs to rFVIIIFc | 89 | 89 | 89 |
| Incidence of inhibitor formation, % (95% CI) | 15.73 (8.88-24.98) | 15.73 (8.88-24.98) | 31.46 (22.03-42.17) |
| Subjects with ≥50 EDs to rFVIIIFc | 86 | 86 | 86 |
| Incidence of inhibitor formation, % (95% CI) | 16.28 (9.20-25.80) | 16.28 (9.20-25.80) | 32.56 (22.84-43.52) |
| . | High-titer inhibitor (≥5.00 BU/mL) (n = 14) . | Low-titer inhibitor (≥0.60 and <5.00 BU/mL) (n = 14) . | All inhibitor subjects (n = 28) . |
|---|---|---|---|
| All treated subjects with an inhibitor test or inhibitor | 101 | 101 | 101 |
| Incidence of inhibitor formation, % (95% CI) | 13.86 (7.79-22.16) | 13.86 (7.79-22.16) | 27.72 (19.28-37.52) |
| Subjects with ≥10 EDs to rFVIIIFc* | 90 | 90 | 90 |
| Incidence of inhibitor formation, % (95% CI) | 15.56 (8.77-24.72) | 15.56 (8.77-24.72) | 31.11 (21.77-41.74) |
| Subjects with ≥20 EDs to rFVIIIFc | 89 | 89 | 89 |
| Incidence of inhibitor formation, % (95% CI) | 15.73 (8.88-24.98) | 15.73 (8.88-24.98) | 31.46 (22.03-42.17) |
| Subjects with ≥50 EDs to rFVIIIFc | 86 | 86 | 86 |
| Incidence of inhibitor formation, % (95% CI) | 16.28 (9.20-25.80) | 16.28 (9.20-25.80) | 32.56 (22.84-43.52) |
A high-titer inhibitor was a confirmed inhibitor ≥5.00 BU/mL, and a low-titer inhibitor was a confirmed inhibitor ≥0.60 and <5.00 BU/mL. The numerator for the analyses in each category includes the number of subjects with an inhibitor in that category, regardless of how many EDs to rFVIIIFc. Percentages are based on the number of subjects with any inhibitor as well as any subject who reached the ED milestone. CIs were calculated using the Clopper-Pearson exact method.
Primary analysis.