Treatment characteristics and bleeding during ITI
| . | During ITI, overall . | FVIII only . | FVIII and prophylactic rFVIIa . | FVIII and prophylactic aPCC . |
|---|---|---|---|---|
| Number (%) or median (P25-P75) | ||||
| Patients | 202 | 202 | 26 | 21 |
| Treatment courses | 283 | 236 | 26 | 21 |
| Patients with >1 ITI course | 135 (66.8%) | 42 (20.8%) | 0 | 0 |
| Follow-up on ITI, y | 0.85 (0.51-1.38) | 0.84 (0.49-1.29) | 0.93 (0.59-1.46) | 1.10 (0.70-2.56) |
| Age at the start of ITI, y | 2.30 (1.49-3.28) | 2.33 (1.66-3.28) | 2.39 (1.45-3.35) | 1.69 (1.15-3.33) |
| Maximum inhibitor titer (BU) | 66 (12-333) | 58 (9-301) | 53 (15-517) | 189 (63-1004) |
| ITI treatment | ||||
| FVIII dose/kg per wk | 1020 (380-1556) | 1047 (439-1470) | 357 (226-1087) | 1592 (369-3542) |
| Number of patients on: | ||||
| Low-dose nondaily ITI | 49 (17.3%) | 37 (15.7%) | 9 (34.6%) | 3 (14.3%) |
| Low-dose daily ITI | 5 (1.8%) | 5 (2.1%) | 0 | 0 |
| High-dose nondaily ITI | 48 (17.0%) | 36 (15.3%) | 8 (30.8%) | 4 (19.0%) |
| High-dose daily ITI | 181 (63.9%) | 158 (66.9%) | 9 (34.6%) | 14 (66.7%) |
| BPA prophylaxis | ||||
| Infusions per week, n | NA | 3.3 (3-7) | 14 (3.5-14) | |
| Dose/kg per week (μg for rFVIIa and IU for aPCC) | NA | 550 (500-860) | 868 (195-1390) | |
| Bleeding | ||||
| ABR (mean, 95% CI) | 4.43 (3.85-5.09) | 4.18 (3.59-4.87) | 7.08 (4.58-10.93) | 3.67 (2.05-6.60) |
| AJBR (mean, 95% CI) | 1.73 (1.49-2.01) | 1.66 (1.41-1.98) | 2.92 (1.85-4.62) | 0.99 (0.53-1.83) |
| . | During ITI, overall . | FVIII only . | FVIII and prophylactic rFVIIa . | FVIII and prophylactic aPCC . |
|---|---|---|---|---|
| Number (%) or median (P25-P75) | ||||
| Patients | 202 | 202 | 26 | 21 |
| Treatment courses | 283 | 236 | 26 | 21 |
| Patients with >1 ITI course | 135 (66.8%) | 42 (20.8%) | 0 | 0 |
| Follow-up on ITI, y | 0.85 (0.51-1.38) | 0.84 (0.49-1.29) | 0.93 (0.59-1.46) | 1.10 (0.70-2.56) |
| Age at the start of ITI, y | 2.30 (1.49-3.28) | 2.33 (1.66-3.28) | 2.39 (1.45-3.35) | 1.69 (1.15-3.33) |
| Maximum inhibitor titer (BU) | 66 (12-333) | 58 (9-301) | 53 (15-517) | 189 (63-1004) |
| ITI treatment | ||||
| FVIII dose/kg per wk | 1020 (380-1556) | 1047 (439-1470) | 357 (226-1087) | 1592 (369-3542) |
| Number of patients on: | ||||
| Low-dose nondaily ITI | 49 (17.3%) | 37 (15.7%) | 9 (34.6%) | 3 (14.3%) |
| Low-dose daily ITI | 5 (1.8%) | 5 (2.1%) | 0 | 0 |
| High-dose nondaily ITI | 48 (17.0%) | 36 (15.3%) | 8 (30.8%) | 4 (19.0%) |
| High-dose daily ITI | 181 (63.9%) | 158 (66.9%) | 9 (34.6%) | 14 (66.7%) |
| BPA prophylaxis | ||||
| Infusions per week, n | NA | 3.3 (3-7) | 14 (3.5-14) | |
| Dose/kg per week (μg for rFVIIa and IU for aPCC) | NA | 550 (500-860) | 868 (195-1390) | |
| Bleeding | ||||
| ABR (mean, 95% CI) | 4.43 (3.85-5.09) | 4.18 (3.59-4.87) | 7.08 (4.58-10.93) | 3.67 (2.05-6.60) |
| AJBR (mean, 95% CI) | 1.73 (1.49-2.01) | 1.66 (1.41-1.98) | 2.92 (1.85-4.62) | 0.99 (0.53-1.83) |