Coagulation factor products required during emicizumab treatment
| Duration of treatment, days . | Range of dose . | Total number of treatments . | |||
|---|---|---|---|---|---|
| FVIII, IU/kg per day (n = 5) | <25 | 25-50 | 51-75 | >75 | |
| 1 | 10 | 40 | 12 | 1* | 63 |
| 2 | 4 | 4 | 0 | 0 | 8 |
| 3 | 1 | 4 | 1 | 0 | 6 |
| 4 | 0 | 1 | 0 | 0 | 1 |
| >4 | 3 | 2 | 0 | 0 | 5 |
| Total number of treatments per dose category | 18 | 51 | 13 | 1 | 83 |
| aPCC, U/kg per day (n = 5) | <50 | 50-100 | 101-150 | >150 | |
| 1 | 3 | 16 | 1† | 0 | 20 |
| 2 | 0 | 2 | 0 | 1‡ | 3 |
| 3 | 0 | 0 | 0 | 0 | 0 |
| 4 | 0 | 0 | 0 | 0 | 0 |
| >4 | 0 | 0 | 0 | 0 | 0 |
| Total number of treatments per dose category | 3 | 18 | 1 | 1 | 23 |
| rFVIIa, μg/kg per day (n = 4) | <90 | 90-180 | 181-270 | >270 | |
| 1 | 6 | 4 | 13 | 2§ | 25 |
| 2 | 0 | 0 | 9 | 0 | 9 |
| 3 | 0 | 0 | 1 | 0 | 1 |
| 4 | 0 | 0 | 0 | 0 | 0 |
| >4 | 0 | 0 | 0 | 0 | 0 |
| Total number of treatments per dose category | 6 | 4 | 23 | 2 | 35 |
| Duration of treatment, days . | Range of dose . | Total number of treatments . | |||
|---|---|---|---|---|---|
| FVIII, IU/kg per day (n = 5) | <25 | 25-50 | 51-75 | >75 | |
| 1 | 10 | 40 | 12 | 1* | 63 |
| 2 | 4 | 4 | 0 | 0 | 8 |
| 3 | 1 | 4 | 1 | 0 | 6 |
| 4 | 0 | 1 | 0 | 0 | 1 |
| >4 | 3 | 2 | 0 | 0 | 5 |
| Total number of treatments per dose category | 18 | 51 | 13 | 1 | 83 |
| aPCC, U/kg per day (n = 5) | <50 | 50-100 | 101-150 | >150 | |
| 1 | 3 | 16 | 1† | 0 | 20 |
| 2 | 0 | 2 | 0 | 1‡ | 3 |
| 3 | 0 | 0 | 0 | 0 | 0 |
| 4 | 0 | 0 | 0 | 0 | 0 |
| >4 | 0 | 0 | 0 | 0 | 0 |
| Total number of treatments per dose category | 3 | 18 | 1 | 1 | 23 |
| rFVIIa, μg/kg per day (n = 4) | <90 | 90-180 | 181-270 | >270 | |
| 1 | 6 | 4 | 13 | 2§ | 25 |
| 2 | 0 | 0 | 9 | 0 | 9 |
| 3 | 0 | 0 | 1 | 0 | 1 |
| 4 | 0 | 0 | 0 | 0 | 0 |
| >4 | 0 | 0 | 0 | 0 | 0 |
| Total number of treatments per dose category | 6 | 4 | 23 | 2 | 35 |
As of February 2016, 16 of 18 Japanese patients enrolled in the 12-week study continued into the extension study: 6 patients in cohort 1, and 5 patients each in cohorts 2 and 3. All data collected after dose up-titrations were included.
The patient 1-6 used 2000 IU of FVIII 3 times per day (98 IU/kg per day) to treat breakthrough bleeding during treatment with 3 mg/kg of emicizumab. This patient had 59 treatment events in total and was the only 1 who used >50 IU/kg per day of FVIII.
The patient 2-1 used 3000 U of aPCC 3 times per day (115 U/kg per day) to treat bleeding related to a procedure (not counted as breakthrough bleeding) during treatment with 1 mg/kg of emicizumab.
The patient 1-2 used 7000 U of aPCC twice per day (203 U/kg per day) for 2 days to treat breakthrough bleeding during treatment with 0.3 mg/kg of emicizumab.
The patient 1-3 used 15 mg of rFVIIa twice per day (504 μg/kg per day) to treat breakthrough bleeds during treatment with 0.3 and 1 mg/kg of emicizumab.