Literature search and detailed data on patient populations used to construct available FIX population PK models
| Author, y . | Factor concentrate . | Endogenous FIX, IU/mL . | Total population . | Pediatrics . | |||||
|---|---|---|---|---|---|---|---|---|---|
| N . | Age, y (range) . | BW, kg (range) . | Other morphometric variables (range) . | N . | Age, y (range) . | BW, kg (range) . | |||
| Standard half-life factor concentrates | |||||||||
| Bjorkman, 201230 | pdFIX* | ≤0.02 | 26 | 39 (16-65) | 70 (47-115) | NA | NA | NA | NA |
| Brekkan, 201648 | pdFIX† | ≤0;02 | 34 | Mean 28 (10.9 SD) | Mean 67 (13.5 SD) | NA | >16‡ | NA‡ | NA |
| Bjorkman, 201349 | BeneFIX | <0.01-0.05 | 56 | 23 (4-56) | NA (18-133) | NA | 22 | Otherwise§ | NA |
| Suzuki, 201628 | BeneFIX | 0.01-0.02 | 201 | 12 (0-69) | 44 (1-173) | NA | >88ǁ | NA | NA |
| Extended half-life factor concentrates | |||||||||
| Diao, 201427 | Alprolix | ≤0.02 | 135 | 31 (12-76) | 73 (45-187) | NA | 11 | NA | NA |
| Collins, 201225 | Refixia | <0.013 | 15 | 30 (21-55) | 78 (47-101)ǁ | BMI 25.2 (18-29) | —¶ | — | — |
| Zhang, 201626 | Idelvion | ≤0.02 | 104 | 26 (1-61) | 64 (11-132) | BMI 21.8 (13-63) | 38 | 8 (1-17)ǁ | 28 (11 –71)ǁ |
| Author, y . | Factor concentrate . | Endogenous FIX, IU/mL . | Total population . | Pediatrics . | |||||
|---|---|---|---|---|---|---|---|---|---|
| N . | Age, y (range) . | BW, kg (range) . | Other morphometric variables (range) . | N . | Age, y (range) . | BW, kg (range) . | |||
| Standard half-life factor concentrates | |||||||||
| Bjorkman, 201230 | pdFIX* | ≤0.02 | 26 | 39 (16-65) | 70 (47-115) | NA | NA | NA | NA |
| Brekkan, 201648 | pdFIX† | ≤0;02 | 34 | Mean 28 (10.9 SD) | Mean 67 (13.5 SD) | NA | >16‡ | NA‡ | NA |
| Bjorkman, 201349 | BeneFIX | <0.01-0.05 | 56 | 23 (4-56) | NA (18-133) | NA | 22 | Otherwise§ | NA |
| Suzuki, 201628 | BeneFIX | 0.01-0.02 | 201 | 12 (0-69) | 44 (1-173) | NA | >88ǁ | NA | NA |
| Extended half-life factor concentrates | |||||||||
| Diao, 201427 | Alprolix | ≤0.02 | 135 | 31 (12-76) | 73 (45-187) | NA | 11 | NA | NA |
| Collins, 201225 | Refixia | <0.013 | 15 | 30 (21-55) | 78 (47-101)ǁ | BMI 25.2 (18-29) | —¶ | — | — |
| Zhang, 201626 | Idelvion | ≤0.02 | 104 | 26 (1-61) | 64 (11-132) | BMI 21.8 (13-63) | 38 | 8 (1-17)ǁ | 28 (11 –71)ǁ |
All data are reported in median (range) unless otherwise specified.
pdFIX, plasma-derived FIX.
Alphanine, Mononine, Preconativ, Nanotiv, Replenine-VF.
Alphanine, Mononine, Preconativ, Nanotiv, factor IX Grifols, Immunine, Octanin.
At least 16 pediatric patients with minimal age of 12 y.
Number of patients and mean age per age group: age 4-9 y, N = 11, mean 6; age 10-19 y, N = 10, mean 13.
Data provided by authors/pharmaceutical company on request.
Therapeutic indicated as administered to patients ≥12 y.