Table 5.
Parameters used for quantifying product consumption associated to prophylaxis treatment and to the resolution of bleeding events in pediatric and adult patients per week
| Prophylaxis treatment | Treatment for the resolution of bleeding | |||||
|---|---|---|---|---|---|---|
| Median dosage (IU/Kg) | Num. of administration per week | References | Annual bleeding events | Median dosage (IU/kg) | References | |
| Paediatric patients | ||||||
| rFVIIIFc | 44.05 | 2 | [7]a | 1.96 | 54.9 | [7] |
| Conventional products | 33.8 | 3.07 | [20]b | 4 | 46.6 | [20] |
| Adult patients | ||||||
| rFVIIIFc | 38.95 | 2 | [10]c | 1.66 | 31.32 | [23]e |
| Conventional products | 43.0 | 2.3 | [19]d | 3.84 | 34.5 | [20, 24]f |
aThe study reported a median weekly dose of 88.11 IU/Kg and a median dose per infusion equal to 44.05 IU/Kg, the median number of administration per week was obtained dividing the median weekly dose by the median dose per infusion
bThe study reported a median weekly dose of 103.8 IU/Kg and a median dose per infusion equal to 33.8 IU/Kg, the median number of administration per week was obtained dividing the median weekly dose by the median dose per infusion
cThe study reported a median weekly dose of 77.9 IU/Kg and a median dose per infusion equal to 47.2 IU/Kg, the median number of administration per week was obtained dividing the median weekly dose by the median dose per infusion
dAmong 141 subjects treated with individualized and standard prophylaxis and enrolled in the A-LONG study a total of 301 bleeding events were recorded over 67 weeks, annual number of bleeding for a single subjects was thus obtained as the ratio of number of bleeding events and person-days (301/(67*7*141))*365.25
eThe study reported a median dose per infusion equal to 43.0 UI/Kg during the individualized prophylaxis regimen. In the model the median dose and average dose are equivalent
fValentino et al.[19] reported a total of 245 bleeding events over 23,282 person-days, data were adapted to 1 year multiplying the bleeding rate observed in the study by 365.25 [(245/23,282)*365.25]