Table 1.
Comparison of the medians, average values and standard deviations of the ABRs between on-demand treatment and prophylaxis in phase III trials of EHL rFVIII concentrates.
| Product | Treatment on-demand |
Weekly prophylaxis |
|||||
|---|---|---|---|---|---|---|---|
| Patients (n) | Dose (IU/kg) | ABR median (Q1–Q3) mean + SD | Patients (n) | Dose (IU/kg) | ABR median (Q1–Q3) mean + SD | Ref. | |
| Elocta TM | 23 | 10–50 as required | 33.6 (21.1–48.7) | 24 | 65 | 3.6 (1.9–8.4) | Brand and colleagues14 |
| 14 | 18.36 (10.45–30.46) | 27 | 150 | 2.03 (0.60–4.39) | Bjørnsdottir and colleagues15 | ||
| BAX 855 | 17 | according to treater | 41.58 (31.7–51.1) | 101 | 45 ± 5 2/week | 1.9 (0.0–5.8) | Stidl and colleagues16 |
| 40.8 ± 16.3 | 3.7 ± 4.7 | ||||||
| N8-GP | 12 | according to treater | 30.9 | 175 | 50 every 4 days | 1.3 | Turecek and colleagues17 |
| BAY 94-9027 | 20 | according to treater | 23.4 | 13 | 2/week | 4.1 | Mei and colleagues18 |
| 43 | 45–60 every 5 days | 1.9 | |||||
| 43 | 60 every 7 days | 3.9 | |||||
| FVIII Single Chain | 27 | according to treater | 19.54 (6.2–46.5) 31.14 ± 35.56 | 79 | 20–40 eod | 1.93 (0.00, 4.9) | Morfini and Zanon19 |
| 47 | 20–50 2–3/week | 0.0 (0.0, 3.3) | |||||
ABR, annualized bleeding rate; eod, every other day; EHL, extended half-life; rF, recombinant factor; SD, standard deviation.