Table 1.
Demographic and baseline characteristics of subjects who switched from on-demand treatment to prophylaxis with rFVIIIFc/rFIXFc in A-LONG/ASPIRE or B-LONG/B-YOND, respectively.
| Demographic/characteristic | Subjects in A-LONG/ASPIRE (rFVIIIFc) |
Subjects in B-LONG/B-YOND (rFIXFc) |
||||
|---|---|---|---|---|---|---|
| Total population (N = 67) | Subjects switching at A-LONG entry (n = 51) | Subjects switching at entry or during ASPIRE (n = 16) | Total population (N = 50) | Subjects switching at B-LONG entry (n = 41) | Subjects switching at entry or during B-YOND (n = 9) | |
| Age (years) | ||||||
| Overall, median (range) | 35.0 (13.0-64.0) | 36.0 (16.0-64.0) | 30.0 (13.0-62.0) | 29.5 (12.0-68.0) | 29.0 (12.0-68.0) | 36.0 (14.0-61.0) |
| 12-25 y, n (%) | 19 (28.4) | 12 (23.5) | 7 (43.8) | 21 (42.0) | 17 (41.5) | 4 (44.4) |
| 26-40 y, n (%) | 23 (34.3) | 18 (35.3) | 5 (31.3) | 17 (34.0) | 14 (34.1) | 3 (33.3) |
| ≥41 y, n (%) | 25 (37.3) | 21 (41.2) | 4 (25.0) | 12 (24.0) | 10 (24.4) | 2 (22.2) |
| Weight (kg) | ||||||
| Median (IQR) | 75.0 (62.0-82.5) | 75.3 (62.0-85.5) | 68.8 (61.5-79.1) | 70.0 (59.1-83.0) | 70.0 (61.0-82.3) | 58.7 (50.5-84.0) |
| BMI (kg/m2) | ||||||
| Median (IQR) | 23.3 (20.8-27.9) | 24.2 (21.1-28.5) | 22.2 (20.6-25.6) | 24.5 (20.8-26.6) | 24.6 (21.4-26.6) | 19.2 (17.5-26.6) |
| Region, n (%) | ||||||
| Europe | 8 (11.9) | 6 (11.8) | 2 (12.5) | 10 (20.0) | 9 (22.0) | 1 (11.1) |
| North America | 14 (20.9) | 12 (23.5) | 2 (12.5) | 10 (20.0) | 9 (22.0) | 1 (11.1) |
| Othera | 45 (67.2) | 33 (64.7) | 12 (75.0) | 30 (60.0) | 23 (56.1) | 7 (77.8) |
| Race, n (%) | ||||||
| White | 37 (55.2) | 28 (54.9) | 9 (56.3) | 26 (52.0) | 24 (58.5) | 2 (22.2) |
| Black | 7 (10.4) | 5 (9.8) | 2 (12.5) | 4 (8.0) | 4 (9.8) | 0 (0.0) |
| Asian | 23 (34.3) | 18 (35.3) | 5 (31.3) | 16 (32.0) | 9 (22.0) | 7 (77.8) |
| Otherb | - | - | - | 4 (8.0) | 4 (9.8) | 0 (0.0) |
| Number of target joints at A-LONG/B-LONG entry | ||||||
| Median (IQR) | 1.0 (1.0-3.0) | 1.0 (1.0-3.0) | 1.0 (0.5-2.0) | 1.0 (0.0-3.0) | 1.0 (0.0-2.0) | 4.0 (1.0-5.0) |
| Target joints, n (%)c | ||||||
| ≥1 | 56 (83.6) | 44 (86.3) | 12 (75.0) | 35 (70.0) | 28 (68.3) | 7 (77.8) |
Percentages may not sum to 100 due to rounding.
BMI, body mass index; IQR, interquartile range; kg, kilogram; rFVIIIFc, recombinant factor VIII Fc fusion protein; rFIXFc, recombinant factor IX Fc fusion protein.
Other regions included Australia, Brazil, China, India, Israel, Japan, New Zealand, and South Africa.
Other races/ethnic groups included Native American/American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, Hispanic or Latino, North African, Afghan, and mixed races.
Target joints in the rFVIIIFc studies were defined as major joints with ≥3 bleeding episodes into the same joint in a 6-month period whereas in the rFIXFc studies, target joints were defined as major joints with ≥3 bleeding episodes into the same joint in a consecutive 3-month period.