Table 1.
Characteristics | Eculizumab naive (part 2) IV loading doses on day 1 (375 mg), day 8 (500 mg), day 22 (1000 mg); 170 mg s.c. weekly starting on day 29 (N = 10) | Switched to crovalimab (part 3) | |||
---|---|---|---|---|---|
Group A: IV loading dose (1000 mg), followed by 680 mg s.c. every 4 wk* (n = 7) | Group B: IV loading dose (1000 mg), followed by 340 mg s.c. every 2 wk (n = 6) | Group C: IV loading dose (1000 mg), followed by 170 mg s.c. weekly (n = 6) | All (N = 19) | ||
Age, mean ± SD, y | 53.9 ± 11.8 | 48.9 ± 4.8 | 53.2 ± 13.7 | 46.5 ± 13.7 | 49.5 ± 11.0 |
Sex | |||||
Female | 4 (40) | 4 (57.1) | 0 | 2 (33.3) | 6 (31.6) |
Male | 6 (60) | 3 (42.9) | 6 (100) | 4 (66.7) | 13 (68.4) |
Race | |||||
Asian | 3 (30) | 2 (28.6) | 2 (33.3) | 3 (50.0) | 7 (36.8) |
White | 7 (70) | 4 (57.1) | 3 (50.0) | 2 (33.3) | 9 (47.4) |
Unknown | 0 | 1 (14.3) | 1 (16.7) | 1 (16.7) | 3 (15.8) |
Weight, mean ± SD, kg | 75.35 ± 15.98 | 88.27 ± 28.36 | 85.67 ± 26.17 | 65.03 ± 19.65 | 80.11 ± 26.03 |
C5 polymorphism | 1 (10) | 0 | 0 | 1 (17) | 1 (6) |
Granulocyte clone size, mean ± SD | 80 ± 18 | 92 ± 8 | 84 ± 18 | 80 ± 13 | 86 ± 13 |
Baseline LDH,† mean ± SD, U/L | 1159 ± 608 | 230 ± 46 | 415 ± 256 | 353 ± 323 | 327 ± 233 |
Baseline hemoglobin, mean ± SD, g/L | 95.2 ± 14.7 | 106.4 ± 14.7 | 94.8 ± 8.3 | 112.5 ± 24.5 | 104.7 ± 17.7 |
Eculizumab dose regimen before switch | |||||
Labeled dose (900 mg every 2 wk) | NA | 5 (71) | 4 (67) | 6 (100) | 15 (79) |
Higher dose or higher frequency (1200 mg every 2 wk) | NA | 2 (29) | 2 (33) | 0 (0) | 4 (21) |
Patients with RBC transfusion in past 12 mo | 3 (30) | 3 (43) | 3 (50) | 2 (33) | 8 (42) |
RBC units transfused in past 12 mo, n | 6 | 22 | 30 | 4 | 56 |
Unless otherwise noted, all data are n (%).
NA, not applicable; s.c., subcutaneously; SD, standard deviation.
After the first 2 patients, the treatment regimen was modified to 170 mg weekly for the first 8 wk of subcutaneous dosing.
Upper limit of normal, 210 U/L.