Table 1 Baseline demographics and disease characteristics
Characteristic | MEDI-546 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
0.1 mg/kg single dose | 0.3 mg/kg single dose | 1.0 mg/kg single dose | 3.0 mg/kg single dose | 10.0 mg/kg single dose | 20.0 mg/kg single dose | 0.3 mg/kg/week multiple dose | 1.0 mg/kg/week multiple dose | 5.0 mg/kg/week multiple dose | Total | |
(n = 1) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 4) | (n = 5) | (N = 34) | |
Age, mean (SD), years | 41.0 (NA) | 58.3 (10.0) | 45.0 (7.1) | 33.0 (10.4) | 48.0 (12.5) | 45.5 (9.5) | 42.5 (11.4) | 49.3 (9.5) | 57.2 (12.3) | 47.4 (12.0) |
Female, n (%) | 1 (100.0) | 3 (75.0) | 4 (100.0) | 3 (75.0) | 4 (100.0) | 3 (75.0) | 2 (50.0) | 3 (75.0) | 4 (80.0) | 27 (79.4) |
White, n (%) | 1 (100.0) | 3 (75.0) | 2 (50.0) | 2 (50.0) | 2 (50.0) | 3 (75.0) | 4 (100.0) | 4 (100.0) | 4 (80.0) | 25 (73.5) |
Weight, mean (SD), kg | 63.5 (NA) | 57.7 (5.4) | 71.7 (26.8) | 72.8 (30.1) | 73.4 (28.2) | 68.7 (13.6) | 87.8 (11.6) | 75.9 (33.7) | 72.2 (21.8) | 72.3 (21.8) |
Diffuse cutaneous systemic SSc, n (%) | 1 (100.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 3 (75.0) | 4 (100.0) | 4 (80.0) | 32 (94.1) |
Raynaud’s, n (%) | 1 (100.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 4 (100.0) | 3 (75.0) | 4 (100.0) | 5 (100.0) | 33 (97.1) |
mRSS, mean (SD) | 16.0 (NA) | 24.5 (6.6) | 23.0 (11.0) | 21.0 (2.4) | 22.0 (10.4) | 31.8 (12.2) | 17.5 (5.1) | 24.5 (10.1) | 23.8 (7.9) | 23.3 (8.6) |
Positive type I IFN gene signaturea | ||||||||||
Whole blood, n (%) | 0 (0.0) | 4 (100.0) | 2 (50.0) | 3 (75.0) | 3 (75.0) | 3 (75.0) | 1 (25.0) | 3 (75.0) | 3 (60.0) | 22 (64.7) |
Skin, n (%) | 0 (0.0) | 2 (50.0) | 3 (75.0) | 1 (25.0) | 4 (100.0) | 1 (25.0) | 0 (0.0) | 3 (75.0) | 1 (20.0) | 15 (44.1) |
History of viral reactivation, n (%) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (50.0) | 1 (25.0) | 2 (50.0) | 1 (20.0) | 7 (20.6) |
Positive antinuclear antibody, n (%) | 1 (100.0) | 2 (50.0) | 4 (100.0) | 4 (100.0) | 3 (75.0) | 2 (50.0) | 3 (75.0) | 3 (75.0) | 2 (40.0) | 24 (70.6) |
Positive anti-SCL-70 antibody, n (%) | 1 (100.0) | 2 (50.0) | 0 (0.0) | 3 (75.0) | 1 (25.0) | 1 (25.0) | 2 (50.0) | 0 (0.0) | 1 (20.0) | 11 (32.4) |
Corticosteroids ≤10 mg/day | ||||||||||
for <6 months, n (%) | 0 (0.0) | 1 (25.0) | 2 (50.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 4 (11.8) |
for >6 months, n (%) | 0 (0.0) | 0 (0.0) | 2 (50.0) | 3 (75.0) | 1 (25.0) | 3 (75.0) | 0 (0.0) | 1 (25.0) | 2 (40.0) | 12 (35.3) |
Corticosteroids >10 and ≤20 mg/day | ||||||||||
for <6 months, n (%) | 0 (0.0) | 1 (25.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (5.9) |
for >6 months, n (%) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 2 (50.0) | 2 (50.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (17.6) |
Antimalarials for >6 months, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 1 (25.0) | 2 (50.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 5 (14.7) |
Methotrexate | ||||||||||
for <6 months, n (%) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (25.0) | 0 (0.0) | 0 (0.0) | 2 (5.9) |
for >6 months, n (%) | 0 (0.0) | 1 (25.0) | 1 (25.0) | 3 (75.0) | 2 (50.0) | 2 (50.0) | 0 (0.0) | 1 (25.0) | 1 (20.0) | 11 (32.4) |