Table 1 Baseline characteristics of study subjects
Characteristic | Placebo | MEDI-551 (n = 24) | Total | ||||
|---|---|---|---|---|---|---|---|
0.1Â mg/kg | 0.3Â mg/kg | 1.0Â mg/kg | 3.0Â mg/kg | 10Â mg/kg | |||
(n = 4) | (n = 1) | (n = 4) | (n = 6) | (n = 6) | (n = 7) | (N = 28) | |
Age, years, mean (SD) | 42.3 (14.4) | 52.0 (NA) | 47.3 (11.6) | 48.8 (9.8) | 49.8 (9.3) | 46.0 (8.6) | 47.3 (9.7) |
Female, n (%) | 2 (50.0) | 0 (0.0) | 3 (75.0) | 3 (50.0) | 5 (83.3) | 6 (85.7) | 19 (67.9) |
White, n (%) | 4 (100.0) | 1 (100.0) | 2 (50.0) | 6 (100.0) | 5 (83.3) | 6 (85.7) | 24 (85.7) |
Weight, kg, mean (SD) | 84.7 (7.9) | 114.2 (NA) | 75.3 (4.4) | 68.2 (18.7) | 73.4 (14.6) | 71.7 (20.5) | 75.2 (17.1) |
Diffuse cutaneous SSc, n (%) | 3 (75.0) | 1 (100.0) | 3 (75.0) | 5 (83.3) | 6 (100.0) | 6 (85.7) | 24 (85.7) |
Disease duration, years, mean (SD) | 5.6 (6.2) | 5.3 (NA) | 5.7 (3.35) | 6.7 (4.7) | 3.7 (3.0) | 5.4 (5.1) | 5.4 (4.3) |
Positive antinuclear antibody, n (%) | 2 (50.0) | 0 (0.0) | 4 (100.0) | 4 (66.7) | 4 (66.7) | 7 (100.0) | 21 (75.0) |
Positive anti-Scl70 antibody, n (%) | 3 (75.0) | 0 (0.0) | 1 (25.0) | 2 (33.3) | 4 (66.7) | 2 (28.6) | 12 (42.9) |
Elevated acute phase reactants (ESR, CRP), n (%) | 2 (50.0) | 1 (100.0) | 1 (25.0) | 4 (66.7) | 3 (50.0) | 3 (42.9) | 14 (50.0) |
MRSS, mean (SD) | 22.8 (7.5) | 31.0 (NA) | 23.5 (7.6) | 20.0 (9.8) | 23.3 (12.8) | 24.0 (5.1) | 23.0 (8.5) |
FVC, % predicted, mean (SD) | 87.9 (10.9) | 83.0 (NA) | 87.0 (10.9) | 75.0 (19.0) | 83.8 (21.9) | 82.1 (22.8) | 82.5 (17.8) |
DLco, % predicted, mean (SD) | 69.8 (30.2) | 98.0 (NA) | 79.5 (20.9) | 54.5 (10.0) | 74.8 (29.2) | 77.9 (20.7) | 72.0 (23.1) |
CD19 B cell count, cells/uL, mean (SD) | 223.8 (209.5) | 182.0 (NA) | 187.3 (149.9) | 119.2 (115.7) | 175.8 (116.1) | 175.3 (211.8) | 172.3 (152.9) |
CD20 B cell count, cells/uL, mean (SD) | 221.0 (210.7) | 174.0 (NA) | 180.0 (135.3) | 115.8 (113.9) | 177.0 (116.5) | 173.3 (211.4) | 169.6 (151.3) |