Skip to main content

Table 1 Baseline characteristics of study subjects

From: Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study

Characteristic Placebo MEDI-551 (n = 24) Total
0.1 mg/kg 0.3 mg/kg 1.0 mg/kg 3.0 mg/kg 10 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)
  1. CRP C-reactive protein, DL co diffusing capacity for carbon monoxide, ESR erythrocyte sedimentation rate, FVC forced vital capacity, MRSS modified Rodnan skin score, NA not available, SSc systemic scleroderma
\