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Table 1 Baseline demographics and disease characteristics

From: Dose-escalation of human anti-interferon-α receptor monoclonal antibody MEDI-546 in subjects with systemic sclerosis: a phase 1, multicenter, open label study

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)
  1. aPositive type I IFN gene signature was defined as a baseline (day 0 pre-dose) fold change value >2.9 in whole blood and >1.8 in skin.
  2. IFN interferon, mRSS modified Rodnan Skin Score, SD standard deviation, SSc systemic sclerosis.