Table 1

Demographics and baseline disease characteristics

Treatment group
Placebo
pooled
(N=269)
Blisibimod
pooled
(N=277)
Blisibimod
200 mg Q4W
(N=92)
Blisibimod
100 mg QW
(N=93)
Blisibimod
200 mg QW
(N=92)
Mean age at screening (years)37.937.137.035.838.4
Female (n (%))257 (95.5)256 (92.4)85 (92.4)85 (91.4)86 (93.5)
Male (n (%))12 (4.5)21 (7.6)7 (7.6)8 (8.6)6 (6.5)
Hispanic or Latino (n (%))189 (70.3)196 (70.8)54 (58.7)75 (80.6)67 (72.8)
Race (n (%)):
 Asian56 (20.8)52 (18.8)26 (28.3)13 (14.0)13 (14.1)
 Black/African-American22 (8.2)24 (8.7)8 (8.7)8 (8.6)8 (8.7)
 White57 (21.2)80 (28.9)25 (27.2)27 (29.0)28 (30.4)
 Other134 (49.8)121 (43.7)33 (35.9)45 (48.4)43 (46.7)
Time since SLE diagnosis (years)6.465.665.975.025.99
Subjects with 2 organ domains (%)32.733.932.633.335.9
Subjects with ≥3 organ domains (%)64.761.065.259.158.7
Mean SELENA-SLEDAI score10.289.969.9610.039.89
BILAG 1A or 2B, %51.948.745.752.747.8
PGA (mean score)1.41.441.411.421.5
Corticosteroid use (%)90.487.483.790.388
 Mean prednisone* dose (mg/day)12.8411.1611.9811.0510.48
 >7.5 mg/day prednisone* (%)62.257.457.658.156.5
Immunosuppressive use (%)52.238.335.933.345.7
Antimalarial use (%)71.970.468.568.873.9
Proteinuria ≥0.5 g/24 h (%)13.79.48.711.87.6
ANA >1:80, %77.480.182.679.678.3
Anti-dsDNA ≥30 IU/mL (%)71.565.372.864.558.7
Mean C3 (g/L)0.9870.9770.9840.9421.005
Mean C4 (g/L)0.1740.1790.1760.1740.186
  • N: number of subjects in specified population and treatment group; n: number of subjects with data available. % based on N; *or prednisone equivalent. Race was identified from subjects’ selection from the following options: Asian, Black/African-American, White or Other. Baseline is defined as the last non-missing value that was obtained prior to the first administration of study drug.

  • ANA, autoantibodies to nuclear antigens; BILAG, British Isles Lupus Assessment Group; PGA, Physician's Global Assessment; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment—Systemic Lupus Erythematosus Disease Activity Index; SLE, systemic lupus erythematosus.