Table 1

Demographics and baseline disease characteristics

Blisibimod (n=245)Placebo (n=197)Overall (n=442)
Age, mean (SD) (years)36.7 (10.98)35.6 (10.78)36.2 (10.89)
Gender (female:male, %)92.7:7.394.9:5.193.7:6.3
Race, n (%)
 Black or African-American10 (4.1)4 (2.0)14 (3.2)
 White167 (68.2)132 (67.3)299 (67.8)
 Asian67 (27.3)60 (30.6)127 (28.8)
 Native Hawaiian or other Pacific Islander1 (0.4)01 (0.2)
Region, n (%)
 Asia Pacific67 (27.3)60 (30.5)127 (28.7)
 Central and South America89 (36.3)58 (29.4)147 (33.3)
 Europe89 (36.3)79 (40.1)168 (38.0)
Weight, mean (SD) (kg)65.1 (15.46)64.8 (15.31)65.0 (15.38)
BMI, mean (SD) (kg/m2)25.1 (5.33)25.0 (4.96)25.0 (5.17)
SELENA-SLEDAI mean score (SD)13.4 (4.31)13.5 (4.01)13.5 (4.18)
SELENA-SLEDAI activity, n (%)
 Total score ≤12133 (54.3)107 (54.3)240 (54.3)
 Total score >12112 (45.7)89 (45.2)201 (45.5)
 Dermal234 (95.5)188 (95.9)422 (95.7)
 Immunologic222 (90.6)178 (90.8)400 (90.7)
 Musculoskeletal193 (78.8)159 (81.1)352 (79.8)
 Renal78 (31.8)54 (27.6)132 (29.9)
BILAG A, B or C domain score, n (%)
 Mucocutaneous236 (96.3)190 (96.9)426 (96.6)
 Musculoskeletal209 (85.3)169 (86.2)378 (85.7)
 Haematological121 (49.4)101 (51.5)222 (50.3)
 Renal96 (39.2)64 (32.7)160 (36.3)
 Constitutional35 (14.3)28 (14.3)63 (14.3)
PGA score, mean (SD)1.59 (0.475)1.64 (0.475)1.61 (0.475)
PGA score (range)0.1–2.70.4–2.80.1–2.8
Corticosteroid dose (prednisone dose equivalent, mg (SD))15.6 (8.58)15.6 (9.75)15.6 (9.11)
 <Median prednisone dose, n (%)108 (44.1)103 (52.3)211 (47.7)
 ≥Median prednisone dose, n (%)137 (55.9)94 (47.7)231 (52.3)
Systemic SLE medications, n (%)
 Any (including corticosteroid)245 (100.0)195 (99.5)440 (99.8)
 Antimalarial150 (61.2)122 (62.2)272 (61.7)
 Any immunosuppressive agent104 (42.4)82 (41.8)186 (42.2)
 Azathioprine60 (24.5)47 (24.0)107 (24.3)
 Mycophenolate (any derivative)35 (14.3)22 (11.7)58 (13.1)
 Methotrexate14 (5.7)15 (7.7)29 (6.6)
SLE markers, n (%)
 Anti-dsDNA positive239 (97.6)194 (98.5)433 (98.0)
 Low C3 (<0.9 g/L)132 (53.9)105 (53.6)237 (53.7)
 Low C4 (<0.18 g/L)138 (56.3)100 (51.0)238 (54.0)
 Low C3/C4 and anti-dsDNA153 (62.4)121 (61.7)274 (62.1)
UPCR, n (%)
 ≥56.5 mg/mmol80 (32.7)55 (27.9)135 (30.5)
 ≥113 mg/mmol47 (19.2)35 (17.8)82 (18.6)
 ≥226 mg/mmol23 (9.4)15 (7.7)38 (8.6)
  • BMI, body mass index; dsDNA, double-stranded DNA; SLE, systemic lupus erythematosus; UPCR, urinary protein:creatinine ratio.