Table 1

Baseline patient characteristics

CharacteristicPlaceboBelimumab 10 mg/kg
mITT population(n=226)(n=451)
Country, n (%)
 China171 (75.7)346 (76.7)
 Korea34 (15.0)66 (14.6)
 Japan21 (9.3)39 (8.6)
Female, n (%)210 (92.9)419 (92.9)
Age (years), mean (SD)31.7 (9.18)32.3 (9.65)
BMI (kg/m2), mean (SD)22.3 (4.04)*22.3 (3.42)
SLE disease duration (years), mean (SD)5.97 (5.19)6.07 (5.04)
BILAG organ domain involvement, n (%)
 At least 1A or 2B108 (47.8)204 (45.2)
 At least 1A24 (10.6)40 (8.9)
 At least 1B174 (77.0)361 (80.0)
 No A or B46 (20.4)79 (17.5)
BILAG organ domain involvement (A or B), by category, n (%)
 General12 (5.3)24 (5.3)
 Mucocutaneous106 (46.9)225 (49.9)
 Neurological1 (0.4)   0
 Musculoskeletal64 (28.3)119 (26.4)
 Cardiovascular and respiratory2 (0.9)2 (0.4)
 Vasculitis29 (12.8)59 (13.1)
 Renal60 (26.5)109 (24.2)
 Haematology50 (22.1)94 (20.8)
SELENA-SLEDAI category, n (%)
 ≤9102 (45.1)218 (48.3)
 ≥10124 (54.9)233 (51.7)
SELENA-SLEDAI score, mean (SD)10.2 (4.11)9.8 (3.83)
SFI*, n (%)
 At least one flare28 (12.4)53 (11.8)
 At least one severe flare10 (4.4)15 (3.3)
PGA category, n (%)
 0–18 (3.5)26 (5.8)
 >1–2.5209 (92.5)413 (91.6)
 >2.58 (3.5)11 (2.4)
 Missing1 (0.4)1 (0.2)
SDI score
 Mean (SD)0.3 (0.61)0.2 (0.55)
 Median (min, max)0.0 (0, 4)0.0 (0, 4)
Allowable SLE concomitant medications, n (%)
 Steroids223 (98.7)443 (98.2)
 Antimalarials157 (69.5)320 (71.0)
 Other immunosuppressive/immunomodulatory agents146 (64.6)292 (64.7)
  Azathioprine15 (6.6)48 (10.6)
  Leflunomide19 (8.4)46 (10.2)
  Methotrexate/methotrexate sodium15 (6.6)29 (6.4)
  Mycophenolic acid/mycophenolate mofetil75 (33.2)130 (28.8)
 Traditional Chinese medicineglycosides of paeony/tripterygium31 (13.7)59 (13.1)