Table 2.
Baseline demographics and patient characteristics
| Characteristic | Patients (mITT population; N=169) |
| Age, years, mean (SD) | 39.7 (12.7) |
| Female, n (%) | 155 (91.7) |
| Race, n (%) | |
| Caucasian | 63 (37.3) |
| African-American | 17 (10.1) |
| American Indian or Alaska Native | 36 (21.3) |
| Other | 53 (31.4) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 136 (80.5) |
| Weight, kg, mean (SD) | 73.1 (18.7) |
| SLEDAI-2K total score, mean (SD)* | 9.9 (3.1) |
| BILAG-2004 total score, mean (SD)† | 18.1 (5.3) |
| Physician’s Global Assessment (0–100 scale), mean (SD)‡ | 59.7 (16.2) |
| Prednisone or equivalent daily dosage, mg, mean (SD) | 11.1 (4.7) |
| Prednisone or equivalent daily dosage, n (%) | |
| ≤20 mg/day | 161 (95.3) |
| >20 mg/day | 8 (4.7) |
| Antimalarials, n (%) | 134 (79.3) |
| Immunosuppressants, n (%) | 109 (64.5) |
| Complement C3, mg/dL, mean (SD) | 112.4 (33.5) |
| Complement C4, mg/dL, mean (SD) | 19.1 (10.4) |
| Anti-double stranded DNA antibody, IU/mL, mean (SD) | 81.1 (192.1) |
*SLEDAI-2K was assessed over a 10-day window, and total scores were the sum of all weighted scores of all 24 manifestations in the questionnaire.
†The BILAG-2004 Index was assessed over a 4-week period, and total scores were the sum of scores from all nine organ systems in the BILAG-2004 questionnaire using the coding scheme of A=12, B=8, C=1 and D/E=0.
‡n=168.
BILAG-2004, British Isles Lupus Assessment Group-2004; mITT, modified intent-to-treat; SLEDAI-2K, SLE Disease Activity Index-2000.