Demographics and clinical characteristics at baseline
| SLE subjects without LN | SLE subjects with LN | |||
| Placebo (n = 8) | AMG 811 (n = 20) | Placebo (n = 7) | AMG 811 (n = 21) | |
| Age, mean years (SD) | 47.6 (11.6) | 37.6 (14.1) | 36.9 (11.7) | 30.0 (8.1) |
| Sex, no of female (%) | 8 (100) | 19 (95.0) | 4 (57.1) | 21 (100) |
| Race, n (%) | ||||
| White/Caucasian | 7 (87.5) | 10 (50.0) | 2 (28.6) | 6 (28.6) |
| Black/African-American | 1 (12.5) | 4 (20.0) | 0 | 0 |
| Hispanic/Latino | 0 | 5 (25.0) | 2 (28.6) | 12 (57.1) |
| Asian | 0 | 0 | 3 (42.9) | 3 (14.3) |
| Other | 0 | 1 (5.0) | 0 | 0 |
| Duration of SLE, mean years (SD) | 7.0 (3.2) | 6.5 (4.9) | 12.0 (5.5) | 6.2 (6.3) |
| ANA ≥ 1:40, n (%) | 8 (100) | 17 (85.0) | 6 (85.7) | 16 (76.2) |
| Anti-dsDNA ≥ 99 IU/mL, n (%) | 0 | 3 (15.0) | 4 (57.1) | 11 (52.4) |
| C3 below LLN, n (%) | 2 (25.0) | 3 (15.0) | 3 (42.9) | 11 (52.4) |
| C4 below LLN, n (%) | 0 | 2 (10.0) | 3 (42.9) | 5 (23.8) |
| BILAG global score, mean (SD) | 0.88 (0.64) | 2.50 (3.02) | 7.71 (2.93) | 8.76 (3.40) |
| SELENA-SLEDAI, mean score (SD) | 1.25 (1.49) | 2.60 (3.05) | 9.71 (4.68) | 12.71 (4.53) |
| Concomitant medications, n (%) | ||||
| Prednisone | 3 (37.5) | 8 (40.0) | 6 (85.7) | 21 (100) |
| Mycophenolate | 2 (25.0) | 2 (10.0) | 6 (85.7) | 15 (71.4) |
| Azathioprine | 0 | 0 | 3 (42.9) | 5 (23.8) |
| Methotrexate | 1 (12.5) | 1 (5.0) | 0 | 0 |
| Antimalarials | 6 (75.0) | 19 (95.0) | 3 (42.9) | 11 (52.4) |
ANA, antinuclear antibodies; BILAG, British Isles Lupus Assessment Group; dsDNA, double-stranded DNA antibodies; LLN, lower limit of normal; LN, lupus nephritis; SLE, systemic lupus erythematosus; SELENA-SLEDAI, Safety of estrogen in lupus erythematosus national assessment- Systemic Lupus Erythematosus Disease Activity Index.