Treatment-emergent AEs
| SLE subjects without LN | SLE subjects with LN | |||
| Placebo (n = 8) | AMG 811 (n = 20) | Placebo (n = 7) | AMG 811 (n = 21) | |
| All treatment-emergent AEs, n (%) | 7 (87.5) | 18 (90.0) | 6 (85.7) | 20 (95.2) |
| Grade ≥ 2 | 5 (62.5) | 9 (45.0) | 6 (85.7) | 16 (76.2) |
| Grade ≥ 3 | 1 (12.5) | 4 (20.0) | 4 (57.1) | 8 (38.1) |
| Grade ≥ 4 | 0 | 0 | 1 (14.3) | 1 (4.8) |
| Treatment-emergent SAEs, n (%) | 0 | 3 (15.0) | 2 (28.6) | 7 (33.3) |
| Fatal AEs | 0 | 0 | 0 | 0 |
| AEs reported by ≥ 15% of subjects, n (%) | ||||
| Arthralgia | 0 | 3 (15.0) | 0 | 7 (33.3) |
| Headache | 0 | 5 (25.0) | 0 | 6 (28.6) |
| Lupus nephritis worsening | NA | NA | 0 | 6 (28.6) |
| Cough | 0 | 3 (15.0) | 2 (28.6) | 5 (23.8) |
| Fatigue | 0 | 1 (5.0) | 0 | 5 (23.8) |
| Hypertension | 0 | 1 (5.0) | 1 (14.3) | 4 (19.0) |
| Mouth ulceration | 1 (12.5) | 1 (5.0) | 0 | 4 (19.0) |
| Nausea | 1 (12.5) | 1 (5.0) | 1 (14.3) | 4 (19.0) |
| Oral herpes | 0 | 1 (5.0) | 0 | 4 (19.0) |
| Pyrexia | 0 | 1 (5.0) | 1 (14.3) | 4 (19.0) |
| Sinusitis | 0 | 6 (30.0) | 0 | 0 |
| Urinary tract infection | 1 (12.5) | 3 (15.0) | 0 | 2 (9.5) |
AEs, adverse events; NA, not available; SAE, serious AEs.