Single-ascending dose study | Multiple-ascending dose study | |||
---|---|---|---|---|
Placebo Total (N=20) | AMG 557 Total (N=36) | Placebo Total (N=14) | AMG 557 Total (N=42) | |
Age (years) | ||||
Mean (SD) | 48.5 (12.1) | 44.8 (12.8) | 48.2 (10.5) | 48.8 (12.7) |
Sex, n (%) | ||||
Female; male | 18 (90); 2 (10) | 35 (97); 1 (3) | 12 (86); 2 (14) | 40 (95); 2 (5) |
Race, n (%) | ||||
Caucasian | 15 (75) | 28 (78) | 9 (64) | 30 (71) |
Black/African | 4 (20) | 2 (6) | 1 (7) | 8 (19) |
American | 1 (5) | 5 (14) | 3 (21) | 3 (7) |
Hispanic or Latino Asian | 0 (0) | 1 (3) | 1 (7) | 1 (2) |
Duration of SLE (years) | ||||
Mean (SD) | 8.9 (8.6) | 10.2 (9.7) | 8.8 (12.8) | 10.7 (9.6) |
BILAG | ||||
Mean (SD) | 4.7 (3.5) | 3.4 (3.4) | nd | nd |
SELENA-SLEDAI | ||||
Mean (SD) | nd | nd | 2.3 (2.2) | 2.6 (3.3) |
Positive ANA, n (%) | 17 (85) | 30 (83) | 9 (64) | 26 (62) |
Anti-dsDNA, n (%) | 3 (15) | 3 (8) | 4 (29) | 4 (10) |
C3 below LLN, n (%) | 4 (20) | 5 (14) | 2 (14) | 1 (2) |
C4 below LLN, n (%) | 1 (5) | 2 (6) | 2 (14) | 2 (5) |
Prednisone, n (%) | 9 (45) | 8 (22) | 4 (29) | 14 (33) |
Mean daily dose (mg) | 6.7 | 7.8 | 4.9 | 8.4 |
Immunosuppression*, n (%) | 6 (30) | 7 (19) | 4 (29) | 12 (29) |
*Mycophenolate, azathioprine or methotrexate.
ANA, antinuclear antibodies; BILAG, British Isles Lupus Assessment Group index; nd, not determined; SELENA-SLEDAI, Systemic Lupus Erythematosus Disease Activity Index SELENA.