Table 1

Subject demographics and baseline characteristics

Single-ascending dose studyMultiple-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; male18 (90); 2 (10)35 (97); 1 (3)12 (86); 2 (14)40 (95); 2 (5)
Race, n (%)
 Caucasian15 (75)28 (78)9 (64)30 (71)
 Black/African4 (20)2 (6)1 (7)8 (19)
American1 (5)5 (14)3 (21)3 (7)
 Hispanic or Latino Asian0 (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)ndnd
SELENA-SLEDAI
 Mean (SD)ndnd2.3 (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.