Table 1.
Baseline characteristics of ADDRESS II patients with HDA (SLEDAI-2K ≥10) at screening
| Placebo (n = 52) | Atacicept 75 mg (n = 55) | Atacicept 150 mg (n = 51) | |
|---|---|---|---|
| Age, mean (s.d.), years | 39 (13.7) | 35 (11.1) | 37 (10.4) |
| Female, n (%) | 47 (90.4) | 50 (90.9) | 49 (96.1) |
| Race or ethnicity, n (%) | |||
| White | 40 (76.9) | 35 (63.6) | 31 (60.8) |
| Black/African American | 2 (3.8) | 3 (5.5) | 4 (7.8) |
| Hispanic or Latino | 30 (57.7) | 30 (54.5) | 23 (45.1) |
| Disease characteristics | |||
| SLE disease duration, mean (s.d.), years | 6.8 (7.6) | 7.1 (7.6) | 5.5 (5.0) |
| SLEDAI-2K score, mean (s.d.) | 12 (2.3) | 12 (3.0) | 12 (2.4) |
| Serologically active disease,an (%) | 38 (73.1) | 43 (78.2) | 35 (68.6) |
| Medication history | |||
| Prednisone-equivalent dose at screening, mean (s.d.), mg/day | 10.4 (8.0) | 11.8 (8.6) | 11.1 (8.5) |
| >7.5 mg/day prednisone equivalent, n (%) | 30 (57.7) | 35 (63.6) | 29 (56.9) |
| Antimalarial, n (%) | 39 (75.0) | 42 (76.4) | 38 (74.5) |
| AZA, n (%) | 11 (21.2) | 13 (23.6) | 7 (13.7) |
| MTX, n (%) | 9 (17.3) | 7 (12.7) | 7 (13.7) |
| MMF, n (%) | 8 (15.4) | 11 (20.0) | 9 (17.6) |
| Serum biomarkers, n (%) | |||
| ANA ≥1:80 | 49 (94.2) | 53 (96.4) | 48 (94.1) |
| Anti-dsDNA ≥15 IU/ml | 36 (69.2) | 39 (70.9) | 32 (62.7) |
| Low C3 <LLN (0.9 g/l) | 23 (44.2) | 29 (52.7) | 20 (39.2) |
| Low C4 <LLN (0.1 g/l) | 16 (30.8) | 14 (25.5) | 15 (29.4) |
a
Positive anti-dsDNA antibodies or low complement at screening. C: complement; HDA: high disease activity, LLN: lower limit of normal; SLEDAI-2K: SLEDAI 2000.