Baseline characteristics of total pooled phase 3 population and low complement/anti-dsDNA-positive subgroup
| Total phase 3 pooled (n=1684) | Low complement/anti-dsDNA positive (n=876) | |
|---|---|---|
| Mean SELENA–SLEDAI score ±SD | 9.7±3.8 | 10.8±3.8 |
| SELENA–SLEDAI ≥10, % | 52.1 | 65.5 |
| Proteinuria (≥2 g/24 h), % | 5.9 | 8.8 |
| Anti-dsDNA (≥30 IU/ml), % | 69.4 | 100 |
| IgG (>16.2 g/l), % | 44.2 | 53.0 |
| Low C3 (<90 mg/dl), % | 45.0 | 75.3 |
| Low C4 (<16 mg/dl), % | 56.1 | 91.4 |
| Corticosteroid use, % | 86.3 | 91.4 |
| >7.5 mg/day, % | 58.0 | 63.5 |
| Immunosuppressant use, % | 48.7 | 53.4 |
| Mean SLICC damage index score ±SD | 0.8±1.2 | 0.7±1.1 |
| Mean PGA score ±SD | 1.4±0.5 | 1.4±0.5 |
C, complement; Ig, immunoglobulin; PGA, Physician's Global Assessment; SELENA–SLEDAI, Safety Of Estrogens In Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index; SLICC, Systemic Lupus International Collaborating Clinics.