| Safety population | n=235 | n=470 |
| Anti-dsDNA positive (≥30 IU/mL), n (%) | 186 (79.1) | 385 (81.9) |
| ANA positive (index ≥0.8), n (%) | 234 (99.6)§ | 470 (100) |
| Low C3 (<90 mg/dL), n (%) | 163 (69.4) | 344 (73.2) |
| Low C4 (<10 mg/dL), n (%) | 77 (32.8) | 139 (29.6) |
*n=225.
† Patients may have been included in more than one category.
‡ One patient had a seizure between the screening and baseline visits, which resulted in the BILAG neurological domain (seizure) being scored at the Day 0 (baseline) visit.
§ One patient was positive during the screening period (as per the inclusion criteria), but not at baseline.
ANA, antinuclear antibody; Anti-dsDNA, anti-double-stranded DNA; BILAG, British Isles Lupus Assessment Group; BMI, body mass index; C3/C4, complement 3/complement 4; mITT, modified intent-to-treat; PGA, Physician’s Global Assessment; SDI, Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SELENA-SLEDAI, Safety of Oestrogen in Lupus Erythematosus National Assessment-SLE Disease Activity Index; SFI, SLE Flare Index; SLE, systemic lupus erythematosus.