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.