Patient characteristics at baseline
| Study group 1 | Study group 2 | Study group 3 | Study groups 1–3 | |
| Number of patients | 37 | 64 | 23 | 124 |
| Age | 34±2 | 42±1 | 56±3 | 42±1 |
| Gender (% of women) | 95 | 97 | 100 | 97 |
| Study visit per subject, average± SEM, median (range) | 10.5±0.6, 387 (2–3) | 2.0±0, 129 (2–3) | 4.7±0.2, 108 (3–7) | 5.0±0.4, 624 (2–13) |
| Ethnicities | ||||
| Caucasians (%) | 14 | 34 | 52 | 31 |
| African-Americans (%) | 24 | 36 | 43 | 34 |
| Hispanics (%) | 35 | 13 | 0 | 17 |
| Asians (%) | 22 | 8 | 0 | 10 |
| Others (%) | 5 | 9 | 4 | 7 |
| PGA (0–3 cm) | ||||
| Average±SEM | 1.6±0.1 | 1.4±0.1 | 0.6±0.1 | 1.3±0.1 |
| Median (range) | 1.6 (0.2–2.8) | 1.2 (0.6–2.6) | 0.5 (0.0– 2.0) | 1.3 (0.0– 2.8) |
| Clinical SELENA-SLEDAI | ||||
| Average±SEM | 8.1 ± 0.8 | 6.3±0.1 | 1.4±0.1 | 6.0±0.4 |
| Median, range | 8.0 (2–25) | 6.0 (2-17) | 2.0 (0–4) | 5.0 (0–25) |
| ANA titres (≥1:80) | 96% | 80% | 76% | 86% |
| Antibody measures | ||||
| Anti-dsDNA (units; %>35 units) | 615±180; 91 | 74±18; 38 | 14±1; 4 | 211±55;46 |
| Anti-C1q (units; %>20 units) | 58±11; 62 | 14±2; 20 | 8±2; 13 | 26%±4; 31 |
| Complement measures | ||||
| EC4d (net MFI; %>14 net MFI) | 51±19; 86 | 20±3; 39 | 14±6; 14 | 28±6; 49 |
| Low C3 or C4 (%) | 73 | 39 | 22 | 46 |
| Treatment information | ||||
| Prednisone (%; dose (mg/day)) | 47; 22.8±4.8 | 9; 16.0±2.9 | 26; 5.0±0.0 | 24; 17.8±3.2 |
| Hydroxychloroquine (%) | 58 | 75 | 100 | 75 |
| Azathioprine (%) | 11 | 0 | 0 | 5 |
| Methotrexate (%) | 8 | 3 | 100 | 24 |
| Mycophenolate (%) | 33 | 23 | 0 | 21 |
| Belimumab (%) | 8 | 2 | 0 | 3 |
Results are expressed as average, SEM and median (range) as appropriate.
dsDNA, double-stranded DNA; EC4d, erythrocyte-bound C4d; MFI, mean fluorescence intensity; PGA, Physicians Global Assessment; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment—SLE Disease Activity Index.