Baseline demographics and clinical characteristics
| 120 Q2W n=372 | 120 Q4W n=376 | Placebo n=376 | |
|---|---|---|---|
| Age, year | 42±12 | 41±13 | 42±12 |
| Age, range | 18–75 | 18–83 | 19–80 |
| Women, n (%) | 342 (91.9) | 346 (92.0) | 349 (92.8) |
| Race, n (%) | |||
| Indigenous American* | 31 (8.3) | 33 (8.8) | 30 (8.0) |
| Asian | 38 (10.2) | 34 (9.0) | 40 (10.6) |
| Black/African–American | 43 (11.6) | 46 (12.2) | 51 (13.6) |
| Native Hawaiian or Pacific Islander | 1 (0.3) | 2 (0.5) | 0 |
| White | 245 (65.9) | 247 (65.7) | 249 (66.2) |
| Multiple races | 14 (3.8) | 14 (3.7) | 6 (1.6) |
| Hispanic/Latino origin, n (%)† | 110 (29.6) | 92 (24.5) | 99 (26.3) |
| Geographical region, n (%) | |||
| USA/Canada | 146 (39.2) | 140 (37.2) | 150 (39.9) |
| Mexico/Central America/South America | 62 (16.7) | 64 (17.0) | 57 (15.2) |
| Asia-Pacific | 45 (12.1) | 39 (10.4) | 40 (10.6) |
| Europe | 75 (20.2) | 89 (23.7) | 90 (23.9) |
| Africa/Middle East | 44 (11.8) | 44 (11.7) | 39 (10.4) |
| SLE disease activity | |||
| Time since SLE onset, year | 8±9 | 8±8 | 8±7 |
| SELENA-SLEDAI organ system involvement, n (%) | |||
| CNS | 8 (2.2) | 8 (2.1) | 7 (1.9) |
| Vascular | 25 (6.7) | 30 (8.0) | 26 (6.9) |
| Musculoskeletal | 319 (85.8) | 317 (84.3) | 315 (83.8) |
| Renal | 35 (9.4) | 36 (9.6) | 30 (8.0) |
| Mucocutaneous | 330 (88.7) | 347 (92.3) | 332 (88.3) |
| Cardiovascular and respiratory | 32 (8.6) | 30 (8.0) | 30 (8.0) |
| Immunological | 261 (70.2) | 271 (72.1) | 259 (68.9) |
| Constitutional | 4 (1.1) | 10 (2.7) | 10 (2.7) |
| Haematological | 35 (9.4) | 31 (8.2) | 24 (6.4) |
| SELENA-SLEDAI score | 10.4±4.1 | 10.4±4.2 | 9.8±3.3 |
| SELENA-SLEDAI ≥10, n (%) | 207 (55.6) | 208 (55.3) | 197 (52.4) |
| SLEDAI-2K score | 10.3±4.2 | 10.4±4.0 | 9.8±3.4 |
| ≥1 A or 2 B BILAG scores, n (%) | 230 (62.0) | 218 (58.3) | 209 (55.6) |
| PGA score | 47.2±15.5 | 46.8±15.6 | 44.9±16.6 |
| SLICC damage index | 0.6±1.1 | 0.6±1.2 | 0.7±1.2 |
| Medications | |||
| Prednisone, n (%) | 275 (73.9) | 284 (75.5) | 274 (72.9) |
| Mean prednisone dose (or equivalent), mg/day | 12.3±8.0 | 12.4±10.7 | 11.8±8.1 |
| Prednisone >7.5 mg/day, n (%) | 182 (48.9) | 177 (47.1) | 173 (46.0) |
| Antimalarial, n (%) | 262 (70.4) | 248 (66.0) | 280 (74.5) |
| Any immunosuppressant, n (%) | 149 (40.1) | 160 (42.6) | 140 (37.2) |
| MMF, n (%) | 36 (9.7) | 29 (7.7) | 25 (6.4) |
| AZA, n (%) | 61 (16.4) | 71 (18.9) | 62 (16.5) |
| MTX, n (%) | 45 (12.1) | 52 (13.8) | 48 (12.8) |
| None, n (%) | 22 (5.9) | 17 (4.5) | 13 (3.5) |
| Biomarkers and other laboratory measures | |||
| uPCR, n (%) | |||
| <45 mg/mmol | 35 (9.4) | 28 (7.4) | 27 (7.2) |
| ≥45 mg/mmol | 337 (90.6) | 348 (92.6) | 348 (92.8) |
| Total B-cell counts, median (range), cells/µL | 148.5 (4–3666) | 124.0 (1–1245) | 128.0 (0–1141) |
| BAFF concentration, pg/mL | 1859±2744 | 1935±3447 | 1859±2591 |
| Anti-dsDNA ≥30 IU/mL, n (%)‡ | 225 (60.5) | 224 (59.6) | 220 (58.5) |
| Anti-dsDNA, IU/mL | 117±118 | 111±114 | 112±117 |
| C3 <LLN, n (%) | 147 (39.7) | 157 (41.8) | 140 (37.2) |
| C3, g/L | 1.03±0.33 | 1.00±0.32 | 1.02±0.33 |
| C4 <LLN, n (%) | 83 (22.4) | 84 (22.3) | 79 (21.0) |
| C4, g/L | 0.18±0.10 | 0.18±0.10 | 0.18±0.10 |
| IgG, g/L | 15.2±5.7 | 15.0±6.1 | 14.7±4.8 |
| IgG <LLN, n (%) | 3 (0.8) | 1 (0.3) | 2 (0.5) |
| IgM, g/L | 1.2±0.9 | 1.2±1.0 | 1.1±0.7 |
| IgM <LLN, n (%) | 31 (8.3) | 37 (9.8) | 25 (6.6) |
| IgA, g/L | 3.1±1.6 | 2.9±1.5 | 3.1±1.8 |
| IgA <LLN, n (%) | 6 (1.6) | 12 (3.2) | 6 (1.6) |
All data are mean±SD unless otherwise indicated as n (%).
*American Indian from North, Central and South America and Alaska Native.
†Ethnicity (Hispanic/Latino) information was only required to be collected in the USA.
‡<30 IU negative; 30–60 IU low; 61–200 IU positive; >200 IU strong positive.
Anti-dsDNA, anti-double-stranded DNA; AZA, azathioprine; BAFF, B-cell activating factor; BILAG, British Isles Lupus Assessment Group Index; CNS, central nervous system; LLN, lower limit of normal; MMF, mycophenolate mofetil; MTX, methotrexate; PGA, Physician's Global Assessment; Q2W, every 2 weeks; Q4W, every 4 weeks; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment—Systemic Lupus Erythematosus Disease Activity Index; SLE, Systemic Lupus Erythematosus; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SLICC, Systemic Lupus International Collaborating Clinics; uPCR, urine protein to urine creatinine ratio.