Baseline demographics and clinical characteristics
| 120 Q2W n=381 | 120 Q4W n=378 | Placebo n=379 | |
|---|---|---|---|
| Age, years | 40±13 | 40±11 | 39±12 |
| Age, range | 18–87 | 19–79 | 18–72 |
| Women, n (%) | 354 (92.9) | 352 (93.1) | 360 (95.0) |
| Race, n (%) | |||
| Indigenous American† | 65 (17.1) | 55 (14.6) | 67 (17.7) |
| Asian | 68 (17.8) | 61 (16.1) | 66 (17.4) |
| Black/African–American | 40 (10.5) | 41 (10.8) | 39 (10.3) |
| Native Hawaiian or Pacific Islander | 0 | 1 (0.3) | 0 |
| White | 204 (53.5) | 218 (57.7) | 205 (54.1) |
| Multiple races | 4 (1.0) | 2 (0.5) | 2 (0.5) |
| Hispanic/Latino origin, n (%)‡ | 119 (31.2) | 116 (30.7) | 122 (32.2) |
| Geographic region, n (%) | |||
| USA/Canada | 133 (34.9) | 140 (37.0) | 129 (34.0) |
| Mexico/Central America/South America | 89 (23.4) | 84 (22.2) | 92 (24.3) |
| Asia Pacific | 66 (17.3) | 58 (15.3) | 62 (16.4) |
| Europe | 74 (19.4) | 77 (20.4) | 75 (19.8) |
| Africa/Middle East | 19 (5.0) | 19 (5.0) | 21 (5.5) |
| SLE disease activity | |||
| Time since SLE onset, years | 8±7* | 8±8* | 6±7 |
| SELENA-SLEDAI organ system involvement, n (%) | |||
| CNS | 6 (1.6) | 3 (0.8) | 6 (1.6) |
| Vascular | 28 (7.3) | 29 (7.7) | 30 (7.9) |
| Musculoskeletal | 318 (83.5) | 298 (78.8) | 308 (81.3) |
| Renal | 36 (9.4) | 40 (10.6) | 42 (11.1) |
| Mucocutaneous | 344 (90.3) | 348 (92.1) | 349 (92.1) |
| Cardiovascular and respiratory | 27 (7.1) | 25 (6.6) | 26 (6.9) |
| Immunologic | 272 (71.4) | 284 (75.1) | 273 (72.0) |
| Constitutional | 5 (1.3) | 4 (1.1) | 5 (1.3) |
| Haematologic | 39 (10.2) | 40 (10.6) | 46 (12.1) |
| SELENA-SLEDAI score | 10.2±3.5 | 10.4±3.6 | 10.7±3.9 |
| SELENA-SLEDAI ≥10, n (%) | 222 (58.3) | 219 (57.9) | 224 (59.1) |
| SLEDAI-2K score | 10.6±3.7 | 10.7±3.9 | 10.8±4.0 |
| ≥1 A or 2 B BILAG scores, n (%) | 228 (59.8) | 228 (60.3) | 220 (58.2) |
| PGA score | 46.3±15.7 | 46.1±16.2 | 47.1±16.1 |
| SLICC damage index | 0.5±1.0* | 0.6±1.2* | 0.4±0.8 |
| Medications | |||
| Prednisone, n (%) | 300 (78.7) | 296 (78.3) | 295 (77.8) |
| Mean prednisone dose (or equivalent), mg/day | 11.9±7.4 | 12.1±7.8 | 12.1±7.9 |
| Prednisone >7.5 mg/day, n (%) | 197 (51.7) | 200 (52.9) | 196 (51.7) |
| Antimalarial, n (%) | 241 (63.3) | 241 (63.8) | 243 (64.1) |
| Any immunosuppressant, n (%) | 158 (41.5) | 176 (46.6) | 164 (43.3) |
| MMF, n (%) | 24 (6.3) | 38 (10.1) | 32 (8.4) |
| AZA, n (%) | 66 (17.3) | 80 (21.2) | 80 (21.1) |
| MTX, n (%) | 50 (13.1) | 40 (10.6) | 40 (10.6) |
| Biomarkers and other laboratory measures | |||
| ≤45 mg/mmol | 330 (86.8) | 326 (86.2) | 332 (87.6) |
| >45 mg/mmol | 50 (13.2) | 52 (13.8) | 47 (12.4) |
| Total B-cell counts, median (range), cells/µL | 131.5 (3–1979) | 128.0 (6–1727) | 129.5 (3–1345) |
| BAFF concentration, pg/mL | 2559±8277 | 2230±4230 | 1753±2439 |
| Anti-dsDNA ≥30 IU/mL, n (%)§ | 228 (59.8) | 231 (61.1) | 226 (59.6) |
| Anti-dsDNA, IU | 107.2±113.5 | 110.4±111.6 | 107.1±112.4 |
| C3 <LLN, n (%) | 144 (37.9) | 150 (39.8) | 163 (43.1) |
| C3, g/L | 1.0±0.3 | 1.0±0.3 | 1.0±0.3 |
| C4 <LLN, n (%) | 84 (22.1) | 85 (22.5) | 98 (25.9) |
| C4, g/L | 0.2±0.1 | 0.2±0.1 | 0.2±0.1 |
| IgG, g/L | 15.6±5.7 | 15.7±5.9 | 15.6±5.6 |
| IgG <LLN, n (%) | 2 (0.5) | 1 (0.3) | 2 (0.5) |
| IgM, g/L | 1.1±0.7 | 1.2±0.8 | 1.2±1.0 |
| IgM <LLN, n (%) | 36 (9.4) | 34 (9.0) | 35 (9.2) |
| IgA, g/L | 3.1±1.6 | 3.2±1.6 | 3.1±1.5 |
| IgA <LLN, n (%) | 10 (2.6) | 7 (1.9) | 11 (2.9) |
| uPCR, n (%) | |||
*p<0.05, p value for comparison of treatment groups derived using an analysis of variance model with treatment group and geographic region fitted as explanatory variables.
†American Indian from North, Central and South America and Alaska Native.
‡Ethnicity (Hispanic/Latino) information was only required to be collected in the USA.
§Or >10 IU/mL for patients for whom the original DNA autoantibody assay was performed.
Anti-dsDNA, anti-double-stranded DNA; AZA, azathioprine; BAFF, B-cell activating factor; BILAG, British Isles Lupus Assessment Group index; CNS, central nervous system; Ig, immunoglobulin; LLN, lower limit of normal; MMF, mycophenolate mofetil; MTX, methotrexate; PGA, physician's global assessment; Q2W, every two weeks; Q4W, every four 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.