Demographic and disease characteristics (populations: complete ITT population and maintenance population)
| Complete population (N=370) n (%) | Maintenance population (N=227) n (%) | |
|---|---|---|
| Race | 370 (100.0) | 227 (100.0) |
| Caucasian | 147 (39.7) | 99 (43.6) |
| Black | 46 (12.4) | 23 (10.1) |
| Asian | 123 (33.2) | 76 (33.5) |
| Other | 54 (14.6) | 29 (12.8) |
| Ethnicity | 370 (100.0) | 227 (100.0) |
| Hispanic | 131 (35.4) | 77 (33.9) |
| Non-Hispanic | 239 (64.6) | 150 (66.1) |
| Age at randomisation (years) | 370 (100.0) | 227 (100.0) |
| ≤20 | 50 (13.5) | 35 (15.4) |
| >20 and ≤30 | 124 (33.5) | 73 (32.2) |
| >30 and ≤40 | 120 (32.4) | 77 (33.9) |
| >40 | 76 (20.5) | 42 (18.5) |
| Biopsy class | 370 (100.0) | 227 (100.0) |
| III/IV | 260 (70.3) | 169 (74.4) |
| III/V or IV/V | 50 (13.5) | 23 (10.1) |
| V | 60 (16.2) | 35 (15.4) |
| Lupus nephritis duration (years) | 370 (100.0) | 227 (100.0) |
| ≤1 | 236 (63.8) | 155 (68.3) |
| >1 and <5 | 69 (18.7) | 31 (13.7) |
| ≥5 | 65 (17.6) | 41 (18.1) |
| eGFR baseline (mL/min/1.73 m2) | 332 (100.0) | 227 (100.0) |
| <90 | 188 (56.6) | 131 (57.7) |
| ≥90 | 144 (43.4) | 96 (42.3) |
| Anti-dsDNA baseline (IU/mL) | 325 (100.0) | 222 (100.0) |
| Negative (<30) | 14 (4.3) | 14 (6.3) |
| Positive (≥30) | 311 (95.7) | 208 (93.7) |
| C3 baseline (mg/dL) | 328 (100.0) | 224 (100.0) |
| ≥90 | 80 (24.4) | 50 (22.3) |
| <90 | 248 (75.6) | 174 (77.7) |
| C4 baseline (mg/dL) | 327 (100.0) | 223 (100.0) |
| ≥16 | 111 (33.9) | 70 (31.4) |
| <16 | 216 (66.1) | 153 (68.6) |
| UP/C baseline | 325 (100.0) | 223 (100.0) |
| ≤1 | 53 (16.3) | 33 (14.8) |
| >1 and ≤3 | 123 (37.8) | 88 (39.5) |
| >3 | 149 (45.9) | 102 (45.7) |
| Antimalarial treatment | 370 (100.0) | 227 (100.0) |
| Concomitant treatment with anti-malarials | 127 (34.3) | 84 (37.0) |
| No antimalarial treatment | 243 (65.7) | 143 (63.0) |
| Lipid-modifying agent treatment | 370 (100.0) | 227 (100.0) |
| Statin | 85 (23.0) | 52 (22.9) |
| No statin | 285 (77.0) | 175 (77.1) |
| Induction treatment | 370 (100.0) | 227 (100.0) |
| MMF | 185 (50.0) | 120 (52.9) |
| IVC | 185 (50.0) | 107 (47.1) |
Anti-dsDNA, anti-double-stranded DNA; eGFR, estimated glomerular filtration rate; ITT, intention to treat; IVC, intravenous cyclophosphamide; MMF, mycophenolate mofetil; UP/C, urine protein:creatinine ratio.