Table 3.
Patient demographics and baseline/disease characteristics from EXPLORER, LUNAR, and CALIBRATE clinical trials.
| EXPLORER (SLE without active LN) | LUNAR, CALIBRATE (active LN) | ||||
|---|---|---|---|---|---|
| Placebo (n = 88) |
Rituximab (n = 169) |
Placebo (n = 72) |
Rituximab (n = 94) |
||
| Patient demographics | |||||
| Age, years | Median (range) | 40.5 ± 12.8 | 40.2 ± 11.4 | 29.4 ± 9.3 | 32.0 ± 9.6 |
| Sex | Female, n (%) | (93.2) | (89.9) | 67 (93.1) | 81 (86.2) |
| Race, (%) | White | 55.7 | 56.2 | 26 (36.1) | 26 (27.7) |
| Black/African American | 27.3 | 23.7 | 20 (27.8) | 29 (30.8) | |
| Asian/Pacific Islander | 5.7 | 3.6 | 3 (3.2) | ||
| Hispanic | 9.1 | 14.2 | 3 (4.2) | 14 (14.9) | |
| Other | 2.2 | 1.1 | 23 (31.9) | 32 (34.0) | |
| Baseline disease characteristics | |||||
| Disease duration SLE | Mean ± SD years | 8.7 ± 7.6 | 8.5 ± 7.2 | ||
| Duration since LN diagnosis, months | Mean ± SD Median (range) |
28.8 ± 51.6 5.4 (0.4-306) |
32.4 ± 48.0 7,95 (0.4-211) |
||
| History of LN | – | – | 30 (41.7) | 36 (50) | |
| Renal biopsy result at screening, n (%) | Class III | – | – | 24 (33.3) | 26 (27.7) |
| Class III+IV | – | – | 8 (11.1) | 25 (26.6) | |
| Class IV | – | – | 48 (66.7) | 55 (58.5) | |
| Class IV+V | – | – | 15 (20.8) | 19 (20.2) | |
| 24-hour UPCR, mg/mg | Mean (SD) | – | – | 4.2 ± 3.0 | 3.6 ± 2.1 |
| >3.0, n (%) | – | – | 42 (58.3) | 52 (55.3) | |
| eGFR* mL/min/1.73 m2 | Mean (SD) | – | – | 96.0 ± 51.1 | 87.7 ± 34.9 |
| ≥60, n (%) | – | – | 52 (72.2) | 55 (76.4) | |
| BILAG index global score | Mean (SD) | 14.5 ± 5.6 | 14.0 ± 5.1 | 15.3 ± 6.2 | 15.3 ± 6.4 |
| Serology | ANA positive (%) | – | – | 83.3 | 81.9 |
| Anti-dsDNA positive | – | – | |||
| ≥30, n (%) | – | – | 61 (84.7) | 59 (81.9) | |
| ≥75, n (%) | – | – | 46 (63.9) | 46 (63.9) | |
| C3 <90, n (%) | – | – | 54 (75) | 69 (73.4) | |
| C4 <10, n (%) | – | – | 31 (43.1) | 38 (40.4) | |
| Baseline treatments | |||||
| Assigned prednisone dosage at screening, mg/kg/day | 0.5, (%) | 61.4 | 62.7 | ||
| 0.75, (%) | 29.5 | 32.0 | |||
| 1.0, (%) | 9.1 | 5.3 | |||
| Background immunosuppressive drugs, (%) | Azathioprine | 36.4 | 32.0 | – | – |
| Methotrexate | 27.3 | 27.8 | – | – | |
| MMF | 36.4 | 39.6 | 72 (100) – dosage 3mg/day | 72 (100) – dosage 3mg/day |
|
| Cyclophosphamide | 22 (100) (CALIBRATE) | ||||
ANA, antinuclear antibodies; anti-dsDNA, anti-double-stranded DNA; C3, complement 3; C4, complement 4; eGFR, estimated glomerular filtration rate; SD, standard deviation; LN, lupus nephritis; MMF, mycophenolate mofetil; SLE, systemic lupus erythematosus; BILAG, British Isles Lupus Assessment Group; UPCR, urine protein-creatinine ratio.