Table 2.
Patient demographics and baseline/disease characteristics from the LBSL02, BLISS-52, BLISS-76 and BLISS-LN clinical trials.
| BLISS-52, BLISS-76, LBSL02, Study 113750, EMBRACE, BASE (SLE without active LN) | BLISS-LN (active LN) | |||||
|---|---|---|---|---|---|---|
| Placebo (n = 3053) | Belimumab (n = 3425) | Placebo (n = 223) | Belimumab (n = 223) | |||
| Patient demographics | ||||||
| Age, years | Mean (range) | 38.4 ± 11.6 | 38.2 ± 10.8 | 33.1 ± 10.6 | 33.7 ± 10.7 | |
| Sex | Female, n (%) | 2839 (93.0) | 3247 (94.8) | 196 (88) | 197 (88) | |
| Race, (%) | White/Caucasian | (51.8) | (50.1) | 75 (34) | 73 (33) | |
| Black/African American | (11.0) | (11.6) | 31 (14) | 30 (13) | ||
| Asian | (17.8) | (19.4) | 109 (49) | 114 (51) | ||
| Hispanic or Latino | (32.4) | (31.6) | - | - | ||
| American Indian/ Alaska Native | (19.0) | (18.7) | 6 (3) | 4 (2) | ||
| Others | (0.4) | (0.1) | 2 (1) | 2 (1) | ||
| Baseline disease characteristics | ||||||
| Disease duration SLE | Mean ± SD years | 6.3 ± 6.7 | 6.2 ± 6.8 | 3.3 (0.2-8.0) | 3.3 (0.3-8.1) | |
| Duration since LN diagnosis | Mean ± SD years | – | – | 0.2 (0.1-3.4) | 0.2 (0.1-3.3) | |
| Renal biopsy result at screening, n (%) | Class III or IV | - | - | 132 (59) | 126 (56) | |
| Class III+IV or IV+V | - | - | 55 (25) | 61 (27) | ||
| Class V | - | - | 36 (16) | 36 (16) | ||
| 24-hour UPCR, mg/mg | Mean (SD) | – | – | 3.5 ± 3.6 | 3.2 ± 2.7 | |
| >2 or 3, n (%) | (6.0) | (6.4) | 92 (41) | 91 (41) | ||
| eGFR*mL/min/1.73 m2 | ≥60, n (%) | - | - | 182 (82) | 190 (85) | |
| ≥90, n (%) | - | - | 133 (60) | 131 (59) | ||
| SELENA-SLEDAI score | Mean (SD) | 9.5 ± 4.1 | 9.3 ± 3.8 | |||
| SLEDAI-2K score | Mean (SD) | 12.2 ± 4.8 | 12.5 ± 5.3 | |||
| BILAG A or BILAG B scores | ≥1 or 2, n (%) | (60.7) | (59.6) | |||
| Serology | ANA positive, n (%) | (84.0) | (85.1) | 197 (88) | 194 (87) | |
| Anti-dsDNA positive | 169 (76) | 173 (78) | ||||
| ≥30, n (%) | (58.2) | (56.9) | ||||
| C3 <90, n (%) | (41.0) | (44.1) | 133 (60) | 134 (60) | ||
| C4 <10, n (%) | (51.1) | (55.0) | 58 (26) | 65 (29) | ||
| Baseline treatments | ||||||
| Prednisone use | Mean dose (SD) | 11.35 ± 9.4 | 11.2 ± 9.9 | |||
| >7.5 mg/day at baseline, (%) | (66.7) | (65.6) | ||||
| Background immunosuppressive drugs, n (%) | Azathioprine | (14.1) | (17.4) | |||
| Methotrexate | (11.3) | (8.85) | ||||
| MMF | (21.9) | (20.25) | 164 (73.5) | 164 (73.5) | ||
| Cyclophosphamide | 59 (26.5) | 59 (26.5) | ||||
| Antimalarials | (%) | (73.9) | (71.4) | 154 (69) | 166 (74) | |
| ACEI or ARB | (%) | 150 (67) | 147 (66) | |||
ACEI, ACE inhibitors; ANA, antinuclear antibodies; anti-dsDNA, anti-double-stranded DNA; ARB, angiotensin receptor blockers; BILAG, British Isles Lupus Assessment Group; C3,
complement 3; C4, complement 4; eGFR, estimated glomerular filtration rate; SD, standard deviation; LN, lupus nephritis; MMF, mycophenolate mofetil; SLEDAI-2K, Systemic Lupus
Erythematosus Disease Activity Index 2000; UPCR, urine protein-creatinine ratio.