Table 1.
Baseline patient characteristics (ITT population)
| Characteristic | Pre-belimumab cohort N = 34 | Belimumab-concurrent cohort N = 45 | Total N = 79 |
|---|---|---|---|
| Female, n (%) | 29 (85.3) | 43 (95.6) | 72 (91.1) |
| Age (years), mean (SD) | 41.0 (12.57) | 38.6 (12.31) | 39.6 (12.40) |
| BMI (kg/m2), mean (SD) | 29.4 (7.40) | 30.0 (8.87) | 29.7 (8.23) |
| Race, n (%) | |||
| White | 25 (73.5) | 27 (60.0) | 52 (65.8) |
| Black or African American/African heritage | 8 (23.5) | 12 (26.7) | 20 (25.3) |
| Other | 1 (2.9) | 6 (13.3) | 7 (8.9) |
| SLE disease duration (years), mean (SD)a | 7.9 (8.71) | 7.6 (7.36) | 7.7 (7.92) |
| Duration of exposure (days), mean (SD)b | 205.9 (53.47) | 219.8 (23.26) | 213.8 (39.54) |
| Total number of infusions per patient, mean (SD) | 8.1 (2.06) | 8.6 (0.83) | 8.4 (1.50) |
| SLE medication usage, n (%) | |||
| Steroid and immunosuppressant and antimalarial only | 12 (35.3) | 14 (31.1) | 26 (32.9) |
| Antimalarial only | 5 (14.7) | 14 (31.1) | 19 (24.1) |
| Steroid and antimalarial only | 7 (20.6) | 10 (22.2) | 17 (21.5) |
| Immunosuppressant and antimalarial only | 4 (11.8) | 2 (4.4) | 6 (7.6) |
| Steroid and immunosuppressant only | 0 | 3 (6.7) | 3 (3.8) |
| Steroid only | 2 (5.9) | 0 | 2 (2.5) |
| Immunosuppressant only | 1 (2.9) | 0 | 1 (1.3) |
| Average daily corticosteroid dose, mean (SD) | 6.5 (8.73) | 7.1 (7.95) | 6.9 (8.25) |
| 0 mg/day, n (%) | 13 (38.2) | 18 (40.0) | 31 (39.2) |
| >0 to ≤7.5 mg/day, n (%) | 9 (26.5) | 6 (13.3) | 15 (19.0) |
| >7.5 mg/day, n (%) | 12 (35.3) | 21 (46.7) | 33 (41.8) |
BMI: body mass index; ITT: intent-to-treat; SD: standard deviation; SLE: systemic lupus erythematosus.
a
Duration defined as screening date to SLE diagnosis date plus one day.
b
Duration of exposure defined as the last infusion date to the first infusion date plus 28 days. Only complete dates were used; first and last infusion dates were used, regardless of any missed doses.