Table 1.
Baseline characteristics of the patients with SLE treated with placebo or belimumaba
| Placebo (n = 108) | SC belimumab 200 mg (n = 248) | |
|---|---|---|
| Women, no. (%) | 106 (98.1) | 236 (95.2) |
| Age, mean ± SD years | 34.6 ± 10.38 | 34.6 ± 10.96 |
| Weight, mean ± SD kg | 64.9 ± 17.86 | 64.5 ± 16.30 |
| Enrollment by region, no. (%) | ||
| US | 24 (22.2) | 55 (22.2) |
| Americas excluding US | 21 (19.4) | 52 (21.0) |
| Western Europe/Australia/Israel | 6 (5.6) | 24 (9.7) |
| Eastern Europe | 24 (22.2) | 58 (23.4) |
| Asia | 33 (30.6) | 59 (23.8) |
| Ethnicity, no. (%) | ||
| Hispanic or Latino | 33 (30.6) | 70 (28.2) |
| Not Hispanic or Latino | 75 (69.4) | 178 (71.8) |
| Race, no. (%) | ||
| White | 58 (53.7) | 140 (56.5) |
| Asian | 32 (29.6) | 63 (25.4) |
| African American/African heritage | 7 (6.5) | 26 (10.5) |
| Other | 13 (12.0) | 23 (9.3) |
| Disease duration, median (range) years | 4.0 (0–32) | 5.1 (0–35) |
| SELENA–SLEDAI score, mean ± SDb | 11.7 ± 3.14 | 11.5 ± 3.31 |
| SELENA–SLEDAI score, no. (%)b | ||
| ≤9 | 30 (27.8) | 62 (25.0) |
| ≥10 | 78 (72.2) | 186 (75.0) |
| SELENA–SLEDAI organ involvement, no. (%) | ||
| Mucocutaneous | 91 (84.3) | 205 (82.7) |
| Musculoskeletal | 72 (66.7) | 184 (74.2) |
| Immunologic | 108 (100.0) | 248 (100.0) |
| Renal | 26 (24.1) | 38 (15.3) |
| Hematologic | 13 (12.0) | 23 (9.3) |
| Vascular | 4 (3.7) | 14 (5.6) |
| Cardiovascular and respiratory | 6 (5.6) | 16 (6.5) |
| ≥1 flare, no. (%)c | 24 (22.2) | 48 (19.4) |
| ≥1 severe flare, no. (%)c | 1 (0.9) | 5 (2.0) |
| PGA, mean ± SD | 1.57 ± 0.457 | 1.59 ± 0.434 |
| FACIT‐Fatigue, mean ± SD | 33.4 ± 10.82 | 34.0 ± 11.75 |
| Medications | ||
| Any corticosteroid, no. (%) | 99 (91.7) | 231 (93.1) |
| Corticosteroid dosage, mean ± SD mg/dayd | 11.4 ± 7.39 | 12.2 ± 8.34 |
| Corticosteroid dosage, no. (%) | ||
| 0 mg/day | 9 (8.3) | 17 (6.9) |
| >0 to ≤7.5 mg/day | 29 (26.9) | 67 (27.0) |
| >7.5 mg/day | 70 (64.8) | 164 (66.1) |
| Any antimalarial, no. (%) | 68 (63.0) | 177 (71.4) |
| Any immunosuppressant, no. (%) | 59 (54.6) | 117 (47.2) |
| Azathioprine | 26 (24.1) | 48 (19.4) |
| Cyclosporine | 2 (1.9) | 4 (1.6) |
| Cyclophosphamide | 1 (0.9) | 1 (0.4) |
| Leflunomide | 0 | 1 (0.4) |
| Methotrexate | 12 (11.1) | 24 (9.7) |
| Mizoribine | 4 (3.7) | 6 (2.4) |
| Mycophenolate | 16 (14.8) | 35 (14.1) |
| Tacrolimus | 5 (4.6) | 5 (2.0) |
a
SLE = systemic lupus erythematosus; SC = subcutaneous; PGA = physician's global assessment of disease activity; FACIT‐Fatigue = Functional Assessment of Chronic Illness Therapy–Fatigue.
b
Patients were required to have a score of ≥8 on the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at screening (occurring within 35 days prior to baseline).
c
During the screening period (day −35 to day 0).
d
Prednisone equivalent.