Table 1.
Baseline patient demographics and characteristics (intent-to-treat population)
| Characteristic | Placebo-to-belimumab 200 mg SC n = 206 | Belimumab 200 mg SC n = 456 |
|---|---|---|
| Female, n (%) | 196 (95.1) | 430 (94.3) |
| Age (years), mean (SD) | 39.4 (12.04) | 38.3 (11.77) |
| Weight (kg), mean (SD) | 70.0 (20.27) | 68.4 (17.67) |
| Enrolment by region, n (%) | ||
| USA | 56 (27.2) | 109 (23.9) |
| Americas excluding USA | 39 (18.9) | 101 (22.1) |
| Western Europe | 14 (6.8) | 40 (8.8) |
| Eastern Europe | 48 (23.3) | 112 (24.6) |
| Asia | 49 (23.8) | 94 (20.6) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 59 (28.6) | 135 (29.6) |
| Not Hispanic or Latino | 147 (71.4) | 321 (70.4) |
| Disease duration (years), median (range) | 4.8 (1, 33) | 4.5 (0, 35) |
| SELENA-SLEDAI, mean (SD)a | 5.8 (3.90) | 10.4 (3.16) |
| SELENA-SLEDAI organ involvement, n (%) | ||
| Mucocutaneous | 108 (52.4) | 397 (87.1) |
| Musculoskeletal | 54 (26.2) | 367 (80.5) |
| Immunological | 151 (73.3) | 349 (76.5) |
| Renal | 24 (11.7) | 42 (9.2) |
| Haematological | 10 (4.9) | 30 (6.6) |
| Vascular | 7 (3.4) | 39 (8.6) |
| Cardiovascular and respiratory | 4 (1.9) | 20 (4.4) |
| Constitutional | 0 | 6 (1.3) |
| CNS | 1 (0.5) | 7 (1.5) |
| BILAG organ domain involvementb, n (%) | ||
| ≥ 1A or 2B | 42 (20.4) | 314 (68.9) |
| ≥ 1A | 5 (2.4) | 69 (15.1) |
| ≥ 1B | 123 (59.7) | 405 (88.8) |
| No A or B | 79 (38.3) | 26 (5.7) |
| PGA, mean (SD) | 0.8 (0.55) | 1.6 (0.41)c |
| Anti-dsDNA ≥ 30 IU/mL, n (%) | 126 (61.8) | 333 (73.0) |
| Low C3 ( < 90 mg/dL), n (%) | 91 (44.6) | 201 (44.1) |
| Low C4 ( < 10 mg/dL), n (%) | 45 (22.1) | 119 (26.1) |
| FACIT-Fatigue, mean (SD) | 36.5 (11.45) | 32.2 (12.01)d |
| Medications, n (%) | ||
| Corticosteroid only | 23 (11.2) | 44 (9.6) |
| Antimalarial only | 11 (5.3) | 31 (6.8) |
| Immunosuppressant only | 4 (1.9) | 9 (2.0) |
| Corticosteroid and antimalarial only | 72 (35.0) | 172 (37.7) |
| Corticosteroid and immunosuppressant only | 38 (18.4) | 70 (15.4) |
| Immunosuppressant and antimalarial only | 14 (6.8) | 12 (2.6) |
| Corticosteroid, immunosuppressant and antimalarial | 41 (19.9) | 112 (24.6) |
Baseline was defined as the last assessment prior to the first dose of belimumab; for the belimumab group this was day 0 of the double-blind phase and for the placebo-to-belimumab group this was week 52 of the double-blind phase.
Among all patients; however, 55 patients in the placebo-to-belimumab group and 2 patients in the belimumab group had a baseline SELENA-SLEDAI score < 4.
Patients may be included in more than one category.
n = 455.
n = 454.
BILAG: British Isles Lupus Assessment Group; C3: complement 3; C4: complement 4; CNS: central nervous system; dsDNA: double-stranded DNA; FACIT: Functional Assessment of Chronic Illness Therapy; PGA: Physician's Global Assessment; SC: subcutaneous; SD: standard deviation; SELENA-SLEDAI: Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index; SLE: systemic lupus erythematosus.