Patient baseline characteristics
| ITT population (n=501) | 24-month completers (n=277) | |
|---|---|---|
| Mean (SD) age, years | 41.3 (12.1) | 40.9 (12.0) |
| Gender: female, n (%) | 446 (89.0) | 251 (90.6) |
| Race/ethnicity, n (%) | ||
| Caucasian | 265 (52.9) | 146 (52.7) |
| African-American | 123 (24.6) | 69 (24.9) |
| Hispanic | 88 (17.6) | 43 (15.5) |
| Asian | 21 (4.2) | 15 (5.4) |
| Native American | 4 (0.8) | 4 (1.4) |
| Time since SLE diagnosis (years), n (%) | ||
| <1 | 17 (3.4) | 6 (2.2) |
| 1–5 | 262 (52.3) | 156 (56.3) |
| 6–10 | 122 (24.4) | 59 (21.3) |
| >10 | 100 (20.0) | 56 (20.2) |
| Severity of SLE at baseline, n (%)* | ||
| Mild | 9 (2.2) | 5 (1.8) |
| Moderate | 319 (77.6) | 213 (76.9) |
| Severe | 83 (20.2) | 59 (21.3) |
| Patients with SELENA-SLEDAI score at baseline, n (%) | 122 (24.4) | 85 (30.7) |
| Mean (SD) SELENA-SLEDAI score† | 12.4 (3.6) | 12.3 (3.2) |
| Median (range)‡ | 13.0 (2.0–19.0) | 12.0 (2.0–18.0) |
| Patients with SELENA-SLEDAI >10, n (%)† | 86 (70.5) | 60 (70.6) |
| Anti-dsDNA positive and low C3/C4, n (%) | 252 (50.3) | 153 (55.2) |
| Most common reasons reported by (≥10% of patients in either group) for initiating belimumab, n (%)‡ | ||
| Previous treatment regimen ineffective | 357 (71.3) | 195 (70.4) |
| Decrease use of steroids | 286 (57.1) | 162 (58.5) |
| Worsening patient condition | 284 (56.7) | 153 (55.2) |
| Previous treatment regimen not well tolerated | 127 (25.3) | 85 (30.7) |
| Patient request | 54 (10.8) | 37 (13.4) |
| Concomitant SLE medications, n (%) | ||
| Oral steroids | 386 (77.0) | 218 (78.7) |
| Antimalarials | 349 (69.7) | 190 (68.6) |
| Immunosuppressants (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide) | 295 (58.9) | 167 (60.3) |
| NSAIDs | 82 (16.4) | 54 (19.5) |
| Mean (SD) prednisone equivalent dose, mg/day§ | 19.9 (14.4) | 18.0 (12.2) |
| Patients receiving prednisone equivalent dose >7.5 mg/day, n (%)§ | 338 (67.5) | 190 (68.6) |
| SLE organ system manifestation by group, n (%)¶ | ||
| Musculoskeletal | 316 (76.9) | 215 (77.6) |
| Mucocutaneous | 261 (63.5) | 176 (63.5) |
| Constitutional | 233 (56.7) | 166 (59.9) |
| Immunological | 222 (54.0) | 149 (53.8) |
| Haematological | 145 (35.3) | 88 (31.8) |
| Renal | 79 (19.2) | 53 (19.1) |
| Cardiopulmonary | 68 (16.5) | 46 (16.6) |
| CNS | 63 (15.3) | 46 (16.6) |
| Vasculitis | 14 (3.4) | 7 (2.5) |
High disease subgroups are shown in bold.
*SLE severity was assessed based on physician assessment, n=411 for ITT.
†Among patients with data at baseline.
‡Multiple reasons permitted.
§Among patients who received steroids at baseline.
¶Reported in >1% of patients; a patient may have more than one type of clinical manifestation within an organ domain, n=411 for ITT.
CNS, central nervous system; ITT, intent-to-treat; NSAID, non-steroidal anti-inflammatory drug; SELENA-SLEDAI, Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index; SLE, systemic lupus erythematosus.