Patients analyzed in the BLISS-76 vaccine substudy and baseline demographics.
| Characteristic | Standard Therapy + Placebo | Standard Therapy + Belimumab 1 mg/kg | Standard Therapy + Belimumab 10 mg/kg |
|---|---|---|---|
| Preexisting antibody analysis, n | 63 | 78 | 63 |
| Pneumococcal vaccine | 26 | 29 | 22 |
| Tetanus vaccine | 35 | 34 | 26 |
| Influenza vaccine | 44 | 61 | 39 |
| Demographics | |||
| North America, n (%) | 52 (82.5) | 64 (82.1) | 45 (71.4) |
| Western Europe/Israel, n (%) | 8 (12.7) | 10 (12.8) | 11 (17.5) |
| Women, n (%) | 59 (93.7) | 74 (94.9) | 60 (95.2) |
| White, n (%) | 48 (76.2) | 52 (66.7) | 43 (68.3) |
| Black/African American, n (%) | 8 (12.7) | 14 (17.9) | 11 (17.5) |
| Mean age, yrs | 43.2 | 41.0 | 41.9 |
| BILAG: ≥ 1 A or ≥ 2 B scores, n (%) | 42 (66.7) | 49 (62.8) | 40 (63.5) |
| Mean SELENA-SLEDAI score | 8.8 | 9.4 | 9.2 |
| Corticosteroids, n (%) | 37 (58.7) | 54 (69.2) | 41 (65.1) |
| > 7.5 mg/day, n (%) | 19 (30.2) | 28 (35.9) | 20 (31.7) |
| Antimalarials, n (%) | 49 (77.8) | 52 (66.7) | 40 (63.5) |
| Immunosuppressants, n (%) | 34 (54.0) | 48 (61.5) | 37 (58.7) |
| Analysis of response to on-study vaccination, n | 30 | 35 | 21 |
| Pneumococcal vaccine* | 2 | 2 | 3 |
| Tetanus vaccine* | 2 | 2 | 1 |
| Influenza vaccine | 30 | 39 | 24 |
| Demographics | |||
| North America, n (%) | 29 (96.7) | 30 (85.7) | 19 (90.5) |
| Western Europe/Israel, n (%) | 0 | 5 (14.3) | 2 (9.5) |
| Women, n (%) | 26 (86.7) | 31 (88.6) | 21 (100) |
| White, n (%) | 20 (66.7) | 24 (68.6) | 15 (71.4) |
| Black/African American, n (%) | 7 (23.3) | 8 (22.9) | 3 (14.3) |
| Mean age, yrs | 42.7 | 40.7 | 41.7 |
| BILAG: ≥ 1 A or ≥ 2 B scores, n (%) | 19 (63.3) | 22 (62.9) | 11 (52.4) |
| Mean SELENA-SLEDAI score | 8.9 | 8.3 | 9.1 |
| Corticosteroids, n (%) | 18 (60.0) | 27 (77.1) | 11 (52.4) |
| > 7.5 mg/day, n (%) | 9 (30.0) | 12 (34.3) | 6 (28.6) |
| Antimalarials, n (%) | 26 (86.7) | 21 (60.0) | 15 (71.4) |
| Immunosuppressants, n (%) | 14 (46.7) | 21 (60.0) | 16 (76.2) |
↵* Patients with data marked as both preexisting and on-study at different timepoints were analyzed in the on-study aspect of the study only. BILAG: British Isles Lupus Assessment Group index; SELENA-SLEDAI: Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index.