Table 1.
Characteristics of the patients at baselinea
| Characteristic | Placebo/ belimumab (n = 91) | Belimumab/ belimumab (n = 177) | Total (n = 268) |
|---|---|---|---|
| Female sex | 84 (92.3) | 166 (93.8) | 250 (93.3) |
| Age, mean ± SD years | 43.4 ± 12.4 | 42.5 ± 10.8 | 42.8 ± 11.3 |
| Race | |||
| White | 61 (67.0) | 125 (70.6) | 186 (69.4) |
| Black or African American/African heritage | 20 (22.0) | 37 (20.9) | 57 (21.3) |
| Other | 10 (11.0) | 15 (8.5) | 25 (9.3) |
| SLE disease duration, mean ± SD yearsb | 8.2 (6.0) | 7.4 (7.2) | 7.7 (6.8) |
| SRI4 responderc | 17 (18.9) | 109 (61.6) | 126 (47.2) |
| SELENA–SLEDAI score, mean ± SD | 5.6 ± 3.6 | 8.9 ± 3.5 | 7.8 ± 3.9 |
| Anti‐dsDNA positive | 49 (53.8) | 86 (48.6) | 135 (50.4) |
| Low C3 and/or low C4 levels | 41 (45.1) | 78 (44.1) | 119 (44.4) |
| SDI score, mean ± SD | 1.2 ± 1.7 | 1.1 ± 1.4 | 1.2 ± 1.5 |
| SFI (≥1 flare) | 18 (19.8) | 47 (26.6) | 65 (24.3) |
| Daily glucocorticoid dose, mean ± SD mg/day | 5.3 ± 6.0 | 6.8 ± 7.4 | 6.3 ± 7.0 |
| Glucocorticoid dosage >7.5 mg/day | 25 (27.5) | 61 (34.5) | 86 (32.1) |
| SF‐36 PCS, mean ± SD | 42.0 ± 9.8 | 34.5 ± 9.0 | 37.0 ± 9.9 |
| SF‐36 MCS, mean ± SD | 47.9 ± 10.3 | 42.4 ± 11.4 | 44.3 ± 11.3 |
| SF‐36 domain scores, mean ± SD | |||
| Bodily pain | 58.0 ± 22.6 | 41.7 ± 20.0 | 47.2 ± 22.3 |
| General health | 45.3 ± 20.8 | 38.2 ± 19.3 | 40.6 ± 20.1 |
| Mental health | 71.0 ± 19.5 | 64.9 ± 20.2 | 67.0 ± 20.1 |
| Physical functioning | 63.2 ± 27.4 | 51.0 ± 26.8 | 55.2 ± 27.5 |
| Role emotional | 73.1 ± 25.2 | 63.9 ± 28.6 | 67.0 ± 27.8 |
| Role physical | 60.9 ± 28.0 | 46.0 ± 26.6 | 51.1 ± 27.9 |
| Social functioning | 69.1 ± 25.8 | 54.0 ± 26.5 | 59.1 ± 27.2 |
| Vitality | 48.7 ± 24.4 | 34.2 ± 20.3 | 39.1 ± 22.8 |
| FACIT–Fatigue score, mean ± SD | 31.2 ± 13.3 | 24.1 ± 11.2 | 26.5 ± 12.4 |
| FACIT–Fatigue scale score | |||
| 20–34 | 28 (30.8) | 67 (37.9) | 95 (35.4) |
| <20 | 23 (25.3) | 74 (41.8) | 97 (36.2) |
| ≥35 | 40 (44.0) | 35 (19.8) | 75 (28.0) |
Data for the Short Form 36 (SF‐36) and Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue were available for only 176 patients in the belimumab/belimumab group. Except where indicated otherwise, values are the number (%). SRI4 = FACIT–Fatigue for Systemic Lupus Erythematosus (SLE) responder index 4; SELENA–SLEDAI = Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI); anti‐dsDNA = anti–double‐stranded DNA; SDI = Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index; SFI = SLE Flare Index; PCS = physical component summary; MCS = mental component summary.
Duration is defined as the time from the screening date to the time of SLE diagnosis date plus 1 day.
Responders 1 year (48 weeks in study terms) after long‐term extension baseline; 1 patient in the belimumab/placebo group was lost to follow‐up; the percentages were adjusted accordingly.