Table 1:
Baseline demographic and clinical characteristics (mITT population; post hoc analyses).
| Newly diagnosed | Relapsed | GC pulses | No GC pulses | |||||
|---|---|---|---|---|---|---|---|---|
| Characteristics | Placebo (n = 148) |
Belimumab 10 mg/kg IV (n = 148) |
Placebo (n = 75) |
Belimumab 10 mg/kg IV (n = 75) |
Placebo (n = 97) |
Belimumab 10 mg/kg IV (n = 76) |
Placebo (n = 126) |
Belimumab 10 mg/kg IV (n = 147) |
| Region, n (%) | ||||||||
| Asia | 72 (48.6) | 75 (50.7) | 33 (44.0) | 31 (41.3) | 46 (47.4) | 33 (43.4) | 59 (46.8) | 73 (49.7) |
| Europe | 24 (16.2) | 23 (15.5) | 21 (28.0) | 18 (24.0) | 29 (29.9) | 24 (31.6) | 16 (12.7) | 17 (11.6) |
| USA/Canada | 26 (17.6) | 23 (15.5) | 12 (16.0) | 15 (20.0) | 10 (10.3) | 8 (10.5) | 28 (22.2) | 30 (20.4) |
| Americas excluding USA/Canada | 26 (17.6) | 27 (18.2) | 9 (12.0) | 11 (14.7) | 12 (12.4) | 11 (14.5) | 23 (18.3) | 27 (18.4) |
| Female, n (%) | 129 (87.2) | 133 (89.9) | 67 (89.3) | 64 (85.3) | 88 (90.7) | 66 (86.8) | 108 (85.7) | 131 (89.1) |
| Age (years), mean (SD) | 33.0 (10.7) | 33.9 (11.1) | 33.3 (10.7) | 33.5 (10.0) | 33.1 (9.5) | 34.5 (11.7) | 33.1 (11.5) | 33.4 (10.2) |
| Standard therapy, n (%) | ||||||||
| MMF | 111 (75.0) | 116 (78.4) | 53 (70.7) | 48 (64.0) | 61 (62.9) | 49 (64.5) | 103 (81.7) | 115 (78.2) |
| CYC | 37 (25.0) | 32 (21.6) | 22 (29.3) | 27 (36.0) | 36 (37.1) | 27 (35.5) | 23 (18.3) | 32 (21.8) |
| SLE duration (years)a, median (IQR) | 0.9 (0.2–4.3) |
1.1 (0.1–5.6) |
7.8 (4.9–11.2) |
7.3 (4.2–11.1) |
2.9 (0.2–7.3) |
4.1 (0.3–8.0) |
3.4 (0.2–8.2) |
3.2 (0.3–8.5) |
| LN duration (years)a, median (IQR) | 0.1 (0.1–0.2) |
0.1 (0.1–0.2) |
5.5 (3.3–8.7) |
5.1 (2.8–7.9) |
0.2 (0.1–2.7) |
0.3 (0.1–4.1) |
0.2 (0.1–3.4) |
0.2 (0.1–2.7) |
| LN class, n (%) | ||||||||
| Class III or IV | 88 (59.5) | 86 (58.1) | 44 (58.7) | 40 (53.3) | 59 (60.8) | 42 (55.3) | 73 (57.9) | 84 (57.1) |
| Class III + V or class IV + V | 34 (23.0) | 40 (27.0) | 21 (28.0) | 21 (28.0) | 29 (29.9) | 24 (31.6) | 26 (20.6) | 37 (25.2) |
| Class V | 26 (17.6) | 22 (14.9) | 10 (13.3) | 14 (18.7) | 9 (9.3) | 10 (13.2) | 27 (21.4) | 26 (17.7) |
| UPCR (g/g), mean (SD) | 3.5 (3.8) | 2.9 (2.4) | 3.5 (3.0) | 3.9 (3.3) | 4.0 (4.6) | 3.2 (2.9) | 3.2 (2.5) | 3.2 (2.7) |
| UPCR category (≥3 g/g), n (%) | 61 (41.2) | 55 (37.2) | 31 (41.3) | 36 (48.0) | 41 (42.3) | 30 (39.5) | 51 (40.5) | 61 (41.5) |
| SLEDAI-2K score, mean (SD) | 12.4 (5.1) | 12.7 (5.4) | 11.8 (4.2)b | 12.0 (5.0) | 12.9 (4.6)c | 13.0 (5.7) | 11.6 (4.9) | 12.2 (5.0) |
| eGFR (ml/min/1.73 m2), mean (SD) | 100.4 (42.7) | 101.6 (36.5) | 102.1 (43.0) | 96.9 (40.0) | 90.7 (41.5) | 98.1 (36.1) | 108.9 (42.1) | 101.0 (38.6) |
| eGFR category (≥60 ml/min/1.73 m2), n (%) | 116 (78.4) | 131 (88.5) | 66 (88.0) | 59 (78.7) | 70 (72.2) | 65 (85.5) | 112 (88.9) | 125 (85.0) |
| eGFR category (≥90 ml/min/1.73 m2), n (%) | 87 (58.8) | 89 (60.1) | 46 (61.3) | 42 (56.0) | 48 (49.5) | 45 (59.2) | 85 (67.5) | 86 (58.5) |
| Average daily prednisone equivalent dose (mg/day), mean (SD)d | 80.2 (156.3) | 67.8 (98.1) | 57.3 (65.9) | 63.9 (103.2) | – | – | – | – |
a
Duration defined as (Treatment start date–Diagnosis date + 1)/365.25.
b
n = 74.
c
n = 96.
d
GCs were converted to prednisone equivalents. Baseline values take into account only the last 7 days prior to randomization; baseline values are not available for GC pulse subgroups as pulses or highest dose of GC (which could be administered between 60 days prior to baseline or at day 1) would not be captured.
SLEDAI-2K: SLE Disease Activity Index 2000.