Table 4.
Exploratory efficacy endpoints (efficacy population)
| BLyS ≥ 2 ng/mL at baseline |
BLyS < 2 ng/mL at baseline |
|||
|---|---|---|---|---|
| Placebo (N = 136) | Belimumab 10 mg/kg (N = 121) | Placebo (N = 419) | Belimumab 10 mg/kg (N = 432) | |
| Prednisone reduced to ≤ 7.5 mg/day by Week 52 a, n (%) | 9/76 (11.8) | 16/79 (20.3) | 37/240 (15.4) | 55/240 (22.9) |
| Difference versus placebo | 8.41 | 7.50 | ||
| OR (95% CI); p-value versus placebo | 2.05 (0.83, 5.09) | 1.64 (1.03, 2.61) | ||
| p-value | 0.1198 | 0.0368 | ||
| Prednisone increased to > 7.5 mg/day by Week 52 b, n (%) | 25/60 (41.7) | 13/42 (31.0) | 54/179 (30.2) | 51/192 (26.6) |
| Difference versus placebo | –10.7 | –3.61 | ||
| OR (95% CI); p-value versus placebo | 0.70 (0.29, 1.74) | 0.83 (0.52, 1.31) | ||
| p-value | 0.4472 | 0.4147 | ||
| No worsening in PGA score at Week 52 c, n (%) | 77 (56.6) | 87 (71.9) | 289 (69.0) | 326 (75.5) |
| Difference versus placebo | 15.3 | 6.5 | ||
| OR (95% CI); p-value versus placebo | 2.1 (1.2, 3.7) | 1.4 (1.0, 1.9) | ||
| p-value | 0.0066 | 0.0249 | ||
BLyS: B-lymphocyte stimulator; OR: odds ratio; PGA: Physicians Global Assessment.
a
Out of patients with baseline prednisone dose > 7.5 mg/day.
b
Out of patients with baseline prednisone dose ≤ 7.5 mg/day.
c
Worsening defined as an increase of ≥ 0.3 points since baseline.