Table 1. Earliest time point at which significant improvement was observed
| Wk | Belimumab | ||||
|---|---|---|---|---|---|
| Placebo | 1 mg/kg | 10 mg/kg | |||
| SRI | 16 | n (%) | 221 (39.3) | 241 (43.1) | 256 (45.5) |
| p value | 0.12 | 0.03 | |||
| SS reduction ≥4 from BL | 12 | n (%) | 226 (40.5) | 235 (42.7) | 255 (46.2) |
| p value | 0.34 | 0.046 | |||
| SS reduction ≥4 from ≥10 at BL | 8 | n (%) | 120 (40.1) | 120 (42.4) | 145 (49.0) |
| p value | 0.57 | 0.03 | |||
| SS reduction ≥4: anti-dsDNA positive and hypocomplementemia at BL | 8 | n (%) | 91 (31.7) | 105 (37.0) | 120 (39.3) |
| p value | 0.07 | 0.01 | |||
| SS reduction ≥7 from BL | 16 | n (%) | 67 (15.3) | 81 (18.6) | 95 (21.2) |
| p value | 0.11 | 0.01 | |||
| FACIT-Fatigue improvement | 8 | n | 553 | 554 | 547 |
| Mean | 2.25±0.36 | 3.34±0.37 | 3.86±0.39 | ||
| Median | 1.5 | 2.0 | 3.0 | ||
| P value | 0.046 | 0.005 | |||