Prednisone* dose over 52 weeks (mITT population)
| Placebo (n=226) | Belimumab 10 mg/kg (n=451) | |
| Baseline prednisone dose, mean (SD), mg/day | 17.2 (10.82) | 16.0 (10.66) |
| Cumulative prednisone dose over 52 weeks, median (25th, 75th percentile), mg† P value‡ | 4758.1 (3597.5, 6695.0) | 4190.0 (3090.0, 5475.0) 0.0005 |
| Number of patients with baseline prednisone dose >7.5 mg/day, n (%) | 184 (81.4) | 352 (78.0) |
| Number of days that prednisone was reduced to ≤7.5 mg/day and/or by 50% from baseline over 52 weeks, median (25th, 75th percentile)§ P value¶ | 0 (0.0, 172.0) | 0 (0.0, 213.5) 0.0288 |
| Patients with prednisone reduction by ≥25% from baseline to ≤7.5 mg/day during Weeks 40–52, n (%)§ P value¶ | 20 (10.9) | 55 (15.6) 0.0721 |
*Prednisone or equivalent.
†Daily dose imputed after dropout/treatment failure.
‡Versus placebo (rank ANCOVA).
§Among patients with prednisone dose >7.5 mg/day at baseline.
¶Versus placebo (logistic regression).
ANCOVA, analysis of covariance; mITT, modified intent-to-treat.