Table 2.
Efficacy outcomes in low complement/anti-dsDNA-positive subgroup in pooled BLISS-52 and BLISS-76 population
| Efficacy outcome | Placebo (n=287) | Belimumab 1 mg/kg (n=284) | Belimumab 10 mg/kg (n=305) |
|---|---|---|---|
| SRI rate | |||
| SRI at week 52, % | 31.7 | 41.5 | 51.5 |
| p value | 0.002 | <0.001 | |
| Observed treatment difference vs placebo, % | 9.8 | 19.8 | |
| Modified SRI excluding complement and anti-dsDNA changes at week 52, % | 28.9 | 38.7 | 46.2 |
| p value | 0.001 | <0.001 | |
| Observed treatment difference vs placebo, % | 9.8 | 17.3 | |
| SRI at week 76 in BLISS-76, % | (n=131) 27.5 | (n=125) 36.0 | (n=134) 39.6 |
| p value | 0.10 | 0.02 | |
| Observed treatment difference vs placebo, % | 8.5 | 12.1 | |
| Secondary outcomes in pooled population | |||
| Patients with severe flare over 52 weeks, % | 29.6 | 20.4 | 19.0 |
| p value | 0.02 | 0.004 | |
| Observed treatment difference vs placebo, % | 9.2 | 10.6 | |
| Time to severe flare, HR (95% CI) | 0.67 (0.48, 0.94) | 0.61 (0.44, 0.85) | |
| Prednisone reduction by ≥25% from baseline to ≤7.5 mg/day during weeks 40–52, %* | (n=173) 12.1 | (n=188) 22.9 | (n=195) 18.5 |
| p value | 0.02 | 0.15 | |
| Observed treatment difference vs placebo, % | 10.7 | 6.3 | |
| SF-36 PCS score change from baseline at week 52, LS mean±SE | (n=287) 3.19±0.61 | (n=282) 4.57±0.59 | (n=297) 4.76±0.59 |
| p value | 0.03 | 0.01 | |
| Observed mean treatment difference vs placebo | 1.38 | 1.56 | |
| FACIT–Fatigue score improvement from baseline at week 52, LS mean±SE | 1.80±0.77 | 4.74±0.75 | 4.07±0.75 |
| p value | <0.001 | 0.004 | |
| Observed mean treatment difference vs placebo | 2.94 | 2.27 | |
*
Among patients with baseline prednisone dose greater than 7.5 mg/day.
FACIT, functional assessment of chronic illness therapy; HR, hazard ratio; LS, least squares; PCS, physical component summary; SF-36, short form 36; SRI, Systemic Lupus Erythematosus Responder Index.