Table 2

Efficacy outcomes in low complement/anti-dsDNA-positive subgroup in pooled BLISS-52 and BLISS-76 population

Efficacy outcomePlacebo (n=287)Belimumab 1 mg/kg (n=284)Belimumab 10 mg/kg (n=305)
SRI rate
SRI at week 52, %31.741.551.5
 p value0.002<0.001
 Observed treatment difference vs placebo, %9.819.8
Modified SRI excluding complement and anti-dsDNA changes at week 52, %28.938.746.2
 p value0.001<0.001
 Observed treatment difference vs placebo, %9.817.3
SRI at week 76 in BLISS-76, %(n=131) 27.5(n=125) 36.0(n=134) 39.6
 p value0.100.02
 Observed treatment difference vs placebo, %8.512.1
Secondary outcomes in pooled population
Patients with severe flare over 52 weeks, %29.620.419.0
 p value0.020.004
 Observed treatment difference vs placebo, %9.210.6
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 value0.020.15
 Observed treatment difference vs placebo, %10.76.3
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 value0.030.01
 Observed mean treatment difference vs placebo1.381.56
FACIT–Fatigue score improvement from baseline at week 52, LS mean±SE1.80±0.774.74±0.754.07±0.75
 p value<0.0010.004
 Observed mean treatment difference vs placebo2.942.27
  • * 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.