Table 2

SRI responder rates in the mITT population and in the ‘severe’ SLE subgroup

Responder rate (%)p vs pooled placebop vs regimen placeboResponder rate (%)p vs pooled placebop vs regimen placeboResponder rate (%)p vs pooled placebop vs regimen placeboResponder rate (%)p vs pooled placebop vs regimen placebo
mITT population
 Placebo pooledN=26935.334.617.816.7
 Placebo regimen: 200 mg Q4WN=8934.833.718.018.0
 Placebo regimen: 100 mg QWN=8836.436.427.325.0
 Placebo regimen: 200 mg QWN=9234.833.78.77.6
 Blisibimod pooledN=27737.2p=0.63535.0p=0.90119.9p=0.52119.9p=0.321
 Blisibimod 200 mg Q4WN=9235.9p=0.925p=0.88431.5p=0.588p=0.75416.3p=0.711p=0.76516.3p=0.905p=0.765
 Blisibimod 100 mg QWN=9332.3p=0.603p=0.56132.3p=0.695p=0.56118.3p=0.887p=0.14918.3p=0.692p=0.272
 Blisibimod 200 mg QWN=9243.5p=0.154p=0.22741.3p=0.237p=0.28625.0p=0.119p=0.00325.0p=0.069p=0.001
ΔSRI 200 mg QW—regimen placebo8.77.616.317.4
Severe SLE subgroup: SELENA-SLEDAI >10 and Receiving corticosteroids
 Placebo pooledN=13847.146.428.326.1
 Placebo regimen: 200 mg Q4WN=4447.747.729.529.5
 Placebo regimen: 100 mg QWN=4753.253.242.638.3
 Placebo regimen: 200 mg QWN=4740.438.312.810.6
 Blisibimod pooledN=14045.7p=0.68245.0p=0.68232.1p=0.51732.1p=0.291
 Blisibimod 200 mg Q4WN=4250.0p=0.819p=0.83347.6p=0.971p=0.99228.6p=0.983p=0.92128.6p=0.795p=0.921
 Blisibimod 100 mg QWN=5034.0p=0.084p=0.05734.0p=0.100p=0.05726.0p=0.773p=0.08526.0p=0.996p=0.194
 Blisibimod 200 mg QWN=4854.2p=0.482p=0.1854.2p=0.428p=0.12141.7p=0.105p=0.00241.7p=0.054p<0.001
ΔSRI 200 mg QW—regimen placebo13.815.928.931.1
  • SRI-5 responders are defined as achieving ≥5-point decrease in SELENA-SLEDAI score from baseline, and no new BILAG 1A or 2B organ domain flares and no worsening in Physician's Global Assessment (PGA) (< 0.3 increase), and who did not withdraw from study, increase background steroid or immunosuppressive medication, or use prohibited medications at any time prior to the landmark analysis time points. In modified versions of the SRI, responders were required to achieve greater improvements in SELENA-SLEDAI of ≥6 (for SRI-6), ≥7 (for SRI-7), ≥8 (for SRI-8). The mITT population includes all subjects who received at least one dose of blisibimod. N=number of subjects randomised into each treatment arm in the mITT population and ‘severe’ subgroup. Responder rates are reported as the number of subjects responding as a per cent of N. All data are from prospectively planned analyses excepting SRI-8 in the ‘severe’ subgroup.

  • BILAG, British Isles Lupus Assessment Group; mITT, modified intent to treat; PGA, Physician's Global Assessment; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment – Systemic Lupus Erythematosus Disease Activity Index; SLE, systemic lupus erythematosus; SRI–5, SLE Responder Index-5.