Attainment of LLDAS and SRI-4 at week 52 in BLISS-52 and BLISS-76
| BLISS-52 | BLISS-76 | |||||
| Placebo (%) | Belimumab 1 mg/kg | Belimumab10 mg/kg | Placebo (%) | Belimumab 1 mg/kg | Belimumab 10 mg/kg | |
| SRI-4 | 43.6 |
51.4%
OR 1.37 (0.99 to 1.90), p= 0.06 |
57.6%
OR 1.76 (1.27 to 2.45), p= 0.0007 | 33.5 |
40.7%
OR 1.36 (0.95 to 1.93), p= 0.08 |
43.2%
OR 1.51 (1.07 to 2.14), p= 0.02 |
| LLDAS | 5.8 |
10.9%
OR 2.00 (1.02 to 4.11), p= 0.05 |
12.5%
OR 2.32 (1.20 to 4.71), p= 0.02 | 7.8 |
11.6%
OR 1.55 (0.79 to 3.11), p= 0.21 |
14.4%
OR 1.98 (1.04 to 3.91), p= 0.04 |
| LLDAS criterion 1 | 22.5 | 28.8% | 30.9% | 17.7 | 25.4% | 30.6% |
| LLDAS criterion 2 | 76.4 | 73.1% | 76.8% | 63.0 | 73.0% | 69.3% |
| LLDAS criterion 3 | 60.4 | 64.6% | 70.4% | 54.7 | 64.3% | 63.6% |
| LLDAS criterion 4 | 40.5 | 43.3% | 46.5% | 62.4 | 77.8% | 67.0% |
| LLDAS criterion 5 | 97.9 | 99.0% | 99.0% | 98.6 | 97.1% | 98.2% |
LLDAS criterion 1: SLEDAI-2K (SLE Disease Activity Index 2000) score ≤4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis and fever) and no haemolytic anaemia or gastrointestinal activity.
LLDAS criterion 2: no new features of lupus disease activity compared with the previous assessment.
LLDAS criterion 3: Physician Global Assessment of activity score (0–3) ≤1.
LLDAS criterion 4: current prednisolone-equivalent dosage ≤7.5 mg/day.
LLDAS criterion 5: standard maintenance dosages of immunosuppressive drugs and approved biologics allowed.
OR with (95% CI).
LLDAS, Lupus Low Disease Activity State; SRI-4, Systemic Lupus Erythematosus Responder Index-4.