BLISS-52 | BLISS-76 | |||||
Placebo | Belimumab 1 mg/kg | Belimumab10 mg/kg | Placebo | Belimumab 1 mg/kg | Belimumab 10 mg/kg | |
LLDAS (overall) | 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 |
High^{a} vs low^{b} disease activity subgroups | ||||||
n | 160 | 178 | 182 | 116 | 132 | 131 |
High anti-dsDNA antibody levels^{a} | 5.0% | 10.1% OR 2.14 (0.93 to 5.34), p=0.08 | 12.1% OR 2.61 (1.17 to 6.42) p=0.02 | 5.2% | 6.8% OR 1.34 (0.47 to 4.11), p=0.59 | 15.3% OR 3.30 (1.35 to 9.32), p=0.01 |
n | 65 | 60 | 59 | 76 | 75 | 71 |
Normal anti-dsDNA antibody levels^{b} | 7.7% | 13.3% OR 1.85 (0.58 to 6.44), p=0.31 | 13.6% OR 1.89 (0.59 to 6.57), p=0.29 | 11.8% | 20.0% OR 1.86 (0.77 to 4.72), p=0.18 | 12.7% PR 1.08 (0.40 to 2.94), p=0.88 |
n | 139 | 154 | 164 | 108 | 113 | 123 |
Low C3/C4^{a} | 5.8% | 8.4% OR 1.51 (0.61 to 3.92), p=0.37 | 14.0% OR 2.67 (1.20 to 6.56), p=0.02 | 4.6% | 5.3% OR 1.15 (0.33 to 4.19), p=0.82 | 13.0% OR 3.08 (1.16 to 9.70), p=0.03 |
n | 86 | 84 | 77 | 84 | 94 | 79 |
Normal C3/C4^{b} | 5.8% | 15.5% OR 2.97 (1.06 to 9.62), p=0.05 | 9.1% OR 1.62 (0.50 to 5.69), p=0.43 | 11.9% | 19.1% OR 1.75 (0.77 to 4.18), p=0.19 | 16.46% OR 1.46 (0.60 to 3.63), p=0.41 |
n | 183 | 204 | 207 | 142 | 149 | 153 |
High anti-dsDNA or low C3/C4^{a} | 5.5% | 9.3% OR 1.78 (0.82 to 4.08), p=0.16 | 13.0% OR 2.60 (1.26 to 5.78), p=0.01 | 4.9% | 6.0% OR 1.24 (0.45 to 3.56), p=0.68 | 14.4% OR 3.24 (1.40 to 8.43), p=0.01 |
n | 67 | 90 | 88 | 54 | 60 | 64 |
High anti-dsDNA and low C3/C4^{a} | 4.7% | 8.8% OR 2.08 (0.58 to 9.79), p=0.29 | 11.4% OR 2.74 (0.80 to 12.58), p=0.14 | 7.4% | 6.67% OR 0.89 (0.20 to 3.95), p=0.88 | 16.7% OR 2.05 (0.62 to 7.93), p=0.25 |
n | 158 | 148 | 153 | 138 | 147 | 138 |
Normal anti-dsDNA and low C3/C4^{b} | 6.3% | 12.2% OR 2.05 (0.93 to 4.76), p=0.08 | 15.0% OR 2.23 (1.03 to 5.12), p=0.05 | 8.0% | 13.6% OR 1.82 (0.85 to 4.06), p=0.13 | 16.9% OR 1.96 (0.91 to 4.39), p=0.09 |
n | 119 | 111 | 131 | 90 | 103 | 95 |
SLEDAI-2K score ≥10^{a} | 4.2% | 9.9% OR 2.51 (0.88 to 8.19), p=0.09 | 13.0% OR 3.40 (1.30 to 10.62), p=0.01 | 5.6% | 6.8% OR 1.24 (0.38 to 4.32), p=0.72 | 9.5% OR 1.78 (0.59 to 6.00), p=0.32 |
n | 106 | 127 | 110 | 102 | 104 | 107 |
SLEDAI-2K score ≤9^{b} | 7.5% | 11.8% OR 1.64 (0.68 to 4.23), p=0.28 | 11.8% OR 1.64 (0.66 to 4.31), p=0.29 | 9.8% | 10.8% OR 1.80 (0.79 to 4.28), p=0.17 | 18.7% OR 2.11 (0.96 to 4.95), p=0.07 |
n | 155 | 176 | 168 | 78 | 95 | 89 |
Prednisolone dose >7.5 mg/d^{a} | 3.9% | 5.7% OR 1.50 (0.54 to 4.49), p=0.44 | 10.7% OR 2.98 (1.21 to 8.41), p=0.02 | 7.7% | 4.2% OR 0.53 (0.13 to 1.92), p=0.34 | 6.7% OR 0.86 (0.26 to 2.89), p=0.81 |
n | 70 | 62 | 73 | 114 | 112 | 113 |
Prednisolone ≤7.5 mg/d^{b} | 10.0% | 25.8% OR 3.13 (1.23 to 8.72), p=0.02 | 16.4% OR 1.77 (0.67 to 5.04), p=0.26 | 7.9% | 17.9% OR 2.54 (1.13 to 6.11), p=0.03 | 20.4% OR 2.98 (1.35 to 7.11), p=0.009 |
n | 77 | 75 | 83 | 88 | 106 | 93 |
SDI score ≥1^{a} | 6.5% | 8.7% OR 1.25 (0.52 to 3.06), p=0.61 | 7.2% OR 1.12 (0.47 to 2.73), p=0.80 | 10.2% | 8.4% OR 0.72 (0.40 to 1.27), p=0.26 | 9.7% OR 0.94 (0.53 to 1.65), p=0.83 |
n | 148 | 163 | 158 | 104 | 101 | 109 |
SDI=0^{b} | 5.7% | 12.3% OR 2.45 (1.36 to 4.59), p=0.003 | 15.2% OR 3.13 (1.77 to 5.81), p=0.0001 | 5.8% | 15.8% OR 3.07 (1.77 to 5.55), p=0.0001 | 18.4% OR 3.67 (2.16 to 6.54), p=3.92×10^{−6} |
OR with (95% CI).
Shaded boxes denote statistically significant results.
LLDAS, Lupus Low Disease Activity State; SDI, SLICC (Systemic Lupus International Collaborating Clinics) Damage Index; SLEDAI-2K, SLE Disease Activity Index 2000; a, high activity subgroup; anti-dsDNA, antidouble-stranded DNA; b, low activity subgroup.