Patients attaining LLDAS, dual LLDAS–BICLA, or dual LLDAS–SRI(4) response at week 52, by treatment group
| Responder status | Anifrolumab 300 mg (n=360)* | Placebo (n=366)* | OR (95% CI)† | Nominal P value |
| LLDAS | 108 (30.0%) | 72 (19.6%) | 1.8 (1.3 to 2.5) | 0.0011 |
| LLDAS–BICLA dual responder | 100 (27.8%) | 61 (16.7%) | 2.0 (1.4 to 2.8) | 0.0003 |
| LLDAS–SRI(4) dual responder | 108 (30.0%) | 70 (19.1%) | 1.8 (1.3 to 2.6) | 0.0006 |
*Responder rates (percentages), the difference in estimates and associated 95% CIs were weighted and calculated using a stratified Cochran-Mantel-Haenszel approach, with stratification factors SLEDAI-2K score at screening, day 1 glucocorticoid dose, type I IFN gene signature test result at screening and study.
†OR (95% CI and p value) are based on a logistic regression with same stratification factors.
‡
BICLA, British Isles Lupus Assessment Group-based Composite Lupus Assessment; IFN, interferon; LLDAS, lupus low disease activity state; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRI(4), SLE Responder Index-4.