Table 1

Patients attaining LLDAS, dual LLDAS–BICLA, or dual LLDAS–SRI(4) response at week 52, by treatment group

Responder statusAnifrolumab
300 mg (n=360)*
Placebo
(n=366)*
OR
(95% CI)†
Nominal
P value
LLDAS108 (30.0%)72 (19.6%)1.8 (1.3 to 2.5)0.0011
LLDAS–BICLA dual responder100 (27.8%)61 (16.7%)2.0 (1.4 to 2.8)0.0003
LLDAS–SRI(4) dual responder108 (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.