Methods for characterizing
disease activity in patients with
systemic lupus erythematosus (SLE). These methods include obtaining blood, serum,
plasma, or
urine samples from the patient; assessing the expression of biomarkers selected from IFN-α, IL-10, BlyS, IL-7, IFN-γ, TRAIL, IL-15, IP-10 / CXCL10, and IL-4 in the samples; assessing the expression of inflammatory mediators selected from TNFRII, resistin, and
osteopontin (OPN) in the samples; assessing SLE-related
autoantibody-specific biomarkers selected from dsDNA,
chromatin, RiboP, Ro / SSA, La / SSB, Sm, SmRNP, and RNP in the samples; and calculating the Lupus
Disease Activity (Immune) Index (LDAII / L-DAI)
score. The LDAII / L-DAI
score can distinguish between active and low lupus
disease activity. Treatment methods are also provided, including administration after determining that the patient has a prognostic risk of transitioning to classified SLE but before reaching the
clinical disease classification.