After previously being shown to reduce disease progression in mouse models of lupus, a drug comprising inactivated interferon-α (IFN-α) coupled to a carrier molecule was tested in a phase I–II study of 28 women with systemic lupus erythematosus. All immunized patients produced anti-IFN-α antibodies, titres of which correlated with baseline expression of IFN-α-induced genes. The antibody response in patients who expressed IFN-α-induced genes at baseline was associated with reduced expression of those genes, and with recovery of serum levels of complement C3.