Targeting the interferon pathway with sifalimumab for the treatment of systemic lupus erythematosus.

Dysregulation of the type I interferon (IFN) system is associated with various immunologic diseases, such as systemic lupus erythematosus (SLE). Targeting this dysregulation presents an attractive approach for SLE therapy. Sifalimumab, a fully human immunoglobulin G κ monoclonal antibody that binds to and neutralizes most IFN-α subtypes, has been recently evaluated in a Phase IIb study in patients with moderate to severe SLE. Insights gained from earlier studies were used to inform design of the Phase IIb study, to provide a more comprehensive evaluation of sifalimumab. Sifalimumab demonstrated broad efficacy across composite and organ-specific end points, suggesting that targeting of IFN-α is a promising treatment option for SLE, particularly for those patients whose disease is refractory to current standard of care.