Furie R, et al. - Researchers conducted a first-in-human study evaluating the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single BIIB059 doses in healthy volunteers (HV) and patients with systemic lupus erythematosus (SLE) with active cutaneous disease. In addition, they assessed proof of their biological activity and preliminary clinical response in the SLE cohort. Outcomes of this randomized, double-blind, placebo-controlled clinical trial in HV (n = 54) and patients with SLE (n = 12) suggest favorable safety and PK/PD profiles and robust target engagement and biological activity of single doses of BIIB059. This supports further development of BIIB059 in SLE. As per the data, patients with SLE, especially those with cutaneous manifestations may benefit from targeting plasmacytoid DCs.