Inhibition of Complement C1s By Sutimlimab in Patients with Cold Agglutinin Disease (CAD): Efficacy and Safety Results from the Randomized, Placebo-Controlled Phase 3 CADENZA Study

Background: CAD is a rare autoimmune hemolytic anemia mediated by classical complement pathway activation. Sutimlimab, a first-in-class humanized monoclonal anti-C1s IgG antibody, selectively inhibited the classical pathway, halted hemolysis, and improved hemoglobin (Hb) and quality of life (QOL) in patients with CAD and recent transfusion history (single-arm CARDINAL study [NCT03347396]). CADENZA (NCT03347422) is a 26-week (Part A) randomized, double-blind, placebo (PBO)-controlled Phase 3 study with open-label extension (Part B) to assess sutimlimab in patients with CAD without recent transfusion history.