Stapokibart in atopic dermatitis, chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis: a profile of its use
摘要
Stapokibart (Kangyueda®; 康悦达®) is a humanised immunoglobulin (Ig) G4 monoclonal antibody that targets the interleukin (IL)-4 receptor alpha (IL-4Rα) subunit, a shared receptor for IL-4 and IL-13, which are key drivers of type 2 inflammation. It expands the treatment options for adults in China with type 2 inflammatory diseases, specifically moderate-to-severe atopic dermatitis, chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate-to-severe seasonal allergic rhinitis, whose symptoms are inadequately controlled despite standard of care. Stapokibart is injected subcutaneously every 2 weeks. It is the second anti-IL-4Rα monoclonal antibody approved in China after dupilumab. Randomised, double-blind, placebo-controlled, phase 3 trials conducted in adults in China demonstrate that stapokibart significantly improves the signs and symptoms of moderate-to-severe atopic dermatitis, reduces nasal polyp size and congestion in severe CRSwNP and improves daily nasal symptoms in moderate-to-severe seasonal allergic rhinitis. Across all indications, stapokibart improves quality of life and is generally well tolerated, with a low incidence of conjunctivitis and mostly mild-to-moderate adverse events. Infection-related adverse events, including upper respiratory tract infections, were common across all indications. Efficacy and tolerability were sustained up to 52 weeks in patients with moderate-to-severe atopic dermatitis and severe CRSwNP.