Stapokibart in atopic dermatitis, chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis: a profile of its use

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. Type 2 inflammatory diseases arise when the immune response responsible for protecting the body against parasitic pathogens, venoms and toxins becomes overactive. This dysregulation leads to the characteristic immune response seen in type 2 inflammatory diseases such as atopic dermatitis, CRSwNP, allergic rhinitis and asthma. IL-4 and IL-13 are key cytokines that drive type 2 inflammation. They share a common receptor subunit, IL-4Rα. Stapokibart is a humanised IgG4 monoclonal antibody that blocks IL-4 and IL-13 signalling by targeting IL-4Rα. In clinical trials in adults, subcutaneous stapokibart significantly improved the signs and symptoms of moderate-to-severe atopic dermatitis, reduced nasal polyp size and congestion in severe CRSwNP and improved daily nasal symptoms in moderate-to-severe seasonal allergic rhinitis. Stapokibart is generally well tolerated and associated with a low incidence of conjunctivitis. Stapokibart expands the treatment options for adults in China with moderate-to-severe atopic dermatitis, CRSwNP and moderate-to-severe seasonal allergic rhinitis whose symptoms are inadequately controlled despite standard of care.