Abstract: This study reports a case of refractory chronic spontaneous urticaria (CSU) successfully treated with stapokibart. The patient was a 37-year-old female who presented with recurrent erythema and wheals accompanied by pruritus over the entire body for more than 1 year. Previous treatment with multiple medications including omalizumab, cyclosporine, methylprednisolone, and methotrexate achieved unsatisfactory efficacy. Stapokibart was subsequently administered subcutaneously at an initial dose of 600 mg, followed by a maintenance dose of 300 mg every 2 weeks. Symptoms began to improve at 2 weeks after treatment; the skin lesions and pruritus resolved completely at 6 weeks, with the Visual Analogue Scale (VAS) score decreasing from 10 to 0 and the Dermatology Life Quality Index (DLQI) score dropping from 27 to 0. The disease remained stable continuously at 12 weeks, and all oral medications were discontinued with stapokibart maintenance therapy alone. The patient had comorbid autoimmune thyroiditis and a positive autologous serum skin test, suggesting the involvement of autoimmune mechanisms. As an interleukin-4 receptor α monoclonal antibody, stapokibart may exert its therapeutic effects by blocking the IL-4/IL-13 signaling pathway, inhibiting mast cell activation, and regulating autoimmune imbalance.

Key words: urticaria, chronic spontaneous, stapokibart