Wang Menglin, Li Jingyun, Zhang Luo, Zhang Yuan
Department of Otolaryngology Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Beijing Laboratory of Allergic Diseases, Beijing Institute of Otolaryngology, Beijing, China.
Immunotherapy. 2025 Aug;17(12):851-860. doi: 10.1080/1750743X.2025.2554562. Epub 2025 Sep 3.
Seasonal allergic rhinitis (SAR) is a chronic inflammatory condition primarily mediated by type 2 immune responses, typically triggered by specific pollens. Stapokibart is a humanized monoclonal antibody anti-interleukin-4 receptor α subunit, thereby blocking IL-4 and IL-13 signaling pathways. Clinical studies of stapokibart in healthy adults and SAR patients revealed a favorable safety profile and significant clinical efficacy. Stapokibart has been approved for treating adults with atopic dermatitis, chronic rhinosinusitis with nasal polyposis, and SAR in China. This article reviews the mechanism of action, pharmacology, and available clinical trial data regarding the efficacy and safety of stapokibart in SAR.
季节性变应性鼻炎(SAR)是一种主要由2型免疫反应介导的慢性炎症性疾病,通常由特定花粉引发。司他泊巴特是一种抗白细胞介素-4受体α亚基的人源化单克隆抗体,从而阻断白细胞介素-4和白细胞介素-13信号通路。司他泊巴特在健康成年人和SAR患者中的临床研究显示出良好的安全性和显著的临床疗效。司他泊巴特已在中国获批用于治疗成人特应性皮炎、伴有鼻息肉的慢性鼻-鼻窦炎和SAR。本文综述了司他泊巴特在SAR中的作用机制、药理学以及有关其疗效和安全性的现有临床试验数据。