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评估斯塔波基巴特治疗季节性变应性鼻炎的效果。

Evaluating stapokibart in the treatment of seasonal allergic rhinitis.

作者信息

Wang Menglin, Li Jingyun, Zhang Luo, Zhang Yuan

机构信息

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.

出版信息

Immunotherapy. 2025 Aug;17(12):851-860. doi: 10.1080/1750743X.2025.2554562. Epub 2025 Sep 3.

DOI:10.1080/1750743X.2025.2554562
PMID:40900141
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12439562/
Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa62/12439562/e968f65e3595/IIMY_A_2554562_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa62/12439562/08ac559dbf9c/IIMY_A_2554562_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa62/12439562/e968f65e3595/IIMY_A_2554562_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa62/12439562/08ac559dbf9c/IIMY_A_2554562_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa62/12439562/e968f65e3595/IIMY_A_2554562_F0002_OC.jpg

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本文引用的文献

1
Targeting IL-13 and IL-4 in Asthma: Therapeutic Implications on Airway Remodeling in Severe Asthma.靶向白细胞介素-13和白细胞介素-4治疗哮喘:对重度哮喘气道重塑的治疗意义
Clin Rev Allergy Immunol. 2025 Apr 21;68(1):44. doi: 10.1007/s12016-025-09045-2.
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Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial.Stapokibart用于中重度季节性过敏性鼻炎:一项随机3期试验。
Nat Med. 2025 Apr 4. doi: 10.1038/s41591-025-03651-5.
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Stapokibart: First Approval.斯他泊基巴特:首次获批。
Drugs. 2025 May;85(5):715-720. doi: 10.1007/s40265-025-02151-7. Epub 2025 Mar 17.
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Medication adherence, sensory attributes, and adverse effects of intranasal corticosteroids in allergic rhinitis patients: A systematic review and meta-analysis.
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Long-term efficacy and safety of stapokibart for moderate-to-severe atopic dermatitis: 52-week results from a phase 3 trial.司他泊基巴特治疗中重度特应性皮炎的长期疗效和安全性:一项3期试验的52周结果
Allergy. 2025 May;80(5):1348-1357. doi: 10.1111/all.16368. Epub 2024 Oct 25.
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Stapokibart (CM310) targets IL-4Rα for the treatment of type 2 inflammation.斯塔波基巴特(CM310)靶向白细胞介素-4受体α用于治疗2型炎症。
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7
Anti-IL-4Rα monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.抗白细胞介素-4受体α单克隆抗体(CM310)用于慢性鼻-鼻窦炎伴鼻息肉患者(CROWNS-2):一项多中心、随机、双盲、安慰剂对照、平行组研究的原理与设计
Asia Pac Allergy. 2024 Aug;14(3):118-123. doi: 10.5415/apallergy.0000000000000156. Epub 2024 Aug 5.
8
Main Airborne Pollen Species and Characteristics of Allergic Rhinitis Patients with Pollen-Related Allergies in 13 Northern Chinese Cities.中国北方13个城市气传花粉主要种类及花粉相关性变应性鼻炎患者的特征
J Asthma Allergy. 2024 Aug 8;17:757-768. doi: 10.2147/JAA.S471540. eCollection 2024.
9
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BioDrugs. 2024 Sep;38(5):681-689. doi: 10.1007/s40259-024-00668-z. Epub 2024 Jul 31.
10
Efficacy and safety of stapokibart (CM310) in adults with moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 3 trial.Stapokibart(CM310)治疗中重度特应性皮炎成人患者的疗效和安全性:一项多中心、随机、双盲、安慰剂对照的3期试验。
J Am Acad Dermatol. 2024 Nov;91(5):984-986. doi: 10.1016/j.jaad.2024.07.1447. Epub 2024 Jul 20.