Gyawali Bishal, Georas Steve N, Khurana Sandhya
Division of Pulmonary and Critical Care Medicine, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Mary Parkes Center for Asthma, Allergy and Pulmonary Care, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Eur Respir Rev. 2025 Jan 8;34(175). doi: 10.1183/16000617.0088-2024. Print 2025 Jan.
Asthma is considered severe if it remains uncontrolled despite optimal conventional therapy, characterised by poor symptom control, frequent exacerbations and increased exposure to systemic corticosteroids. This has a significant impact on morbidity, mortality and healthcare resource utilisation. Recent advances in the understanding of asthma heterogeneity and immunopathogenesis have helped delineate precise disease pathways. The discovery of these pivotal pathways has led to the development of highly effective biologic therapies. Currently available asthma biologics target immunoglobulin E, interleukin (IL)-5/IL-5Rα, IL-4Rα and thymic stromal lymphopoietin. Identification of specific asthma phenotypes, utilising easily measurable biomarkers, has paved the way towards personalised and precision asthma management. Biologic therapies play a significant role in reducing exacerbations, hospitalisations and the need for maintenance systemic steroids, while also improving the quality of life in patients with severe asthma. The evidence for their clinical efficacy comes from randomised controlled trials (RCTs), extension studies, metanalyses and real-world data. This review synthesises findings from early, pivotal RCTs and subsequent studies following the approval of biologics for severe asthma. The safety and efficacy data from these studies, completed in a variety of settings, provide practical perspectives on their application and enhance their generalisability.
如果哮喘尽管接受了最佳的传统治疗仍未得到控制,其特征为症状控制不佳、频繁发作以及全身用糖皮质激素暴露增加,则被视为重度哮喘。这对发病率、死亡率和医疗资源利用有重大影响。对哮喘异质性和免疫发病机制认识的最新进展有助于明确精确的疾病途径。这些关键途径的发现导致了高效生物疗法的开发。目前可用的哮喘生物制剂靶向免疫球蛋白E、白细胞介素(IL)-5/IL-5Rα、IL-4Rα和胸腺基质淋巴细胞生成素。利用易于测量的生物标志物识别特定的哮喘表型,为个性化和精准哮喘管理铺平了道路。生物疗法在减少发作、住院次数以及维持全身用类固醇的需求方面发挥着重要作用,同时还改善了重度哮喘患者的生活质量。其临床疗效的证据来自随机对照试验(RCT)、扩展研究、荟萃分析和真实世界数据。本综述综合了重度哮喘生物制剂获批后的早期关键RCT及后续研究的结果。这些在各种环境中完成的研究的安全性和有效性数据为其应用提供了实用观点,并增强了其普遍性。