Department of Biomedical Sciences, Humanitas University , Pieve Emanuele , Italy.
Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS , Rozzano , Italy.
Expert Rev Clin Immunol. 2019 Sep;15(9):951-958. doi: 10.1080/1744666X.2019.1653758. Epub 2019 Aug 12.
: The precision medicine approach that is now mandatory for severe asthma management includes the use of novel biologic agents blocking specific immunological mechanisms that are responsible for disease phenotypes and endotypes: monoclonal antibodies blocking IgE, IL-5 and IL-4/IL-13 immunological pathways are so far available. : Clinical trials involving a large number of patients proved their efficacy in reducing asthma exacerbations, improving lung function and quality of life, and reducing the need for systemic corticosteroid treatment. Since biologics have been available for routine use, a series of real-life experiences on severe asthmatics treated with them have been published: these studies confirmed the beneficial effects in a real-world setting (effectiveness) of these drugs and showed novel aspects that were not covered by clinical trials, such as their effect on particular subgroup of patients, unexpected adverse events, and potential novel indications. : Both clinical trials and real-life experiences are needed to establish robust data on biologic agents for severe asthma, with real-life studies giving more broader insights on different aspects related to the biologics themselves and to the disease.
目前，严重哮喘管理必须采用精准医疗方法，包括使用新型生物制剂来阻断导致疾病表型和内型的特定免疫机制：目前已有阻断 IgE、IL-5 和 IL-4/IL-13 免疫途径的单克隆抗体。大量临床试验证明，这些药物在减少哮喘恶化、改善肺功能和生活质量以及减少全身皮质类固醇治疗需求方面具有疗效。由于生物制剂已可常规使用，因此已发表了一系列关于使用这些药物治疗严重哮喘患者的真实生活经验：这些研究在真实环境中（有效性）证实了这些药物的有益效果，并显示出临床试验未涵盖的新方面，例如它们对特定亚组患者、意外不良事件和潜在新适应症的影响。需要临床试验和真实生活经验来为严重哮喘的生物制剂建立可靠的数据，真实生活研究为生物制剂本身和疾病的不同方面提供了更广泛的见解。
