Bavbek Sevim, Al-Ahmad Mona, Samaha Hala, Kathuria Pooran Chand, Fernandez Patricia, Al Busaidi Nasser, Ibrahim Tayseer, Mahboub Bassam, Haider Seema, Noibi Saeed, Levy Gur, Al-Lehebi Riyad Omar
Department of Chest Diseases, Division of Immunology and Allergic Diseases, Ankara University School of Medicine, Ankara, Türkiye.
Microbiology Department, College of Medicine, Kuwait University, Kuwait City, Kuwait.
Adv Ther. 2025 Aug 29. doi: 10.1007/s12325-025-03338-w.
Before the availability of biologic therapies, the main treatment for patients with severe asthma in Asia, Latin America, and the Middle East was oral corticosteroids (OCS), despite long-term use causing serious adverse effects. This post hoc analysis of the NUCALA Effectiveness Study (NEST) evaluated the effectiveness of mepolizumab, an anti-interleukin-5 monoclonal antibody, in patients with severe asthma and OCS dependence from regions with limited representation in real-world studies.
NEST was a multicountry, observational cohort study in adults with severe asthma from Colombia, Chile, India, Türkiye, Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar. Patients received ≥ 1 dose of 100 mg mepolizumab. OCS dependence was defined as receiving maintenance OCS at mepolizumab initiation or for ≥ 26 weeks during the 12 months prior. Data were collected 12 months pre- and post-initiation. Outcomes included OCS use, rate of clinically significant exacerbations (CSEs), and level of asthma symptom control.
Of 524 patients with OCS use data, 58.4% (n = 306) had OCS dependence pre-initiation. Mean (standard deviation) age was 49.2 (13.4) years; 73.9% (n = 226) were women. Of 251 patients with available data, 87.6% (n = 220) received lower OCS doses post-initiation and 68.9% (n = 173) stopped OCS use altogether. CSEs were reduced by 76.9% post-initiation. Of 222 patients with available data, 72.5% (n = 161) had improvements in Asthma Control Test scores post-initiation.
In patients with severe asthma and OCS dependence from the countries studied, mepolizumab reduced OCS use and dose, asthma exacerbations, and improved symptom control.
在生物疗法出现之前,亚洲、拉丁美洲和中东地区重度哮喘患者的主要治疗方法是口服糖皮质激素(OCS),尽管长期使用会导致严重的不良反应。这项对NUCALA有效性研究(NEST)的事后分析评估了抗白细胞介素-5单克隆抗体美泊利珠单抗在现实世界研究中代表性有限地区的重度哮喘且依赖OCS患者中的有效性。
NEST是一项针对来自哥伦比亚、智利、印度、土耳其、沙特阿拉伯、阿联酋、科威特、阿曼和卡塔尔的重度哮喘成人患者的多国观察性队列研究。患者接受≥1剂100mg美泊利珠单抗。OCS依赖定义为在开始使用美泊利珠单抗时接受维持性OCS治疗,或在之前12个月内接受维持性OCS治疗≥26周。在开始治疗前12个月和开始治疗后收集数据。结果包括OCS使用情况、具有临床意义的加重发作(CSE)率和哮喘症状控制水平。
在524例有OCS使用数据的患者中,58.4%(n = 306)在开始治疗前存在OCS依赖。平均(标准差)年龄为49.2(13.4)岁;73.9%(n = 226)为女性。在251例有可用数据的患者中,87.6%(n = 220)在开始治疗后接受的OCS剂量降低,68.9%(n = 173)完全停止使用OCS。开始治疗后CSE减少了76.9%。在222例有可用数据的患者中,72.5%(n = 161)在开始治疗后哮喘控制测试评分有所改善。
在所研究国家的重度哮喘且依赖OCS的患者中,美泊利珠单抗减少了OCS的使用和剂量,降低了哮喘发作次数,并改善了症状控制。