Centre of Excellence in Severe Asthma and Priority Research Centre for Healthy Lungs, Faculty of Health, University of Newcastle, Newcastle, Australia.
Dept of Respiratory and Sleep Medicine, John Hunter Hospital, Newcastle, Australia.
Eur Respir J. 2020 May 21;55(5). doi: 10.1183/13993003.02420-2019. Print 2020 May.
Severe asthma is a high-burden disease. Real-world data on mepolizumab in patients with severe eosinophilic asthma is needed to assess whether the data from randomised controlled trials are applicable in a broader population.The Australian Mepolizumab Registry (AMR) was established with an aim to assess the use, effectiveness and safety of mepolizumab for severe eosinophilic asthma in Australia.Patients (n=309) with severe eosinophilic asthma (median age 60 years, 58% female) commenced mepolizumab. They had poor symptom control (median Asthma Control Questionnaire (ACQ)-5 score of 3.4), frequent exacerbations (median three courses of oral corticosteroids (OCS) in the previous 12 months), and 47% required daily OCS. Median baseline peripheral blood eosinophil level was 590 cells·µL Comorbidities were common: allergic rhinitis 63%, gastro-oesophageal reflux disease 52%, obesity 46%, nasal polyps 34%.Mepolizumab treatment reduced exacerbations requiring OCS compared with the previous year (annualised rate ratio 0.34 (95% CI 0.29-0.41); p<0.001) and hospitalisations (rate ratio 0.46 (95% CI 0.33-0.63); p<0.001). Treatment improved symptom control (median ACQ-5 reduced by 2.0 at 6 months), quality of life and lung function. Higher blood eosinophil levels (p=0.003) and later age of asthma onset (p=0.028) predicted a better ACQ-5 response to mepolizumab, whilst being male (p=0.031) or having body mass index ≥30 (p=0.043) predicted a lesser response. Super-responders (upper 25% of ACQ-5 responders, n=61, 24%) had a higher T2 disease burden and fewer comorbidities at baseline.Mepolizumab therapy effectively reduces the significant and long-standing disease burden faced by patients with severe eosinophilic asthma in a real-world setting.
重度哮喘是一种高负担疾病。需要真实世界的数据来评估美泊利珠单抗在重度嗜酸性粒细胞性哮喘患者中的疗效，以确定随机对照试验的数据是否适用于更广泛的人群。澳大利亚美泊利珠单抗登记研究（AMR）旨在评估美泊利珠单抗在澳大利亚用于重度嗜酸性粒细胞性哮喘的使用情况、疗效和安全性。
309 名重度嗜酸性粒细胞性哮喘患者（中位年龄 60 岁，58%为女性）开始接受美泊利珠单抗治疗。他们的症状控制不佳（中位哮喘控制问卷（ACQ-5）评分为 3.4），哮喘发作频繁（过去 12 个月中中位有 3 次口服皮质类固醇（OCS）疗程），47%需要每日使用 OCS。中位基线外周血嗜酸性粒细胞水平为 590 个/μL。合并症常见：过敏性鼻炎 63%、胃食管反流病 52%、肥胖 46%、鼻息肉 34%。
与前一年相比，美泊利珠单抗治疗减少了需要 OCS 的哮喘发作（年化率比值 0.34（95%CI 0.29-0.41）；p<0.001）和住院（率比值 0.46（95%CI 0.33-0.63）；p<0.001）。治疗改善了症状控制（中位 ACQ-5 在 6 个月时降低了 2.0）、生活质量和肺功能。更高的血嗜酸性粒细胞水平（p=0.003）和哮喘发病年龄较晚（p=0.028）预示着对美泊利珠单抗的 ACQ-5 反应更好，而男性（p=0.031）或 BMI≥30（p=0.043）预示着反应较差。超级应答者（ACQ-5 应答者中前 25%，n=61，24%）在基线时有更高的 T2 疾病负担和更少的合并症。
在真实环境中，美泊利珠单抗治疗有效地减轻了重度嗜酸性粒细胞性哮喘患者面临的重大且长期的疾病负担。
