生物治疗时代英国严重哮喘登记处严重哮喘患者的特征
2021/01/28
摘要
背景：英国严重哮喘登记（UKSAR）是世界上收集转诊至英国专科的标准化数据的最大的国家严重哮喘登记中心，。新型生物疗法改变了尽管使用皮质类固醇抑制了T2细胞因子途径，但仍然有持续症状的2型（T2）重症哮喘患者的治疗方法。
方法：对符合欧洲呼吸学会/美国胸科学会重症哮喘标准，来自15个专科重症哮喘中心的2225名患者的人口学，临床和治疗特征进行了统计。我们比较了生物标志物低的患者（呼出一氧化氮（FeNO）<25 ppb，血液嗜酸性粒细胞<150/μL）与生物标志物高的人群（FeNO≥25 ppb，血液嗜酸性粒细胞≥150/μL）的差异。
结果：年龄（平均49.6（14.3）岁），哮喘发作年龄（24.2（19.1）岁）和女性占优势（62.4%）与之前的严重哮喘队列一致。尽管使用高剂量可吸入激素（维持性口服皮质类固醇激素（mOCS）为51.7%），但仍症状控制不佳（哮喘控制问卷-6：2.9（1.4））伴有高急性发作率（4（IQR:2,7））是常见的。68.9%的患者接受了包括美泊利单抗（50.3%），benralizumab（26.1%）和奥马珠单抗（22.6%）在内的生物治疗。低T2患者体重指数较高（32.1 vs 30.2，p<0.001），抑郁/焦虑患病率高（12.3% vs 7.6%，p=0.04）和mOCS使用者多（57.9% vs 42.1%，p<0.001）。许多低T2哮喘患者有血液嗜酸性粒细胞计数升高的证据（0.35（0.13，0.60））。
结论：UKSAR描述了被转诊到英国重症哮喘专科服务机构的哮喘患者的特征。它在一系列研究领域提供了新见解的前景，并强调了有大量哮喘控制不佳、肺功能受损和高急性发作率需得到有效控制的需求。高T2表型与低T2患者明显不同并占主要地位。然而，低T2的患者常有既往血液嗜酸性粒细胞增多并可能与皮质类固醇的暴露相一致。
Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era
David J Jackson, John Busby, Paul E Pfeffer, Andrew Menzies-Gow, Thomas Brown, Robin Gore, Martin Doherty, Adel H Mansur, Simon Message, Robert Niven, Mitesh Patel, Liam G Heaney, UK Severe Asthma Registry
Abstract
Background: The UK Severe Asthma Registry (UKSAR) is the world's largest national severe asthma registry collecting standardised data on referrals to UK specialist services. Novel biologic therapies have transformed the management of type 2(T2)-high severe asthma but have highlighted unmet need in patients with persisting symptoms despite suppression of T2-cytokine pathways with corticosteroids.
Methods: Demographic, clinical and treatments characteristics for patients meeting European Respiratory Society / American Thoracic Society severe asthma criteria were examined for 2225 patients attending 15 specialist severe asthma centres. We assessed differences in biomarker low patients (fractional exhaled nitric oxide (FeNO) <25 ppb, blood eosinophils <150/μL) compared with a biomarker high population (FeNO ≥25 ppb, blood eosinophils ≥150/µL).
Results: Age (mean 49.6 (14.3) y), age of asthma onset (24.2 (19.1) y) and female predominance (62.4%) were consistent with prior severe asthma cohorts. Poor symptom control (Asthma Control Questionnaire-6: 2.9 (1.4)) with high exacerbation rate (4 (IQR: 2, 7)) were common despite high-dose treatment (51.7% on maintenance oral corticosteroids (mOCS)). 68.9% were prescribed biologic therapies including mepolizumab (50.3%), benralizumab (26.1%) and omalizumab (22.6%). T2-low patients had higher body mass index (32.1 vs 30.2, p<0.001), depression/anxiety prevalence (12.3% vs 7.6%, p=0.04) and mOCS use (57.9% vs 42.1%, p<0.001). Many T2-low asthmatics had evidence of a historically elevated blood eosinophil count (0.35 (0.13, 0.60)).
Conclusions: The UKSAR describes the characteristics of a large cohort of asthmatics referred to UK specialist severe asthma services. It offers the prospect of providing novel insights across a range of research areas and highlights substantial unmet need with poor asthma control, impaired lung function and high exacerbation rates. T2-high phenotypes predominate with significant differences apparent from T2-low patients. However, T2-low patients frequently have prior blood eosinophilia consistent with possible excessive corticosteroid exposure.
背景：英国严重哮喘登记（UKSAR）是世界上收集转诊至英国专科的标准化数据的最大的国家严重哮喘登记中心，。新型生物疗法改变了尽管使用皮质类固醇抑制了T2细胞因子途径，但仍然有持续症状的2型（T2）重症哮喘患者的治疗方法。
方法：对符合欧洲呼吸学会/美国胸科学会重症哮喘标准，来自15个专科重症哮喘中心的2225名患者的人口学，临床和治疗特征进行了统计。我们比较了生物标志物低的患者（呼出一氧化氮（FeNO）<25 ppb，血液嗜酸性粒细胞<150/μL）与生物标志物高的人群（FeNO≥25 ppb，血液嗜酸性粒细胞≥150/μL）的差异。
结果：年龄（平均49.6（14.3）岁），哮喘发作年龄（24.2（19.1）岁）和女性占优势（62.4%）与之前的严重哮喘队列一致。尽管使用高剂量可吸入激素（维持性口服皮质类固醇激素（mOCS）为51.7%），但仍症状控制不佳（哮喘控制问卷-6：2.9（1.4））伴有高急性发作率（4（IQR:2,7））是常见的。68.9%的患者接受了包括美泊利单抗（50.3%），benralizumab（26.1%）和奥马珠单抗（22.6%）在内的生物治疗。低T2患者体重指数较高（32.1 vs 30.2，p<0.001），抑郁/焦虑患病率高（12.3% vs 7.6%，p=0.04）和mOCS使用者多（57.9% vs 42.1%，p<0.001）。许多低T2哮喘患者有血液嗜酸性粒细胞计数升高的证据（0.35（0.13，0.60））。
结论：UKSAR描述了被转诊到英国重症哮喘专科服务机构的哮喘患者的特征。它在一系列研究领域提供了新见解的前景，并强调了有大量哮喘控制不佳、肺功能受损和高急性发作率需得到有效控制的需求。高T2表型与低T2患者明显不同并占主要地位。然而，低T2的患者常有既往血液嗜酸性粒细胞增多并可能与皮质类固醇的暴露相一致。
(中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校)
(Thorax. 2020 Dec 9; thoraxjnl-2020-215168. doi: 10.1136/thoraxjnl-2020-215168.)
(Thorax. 2020 Dec 9; thoraxjnl-2020-215168. doi: 10.1136/thoraxjnl-2020-215168.)
Characterisation of patients with severe asthma in the UK Severe Asthma Registry in the biologic era
David J Jackson, John Busby, Paul E Pfeffer, Andrew Menzies-Gow, Thomas Brown, Robin Gore, Martin Doherty, Adel H Mansur, Simon Message, Robert Niven, Mitesh Patel, Liam G Heaney, UK Severe Asthma Registry
Abstract
Background: The UK Severe Asthma Registry (UKSAR) is the world's largest national severe asthma registry collecting standardised data on referrals to UK specialist services. Novel biologic therapies have transformed the management of type 2(T2)-high severe asthma but have highlighted unmet need in patients with persisting symptoms despite suppression of T2-cytokine pathways with corticosteroids.
Methods: Demographic, clinical and treatments characteristics for patients meeting European Respiratory Society / American Thoracic Society severe asthma criteria were examined for 2225 patients attending 15 specialist severe asthma centres. We assessed differences in biomarker low patients (fractional exhaled nitric oxide (FeNO) <25 ppb, blood eosinophils <150/μL) compared with a biomarker high population (FeNO ≥25 ppb, blood eosinophils ≥150/µL).
Results: Age (mean 49.6 (14.3) y), age of asthma onset (24.2 (19.1) y) and female predominance (62.4%) were consistent with prior severe asthma cohorts. Poor symptom control (Asthma Control Questionnaire-6: 2.9 (1.4)) with high exacerbation rate (4 (IQR: 2, 7)) were common despite high-dose treatment (51.7% on maintenance oral corticosteroids (mOCS)). 68.9% were prescribed biologic therapies including mepolizumab (50.3%), benralizumab (26.1%) and omalizumab (22.6%). T2-low patients had higher body mass index (32.1 vs 30.2, p<0.001), depression/anxiety prevalence (12.3% vs 7.6%, p=0.04) and mOCS use (57.9% vs 42.1%, p<0.001). Many T2-low asthmatics had evidence of a historically elevated blood eosinophil count (0.35 (0.13, 0.60)).
Conclusions: The UKSAR describes the characteristics of a large cohort of asthmatics referred to UK specialist severe asthma services. It offers the prospect of providing novel insights across a range of research areas and highlights substantial unmet need with poor asthma control, impaired lung function and high exacerbation rates. T2-high phenotypes predominate with significant differences apparent from T2-low patients. However, T2-low patients frequently have prior blood eosinophilia consistent with possible excessive corticosteroid exposure.
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