贝那利珠单抗治疗重症嗜酸性粒细胞性哮喘的最大真实世界有效性研究：ZEPHYR 2
2023/05/25
摘要
背景：贝那丽珠单抗是一种治疗重症嗜酸性粒细胞性哮喘的单克隆抗体。关于其在各种患者群体中的临床有效性的真实世界数据是有限的，例如在美国具有不同嗜酸性粒细胞水平的患者、既往生物制剂应用和长期随访。
目的：确定贝那丽珠单抗在不同哮喘患者队列中的有效性及其长期临床影响。
方法：将2017年11月至2019年6月接受贝那丽珠单抗治疗的哮喘患者纳入这项前后队列研究，该研究使用了美国医疗、实验室和药房保险索赔。比较指数前后12个月哮喘发作率。非互斥患者队列由血液嗜酸性粒细胞计数（<150、≥150、150-299、<300和≥300个细胞/μl）、从另一种生物方法的转换或指数后18或24个月的随访来定义。
结果：有429名患者纳入嗜酸性粒细胞队列中，349名患者纳入有生物制剂应用史队列中，419名患者接受了长期随访。在所有嗜酸性粒细胞队列亚组中，哮喘发作率从发病前的3.10-3.55‰下降到发病后的1.11-1.72‰（下降52%至64%；p＜0.001）。从奥马利珠单抗（3.25至1.25‰，62%）或美伯丽珠单抗（3.81至1.78‰，53%）转为贝那丽珠单抗的患者以及随访18个月（3.38至1.18‰，65%）或24个月（3.3 8至1.08‰，68%）的患者也出现了类似的下降（均p＜0.001）。在延长随访队列中，39%和49%的患者在指数后0-12个月和12-24个月内没有发作。
结论：贝那丽珠单抗在不同血嗜酸性粒细胞计数（包括<150至≥300个细胞/μl的嗜酸性粒细胞核计数）、从其他生物制剂转换或治疗长达24个月的真实世界患者中能显著改善哮喘控制。
Largest real-world effectiveness study of benralizumab for severe eosinophilic asthma: ZEPHYR 2
Donna Carstens, Diego J Maselli, Fan Mu, Erin E Cook, Danni Yang, Joshua A Young, Keith A Betts, Eduardo Genofre, Yen Chung
Abstract
Background: Benralizumab is a monoclonal antibody therapy for severe eosinophilic asthma. Real-world data on its clinical impact in various patient populations such as patients with varying eosinophil levels, prior biologic use, and extended follow-up in the US are limited.
Objective: To determine the effectiveness of benralizumab in different asthma patient cohorts and its long-term clinical impact.
Methods: Asthma patients treated with benralizumab from 11/2017-6/2019 with ≥2 exacerbations in the 12 months prior to benralizumab initiation (index) were included in this pre-post cohort study that used medical, laboratory, and pharmacy US insurance claims. Asthma exacerbation rates in the 12 months pre and post index were compared. Non-mutually exclusive patient cohorts were defined by blood eosinophil counts (<150, ≥150, 150-299, <300, and ≥300 cells/μl), a switch from another biologic, or follow-up for 18 or 24 months post index.
Results: There were 429 patients in the eosinophil cohort, 349 in the biologic-experienced cohort, and 419 with extended follow-up. In all eosinophil cohort subgroups, the asthma exacerbation rate decreased from 3.10-3.55 per patient-year (PPY) pre index to 1.11-1.72 PPY post index (52%-64% decrease; p<0.001). Similar decreases were observed in patients switching from omalizumab (3.25 to 1.25 PPY, 62%) or mepolizumab (3.81 to 1.78 PPY, 53%) to benralizumab and those followed up for 18 months (3.38 to 1.18 PPY, 65%) or 24 months (3.38 to 1.08 PPY, 68%) (all p<0.001). In the extended follow-up cohort, 39% and 49% had no exacerbations in the 0-12 and 12-24 months post index, respectively.
Conclusion: Benralizumab achieved significantly improved asthma control in real-world patients with different blood eosinophil counts, including eosinophil counts ranging from <150 to ≥300 cells/μl, switching from other biologics, or treated for up to 24 months.
背景：贝那丽珠单抗是一种治疗重症嗜酸性粒细胞性哮喘的单克隆抗体。关于其在各种患者群体中的临床有效性的真实世界数据是有限的，例如在美国具有不同嗜酸性粒细胞水平的患者、既往生物制剂应用和长期随访。
目的：确定贝那丽珠单抗在不同哮喘患者队列中的有效性及其长期临床影响。
方法：将2017年11月至2019年6月接受贝那丽珠单抗治疗的哮喘患者纳入这项前后队列研究，该研究使用了美国医疗、实验室和药房保险索赔。比较指数前后12个月哮喘发作率。非互斥患者队列由血液嗜酸性粒细胞计数（<150、≥150、150-299、<300和≥300个细胞/μl）、从另一种生物方法的转换或指数后18或24个月的随访来定义。
结果：有429名患者纳入嗜酸性粒细胞队列中，349名患者纳入有生物制剂应用史队列中，419名患者接受了长期随访。在所有嗜酸性粒细胞队列亚组中，哮喘发作率从发病前的3.10-3.55‰下降到发病后的1.11-1.72‰（下降52%至64%；p＜0.001）。从奥马利珠单抗（3.25至1.25‰，62%）或美伯丽珠单抗（3.81至1.78‰，53%）转为贝那丽珠单抗的患者以及随访18个月（3.38至1.18‰，65%）或24个月（3.3 8至1.08‰，68%）的患者也出现了类似的下降（均p＜0.001）。在延长随访队列中，39%和49%的患者在指数后0-12个月和12-24个月内没有发作。
结论：贝那丽珠单抗在不同血嗜酸性粒细胞计数（包括<150至≥300个细胞/μl的嗜酸性粒细胞核计数）、从其他生物制剂转换或治疗长达24个月的真实世界患者中能显著改善哮喘控制。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校)
(J Allergy Clin Immunol Pract. 2023 May 3;S2213-2198(23)00470-1. doi: 10.1016/j.jaip.2023.04.029.)
(J Allergy Clin Immunol Pract. 2023 May 3;S2213-2198(23)00470-1. doi: 10.1016/j.jaip.2023.04.029.)
Largest real-world effectiveness study of benralizumab for severe eosinophilic asthma: ZEPHYR 2
Donna Carstens, Diego J Maselli, Fan Mu, Erin E Cook, Danni Yang, Joshua A Young, Keith A Betts, Eduardo Genofre, Yen Chung
Abstract
Background: Benralizumab is a monoclonal antibody therapy for severe eosinophilic asthma. Real-world data on its clinical impact in various patient populations such as patients with varying eosinophil levels, prior biologic use, and extended follow-up in the US are limited.
Objective: To determine the effectiveness of benralizumab in different asthma patient cohorts and its long-term clinical impact.
Methods: Asthma patients treated with benralizumab from 11/2017-6/2019 with ≥2 exacerbations in the 12 months prior to benralizumab initiation (index) were included in this pre-post cohort study that used medical, laboratory, and pharmacy US insurance claims. Asthma exacerbation rates in the 12 months pre and post index were compared. Non-mutually exclusive patient cohorts were defined by blood eosinophil counts (<150, ≥150, 150-299, <300, and ≥300 cells/μl), a switch from another biologic, or follow-up for 18 or 24 months post index.
Results: There were 429 patients in the eosinophil cohort, 349 in the biologic-experienced cohort, and 419 with extended follow-up. In all eosinophil cohort subgroups, the asthma exacerbation rate decreased from 3.10-3.55 per patient-year (PPY) pre index to 1.11-1.72 PPY post index (52%-64% decrease; p<0.001). Similar decreases were observed in patients switching from omalizumab (3.25 to 1.25 PPY, 62%) or mepolizumab (3.81 to 1.78 PPY, 53%) to benralizumab and those followed up for 18 months (3.38 to 1.18 PPY, 65%) or 24 months (3.38 to 1.08 PPY, 68%) (all p<0.001). In the extended follow-up cohort, 39% and 49% had no exacerbations in the 0-12 and 12-24 months post index, respectively.
Conclusion: Benralizumab achieved significantly improved asthma control in real-world patients with different blood eosinophil counts, including eosinophil counts ranging from <150 to ≥300 cells/μl, switching from other biologics, or treated for up to 24 months.
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支气管热成形术治疗超重/肥胖和低生活质量哮喘患者的疗效
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Tezepelumab治疗重症、未控制哮喘的疗效：PATHWAY和NAVIGATOR研究的汇总分析
