Sameer Desai PhD , Sophia Shen MD , Zosia Gryz BSc , Elizabeth Tullis MD , Anne L. Stephenson MD, PhD , Bradley S. Quon MD, MSc
{"title":"一项评估il -5靶向生物疗法治疗成人囊性纤维化患者哮喘和过敏性支气管肺曲菌病的多中心回顾性研究","authors":"Sameer Desai PhD , Sophia Shen MD , Zosia Gryz BSc , Elizabeth Tullis MD , Anne L. Stephenson MD, PhD , Bradley S. Quon MD, MSc","doi":"10.1016/j.chpulm.2025.100163","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Biologic therapies targeting T-helper cell type 2 (Th2) eosinophilic inflammation have been used for difficult-to-treat asthma and allergic bronchopulmonary aspergillosis (ABPA), but safety and efficacy data are limited in the cystic fibrosis (CF) population.</div></div><div><h3>Research Question</h3><div>Are Th2 biologic therapies targeting eosinophilic inflammation effective and safe when used in adults with CF with asthma and/or ABPA overlap?</div></div><div><h3>Study Design and Methods</h3><div>This was a retrospective multicenter study. Individuals with CF receiving Th2 biologic therapies for asthma or ABPA at 2 large adult CF centers between 2016 and 2021 were included. Treatment safety and effectiveness up to 12 months after biologic initiation were evaluated. Outcomes of interest included percent predicted FEV<sub>1</sub> (ppFEV<sub>1</sub>), rate of change in ppFEV<sub>1</sub>, cumulative systemic corticosteroid (SCS) dose, and frequency of pulmonary exacerbations (PExs).</div></div><div><h3>Results</h3><div>Forty adults with CF received Th2 biologic therapies targeting eosinophilic inflammation during the study period. A total of 38 were eligible for study inclusion, and all received IL-5-directed therapies (mepolizumab: n = 27, benralizumab: n = 11): 17 (45%) for asthma only and 21 for ABPA (55%) with or without asthma. No significant biologic-related adverse effects were observed. There was no statistical difference in ppFEV<sub>1</sub> from baseline to 12-months postbiologic initiation, but the rate of change in ppFEV<sub>1</sub> improved in the 12 months postbiologic vs prebiologic with a pre-to-post difference of 3.7% (95% CI, 1.2%-6.3%). SCS dose and frequency of PExs requiring hospitalization did not differ significantly in the 12 months before biologic vs after biologic initiation.</div></div><div><h3>Interpretation</h3><div>Our results show that in adults with CF, anti-IL-5 biologic therapies were well tolerated and can improve rate of change in lung function, but there was no impact on SCS use or PEx frequency. Further study is needed to better define the role of Th2 biologics in the era of highly effective modulator therapy.</div></div>","PeriodicalId":94286,"journal":{"name":"CHEST pulmonary","volume":"3 2","pages":"Article 100163"},"PeriodicalIF":0.0000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Multicenter Retrospective Study Evaluating IL-5-Targeted Biologic Therapies for the Treatment of Asthma and Allergic Bronchopulmonary Aspergillosis in Adults With Cystic Fibrosis\",\"authors\":\"Sameer Desai PhD , Sophia Shen MD , Zosia Gryz BSc , Elizabeth Tullis MD , Anne L. Stephenson MD, PhD , Bradley S. Quon MD, MSc\",\"doi\":\"10.1016/j.chpulm.2025.100163\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Biologic therapies targeting T-helper cell type 2 (Th2) eosinophilic inflammation have been used for difficult-to-treat asthma and allergic bronchopulmonary aspergillosis (ABPA), but safety and efficacy data are limited in the cystic fibrosis (CF) population.</div></div><div><h3>Research Question</h3><div>Are Th2 biologic therapies targeting eosinophilic inflammation effective and safe when used in adults with CF with asthma and/or ABPA overlap?</div></div><div><h3>Study Design and Methods</h3><div>This was a retrospective multicenter study. Individuals with CF receiving Th2 biologic therapies for asthma or ABPA at 2 large adult CF centers between 2016 and 2021 were included. Treatment safety and effectiveness up to 12 months after biologic initiation were evaluated. Outcomes of interest included percent predicted FEV<sub>1</sub> (ppFEV<sub>1</sub>), rate of change in ppFEV<sub>1</sub>, cumulative systemic corticosteroid (SCS) dose, and frequency of pulmonary exacerbations (PExs).</div></div><div><h3>Results</h3><div>Forty adults with CF received Th2 biologic therapies targeting eosinophilic inflammation during the study period. A total of 38 were eligible for study inclusion, and all received IL-5-directed therapies (mepolizumab: n = 27, benralizumab: n = 11): 17 (45%) for asthma only and 21 for ABPA (55%) with or without asthma. No significant biologic-related adverse effects were observed. There was no statistical difference in ppFEV<sub>1</sub> from baseline to 12-months postbiologic initiation, but the rate of change in ppFEV<sub>1</sub> improved in the 12 months postbiologic vs prebiologic with a pre-to-post difference of 3.7% (95% CI, 1.2%-6.3%). SCS dose and frequency of PExs requiring hospitalization did not differ significantly in the 12 months before biologic vs after biologic initiation.</div></div><div><h3>Interpretation</h3><div>Our results show that in adults with CF, anti-IL-5 biologic therapies were well tolerated and can improve rate of change in lung function, but there was no impact on SCS use or PEx frequency. 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引用次数: 0
摘要
背景：靶向t辅助细胞2型（Th2）嗜酸性粒细胞炎症的生物疗法已被用于治疗难以治疗的哮喘和过敏性支气管肺曲霉病（ABPA），但在囊性纤维化（CF）人群中的安全性和有效性数据有限。研究问题：针对嗜酸性粒细胞炎症的Th2生物疗法用于合并哮喘和/或ABPA重叠的成人CF患者是否有效和安全？研究设计与方法本研究为回顾性多中心研究。纳入了2016年至2021年间在2家大型成人CF中心接受Th2生物疗法治疗哮喘或ABPA的CF患者。评估生物起始治疗后12个月的安全性和有效性。结果包括预测FEV1百分比（ppFEV1）， ppFEV1变化率，累积全身皮质类固醇（SCS）剂量和肺恶化频率（PExs）。结果40例成年CF患者在研究期间接受了针对嗜酸性粒细胞炎症的Th2生物治疗。共有38例患者符合纳入研究的条件，所有患者均接受了il -5定向治疗（mepolizumab: n = 27, benralizumab: n = 11）：仅哮喘患者17例（45%），合并或不合并哮喘的ABPA患者21例（55%）。未观察到明显的生物相关不良反应。从基线到生物起始后12个月ppFEV1无统计学差异，但生物起始后12个月ppFEV1变变率与生物起始前相比有所改善，前后差异为3.7% （95% CI, 1.2%-6.3%）。在生物制剂开始前和生物制剂开始后的12个月内，需要住院治疗的PExs的SCS剂量和频率没有显着差异。我们的研究结果表明，在成年CF患者中，抗il -5生物疗法耐受性良好，可以改善肺功能变化率，但对SCS的使用或PEx频率没有影响。需要进一步的研究来更好地定义Th2生物制剂在高效调节剂治疗时代的作用。
A Multicenter Retrospective Study Evaluating IL-5-Targeted Biologic Therapies for the Treatment of Asthma and Allergic Bronchopulmonary Aspergillosis in Adults With Cystic Fibrosis
Background
Biologic therapies targeting T-helper cell type 2 (Th2) eosinophilic inflammation have been used for difficult-to-treat asthma and allergic bronchopulmonary aspergillosis (ABPA), but safety and efficacy data are limited in the cystic fibrosis (CF) population.
Research Question
Are Th2 biologic therapies targeting eosinophilic inflammation effective and safe when used in adults with CF with asthma and/or ABPA overlap?
Study Design and Methods
This was a retrospective multicenter study. Individuals with CF receiving Th2 biologic therapies for asthma or ABPA at 2 large adult CF centers between 2016 and 2021 were included. Treatment safety and effectiveness up to 12 months after biologic initiation were evaluated. Outcomes of interest included percent predicted FEV1 (ppFEV1), rate of change in ppFEV1, cumulative systemic corticosteroid (SCS) dose, and frequency of pulmonary exacerbations (PExs).
Results
Forty adults with CF received Th2 biologic therapies targeting eosinophilic inflammation during the study period. A total of 38 were eligible for study inclusion, and all received IL-5-directed therapies (mepolizumab: n = 27, benralizumab: n = 11): 17 (45%) for asthma only and 21 for ABPA (55%) with or without asthma. No significant biologic-related adverse effects were observed. There was no statistical difference in ppFEV1 from baseline to 12-months postbiologic initiation, but the rate of change in ppFEV1 improved in the 12 months postbiologic vs prebiologic with a pre-to-post difference of 3.7% (95% CI, 1.2%-6.3%). SCS dose and frequency of PExs requiring hospitalization did not differ significantly in the 12 months before biologic vs after biologic initiation.
Interpretation
Our results show that in adults with CF, anti-IL-5 biologic therapies were well tolerated and can improve rate of change in lung function, but there was no impact on SCS use or PEx frequency. Further study is needed to better define the role of Th2 biologics in the era of highly effective modulator therapy.
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