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靶向白细胞介素-5/5 受体生物制剂治疗伴有支气管扩张症的严重嗜酸性粒细胞性哮喘的真实世界疗效。

Real-World Effectiveness of IL-5/5Ra Targeted Biologics in Severe Eosinophilic Asthma With Comorbid Bronchiectasis.

机构信息

Department of Pulmonology, Haga Teaching Hospital, The Hague, the Netherlands.

Department of Clinical Pharmacy and Pharmacology, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.

出版信息

J Allergy Clin Immunol Pract. 2023 Sep;11(9):2724-2731.e2. doi: 10.1016/j.jaip.2023.05.041. Epub 2023 Jun 7.

DOI:10.1016/j.jaip.2023.05.041
PMID:37295671
Abstract

BACKGROUND

Bronchiectasis is a common comorbidity in patients with asthma and is associated with increased disease severity. In patients with severe eosinophilic asthma, biologics targeting IL-5/5Ra have beneficial effects on oral corticosteroid (OCS) use and exacerbation frequency. However, how coexisting bronchiectasis affects the response to such treatments is unknown.

OBJECTIVE

To evaluate the real-world effectiveness of anti-IL-5/5Ra therapy in patients with severe eosinophilic asthma and comorbid bronchiectasis on exacerbation frequency and daily maintenance and cumulative OCS dose.

METHODS

This real-world study evaluated data from 97 adults with severe eosinophilic asthma and computed tomography-confirmed bronchiectasis from the Dutch Severe Asthma Registry, who initiated anti-IL5/5Ra biologics (mepolizumab, reslizumab, and benralizumab) and had follow-up data for 12 months or greater. The analysis was performed for the total population and subgroups with or without maintenance OCS use.

RESULTS

Anti-IL-5/5Ra therapy significantly reduced exacerbation frequency in patients with maintenance OCS use as well as in those without it. In the year before biologic initiation, 74.5% of all patients had two or more exacerbations, which decreased to 22.1% in the follow-up year (P < .001). The proportion of patients on maintenance OCS decreased from 47% to 30% (P < .001), and in the OCS-dependent patients (n = 45) maintenance OCS dose decreased from median (interquartile range) of 10.0 mg/d (5-15 mg/d) to 2.5 mg/d (0-5 mg/d) after 1 year (P < .001).

CONCLUSIONS

This real-world study shows that anti-IL-5/5Ra therapy reduces exacerbation frequency and daily maintenance as well as the cumulative OCS dose in patients with severe eosinophilic asthma and comorbid bronchiectasis. Although it is an exclusion criterion in phase 3 trials, comorbid bronchiectasis should not preclude anti-IL-5/5Ra therapy in patients with severe eosinophilic asthma.

摘要

背景

支气管扩张症是哮喘患者常见的合并症,与疾病严重程度增加有关。在重度嗜酸性粒细胞性哮喘患者中,靶向 IL-5/5Ra 的生物制剂对口服皮质类固醇(OCS)的使用和加重频率有有益影响。然而,共存的支气管扩张症如何影响此类治疗的反应尚不清楚。

目的

评估抗 IL-5/5Ra 治疗在伴有 CT 证实的支气管扩张症的重度嗜酸性粒细胞性哮喘患者中的真实世界疗效,评估其对加重频率、每日维持治疗和累积 OCS 剂量的影响。

方法

本真实世界研究评估了来自荷兰重度哮喘登记处的 97 名重度嗜酸性粒细胞性哮喘且 CT 证实存在支气管扩张症的成年人的数据,这些患者接受了抗 IL5/5Ra 生物制剂(美泊利珠单抗、瑞利珠单抗和贝那利珠单抗)治疗,且随访时间超过 12 个月。对所有患者及使用或不使用维持 OCS 的患者亚组进行了分析。

结果

抗 IL-5/5Ra 治疗可显著降低使用和不使用维持 OCS 的患者的加重频率。在开始生物制剂治疗前的 1 年中,所有患者中有 74.5%发生了 2 次或更多次加重,而在随访的 1 年中,这一比例下降到 22.1%(P<0.001)。使用维持 OCS 的患者比例从 47%降至 30%(P<0.001),而在依赖 OCS 的患者(n=45)中,维持 OCS 剂量从中位数(四分位间距)10.0mg/d(5-15mg/d)降至 1 年后的 2.5mg/d(0-5mg/d)(P<0.001)。

结论

本真实世界研究表明,抗 IL-5/5Ra 治疗可降低重度嗜酸性粒细胞性哮喘伴支气管扩张症患者的加重频率、每日维持治疗和累积 OCS 剂量。虽然在 3 期试验中这是排除标准,但在重度嗜酸性粒细胞性哮喘患者中,共存的支气管扩张症不应排除抗 IL-5/5Ra 治疗。

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