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在现实生活中的慢性阻塞性肺疾病(COPD)患者或哮喘-慢性阻塞性肺疾病重叠综合征患者中,生物制剂的真正目标人群是什么?

What is the true target population for biologics in real-life COPD or asthma-COPD overlap patients?

作者信息

Zysman Maéva, Herman Fanchon, Grassion Léo, Taillé Camille, Gonzalez-Bermejo Jesus, Guecamburu Marina, Roche Nicolas, Pavot Arthur, Girodet Pierre-Olivier, Bourdin Arnaud, Molinari Nicolas, Berger Patrick

机构信息

Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, CIC 1401, Université de Bordeaux, Bordeaux, France

Département de Pneumologie, Service des Maladies Respiratoires, Hôpital du Haut Lévêque, CHU Bordeaux, Bordeaux, France.

出版信息

BMJ Open Respir Res. 2024 Dec 18;11(1):e002702. doi: 10.1136/bmjresp-2024-002702.

Abstract

INTRODUCTION

Biologics provide significant benefits in asthma, reducing exacerbations and symptoms. Some biologics have shown promising results in small subgroups of patients with chronic obstructive pulmonary disease (COPD) and frequent exacerbations. Nevertheless, real-life data on the size of the COPD target population remain scarce.

METHODS

We analysed the characteristics of COPD and coexisting asthma and COPD patients included in the prospective multicentre, French COhort of BRonchial obstruction and Asthma, between 2008 and 2023 and evaluated the number of patients who could correspond to the inclusion criteria of randomised controlled trials evaluating various biologics targeting interleukin 33 (IL-33) (-receptor), IL-5 (-receptor), IL-4Rα or TSLP, in routine clinical practice.

RESULTS

Among 434 COPD patients, only 21.7% met inclusion criteria for at least one biologic. Among patients with asthma, 54 (3.5%) had coexisting features of COPD in terms of age, smoking status and airflow obstruction and met inclusion criteria for at least one biologic. Notably, these patients were predominantly female, with worse lung function. Globally, the target chronic airway diseases population of the eagerly awaited biologics remains limited to a small part (ie, 1.3%-8%, depending on the biologic).

CONCLUSION

In a real-life COPD and asthma population (including asthmatic patients with features of COPD), the proportion of patients satisfying selection criteria applied in randomised controlled trials assessing the efficacy of biologics remains limited to less than 10% of the whole population.

摘要

引言

生物制剂在哮喘治疗中具有显著益处,可减少病情加重和症状。一些生物制剂在慢性阻塞性肺疾病(COPD)及频繁病情加重的小部分患者亚组中显示出了有前景的结果。然而,关于COPD目标人群规模的真实数据仍然匮乏。

方法

我们分析了2008年至2023年间纳入前瞻性多中心法国支气管阻塞与哮喘队列研究中的COPD患者以及合并哮喘和COPD患者的特征,并评估了在常规临床实践中符合评估针对白细胞介素33(IL-33)(-受体)、白细胞介素5(-受体)、白细胞介素4Rα或胸腺基质淋巴细胞生成素(TSLP)的各种生物制剂的随机对照试验纳入标准的患者数量。

结果

在434例COPD患者中,仅有21.7%符合至少一种生物制剂纳入标准。在哮喘患者中,54例(3.5%)在年龄、吸烟状况和气流阻塞方面具有COPD共存特征且符合至少一种生物制剂纳入标准。值得注意的是,这些患者以女性为主且肺功能较差。总体而言,备受期待的生物制剂的目标慢性气道疾病人群仍局限于一小部分(即1.3% - 8%,取决于生物制剂)。

结论

在真实生活中的COPD和哮喘人群(包括具有COPD特征的哮喘患者)中,满足评估生物制剂疗效的随机对照试验所应用选择标准的患者比例仍局限于整个人口的不到10%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b04b/11667443/c71af1d46276/bmjresp-11-1-g001.jpg

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