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

IF 3.6 3区 医学 Q1 RESPIRATORY SYSTEM
Maéva Zysman, Fanchon Herman, Léo Grassion, Camille Taillé, Jesus Gonzalez-Bermejo, Marina Guecamburu, Nicolas Roche, Arthur Pavot, Pierre-Olivier Girodet, Arnaud Bourdin, Nicolas Molinari, Patrick Berger
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引用次数: 0

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.

在现实生活中的COPD或哮喘-COPD重叠患者中,生物制剂的真正目标人群是什么?
简介:生物制剂对哮喘有显著益处,可减少病情恶化和症状。一些生物制剂在慢性阻塞性肺疾病(COPD)和频繁加重的小亚组患者中显示出有希望的结果。然而,关于COPD目标人群规模的真实数据仍然很少。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和哮喘队列的COPD、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各种靶向白介素33 (IL-33)(受体)、IL-5(受体)、IL-4Rα或TSLP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,只有21.7%符合至少一种生物制剂的纳入标准。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的共存特征,并符合至少一项生物学指标的纳入标准。值得注意的是,这些患者以女性为主,肺功能较差。在全球范围内,期待已久的生物制剂的目标慢性气道疾病人群仍然局限于一小部分(即1.3%-8%,取决于生物制剂)。结论:在现实生活中的COPD和哮喘人群(包括具有COPD特征的哮喘患者)中,在评估生物制剂疗效的随机对照试验中,满足选择标准的患者比例仍然限制在整个人群的10%以下。
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来源期刊
BMJ Open Respiratory Research
BMJ Open Respiratory Research RESPIRATORY SYSTEM-
CiteScore
6.60
自引率
2.40%
发文量
95
审稿时长
12 weeks
期刊介绍: BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.
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