Impact of smoking on biological treatment response in patients from the German Severe Asthma (GAN) Registry.

IF 8.2 1区医学 Q1 ALLERGY Journal of Allergy and Clinical Immunology-In Practice Pub Date : 2025-01-10 DOI:10.1016/j.jaip.2025.01.005

Slagjana Stoshikj, Leonie Biener, Andreas Renner, Christina Bal, Jonas Brugger, Christoph Krall, Katrin Milger, Christian Schulz, Margret Jandl, Rainer Ehmann, Olaf Schmidt, Roland Buhl, Eckard Hamelmann, Christian Taube, Stephanie Korn, Dirk Skowasch, Marco Idzko

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Abstract

Background: Clinical studies of biologics in severe asthma exclude smokers or ex-smokers (ExS) with over 10 pack-years (py). Thus, the effectiveness of this therapy in ex-smokers with severe asthma is not well understood.

Objectives: To assess the impact of smoking on clinical efficiency of biologics in patients with severe asthma from the German Asthma Net (GAN), a comprehensive international registry.

Methods: This analysis included 1129 patients (55.8 % females, mean age 53.82 ± 14.67) from which 56% were never-smokers (NS), while 44% were ExS (<10 py: 22.9%, 10-20 py: 10.3%, >20 py: 10.6%). They received benralizumab (38.3%), dupilumab (28.9%), mepolizumab (18.3%), omalizumab (14%), or reslizumab (0.5%).

Results: Biologic therapy significantly improved asthma control, measured by change in ACT, ACQ-5, and miniAQLQ, lung function, reduced exacerbations and daily oral prednisolone dose in all patients at week 52. Of note, no significant differences in asthma control between NS and ExS at week 52 (P=0.48, 0.09, and 0.15, respectively), were observed. Also, lung function improvement (FEV1, FVC, TLC, PEF, MEF50, P>0.05), reduction in AE (P=0.8) and OCS doses (P=0.15) were comparable in NS and ES. Markers of type 2 inflammation, such as fraction of exhaled nitric oxide (FeNO) and blood eosinophils, decreased in ex-smokers similarly to never-smokers (P=0.29 and P=0.48 respectively).

Conclusion: In summary, ex-smokers with severe asthma experienced similar improvements in asthma control, exacerbations, lung function and biomarkers as NS after one year of biologics, suggesting that severe asthmatics even with a substantial smoking history can benefit from biologic therapy.

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背景：生物制剂治疗重症哮喘的临床研究不包括吸烟者或吸烟超过 10 包年（py）的戒烟者（ExS）。因此，这种疗法对重症哮喘戒烟者的疗效尚不十分清楚：评估吸烟对德国哮喘网（GAN）（一个综合性国际注册机构）重症哮喘患者使用生物制剂临床疗效的影响：分析对象包括 1129 名患者（55.8% 为女性，平均年龄为 53.82 ± 14.67 岁），其中 56% 为从不吸烟者（NS），44% 为 ExS（20py：10.6%）。他们接受了苯拉利珠单抗（38.3%）、杜匹单抗（28.9%）、美博利珠单抗（18.3%）、奥马珠单抗（14%）或雷司利珠单抗（0.5%）治疗：生物疗法明显改善了所有患者的哮喘控制（以ACT、ACQ-5和miniAQLQ、肺功能的变化来衡量），减少了病情恶化，并在第52周时减少了每日口服泼尼松龙的剂量。值得注意的是，在第 52 周时，NS 和 ExS 的哮喘控制率无明显差异（P 分别为 0.48、0.09 和 0.15）。此外，NS 和 ES 的肺功能改善（FEV1、FVC、TLC、PEF、MEF50，P>0.05）、AE 减少（P=0.8）和 OCS 剂量减少（P=0.15）情况相当。2型炎症的标志物，如呼气一氧化氮（FeNO）和血液嗜酸性粒细胞，在戒烟者中的减少与从未吸烟者相似（分别为P=0.29和P=0.48）：总之，重症哮喘戒烟者在使用生物制剂一年后，在哮喘控制、病情恶化、肺功能和生物标志物方面的改善程度与NS相似，这表明即使有大量吸烟史的重症哮喘患者也能从生物制剂治疗中获益。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Allergy and Clinical Immunology-In Practice ALLERGYIMMUNOLOGY-IMMUNOLOGY

CiteScore

11.10

自引率

9.60%

发文量

683

审稿时长

50 days

期刊介绍： JACI: In Practice is an official publication of the American Academy of Allergy, Asthma & Immunology (AAAAI). It is a companion title to The Journal of Allergy and Clinical Immunology, and it aims to provide timely clinical papers, case reports, and management recommendations to clinical allergists and other physicians dealing with allergic and immunologic diseases in their practice. The mission of JACI: In Practice is to offer valid and impactful information that supports evidence-based clinical decisions in the diagnosis and management of asthma, allergies, immunologic conditions, and related diseases. This journal publishes articles on various conditions treated by allergist-immunologists, including food allergy, respiratory disorders (such as asthma, rhinitis, nasal polyps, sinusitis, cough, ABPA, and hypersensitivity pneumonitis), drug allergy, insect sting allergy, anaphylaxis, dermatologic disorders (such as atopic dermatitis, contact dermatitis, urticaria, angioedema, and HAE), immunodeficiency, autoinflammatory syndromes, eosinophilic disorders, and mast cell disorders. The focus of the journal is on providing cutting-edge clinical information that practitioners can use in their everyday practice or to acquire new knowledge and skills for the benefit of their patients. However, mechanistic or translational studies without immediate or near future clinical relevance, as well as animal studies, are not within the scope of the journal.