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. 2025 May;13(5):1125-1138.e4.
doi: 10.1016/j.jaip.2025.01.005. Epub 2025 Jan 10.

Impact of Smoking on Biological Treatment Response in Patients From the German Severe Asthma (GAN) Registry

Slagjana Stoshikj  1 , Leonie Biener  2 , Andreas Renner  1 , Christina Bal  1 , Jonas Brugger  3 , Christoph Krall  3 , Katrin Milger  4 , Christian Schulz  5 , Margret Jandl  6 , Rainer Ehmann  7 , Olaf Schmidt  8 , Roland Buhl  9 , Eckard Hamelmann  10 , Christian Taube  11 , Stephanie Korn  12 , Dirk Skowasch  2 , Marco Idzko  13
Affiliations
Free article

Impact of Smoking on Biological Treatment Response in Patients From the German Severe Asthma (GAN) Registry

Slagjana Stoshikj et al. J Allergy Clin Immunol Pract. 2025 May.
Free article

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 ExS 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, a comprehensive international registry.

Methods: This analysis included 1129 patients (55.8% female, mean age: 53.82 ± 14.67 years), of whom 56% were never-smokers (NS), whereas 44% were ExS (<10 py: 22.9%, 10-20 py: 10.3%, and >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 Asthma Control Test, Asthma Control Questionnaire-5, and Mini-Asthma Quality of Life Questionnaire, 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 = .48, .09, and .15, respectively) were observed. Also, lung function improvement (forced expiratory volume in 1 second, forced vital capacity, total lung capacity, peak expiratory flow, mean expiratory flow at 50%, P > .05), and reduction in acute exacerbation (P = .8) and oral corticosteroid doses (P = .15) were comparable in NS and ExS. Markers of type 2 inflammation, such as fraction of exhaled nitric oxide and blood eosinophils, decreased in ExS similar to NS (P = .29 and P = .48, respectively).

Conclusion: ExS with severe asthma experienced similar improvements in asthma control, exacerbations, lung function, and biomarkers as NS after 1 year of biologics, suggesting that severe asthmatics even with a substantial smoking history can benefit from biologic therapy.

Keywords: Asthma control; Biologics; Biomarkers; Exacerbations; Lung function; Pack-years; Registry; Severe asthma; Smoking.

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