Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Nov 27;9(6):00383-2023.
doi: 10.1183/23120541.00383-2023. eCollection 2023 Nov.

Benralizumab in severe eosinophilic asthma in real life: confirmed effectiveness and contrasted effect on sputum eosinophilia versus exhaled nitric oxide fraction - PROMISE

Florence Schleich  1   2 , Catherine Moermans  1   2 , Laurence Seidel  2 , Céline Kempeneers  3 , Gilles Louis  1   2 , Florence Rogister  4 , Sophie Tombu  5 , Laurence Pottier  5 , Anne-Lise Poirrier  5 , Stéphanie Ziant  1   2 , Monique Henket  1   2 , Carole Sanchez  1   2 , Virginie Paulus  1   2 , Françoise Guissard  1   2 , Anne-Françoise Donneau  3 , Renaud Louis  1   2
Affiliations

Benralizumab in severe eosinophilic asthma in real life: confirmed effectiveness and contrasted effect on sputum eosinophilia versus exhaled nitric oxide fraction - PROMISE

Florence Schleich et al. ERJ Open Res. .

Abstract

Background: Randomised controlled trials have shown that benralizumab, an anti-interleukin-5 receptor monoclonal antibody, reduces exacerbations and oral corticosteroid dose and improves asthma control and lung function in severe eosinophilic asthma. The aim of this study was to confirm results of randomised controlled trials in real life in a population of 73 patients with severe eosinophilic asthma treated with benralizumab for at least 12 months.

Methods: Patients underwent careful monitoring of asthma exacerbations, exhaled nitric oxide fraction, lung function, asthma control and quality of life questionnaire responses and sputum induction, and gave a blood sample at baseline, after 6 months and then every year.

Results: We found significant reductions in exacerbations (by 92%, p<0.0001) and oral corticosteroid dose (by 83%, p<0.001) after 6 months that were maintained over time, with 78% of patients able to stop oral corticosteroid therapy. Patients improved their Asthma Control Test (ACT) score (from 11.7±5.1 to 16.9±5.35, p<0.0001), Asthma Control Questionnaire (ACQ) score (from 2.88±1.26 to 1.77±1.32, p<0.0001) and Asthma Quality of Life Questionnaire score (+1.04, p<0.0001) at 6 months and this was maintained during follow-up. Only 35% and 43% of patients reached asthma control according to an ACT score ≥20 and ACQ score <1.5, respectively. We observed stable post-bronchodilation lung function over time and a significant reduction in sputum eosinophil count, with 85% of patients exhibiting sputum eosinophil counts <3% after 6 months (p<0.01) with no effect on exhaled nitric oxide fraction.

Conclusion: In our real-life study, we confirm the results published in randomised controlled trials showing a sharp reduction in exacerbations and oral corticosteroid therapy, an improvement in asthma control and quality of life, and a dramatic reduction in sputum eosinophil count.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest: F. Schleich reports grants or contracts from GSK, AstraZeneca, Chiesi and Novartis, outside the submitted work; consulting fees from GSK, AstraZeneca, Chiesi and Novartis, outside the submitted work; and lectures for GSK, AstraZeneca, Chiesi and Novartis, outside the submitted work. Conflict of interest: A-L. Poirrier reports a speaker honorarium from GlaxoSmithKline Pharmaceuticals SA outside the submitted work; and advisory board honoraria from GlaxoSmithKline Pharmaceuticals SA and Sanofi Aventis Belgium SA, outside the submitted work. Conflict of interest: R. Louis reports grants or contracts from GSK, AstraZeneca and Chiesi, outside the submitted work; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from GSK, AstraZeneca, Chiesi and TEVA, outside the submitted work; and participation on a data safety monitoring or advisory board for GSK and AstraZeneca, outside the submitted work. Conflict of interest: The remaining authors have nothing to disclose.

Figures

FIGURE 1
FIGURE 1
a) Exacerbations, b) oral corticosteroid (OCS) dose (prednisolone equivalent), c) inhaled corticosteroid (ICS) dose (beclomethasone equivalent), d) Asthma Control Questionnaire-6 item (ACQ-6), e) Asthma Control Test (ACT) and f) Asthma Quality of Life Questionnaire (AQLQ) global score at baseline (n=73) and after 6 months (n=73), 18 months (n=44) and 30 months (n=24) of benralizumab treatment. The dark blue line represents the median and the green whiskers represent the 95% CI of the median. The light blue box and whiskers represent the 95% CI of all data. *: p<0.05; **: p<0.001; ***: p<0.0001.
FIGURE 2
FIGURE 2
a) Blood eosinophil count, b) fraction of exhaled nitric oxide (FENO), c) sputum eosinophil count, d) absolute post-bronchodilation (BD) forced expiratory volume in 1 s (FEV1), e) post-BD FEV1 % predicted and f) post-BD FEV1/forced vital capacity (FVC) at baseline (n=73) and after 6 months (n=73), 18 months (n=44) and 30 months (n=24) of benralizumab treatment. Number of data available for sputum eosinophils are indicated on c. The dark blue line represents the median and the green whiskers represent the 95% CI of the median. The light blue box and whiskers represent the 95% CI of all data. ***: p<0.0001.
FIGURE 3
FIGURE 3
Study flow chart. OCS: oral corticosteroid.
See this image and copyright information in PMC

References

    1. Schleich FN, Chevremont A, Paulus V, et al. Importance of concomitant local and systemic eosinophilia in uncontrolled asthma. Eur Respir J 2014; 44: 97–108. doi: 10.1183/09031936.00201813 - DOI - PubMed
    1. Schleich F, Brusselle G, Louis R, et al. Heterogeneity of phenotypes in severe asthmatics. The Belgian Severe Asthma Registry (BSAR). Respir Med 2014; 108: 1723–1732. doi: 10.1016/j.rmed.2014.10.007 - DOI - PubMed
    1. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43: 343–373. doi: 10.1183/09031936.00202013 - DOI - PubMed
    1. Schleich F, Bougard N, Moermans C, et al. Cytokine-targeted therapies for asthma and COPD. Eur Respir Rev 2023; 32: 220193. doi: 10.1183/16000617.0193-2022 - DOI - PMC - PubMed
    1. Rådinger M, Lötvall J. Eosinophil progenitors in allergy and asthma – do they matter? Pharmacol Ther 2009; 121: 174–184. doi: 10.1016/j.pharmthera.2008.10.008 - DOI - PubMed