Real-world clinical remission of severe asthma with benralizumab in Spanish adults with severe asthma

Abstract

Objective

Patients with severe eosinophilic asthma experience high risk of exacerbations and reduced quality of life. Benralizumab, a monoclonal antibody binding to IL-5 receptor α subunit, is an approved drug for its treatment. The objective was to describe clinical remission after benralizumab prescription in routine clinical practice.

Methods

Retrospective multicenter study with data from four hospitals in Valencian Community (Spain) with asthma units between 2019 and 2020. Data was gathered at baseline and after 12 months. We considered clinical remission after 1 year if the patient remained without exacerbations and use of systemic corticosteroids and with good clinical control and normal lung function.

Results

Data from 139 patients was gathered. At the 12-month follow-up, 44.1% were in clinical remission, since 84.0%, 77.5%, 51.0% and 95.5% of patients did not experience exacerbations, had total asthma control test score of ≥20, prebronchodilator FEV₁ of ≥80% and did not use systemic corticosteroids. A significant reduction of long-acting muscarinic antagonists (p = 0.0001), leukotriene receptor antagonists (p = 0.0326), oral corticosteroids (p < 0.0001) and short-acting beta agonists (p = 0.0499) was observed. Baseline factors with greatest individual influence on clinical remission were employment situation, tobacco use, comorbidity number, eosinophil value, number of exacerbations, FEV₁, emergency visit number, and ACT, MiniAQLQ and TAI scores. Final analysis of multiple logistic regression indicated that having baseline FEV₁ value below 80% increases remission chance 9.7 times a year compared to FEV₁ >80%.

Conclusion

Clinical remission after treatment with benralizumab is achievable in a high percentage of patients with severe asthma eosinophilia not controlled in real life.

Keywords:

• Benralizumab
• clinical remission
• biological treatment
• real-world
• severe asthma

Acknowledgments

Medical writing assistance was provided by Meisys S.A. (Madrid, Spain).

Ethical approval

The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP) and applicable regulatory requirements.

Informed consent

Written informed consent was obtained from all included patients. Ethics committee approval was obtained on 20 September 2020. Patient medical information obtained for this study was confidential and could only be disclosed to the researchers and third parties involved as provided in the informed consent form signed by the patients. Data from all participating sites were combined into a single anonymized dataset for analysis. AstraZeneca maintained confidentiality standards through the assignment of a unique subject identification number for each patient enrolled in this study.

Author contributions

All authors contributed equally to this work.

Disclosure statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: EMM reports personal fees and non-financial support from NOVARTIS, personal fees from ASTRA-ZENECA, personal fees and non-financial support from GSK, and personal fees from TEVA. E Ch reports non-financial support from NOVARTIS and personal fees and non-financial support from TEVA, GSK and Astra-Zeneca. MPC reports personal fees and non-financial support from NOVARTIS, personal fees from ASTRA-ZENECA, personal fees and non-financial support from GSK, and personal fees from TEVA. I LL reports personal fees and non-financial support from NOVARTIS, personal fees from ASTRA-ZENECA, personal fees and non-financial support from GSK, and personal fees from TEVA. Other authors have no relevant COIs to disclose outside the submitted work.

Additional information

Funding

We would like to acknowledge AstraZeneca, Spain, for their financial support.