Analysis of response of severe eosinophilic asthmatic patients to benralizumab

Main Article Content

Juan Carlos Miralles-López https://orcid.org/0000-0001-8811-3939
Rubén Andújar-Espinosa https://orcid.org/0000-0002-6714-9438
Francisco Javier Bravo-Gutiérrez
Manuel Castilla-Martínez https://orcid.org/0000-0001-6832-1474
Isabel Flores-Martín
María Loreto Alemany-Francés
Manuel José Pajarón-Fernández https://orcid.org/0000-0001-6221-1901
Ana Mora-González
Sheila Cabrejos-Perotti
Zouhair El-Molaka
José Meseguer-Arce
María Jesús Avilés-Inglés
José Valverde-Molina https://orcid.org/0000-0002-1971-7613
Virginia Pérez-Fernández https://orcid.org/0000-0003-1877-3055
RE-ASGRAMUR Group

Keywords

benralizumab, corticosteroid intake, exacerbations, response analysis, severe asthma

Abstract

Introduction: Clinical trials and real-life studies have been published showing effectiveness of benralizumab in severe eosinophilic asthmatic patients. The aim of the present study is to describe super-responders to benralizumab in a series of 79 patients who completed at least 1 year of treatment, and to compare super-responders with non super-responders.


Methods: This is a multicenter study of the Register of Severe Asthma of the Region of Murcia (RE-ASGRAMUR) Group performed in eight hospitals under the conditions of routine clinical practice. Patients with zero exacerbations and no oral corticosteroid therapy for asthma were considered super-responders. We analyzed clinical, functional, and inflammatory parameters of selected patients.


Results: In all, 50 of the 79 patients (63%) met the super-responder criteria. In addition, 36% of the patients (26/71) were considered as complete responders to treatment (super--responder + Asthma Control Test [ACT] ≥ 20 + forced expiratory volume in 1 s [FEV1] ≥ 80%). The super--responders were significantly older in age (P = 0.0029), had higher eosinophils count (P = 0.0423), higher proportion of nasal polyps (P = 0.036), and they had less severe disease at baseline. After 1 year of treatment, the super-responders had higher levels of ACT questionnaire (23 vs 19, P = 0.0007) and better percentage of FEV1 (83 vs 75, P = 0.0359).


Conclusion: Almost two of the three patients treated with benralizumab were super--responders after 1 year of treatment and 36% had a complete response. Super-responders were associated with older age, higher eosinophils count, had nasal polyposis as comorbidity, and had less severe disease at baseline. This data illustrated the good real-life response of patients with severe eosinophilic asthma to the treatment with benralizumab.

Abstract 293 | PDF Downloads 133 HTML Downloads 8 XML Downloads 2

References

1. Quirce S, Plaza V, Picado C, Vennera M, Casafont J. Prevalence of uncontrolled severe persistent asthma in pneumology and allergy hospital units in Spain. J Investig Allergol Clin Immunol. 2011;21(6):466–71.

2. Ghazi A, Trikha A, Calhoun WJ. Benralizumab—A humanized mAb to IL-5Rα with enhanced antibody-dependent cellmediated cytotoxicity—A novel approach for the treatment of asthma. Expert Opin Biol Ther. 2012 Jan;12(1):113–8. 10.1517/14712598.2012.642359

3. Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): A randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115–27. 10.1016/S0140-6736(16)31324-1

4. FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): A randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128–41. 10.1016/S0140-6736(16)31322-8

5. Nolasco S, Crimi C, Pelaia C, Benfante A, Caiaffa MF, Calabrese C, et al. Benralizumab effectiveness in severe eosinophilic asthma with and without chronic rhinosinusitis with nasal polyps: A real-world multicenter study. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4371–80.e4. 10.1016/j.jaip.2021.08.004

6. Miralles López JC, Andújar-Espinosa R, Bravo-Gutiérrez FJ, Castilla-Martínez M, Flores-Martín I, Alemany-Francés ML, et al. Effectiveness of benralizumab in severe eosinophilic asthma under routine clinical practice. J Investig Allergol Clin Immunol. 2022 Jun;32(3):220–3. 10.18176/jiaci.0793

7. Kavanagh JE, Hearn AP, Dhariwal J, d'Ancona G, Douiri A, Roxas C, et al. Real-world effectiveness of benralizumab in severe eosinophilic asthma. Chest. 2021 Feb;159(2):496–506. 10.1016/j.chest.2020.08.2083

8. Alvarez-Gutierrez FJ, Blanco-Aparicio M, Plaza V, Cisneros C, Garcia-Rivero JL, Padilla A, et al. Documento de consenso de asma grave en adultos. Actualizacion 2020. Open Respir Arch. 2020;2(3):158–74. 10.1016/j.opresp.2020.03.005

9. Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct;52(4):1800936. 10.1183/13993003.00936-2018

10. Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of serum IgE concentration to predict exacerbation risk and benralizumab efficacy for patients with severe eosinophilic asthma. Adv Ther. 2020 Feb;37(2):718–29. 10.1007/s12325-019-01191-2