Real World Effectiveness of Benralizumab on Respiratory Function and Asthma Control

Overview

Journal Multidiscip Respir Med

Specialty Pulmonary Medicine

Date 2021 Nov 4

PMID 34733505

Citations 9

Authors

Francesco Menzella

Matteo Fontana

Carla Galeone

Giulia Ghidoni

Silvia Capobelli

Patrizia Ruggiero

Chiara Scelfo

Anna Simonazzi

Chiara Catellani

Francesco Livrieri

Nicola Cosimo Facciolongo

Affiliations

Soon will be listed here.

Abstract

Background: Biological drugs have been recognized as a breakthrough in the treatment of severe refractory asthma. This retrospective real-life observational study aims to evaluate the effect of add-on benralizumab on lung function, exacerbation rate, oral corticosteroids (OCS) reduction and asthma control questionnaire (ACQ) score after 52-weeks.

Methods: In this observational study, a cohort of 18 patients with severe eosinophilic asthma (SEA) according to the ERS / ATS and GINA 2020 classifications, with reference to the Pulmonology Unit of the Azienda USL - IRCCS, Reggio Emilia, Italy, were enrolled from 1 September 2019 to 31 August 2020. For each patient, the following data were collected: demographic data (age, sex, age of onset of asthma, history of smoking and atopy); comorbidity; clinical data (lung function, exacerbations, emergency room visits and hospitalizations); asthma control questionnaire (ACQ); biomarkers (blood eosinophil count and total serum IgE); asthma control drugs as high-dose inhaled corticosteroids / long-acting beta-adrenoceptor agonists (ICS / LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), theophylline, OCS. The benralizumab 30 mg treatment schedule was based on the currently recommended dosing regimen.

Results: After end-of-treatment (EOT), a complete weaning of all patients from OCS was confirmed. After 26 weeks, the number of exacerbations decreased from 2.90 to 0.05 (p<0.0001), hospitalizations and ACQ score decreased from 3.37 to 0.97 (p<0.0001). At EOT, the number of exacerbations was unchanged, while no hospitalizations had occurred. Overall, lung function markedly improved over the study period. After 52 weeks, the increase in FEV from baseline was 26,8% (p=0.0002). The subset of patients with nasal polyposis (NP) had an increase of nearly 50% (1008 ml) and patients with blood eosinophils count (BEC) greater than 500 cells / μl showed an increase of 68% (1081 ml) in FEV at EOT.

Conclusions: The notable improvement in respiratory function is a significant result in this study and it is much higher than what has emerged to date. This result, together with the OCS sparing effect and the excellent clinical control of asthma, makes benralizumab a reliable and safe therapeutic option for SEA.

Citing Articles

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References

Bleecker E, Wechsler M, FitzGerald J, Menzies-Gow A, Wu Y, Hirsch I . Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018; 52(4). PMC: 6203407. DOI: 10.1183/13993003.00936-2018. View

Kavanagh J, Hearn A, Dhariwal J, dAncona G, Douiri A, Roxas C . Real-World Effectiveness of Benralizumab in Severe Eosinophilic Asthma. Chest. 2020; 159(2):496-506. DOI: 10.1016/j.chest.2020.08.2083. View

Bagnasco D, Brussino L, Bonavia M, Calzolari E, Caminati M, Caruso C . Efficacy of Benralizumab in severe asthma in real life and focus on nasal polyposis. Respir Med. 2020; 171:106080. DOI: 10.1016/j.rmed.2020.106080. View

Albers F, Mullerova H, Gunsoy N, Shin J, Nelsen L, Bradford E . Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma. 2017; 55(2):152-160. DOI: 10.1080/02770903.2017.1322611. View

Pelaia C, Busceti M, Vatrella A, Rago G, Crimi C, Terracciano R . Real-life rapidity of benralizumab effects in patients with severe allergic eosinophilic asthma: Assessment of blood eosinophils, symptom control, lung function and oral corticosteroid intake after the first drug dose. Pulm Pharmacol Ther. 2019; 58:101830. DOI: 10.1016/j.pupt.2019.101830. View

Holguin F, Cardet J, Chung K, Diver S, Ferreira D, Fitzpatrick A . Management of severe asthma: a European Respiratory Society/American Thoracic Society guideline. Eur Respir J. 2019; 55(1). DOI: 10.1183/13993003.00588-2019. View

Menzella F, Ruggiero P, Galeone C, Scelfo C, Bagnasco D, Facciolongo N . Significant improvement in lung function and asthma control after benralizumab treatment for severe refractory eosinophilic asthma. Pulm Pharmacol Ther. 2020; 64:101966. DOI: 10.1016/j.pupt.2020.101966. View

Bleecker E, FitzGerald J, Chanez P, Papi A, Weinstein S, Barker P . Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016; 388(10056):2115-2127. DOI: 10.1016/S0140-6736(16)31324-1. View

Chipps B, Hirsch I, Trudo F, Alacqua M, Zangrilli J . Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2019; 124(1):79-86. DOI: 10.1016/j.anai.2019.10.006. View

10.

Van Hulst G, Batugedara H, Jorssen J, Louis R, Bureau F, Desmet C . Eosinophil diversity in asthma. Biochem Pharmacol. 2020; 179:113963. DOI: 10.1016/j.bcp.2020.113963. View

11.

Nair P, Wenzel S, Rabe K, Bourdin A, Lugogo N, Kuna P . Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017; 376(25):2448-2458. DOI: 10.1056/NEJMoa1703501. View

12.

Bourdin A, Adcock I, Berger P, Bonniaud P, Chanson P, Chenivesse C . How can we minimise the use of regular oral corticosteroids in asthma?. Eur Respir Rev. 2020; 29(155). PMC: 9488989. DOI: 10.1183/16000617.0085-2019. View

13.

Menzella F, Ruggiero P, Ghidoni G, Fontana M, Bagnasco D, Livrieri F . Anti-IL5 Therapies for Severe Eosinophilic Asthma: Literature Review and Practical Insights. J Asthma Allergy. 2020; 13:301-313. PMC: 7490042. DOI: 10.2147/JAA.S258594. View

14.

Canonica G, Blasi F, Paggiaro P, Senna G, Passalacqua G, Spanevello A . Oral CorticoSteroid sparing with biologics in severe asthma: A remark of the (). World Allergy Organ J. 2020; 13(10):100464. PMC: 7509464. DOI: 10.1016/j.waojou.2020.100464. View

15.

Kolbeck R, Kozhich A, Koike M, Peng L, Andersson C, Damschroder M . MEDI-563, a humanized anti-IL-5 receptor alpha mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010; 125(6):1344-1353.e2. DOI: 10.1016/j.jaci.2010.04.004. View

16.

Ortega H, Liu M, Pavord I, Brusselle G, FitzGerald J, Chetta A . Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014; 371(13):1198-207. DOI: 10.1056/NEJMoa1403290. View

17.

Bel E, Wenzel S, Thompson P, Prazma C, Keene O, Yancey S . Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014; 371(13):1189-97. DOI: 10.1056/NEJMoa1403291. View

18.

Pelaia C, Crimi C, Benfante A, Caiaffa M, Calabrese C, Carpagnano G . Therapeutic Effects of Benralizumab Assessed in Patients with Severe Eosinophilic Asthma: Real-Life Evaluation Correlated with Allergic and Non-Allergic Phenotype Expression. J Asthma Allergy. 2021; 14:163-173. PMC: 7910091. DOI: 10.2147/JAA.S297273. View

19.

Heffler E, Blasi F, Latorre M, Menzella F, Paggiaro P, Pelaia G . The Severe Asthma Network in Italy: Findings and Perspectives. J Allergy Clin Immunol Pract. 2018; 7(5):1462-1468. DOI: 10.1016/j.jaip.2018.10.016. View

20.

FitzGerald J, Bleecker E, Nair P, Korn S, Ohta K, Lommatzsch M . 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; 388(10056):2128-2141. DOI: 10.1016/S0140-6736(16)31322-8. View