Therapeutic Effects of Benralizumab Assessed in Patients with Severe Eosinophilic Asthma: Real-Life Evaluation Correlated with Allergic and Non-Allergic Phenotype Expression
Authors Pelaia C, Crimi C, Benfante A, Caiaffa MF, Calabrese C, Carpagnano GE, Ciotta Jnr D, D'Amato M, Macchia L, Nolasco S, Pelaia G, Pellegrino S, Scichilone N, Scioscia G, Spadaro G, Valenti G, Vatrella A, Crimi N
Received 14 December 2020
Accepted for publication 22 January 2021
Published 22 February 2021 Volume 2021:14 Pages 163—173
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Amrita Dosanjh
Corrado Pelaia,1 Claudia Crimi,2 Alida Benfante,3 Maria Filomena Caiaffa,4 Cecilia Calabrese,5 Giovanna Elisiana Carpagnano,6 Domenico Ciotta Jnr,7 Maria D’Amato,8 Luigi Macchia,9 Santi Nolasco,2 Girolamo Pelaia,1 Simona Pellegrino,7 Nicola Scichilone,3 Giulia Scioscia,10 Giuseppe Spadaro,11 Giuseppe Valenti,12 Alessandro Vatrella,7 Nunzio Crimi2
1Department of Health Sciences, University “Magna Graecia” of Catanzaro, Catanzaro, Italy; 2Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; 3Department of Biomedicine and Internal and Specialistic Medicine, University of Palermo, Palermo, Italy; 4Allergology and Clinical Immunology Unit, University of Foggia, Foggia, Italy; 5Department of Translational Medical Sciences, University of Campania “Luigi Vanvitelli”, Foggia, Italy; 6Department of Basic Medical Sciences, Neuroscience and Sense Organs, Section of Respiratory Disease, University “Aldo Moro” of Bari, Bari, Italy; 7Department of Medicine, Surgery and Dentistry, University of Salerno, Salerno, Italy; 8Division of Pneumology, “V. Monaldi” University Hospital, Naples, Italy; 9Allergology and Clinical Immunology Unit, University “Aldo Moro” of Bari, Bari, Italy; 10Department of Medical and Surgical Sciences, Institute of Respiratory Diseases, University of Foggia, Foggia, Italy; 11Allergology and Immunology Unit, University “Federico II” of Naples, Naples, Italy; 12Allergology and Pulmonology Unit, Provincial Outpatient Center of Palermo, Palermo, Italy
Correspondence: Corrado Pelaia
Department of Health Sciences, University “Magna Graecia” of Catanzaro, Catanzaro, Italy
Tel + 39 0961 3647007
Background: Benralizumab can be utilized as add-on biological treatment of severe eosinophilic asthma. However, so far only a few real-life studies have been published with regard to the use of this anti-IL-5 receptor humanized monoclonal antibody.
Objective: The primary aim of this multicenter observational investigation has been to assess the therapeutic effects of benralizumab in patients with severe uncontrolled, corticosteroid refractory eosinophilic asthma. The secondary objective was to evaluate the efficacy of benralizumab with regard to positive or negative skin prick test (SPT).
Methods: Clinical, functional, and laboratory parameters were evaluated in order to verify the therapeutic actions of benralizumab in atopic and non atopic subjects with difficult-to-treat eosinophilic asthma. Moreover, a comparative evaluation was carried out in relation to the presence or absence of SPT positivity.
Results: After 6 months of add-on biological therapy with benralizumab, our 111 patients experienced a marked improvement of their severe eosinophilic asthma, expressed by significant changes in asthma exacerbation rate, prednisone intake, daily use of short-acting β2-adrenergic agonists (SABA), asthma control test (ACT) score, asthma quality of life questionnaire (AQLQ) score (56 patients), forced expiratory volume in one second (FEV1), forced vital capacity (FVC), blood eosinophil count, blood basophil count (59 patients), and fractional exhaled nitric oxide (FeNO) levels (39 patients). In addition, significantly more effective outcomes were detected in patients with positive SPT, when compared to subjects with negative SPT, only in regard to asthma exacerbation number, ACT score, and daily SABA utilization. No significant correlation was found between serum IgE concentrations and each of all measured parameters.
Conclusion and Clinical Relevance: Taken together, the results of this real-world study indicate that in both allergic and non-allergic subjects benralizumab can be used as a valuable pharmacotherapeutic option for add-on biological therapy of severe eosinophilic asthma, regardless of SPT positivity or negativity.
Keywords: severe eosinophilic asthma, allergic and non-allergic phenotypes, asthma exacerbations, IL-5 receptor, benralizumab
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