Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study

Respiratory Research

Research

Jan Walter Schroeder¹  Maria Filomena Caiaffa²  Giorgio Walter Canonica³  Fabiano Di Marco⁴  Stefano Del Giacco⁵  Gianenrico Senna⁶  Alessandra Vultaggio⁷  Cristiano Caruso⁸  Luisa Brussino⁹  Girolamo Pelaia^1,10  Paola Rogliani^1,11  Pietro Schino^1,12  Marco Benci^1,13  Silvia Boarino^1,14  Pietro Bracciale^1,15  Elena Altieri^1,16  Paolo Cameli^1,17  Stefano Centanni^1,18  Maria Aliani^1,19  Fausto De Michele^2,20  Micaela Romagnoli^2,21  Francesco Menzella^2,22  Maria D’Amato^2,23 

[1] Allergy and Clinical Immunology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy;Cattedra e Scuola di Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche, Università di Foggia, Foggia, Italy;Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy;Personalized Medicine Center: Asthma and Allergology, Humanitas Research Hospital, Rozzano, MI, Italy;Department of Health Sciences, Università degli Studi di Milano, Pneumologia, ASST Papa Giovanni XXIII, Bergamo, Italy;Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy;Department of Medicine, University of Verona, Verona, Italy;Allergy Unit and Asthma Center, Verona University Hospital, Verona, Italy;Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Florence, Italy;Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy;Dipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto I, Torino, Italy;Dipartimento di Scienze della Salute, Università Magna Graecia, Catanzaro, Italy;Division of Respiratory Medicine, University Hospital “Tor Vergata”, Rome, Italy;Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome “Tor Vergata”, Rome, Italy;Fisiopatologia Respiratoria, Ospedale Generale Regionale, Ente Ecclesiastico “F. Miulli”, Acquaviva delle Fonti, BA, Italy;Medical Affairs R&I, AstraZeneca, Milan, Italy;Medical Evidence R&I, AstraZeneca, Milan, Italy;Reparto di Pneumologia, Ospedale Ostuni, Ostuni, BR, Italy;Reparto di Pneumologia, P.O. Garbagnate, Milanese, Italy;Respiratory Diseases and Lung Transplantation, Department of Medical and Surgical Sciences and Neurosciences, Siena University Hospital, Siena, Italy;Respiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di Milano, Milan, Italy;UO Pneumologia e Pneumologia Riabilitativa, ICS Maugeri, IRCCS Bari, Bari, Italy;UOC Pneumologia e Fisiopatologia Respiratoria, AORN A. Cardarelli, Naples, Italy;UOC Pneumologia, AULSS 2 Marca Trevigiana, Treviso, Italy;UOC Pneumologia, Ospedale “S. Valentino”, AULSS 2 Marca Trevigiana, Montebelluna, TV, Italy;UOSD Malattie Respiratorie “Federico II”, Ospedale Monaldi, AO Dei Colli, Naples, Italy;

关键词: Benralizumab;    Asthma;    Eosinophils;    Exacerbations;    Long-term;   

DOI  :  10.1186/s12931-023-02439-w

 received in 2023-03-06, accepted in 2023-04-28,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe efficacy of benralizumab has been broadly demonstrated in severe eosinophilic asthma (SEA), but only few real-life studies evaluated its long-term effects. Here we present novel data from the ANANKE study in which a large cohort of SEA patients was treated for up to 96 weeks.MethodsANANKE (NCT04272463) is an observational retrospective Italian study investigating the key characteristics of SEA patients (collected during the 12 months prior to benralizumab initiation) and the clinical outcomes during benralizumab treatment (annual exacerbation rate [AER], lung function, asthma control, OCS use, healthcare resource utilization). A post hoc analysis was also conducted in groups of patients based on history of previous biologic therapy (bio-experienced versus naïve patients). Analyses were descriptive only.ResultsBefore benralizumab initiation, evaluable SEA patients (N = 162, 61.1% females, mean age 56.0 ± 12.7) showed a median blood eosinophil count (BEC) of 600 cells/mm3 (IQR: 430–890). Patients experienced frequent exacerbations (annualized exacerbation rate [AER]: 4.10, severe AER: 0.98), with impaired lung function and poor asthma control (median ACT score: 14) despite 25.3% reported oral corticosteroid (OCS) use. Nasal polyposis was present in 53.1% patients; 47.5% patients were atopic. After 96 weeks since the start of benralizumab, nearly 90% patients were still on treatment; benralizumab dramatically decreased exacerbations (AER: − 94.9%; severe AER: − 96.9%), improved respiratory parameters (median increase in pre-bronchodilator forced expiratory volume [pre-BD FEV1]: + 400 mL) and asthma control (median ACT score: 23) while eliminating OCS in 60% patients. Importantly, benralizumab effects were either maintained or progressively improved over time, accompanied by a nearly complete depletion of BEC. Benralizumab reduced AER both in naïve (any AER: − 95.9%; severe AER: − 97.5%) and bio-experienced patients (any AER: − 92.4%; severe AER: − 94.0%).ConclusionsProfound and sustained improvements in all asthma outcomes were observed with benralizumab. The correct identification of patients’ eosinophilic-driven asthma phenotype was essential to ensure the achievement of such remarkable results.Trial registration: ClinicalTrials.gov Identifier: NCT04272463.

【 授权许可】

CC BY   
© The Author(s) 2023

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