Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study
Abstract Background The 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....
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
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| Language: | English |
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BMC
2023-05-01
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| Series: | Respiratory Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12931-023-02439-w |
| _version_ | 1827943232985628672 |
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| author | Alessandra Vultaggio Maria Aliani Elena Altieri Pietro Bracciale Luisa Brussino Maria Filomena Caiaffa Paolo Cameli Giorgio Walter Canonica Cristiano Caruso Stefano Centanni Maria D’Amato Fausto De Michele Stefano Del Giacco Fabiano Di Marco Francesco Menzella Girolamo Pelaia Paola Rogliani Micaela Romagnoli Pietro Schino Gianenrico Senna Marco Benci Silvia Boarino Jan Walter Schroeder |
| author_facet | Alessandra Vultaggio Maria Aliani Elena Altieri Pietro Bracciale Luisa Brussino Maria Filomena Caiaffa Paolo Cameli Giorgio Walter Canonica Cristiano Caruso Stefano Centanni Maria D’Amato Fausto De Michele Stefano Del Giacco Fabiano Di Marco Francesco Menzella Girolamo Pelaia Paola Rogliani Micaela Romagnoli Pietro Schino Gianenrico Senna Marco Benci Silvia Boarino Jan Walter Schroeder |
| author_sort | Alessandra Vultaggio |
| collection | DOAJ |
| description | Abstract Background The 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. Methods ANANKE (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. Results Before 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%). Conclusions Profound 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. |
| first_indexed | 2024-03-13T10:12:21Z |
| format | Article |
| id | doaj.art-28c6788b881f4a95a1719795987231a7 |
| institution | Directory Open Access Journal |
| issn | 1465-993X |
| language | English |
| last_indexed | 2024-03-13T10:12:21Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Respiratory Research |
| spelling | doaj.art-28c6788b881f4a95a1719795987231a72023-05-21T11:24:08ZengBMCRespiratory Research1465-993X2023-05-0124111310.1186/s12931-023-02439-wLong-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE studyAlessandra Vultaggio0Maria Aliani1Elena Altieri2Pietro Bracciale3Luisa Brussino4Maria Filomena Caiaffa5Paolo Cameli6Giorgio Walter Canonica7Cristiano Caruso8Stefano Centanni9Maria D’Amato10Fausto De Michele11Stefano Del Giacco12Fabiano Di Marco13Francesco Menzella14Girolamo Pelaia15Paola Rogliani16Micaela Romagnoli17Pietro Schino18Gianenrico Senna19Marco Benci20Silvia Boarino21Jan Walter Schroeder22Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di FirenzeUO Pneumologia e Pneumologia Riabilitativa, ICS Maugeri, IRCCS BariReparto di Pneumologia, P.O. GarbagnateReparto di Pneumologia, Ospedale OstuniDipartimento di Scienze Mediche, SSDDU Allergologia e Immunologia Clinica, Università degli Studi di Torino, AO Ordine Mauriziano Umberto ICattedra e Scuola di Allergologia e Immunologia Clinica, Dipartimento di Scienze Mediche, Università di FoggiaRespiratory Diseases and Lung Transplantation, Department of Medical and Surgical Sciences and Neurosciences, Siena University HospitalDepartment of Biomedical Sciences, Humanitas UniversityDipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro CuoreRespiratory Unit, ASST Santi Paolo e Carlo, Department of Health Sciences, Università degli Studi di MilanoUOSD Malattie Respiratorie “Federico II”, Ospedale Monaldi, AO Dei ColliUOC Pneumologia e Fisiopatologia Respiratoria, AORN A. CardarelliDepartment of Medical Sciences and Public Health, University of CagliariDepartment of Health Sciences, Università degli Studi di Milano, Pneumologia, ASST Papa Giovanni XXIIIUOC Pneumologia, Ospedale “S. Valentino”, AULSS 2 Marca TrevigianaDipartimento di Scienze della Salute, Università Magna GraeciaDivision of Respiratory Medicine, University Hospital “Tor Vergata”UOC Pneumologia, AULSS 2 Marca TrevigianaFisiopatologia Respiratoria, Ospedale Generale Regionale, Ente Ecclesiastico “F. Miulli”Department of Medicine, University of VeronaMedical Affairs R&I, AstraZenecaMedical Evidence R&I, AstraZenecaAllergy and Clinical Immunology, ASST Grande Ospedale Metropolitano NiguardaAbstract Background The 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. Methods ANANKE (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. Results Before 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%). Conclusions Profound 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.https://doi.org/10.1186/s12931-023-02439-wBenralizumabAsthmaEosinophilsExacerbationsLong-term |
| spellingShingle | Alessandra Vultaggio Maria Aliani Elena Altieri Pietro Bracciale Luisa Brussino Maria Filomena Caiaffa Paolo Cameli Giorgio Walter Canonica Cristiano Caruso Stefano Centanni Maria D’Amato Fausto De Michele Stefano Del Giacco Fabiano Di Marco Francesco Menzella Girolamo Pelaia Paola Rogliani Micaela Romagnoli Pietro Schino Gianenrico Senna Marco Benci Silvia Boarino Jan Walter Schroeder Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study Respiratory Research Benralizumab Asthma Eosinophils Exacerbations Long-term |
| title | Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study |
| title_full | Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study |
| title_fullStr | Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study |
| title_full_unstemmed | Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study |
| title_short | Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study |
| title_sort | long term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96 weeks data from the ananke study |
| topic | Benralizumab Asthma Eosinophils Exacerbations Long-term |
| url | https://doi.org/10.1186/s12931-023-02439-w |
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