Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study
Introduction: Benralizumab has demonstrated rapid efficacy in treating severe eosinophilic asthma (SEA). This study aims to characterize early responses to benralizumab, the patient features observed in those with early responses, and the potential patient features that could predict them, and it al...
| Autores: | , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2025 |
| País: | España |
| Institución: | Universitat Pompeu Fabra |
| Repositorio: | Repositorio Digital de la UPF |
| OAI Identifier: | oai:dnet:rdupf_______::fd52699b69f7a97d6c96c5c0c4cb0492 |
| Acceso en línea: | https://hdl.handle.net/10230/73347 http://dx.doi.org/10.3390/jcm14093011 |
| Access Level: | acceso abierto |
| Palabra clave: | ACT FEV1 ORBE II Benralizumab Clinical remission Early response Real world Severe eosinophilic asthma Super-response |
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Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II studyAusín Herrero, Pilar, 1974-Navarrete Rouco, Maria EugeniaCarazo, LuisSánchez-Trincado, José LuisLuzon, ElisaNuevo, JavierSantín, MónicaSánchez, JesúsPadilla-Galo, AliciaACTFEV1ORBE IIBenralizumabClinical remissionEarly responseReal worldSevere eosinophilic asthmaSuper-responseIntroduction: Benralizumab has demonstrated rapid efficacy in treating severe eosinophilic asthma (SEA). This study aims to characterize early responses to benralizumab, the patient features observed in those with early responses, and the potential patient features that could predict them, and it also evaluates whether these improvements are sustained during a one-year follow-up (FUP) in clinical practice. Methods: This analysis was conducted using the ORBE II study database. ORBE II is an observational, retrospective study that included uncontrolled SEA adult patients treated with benralizumab according to routine clinical practice in Spain. We analysed patients with available data on the asthma control test (ACT) at baseline and within the first 120 days after benralizumab initiation, identifying ACT "Early Super-Responders" (ACT-ESR) as patients with a ≥9 point-improvement in the ACT score or reaching an absolute score of ≥24. Likewise, we assessed patients with available data on the pre-BD FEV1 during the same study periods, defining those with a pre-BD FEV1 increment of ≥230 mL as FEV1-ESR patients. Clinical outcomes were described up to 1 year of FUP. Results: A total of 45 and 65 patients with data for ACT and FEV1, respectively, during the first 120 days of treatment were analysed. Of those, 55.5% and 58.5% of patients were categorized as ACT-ESR and FEV1-ESR, respectively. At baseline, both groups showed high T2 inflammation markers and a high prevalence of comorbidities (chronic rhinosinusitis with nasal polyposis: 56% and 50%; gastro-oesophageal reflux disease: 24% and 40%, respectively). Poor asthma control (ACT < 20) was observed at baseline in 96% of ACT-ESR, while impaired lung function (pre-BD FEV1 < 80%) was present in 71.7% of FEV1-ESR. Oral corticosteroid (OCS) dependency affected 25% and 30% of ACT-ESR and FEV1-ESR, respectively. The early gains observed in ACT-ESR and FEV1-ESR were sustained up to 1 year of FUP, with 90.5% and 66.7% of patients achieving a super-response (zero exacerbations and no OCS use) and 92.0% and 71.1% meeting clinical remission criteria (zero exacerbations, no OCS use, ACT ≥ 20 and pre-BD FEV1 increment of ≥100 mL), respectively. Conclusions: Benralizumab provides early benefits for SEA patients in clinical practice, with more than half achieving early super-responses in both ACT score and lung function. These improvements were sustained over a 1-year FUP, resulting in high rates of clinical remission.MDPI2026202620252026info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/10230/73347http://dx.doi.org/10.3390/jcm14093011reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésJournal of Clinical Medicine. 2025;14(9):3011© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:dnet:rdupf_______::fd52699b69f7a97d6c96c5c0c4cb04922026-06-12T07:21:37Z |
| dc.title.none.fl_str_mv |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| title |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| spellingShingle |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study Ausín Herrero, Pilar, 1974- ACT FEV1 ORBE II Benralizumab Clinical remission Early response Real world Severe eosinophilic asthma Super-response |
| title_short |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| title_full |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| title_fullStr |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| title_full_unstemmed |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| title_sort |
Early and sustained clinical benefits of benralizumab in severe eosinophilic asthma: findings from the ORBE II study |
| dc.creator.none.fl_str_mv |
Ausín Herrero, Pilar, 1974- Navarrete Rouco, Maria Eugenia Carazo, Luis Sánchez-Trincado, José Luis Luzon, Elisa Nuevo, Javier Santín, Mónica Sánchez, Jesús Padilla-Galo, Alicia |
| author |
Ausín Herrero, Pilar, 1974- |
| author_facet |
Ausín Herrero, Pilar, 1974- Navarrete Rouco, Maria Eugenia Carazo, Luis Sánchez-Trincado, José Luis Luzon, Elisa Nuevo, Javier Santín, Mónica Sánchez, Jesús Padilla-Galo, Alicia |
| author_role |
author |
| author2 |
Navarrete Rouco, Maria Eugenia Carazo, Luis Sánchez-Trincado, José Luis Luzon, Elisa Nuevo, Javier Santín, Mónica Sánchez, Jesús Padilla-Galo, Alicia |
| author2_role |
author author author author author author author author |
| dc.subject.none.fl_str_mv |
ACT FEV1 ORBE II Benralizumab Clinical remission Early response Real world Severe eosinophilic asthma Super-response |
| topic |
ACT FEV1 ORBE II Benralizumab Clinical remission Early response Real world Severe eosinophilic asthma Super-response |
| description |
Introduction: Benralizumab has demonstrated rapid efficacy in treating severe eosinophilic asthma (SEA). This study aims to characterize early responses to benralizumab, the patient features observed in those with early responses, and the potential patient features that could predict them, and it also evaluates whether these improvements are sustained during a one-year follow-up (FUP) in clinical practice. Methods: This analysis was conducted using the ORBE II study database. ORBE II is an observational, retrospective study that included uncontrolled SEA adult patients treated with benralizumab according to routine clinical practice in Spain. We analysed patients with available data on the asthma control test (ACT) at baseline and within the first 120 days after benralizumab initiation, identifying ACT "Early Super-Responders" (ACT-ESR) as patients with a ≥9 point-improvement in the ACT score or reaching an absolute score of ≥24. Likewise, we assessed patients with available data on the pre-BD FEV1 during the same study periods, defining those with a pre-BD FEV1 increment of ≥230 mL as FEV1-ESR patients. Clinical outcomes were described up to 1 year of FUP. Results: A total of 45 and 65 patients with data for ACT and FEV1, respectively, during the first 120 days of treatment were analysed. Of those, 55.5% and 58.5% of patients were categorized as ACT-ESR and FEV1-ESR, respectively. At baseline, both groups showed high T2 inflammation markers and a high prevalence of comorbidities (chronic rhinosinusitis with nasal polyposis: 56% and 50%; gastro-oesophageal reflux disease: 24% and 40%, respectively). Poor asthma control (ACT < 20) was observed at baseline in 96% of ACT-ESR, while impaired lung function (pre-BD FEV1 < 80%) was present in 71.7% of FEV1-ESR. Oral corticosteroid (OCS) dependency affected 25% and 30% of ACT-ESR and FEV1-ESR, respectively. The early gains observed in ACT-ESR and FEV1-ESR were sustained up to 1 year of FUP, with 90.5% and 66.7% of patients achieving a super-response (zero exacerbations and no OCS use) and 92.0% and 71.1% meeting clinical remission criteria (zero exacerbations, no OCS use, ACT ≥ 20 and pre-BD FEV1 increment of ≥100 mL), respectively. Conclusions: Benralizumab provides early benefits for SEA patients in clinical practice, with more than half achieving early super-responses in both ACT score and lung function. These improvements were sustained over a 1-year FUP, resulting in high rates of clinical remission. |
| publishDate |
2025 |
| dc.date.none.fl_str_mv |
2025 2026 2026 2026 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://hdl.handle.net/10230/73347 http://dx.doi.org/10.3390/jcm14093011 |
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https://hdl.handle.net/10230/73347 http://dx.doi.org/10.3390/jcm14093011 |
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Inglés |
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Inglés |
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Journal of Clinical Medicine. 2025;14(9):3011 |
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http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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MDPI |
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MDPI |
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reponame:Repositorio Digital de la UPF instname:Universitat Pompeu Fabra |
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