Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study
Abstract Background The ORBE II study aimed to describe the characteristics and clinical outcomes of adult patients with severe eosinophilic asthma (SEA) treated with benralizumab in a real-world setting in Spain. Methods ORBE II (NCT04648839) was an observational, retrospective cohort study in adul...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | Respiratory Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12931-023-02539-7 |
| _version_ | 1797557018282688512 |
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| author | Alicia Padilla-Galo Isabel Moya Carmona Pilar Ausín Luis Carazo Fernández Ismael García-Moguel José Luis Velasco-Garrido Rubén Andújar-Espinosa Francisco Casas-Maldonado Eva Martínez-Moragón Carlos Martínez Rivera Elisabet Vera Solsona Fernando Sánchez-Toril López Andrea Trisán Alonso Marina Blanco Aparicio Marcela Valverde-Monge Borja Valencia Azcona Marta Palop Cervera Javier Nuevo Jesús Sánchez Tena Gustavo Resler Elisa Luzón Alberto Levy Naon |
| author_facet | Alicia Padilla-Galo Isabel Moya Carmona Pilar Ausín Luis Carazo Fernández Ismael García-Moguel José Luis Velasco-Garrido Rubén Andújar-Espinosa Francisco Casas-Maldonado Eva Martínez-Moragón Carlos Martínez Rivera Elisabet Vera Solsona Fernando Sánchez-Toril López Andrea Trisán Alonso Marina Blanco Aparicio Marcela Valverde-Monge Borja Valencia Azcona Marta Palop Cervera Javier Nuevo Jesús Sánchez Tena Gustavo Resler Elisa Luzón Alberto Levy Naon |
| author_sort | Alicia Padilla-Galo |
| collection | DOAJ |
| description | Abstract Background The ORBE II study aimed to describe the characteristics and clinical outcomes of adult patients with severe eosinophilic asthma (SEA) treated with benralizumab in a real-world setting in Spain. Methods ORBE II (NCT04648839) was an observational, retrospective cohort study in adult SEA patients who had been prescribed benralizumab. Demographic and clinical data of 204 SEA patients were collected 12 months prior to benralizumab initiation (baseline) and at follow-up. Exacerbation rate, asthma symptoms, maintenance oral corticosteroid (OCS) use and lung function were evaluated, among other variables. Results A total of 204 SEA patients were evaluated. Mean (standard deviation, SD) age of the study population was 56.4 (12.4) years, 62.3% were women and mean (SD) duration of asthma was 15.1 (12.7) years. Median (Q1–Q3) follow-up duration was 19.5 (14.2–24.2) months. At baseline, 72.6% of the overall population (OP) presented blood eosinophil counts ≥ 300 cells/µL; 36.8% had comorbid chronic rhinosinusitis with nasal polyps (CRSwNP); 84.8% reported at least one severe exacerbation, and 29.1% were OCS-dependent. At 1 year of follow-up, patients receiving benralizumab treatment had a 85.6% mean reduction in exacerbations from baseline, and 81.4% of patients achieved zero exacerbations. We also found a clinically relevant mean (SD) increase in pre-bronchodilator (BD) FEV1 of 331 (413) mL, with 66.7% of patients achieving a pre-BD FEV1 increase ≥ 100 mL, and 46.3% of patients achieving a pre-BD FEV1 ≥ 80% of predicted. Regarding symptom control, 73.8% of the OP obtained an ACT score ≥ 20 points. After 1 year of follow-up, mean reduction in the daily OCS dose was 70.5%, and complete OCS withdrawal was achieved by 52.8% of the OCS-dependent patients. Almost half (43.7%) of the OP on benralizumab met all four criteria for clinical remission. Patients with concomitant CRSwNP obtained similar or enhanced outcomes. Conclusions These data support the real-world benefits of benralizumab in SEA patients, and particularly in those with concomitant CRSwNP. Trial registration NCT04648839. |
| first_indexed | 2024-03-10T17:10:19Z |
| format | Article |
| id | doaj.art-9b86c4ec06e54e6d8ecfa9b7342daea8 |
| institution | Directory Open Access Journal |
| issn | 1465-993X |
| language | English |
| last_indexed | 2024-03-10T17:10:19Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Respiratory Research |
| spelling | doaj.art-9b86c4ec06e54e6d8ecfa9b7342daea82023-11-20T10:40:38ZengBMCRespiratory Research1465-993X2023-09-0124111410.1186/s12931-023-02539-7Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II studyAlicia Padilla-Galo0Isabel Moya Carmona1Pilar Ausín2Luis Carazo Fernández3Ismael García-Moguel4José Luis Velasco-Garrido5Rubén Andújar-Espinosa6Francisco Casas-Maldonado7Eva Martínez-Moragón8Carlos Martínez Rivera9Elisabet Vera Solsona10Fernando Sánchez-Toril López11Andrea Trisán Alonso12Marina Blanco Aparicio13Marcela Valverde-Monge14Borja Valencia Azcona15Marta Palop Cervera16Javier Nuevo17Jesús Sánchez Tena18Gustavo Resler19Elisa Luzón20Alberto Levy Naon21Hospital Costa del SolH. Virgen de la VictoriaH. del Mar, Universidad Pompeu Fabra University (UPF)Complejo Asistencial Universitario de LeónH. U. 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (Imas12)H. U. Virgen de la VictoriaH. U. Virgen de la ArrixacaH. U. Clínico San CecilioH. U. Doctor PesetH. U. Germans Trias i PujolH. U. Miguel ServetH. Arnau de Vilanova-LliriaH. U. Puerta de Hierro MajadahondaH. U. A CoruñaH. U. Fundación Jiménez DiazHospital Costa del SolH. de SaguntoMedical Department, AstraZeneca Farmacéutica S.AMedical Department, AstraZeneca Farmacéutica S.AMedical Department, AstraZeneca Farmacéutica S.AMedical Department, AstraZeneca Farmacéutica S.AH. Quirón SaludAbstract Background The ORBE II study aimed to describe the characteristics and clinical outcomes of adult patients with severe eosinophilic asthma (SEA) treated with benralizumab in a real-world setting in Spain. Methods ORBE II (NCT04648839) was an observational, retrospective cohort study in adult SEA patients who had been prescribed benralizumab. Demographic and clinical data of 204 SEA patients were collected 12 months prior to benralizumab initiation (baseline) and at follow-up. Exacerbation rate, asthma symptoms, maintenance oral corticosteroid (OCS) use and lung function were evaluated, among other variables. Results A total of 204 SEA patients were evaluated. Mean (standard deviation, SD) age of the study population was 56.4 (12.4) years, 62.3% were women and mean (SD) duration of asthma was 15.1 (12.7) years. Median (Q1–Q3) follow-up duration was 19.5 (14.2–24.2) months. At baseline, 72.6% of the overall population (OP) presented blood eosinophil counts ≥ 300 cells/µL; 36.8% had comorbid chronic rhinosinusitis with nasal polyps (CRSwNP); 84.8% reported at least one severe exacerbation, and 29.1% were OCS-dependent. At 1 year of follow-up, patients receiving benralizumab treatment had a 85.6% mean reduction in exacerbations from baseline, and 81.4% of patients achieved zero exacerbations. We also found a clinically relevant mean (SD) increase in pre-bronchodilator (BD) FEV1 of 331 (413) mL, with 66.7% of patients achieving a pre-BD FEV1 increase ≥ 100 mL, and 46.3% of patients achieving a pre-BD FEV1 ≥ 80% of predicted. Regarding symptom control, 73.8% of the OP obtained an ACT score ≥ 20 points. After 1 year of follow-up, mean reduction in the daily OCS dose was 70.5%, and complete OCS withdrawal was achieved by 52.8% of the OCS-dependent patients. Almost half (43.7%) of the OP on benralizumab met all four criteria for clinical remission. Patients with concomitant CRSwNP obtained similar or enhanced outcomes. Conclusions These data support the real-world benefits of benralizumab in SEA patients, and particularly in those with concomitant CRSwNP. Trial registration NCT04648839.https://doi.org/10.1186/s12931-023-02539-7BenralizumabSevere eosinophilic asthmaORBE IIReal world evidenceBiologicsChronic rhinosinusitis with nasal polyps |
| spellingShingle | Alicia Padilla-Galo Isabel Moya Carmona Pilar Ausín Luis Carazo Fernández Ismael García-Moguel José Luis Velasco-Garrido Rubén Andújar-Espinosa Francisco Casas-Maldonado Eva Martínez-Moragón Carlos Martínez Rivera Elisabet Vera Solsona Fernando Sánchez-Toril López Andrea Trisán Alonso Marina Blanco Aparicio Marcela Valverde-Monge Borja Valencia Azcona Marta Palop Cervera Javier Nuevo Jesús Sánchez Tena Gustavo Resler Elisa Luzón Alberto Levy Naon Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study Respiratory Research Benralizumab Severe eosinophilic asthma ORBE II Real world evidence Biologics Chronic rhinosinusitis with nasal polyps |
| title | Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study |
| title_full | Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study |
| title_fullStr | Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study |
| title_full_unstemmed | Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study |
| title_short | Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: ORBE II study |
| title_sort | achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real world setting orbe ii study |
| topic | Benralizumab Severe eosinophilic asthma ORBE II Real world evidence Biologics Chronic rhinosinusitis with nasal polyps |
| url | https://doi.org/10.1186/s12931-023-02539-7 |
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