Achieving clinical outcomes with benralizumab in severe eosinophilic asthma patients in a real-world setting: orbe II study

Respiratory Research

Research

Luis Carazo Fernández¹  Fernando Sánchez-Toril López²  Alberto Levy Naon³  Ismael García-Moguel⁴  Marina Blanco Aparicio⁵  Francisco Casas-Maldonado⁶  Eva Martínez-Moragón⁷  Marcela Valverde-Monge⁸  Carlos Martínez Rivera⁹  Elisabet Vera Solsona^1,10  Andrea Trisán Alonso^1,11  Rubén Andújar-Espinosa^1,12  José Luis Velasco-Garrido^1,13  Isabel Moya Carmona^1,14  Marta Palop Cervera^1,15  Pilar Ausín^1,16  Borja Valencia Azcona^1,17  Alicia Padilla-Galo^1,17  Jesús Sánchez Tena^1,18  Elisa Luzón^1,18  Javier Nuevo^1,18  Gustavo Resler^1,18 

[1] Complejo Asistencial Universitario de León, León, Spain;H. Arnau de Vilanova-Lliria, Valencia, Spain;H. Quirón Salud, Málaga, Spain;H. U. 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (Imas12), Madrid, Spain;H. U. A Coruña, A Coruña, Spain;H. U. Clínico San Cecilio, Granada, Spain;H. U. Doctor Peset, Valencia, Spain;H. U. Fundación Jiménez Diaz, Madrid, Spain;H. U. Germans Trias i Pujol, Barcelona, Spain;H. U. Miguel Servet, Zaragoza, Spain;H. U. Puerta de Hierro Majadahonda, Madrid, Spain;H. U. Virgen de la Arrixaca, Murcia, Spain;H. U. Virgen de la Victoria, Málaga, Spain;H. Virgen de la Victoria, Málaga, Spain;H. de Sagunto, Valencia, Spain;H. del Mar, Universidad Pompeu Fabra University (UPF), Barcelona, Spain;Hospital Costa del Sol, Autovía A-7 Km 187, 29603, Marbella, Málaga, Spain;Medical Department, AstraZeneca Farmacéutica S.A, Madrid, Spain;

关键词: Benralizumab;    Severe eosinophilic asthma;    ORBE II;    Real world evidence;    Biologics;    Chronic rhinosinusitis with nasal polyps;    Asthma exacerbations;    Spain;   

DOI  :  10.1186/s12931-023-02539-7

 received in 2023-07-10, accepted in 2023-09-15,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe 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.MethodsORBE 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.ResultsA 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.ConclusionsThese data support the real-world benefits of benralizumab in SEA patients, and particularly in those with concomitant CRSwNP.Trial registrationNCT04648839.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

Fig. 5

13690_2023_1170_Article_IEq85.gif

Fig. 3

Fig. 5