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

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 patien...

Full description

Bibliographic Details
Authors: Padilla-Galo A, Moya Carmona I, Ausín P, Carazo Fernández L, García-Moguel I, Velasco-Garrido JL, Andújar-Espinosa R, Casas-Maldonado F, Martínez-Moragón E, Martínez Rivera C, Vera Solsona E, Sánchez-Toril López F, Trisán Alonso A, Blanco Aparicio M, Valverde-Monge M, Valencia Azcona B, Palop Cervera M, Nuevo J, Sánchez Tena J, Resler G, Luzón E, Levy Naon A
Format: article
Status:Published version
Publication Date:2023
Country:España
Institution:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repository:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p15718
Online Access:https://fisabio.portalinvestigacion.com/publicaciones/15718
Access Level:Open access
Keyword:Benralizumab
Severe eosinophilic asthma
ORBE II
Real world evidence
Biologics
Chronic rhinosinusitis with nasal polyps
Asthma exacerbations
Spain
Description
Summary: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/mu L; 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.

Similar Items