Characteristics of Patients Receiving Budesonide/Glycopyrronium/Formoterol for Chronic Obstructive Pulmonary Disease in Spain: The AURA Study

Myriam Calle Rubio,1 Juan Antonio Trigueros Carrero,2 Paula Chaparro Briones,3 Luciano Escudero Herrera,3 Michael Pollack,4 Ignacio Hernández Subirá,5 Joaquín Sánchez-Covisa3 1Pneumology Service, H. Clínico San Carlos. Institute for Health Research (IdISSC), Department of Medicine, Complutense University, CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; 2Buenavista Primary Care Center, Toledo, Spain; 3AstraZeneca Farmacéutica Spain, Madrid, Spain; 4AstraZeneca, LP. BioPharmaceuticals Medical, Wilmington, DE, USA; 5Atrys Health SA, HEOR, Madrid, SpainCorrespondence: Joaquín Sánchez-Covisa, Email [email protected]: Single-inhaler triple therapy with budesonide/glycopyrronium/formoterol fumarate (BGF; Trixeo Aerosphere®) was approved in the European Union in December 2020 for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by dual therapy, and has been available in Spain since February 2022. This real-world, observational, retrospective cohort study, AURA Spain, describes the demographics, clinical characteristics, and healthcare resource utilization of patients initiating single-inhaler BGF triple therapy.Methods: Electronic medical records in the Spanish Healthcare System anonymized, integrated BIG-PAC® database were analyzed to identify COPD patients aged ≥ 40 years initiating single-inhaler BGF between 1 February 2022 and 31 January 2023.Results: Patients (N=482) had a mean (standard deviation, SD) age of 71.5 (10.0) years, mean BMI of 29.6 (6.2) kg/m2, most were aged ≥ 65 years (73.7%) and male (62.5%). Most were former (62.7%) or current (24.5%) smokers. Applying GOLD FEV1 thresholds, severity of COPD was moderate in 49.8% of patients, severe (41.9%), and very severe (6.5%). The most common comorbidities were hypertension (62.2%), dyslipidemia (56.8%), and anxiety (42.5%), and 85.9% had one or more cardiovascular-related comorbidity. Overall, 57.3% experienced at least one moderate or severe exacerbation in the 12-month baseline period, 9.5% visited the emergency department for COPD-related reasons; and 12.7% were hospitalized for COPD (median length of stay 7 [interquartile range: 6– 8] days). Patients initiating single-inhaled BGF triple therapy escalated from monotherapy (2.3%) or dual therapy (62.7%), switched from other triple therapies (31.3%), or were treatment-naïve (3.7%).Conclusion: Single-inhaler BGF triple therapy was initiated mostly as an escalation from dual maintenance therapy, with many switching from triple therapy, in patients with a high burden of disease, as demonstrated by their frequent exacerbation profile, advanced COPD severity (moderate to very severe obstruction) and the high frequency of several comorbidities, including cardiovascular diseases.Keywords: budesonide/glycopyrronium/formoterol, chronic obstructive pulmonary disease, exacerbations, real-world data, single-inhaler triple therapy