COPD_A_269287 2739..2750

Observational & Pragmatic Research Institute Pte Ltd, Singapore, Singapore; Data to Insights Research Solutions, Lisbon, Portugal; Department of Global Clinical Development, Chiesi SAS, Bois Colombes Cedex, France; Department of Global Clinical Development, Chiesi Farmaceutici S.p.A, Parma, Italy; Mescio Research, Blauwestad, The Netherlands; Section of Respiratory Medicine, Department of Morphology, Surgery and Experimental Medicine, University of Ferrara, Ferrara, Italy; Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, The Netherlands; Respiratory Diseases Unit, University Hospital Virgen Del Rocío, Seville, Spain; Service de Pneumologie, Hôpital Cochin, APHP, CentreUniversité de Paris, Paris, France; University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK; Department of Internal Medicine, Pulmonary and Critical Care Medicine, University of Marburg, Member of the German Centre for Lung Research (DZL), Marburg, Germany; Centre of Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK Purpose: This study aimed to evaluate the non-inferiority of initiating extrafine beclometasone dipropionate/formoterol fumarate (BDP/FF) versus double bronchodilation (longacting beta-agonists [LABA]/long-acting muscarinic antagonists [LAMA]) among patients with a history of chronic obstructive pulmonary disease (COPD) exacerbations. Patients and Methods: A historical cohort study was conducted using data from the UK’s Optimum Patient Care Research Database. Patients with COPD ≥40 years at diagnosis were included if they initiated extrafine BDP/FF or any LABA/LAMA double therapy as a step-up from no maintenance therapy or monotherapy with inhaled corticosteroids (ICS), LAMA, or LABA and a history of ≥2 moderate/severe exacerbations in the previous two years. The primary outcome was exacerbation rate from therapy initiation until a relevant therapy change or end of follow-up. Secondary outcomes included rate of acute respiratory events, acute oral corticosteroids (OCS) courses, and antibiotic prescriptions with lower respiratory indication, modified Medical Research Council score (mMRC) ≥2, and time to first pneumonia diagnosis. The non-inferiority boundary was set at a relative difference of 15% on the ratio scale. Five potential treatment effect modifiers were investigated. Results: A total of 1735 patients initiated extrafine BDP/FF and 2450 patients initiated LABA/ LAMA. The mean age was 70 years, 51% were male, 41% current smokers, and 85% had FEV1 <80% predicted. Extrafine BDP/FF showed non-inferiority to LABA/LAMA for rate of exacerbations (incidence rate ratio [IRR] = 1.01 [95% CI 0.94–1.09]), acute respiratory events (IRR = 0.98 [0.92–1.04]), acute OCS courses (IRR = 1.01 [0.91–1.11]), and antibiotic prescriptions (IRR = 0.99 [0.90–1.09]), but not for mMRC (OR = 0.93 [0.69–1.27]) or risk of pneumonia (HR = 0.50 [0.14–1.73]). None of the a priori defined effect modifier candidates affected the comparative effectiveness. Conclusion: This study found that stepping up to extrafine BDP/FF from no maintenance or monotherapy was not inferior to stepping up to double bronchodilation therapy in patients with a history of exacerbations.