Clinical benefits with Fluticasone furoate/Umeclidinium/Vilanterol therapy for COPD: post hoc subgroup analysis of ELLITHE study

<bold>Introduction:</bold> ELLITHE was a real-world study investigating once-daily single-inhaler triple therapy (odSITT) with fluticasone furoate (inhaled corticosteroid, ICS), umeclidinium (long-acting muscarinic antagonist, LAMA), and vilanterol (long-acting β₂-agonist, LABA) for COPD. In the overall population, rapid, sustained, and meaningful improvements in COPD assessment test (CAT) score, forced expiratory volume in one second (FEV₁) and other outcomes with odSITT were shown. However, benefits may vary in subgroups. <bold>Methods:</bold> We show a post hoc subgroup analysis of patients on prior LAMA/LABA, LABA/ICS or LAMA/LABA/ICS therapy for the primary endpoint CAT according to specified baseline criteria. Responder analyses were performed for clinically relevant improvements in CAT (minimal: ≥ -2 units; large: ≥ -4 units), FEV₁ (≥ +100 mL change), and exacerbations (0 vs. any) after 12 months. <bold>Results:</bold> Data from 617 patients were available for subgroup and responder analyses. CAT improvements were not significantly different (p>0.05) by sex (male -2.7; female -2.6), age (≤65 years -2.9; >65 years -2.5), or smoking status (ex/non-smokers -3.0; active smokers -2.2). Overall, 53.3% were minimal CAT responders and 40.7% large responders. 36.7% of patients were FEV₁ responders, and 90.6% were exacerbation-free at 12 months. 22.1% were “super-responders” with improvements in all three outcomes. <bold>Conclusion:</bold> In COPD patients of this ELLITHE subanalysis, odSITT improved CAT score independent of specified baseline criteria. Despite overlap in response, individual outcome assessments are necessary to fully comprehend differential benefits of real-world odSITT beyond exacerbations.