Comparative Effectiveness of FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy.

INTRODUCTION

Recent data suggest differences in effectiveness of single-inhaler triple therapies (SITTs) for patients with chronic obstructive pulmonary disease (COPD); however, data specifically from patients previously treated with dual bronchodilator therapy are lacking. This real-world comparative effectiveness study assessed patients with COPD treated with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM) who stepped up from dual therapy.

METHODS

This retrospective study used healthcare claims from the Komodo Research database to identify patients with COPD and Medicare Fee-for-Service insurance on dual therapy as their most recent treatment in the 90 days pre-index, stepping up to FF/UMEC/VI or BUD/GLY/FORM between January 1, 2016 and December 31, 2023. Primary outcome was annualized rate of moderate-severe exacerbations per patient-year (PPY) compared using rate ratios (RRs) and 95% confidence intervals (CIs) from Poisson regression models after adjustment with overlap weighting. Secondary outcomes were time to first moderate-severe exacerbation (analyzed as a composite and separately), reported using Kaplan-Meier (KM) analysis and compared using hazard ratios (HRs) with 95% CIs from weighted Cox regression models. All-cause mortality (KM analysis) was included as an exploratory outcome.

RESULTS

Overall, 10,093 FF/UMEC/VI and 3926 BUD/GLY/FORM patients stepping up from dual therapy were included. Patients stepping up to FF/UMEC/VI experienced an 18% significantly lower rate of moderate-severe COPD exacerbations compared with BUD/GLY/FORM [0.80 vs. 0.98 PPY; RR (95% CI) 0.82 (0.77, 0.88); P < 0.001]. Stepping up to FF/UMEC/VI was also associated with a 14% lower risk of moderate-severe COPD exacerbations [HR (95% CI) 0.86 (0.81, 0.92); P < 0.001] and 18% lower risk of all-cause mortality [HR (95% CI) 0.82 (0.68, 0.99); P = 0.040] at 12 months compared with BUD/GLY/FORM.

CONCLUSION

In this real-world study, SITT with FF/UMEC/VI was associated with a significantly lower rate and risk of exacerbations compared with BUD/GLY/FORM in patients stepping up from dual therapy.