FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up from Dual Therapy Stratified by Exacerbations and Prior Dual Therapy: A Subgroup Analysis of a Comparative Effectiveness Study

INTRODUCTION: Three previous publications have reported real-world comparative effectiveness of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FORM) in patients with chronic obstructive pulmonary disease (COPD) in the USA. This subgroup analysis assessed treatment with FF/UMEC/VI and BUG/GLY/FORM in patients with COPD who stepped up from dual therapy, stratified by number of prior exacerbations and class of prior dual therapy. METHODS: -agonist [LAMA/LABA] or inhaled corticosteroid [ICS] plus LABA) and by prior (none or ≥ 1) COPD exacerbation. Results are presented as events per patient year (PPY) and rate ratio (RR) with 95% confidence intervals (CIs). RESULTS: Approximately 14,000 patients contributed to this analysis, 10,093 FF/UMEC/VI and 3926 BUD/GLY/FORM initiators. Baseline characteristics were well balanced following PS weighting. Step-up to FF/UMEC/VI was associated with a statistically significant reduction in moderate-severe exacerbations compared with step-up to BUD/GLY/FORM irrespective of exacerbation history: no prior exacerbation, n = 7235, 0.48 vs 0.56 PPY, RR [95% CI] 0.86 [0.77, 0.95], P = 0.003; ≥ 1 prior exacerbation, n = 6784, 1.14 vs 1.41 PPY, RR [95% CI] 0.81 [0.74, 0.87], P < 0.001. Step-up to FF/UMEC/VI was also associated with a statistically significant reduction in moderate-severe exacerbations compared with step-up to BUD/GLY/FORM across both subgroups of prior dual therapy: LAMA/LABA, n = 5717, 0.71 vs 0.95 PPY; RR [95% CI] 0.75 [0.67, 0.83], P < 0.001; ICS/LABA, n = 8302, 0.85 vs 0.99 PPY; RR [95% CI] 0.86 [0.79, 0.93], P < 0.001. CONCLUSION: Patients newly initiating FF/UMEC/VI following prior treatment with ICS/LABA or LAMA/LABA experienced a significantly lower rate of moderate-severe COPD exacerbations than those newly initiating BUD/GLY/FORM irrespective of number of prior exacerbations or prior dual therapy class.