SINGLE-INHALER TRIPLE THERAPY FLUTICASONE FUROATE/UMECLIDINIUM/VILANTEROL COMPARED WITH TIOTROPIUM MONOTHERAPY IN COPD: A POST HOC ANALYSIS BY AIRFLOW LIMITATION

SESSION TITLE: Obstructive Lung Disease Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: Examine the influence of baseline airflow limitation on outcomes in a 12-week, randomized, double-blind, multicenter trial that compared fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) with tiotropium (TIO) in patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations. METHODS: Eligible patients had symptomatic COPD (COPD Assessment Test [CAT] score ≥10), post-bronchodilator forced expiratory volume in 1 second (FEV1) <50% predicted (or FEV1 <80% predicted and ≥2 moderate or 1 severe exacerbation in the prior year) and had received TIO maintenance therapy for ≥3 months prior to screening. Patients were randomized 1:1 to once-daily single-inhaler FF/UMEC/VI 100/62.5/25 µg via Ellipta or once-daily TIO 18 µg via HandiHaler. Primary endpoint was change from baseline (CFB) in trough FEV1 at Day 85. Post hoc analyses evaluated the effect of baseline % predicted FEV1 (<50% and ≥50% subgroups) on least squares mean CFB in trough FEV1 at Week 4, Week 12 (Day 84) and Day 85, and St George’s Respiratory Questionnaire (SGRQ) total score and CAT score at Week 4 and Week 12. Safety was also assessed. RESULTS: The <50% and ≥50% baseline % predicted FEV1 subgroups comprised 415 and 380 patients, respectively. FF/UMEC/VI significantly improved trough FEV1 CFB versus TIO in <50% and ≥50% baseline % predicted FEV1 subgroups at Week 4 (treatment difference: 117 mL and 124 mL, respectively; both p<0.001), Week 12 (92 mL and 81 mL, both p<0.001) and Day 85 (70 mL [p=0.003] and 119 mL [p<0.001]). In the <50% baseline percent predicted FEV1 subgroup, FF/UMEC/VI also significantly improved CFB in SGRQ total score and CAT score versus TIO at Week 4 (treatment difference: SGRQ total score, −3.8 [p=0.002]; CAT score, −1.5 [p<0.001]) and Week 12 (SGRQ total score, −3.0 [p=0.020]; CAT score, −1.7 [p<0.001]). In the ≥50% baseline % predicted FEV1 subgroup, FF/UMEC/VI significantly improved CFB in SGRQ total score versus TIO at Week 12 (treatment difference: -3.4 [p=0.010]) but not at Week 4 (-1.9 [p=0.122]) and no improvement in CAT score was observed at either timepoint (Week 4, -0.2 [p=0.639]; Week 12, -0.6 [p=0.228]). Treatments had comparable safety profiles; pneumonia occurred in 3 (<1%) patients in each treatment arm. CONCLUSIONS: Treatment with once-daily single-inhaler FF/UMEC/VI triple therapy significantly improved lung function compared with TIO monotherapy, regardless of airflow limitation at baseline, and had a similar safety profile. Improvements in health status with FF/UMEC/VI compared with TIO were more pronounced in patients with more severe baseline airflow limitation. CLINICAL IMPLICATIONS: FF/UMEC/VI provides a viable option for patients with symptomatic COPD and at risk of exacerbations currently receiving long-acting muscarinic antagonist monotherapy. 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