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INTRODUCTION: Single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy was approved by the United States Food and Drug Administration in 2017 as a maintenance therapy for chronic obstructive pulmonary disease (COPD). Patient characteristics and treatment patterns prior to initiating FF/UMEC/VI are currently unknown. This study assessed patient characteristics, exacerbation, and medication history in patients with COPD before the initiation of FF/UMEC/VI or multiple-inhaler triple therapy (MITT). METHODS: This was a retrospective study using the Optum Clinformatics® Data Mart. Patients who initiated FF/UMEC/VI triple therapy or MITT (consisting of a long-acting muscarinic antagonist [LAMA], long-acting ß2-agonist [LABA], and inhaled corticosteroid [ICS]) between October 2017 and September 2018, were enrolled in commercial or Medicare Advantage Prescription Drug plans, were aged > 40 years, and had a COPD diagnosis were eligible. Patient characteristics, comorbidities, COPD medication use, exacerbations, and eosinophil counts were assessed in the 12-month baseline period prior to initiation of FF/UMEC/VI triple therapy or MITT. RESULTS: The study population included 3933 FF/UMEC/VI users and 18,244 MITT users. Mean (standard deviation) patient age was 72.2 (8.6) years in FF/UMEC/VI users and 70.7 (9.7) years in MITT users. Prior to initiating triple therapy, the majority of FF/UMEC/VI (89.1%) and MITT (93.8%) users experienced a moderate or severe exacerbation or used a COPD maintenance therapy during the baseline period. In addition, 41.2% of FF/UMEC/VI users received overlapping ICS/LAMA/LABA, 20.3% received ICS/LABA, and 9.7% received LAMA/LABA. CONCLUSION: In this population of COPD patients, triple therapy was frequently initiated after previous maintenance medication use or an exacerbation, in line with treatment guideline recommendations.
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Background: Adherence to inhaled maintenance therapy is critical to managing chronic obstructive pulmonary disease (COPD), while increasing rescue medication usage may indicate worsening symptoms. This study evaluated adherence and rescue medication use in patients with COPD without a history of exacerbation who initiated combination therapy with budesonide/formoterol (B/F) or umeclidinium/vilanterol (UMEC/VI). Methods: Retrospective observational study of commercially insured and Medicare Advantage with Part D enrollees who initiated UMEC/VI or B/F between January 1, 2014 and December 31, 2017 (earliest fill defined as index date). Eligibility criteria included age ≥40 years, 12 months continuous enrollment pre- and post-index, ≥1 pre-index COPD diagnosis, no pre-index asthma diagnosis, COPD-related exacerbations, or medication fills containing inhaled corticosteroids, long-acting ß2-agonists, or long-acting muscarinic antagonists. Inverse probability of treatment weighting (IPTW) was used to balance treatment groups on potential confounders. Medication adherence (primary endpoint) was evaluated by the proportion of days covered (PDC). Rescue medication use (secondary endpoint) was standardized to canister equivalents (1 metered dose inhaler [200 puffs] or ~100 nebulized doses of short-acting ß2-agonist- and/or short-acting muscarinic agonist-containing medication). Results: After IPTW, covariates were balanced between cohorts (UMEC/VI: N=4082; B/F: N=9529). UMEC/VI initiators had a significantly greater mean PDC (UMEC/VI: 0.47 [0.33]; B/F: 0.38 [0.30]; P<0.001) and significantly higher rates of adherence (PDC≥0.80) than B/F initiators (UMEC/VI: n=1004 [25%], B/F: n=1391 [15%]; relative risk: 1.68, 95% CI: 1.57, 1.81; P<0.001). In the year following initiation, UMEC/VI initiators filled significantly fewer rescue medication canister equivalents than B/F initiators (predicted mean [95% CI]: 1.78 [1.69, 1.88] vs 2.15 [2.08, 2.23]; mean difference [95% CI]: -0.37 [-0.50, -0.24]; P<0.001), corresponding to 17% less (estimated) rescue medication use (incidence rate ratio [95% CI]: 0.83 [0.78, 0.88]). Conclusion: Among non-exacerbating patients with COPD initiating dual therapy, UMEC/VI demonstrated improved adherence and reduced rescue medication use compared with B/F.