Assessment of COPD-related outcomes in patients initiating a once daily or twice daily ICS/LABA.

Background: Use of inhaled corticosteroids and long acting beta agonist (ICS/LABA) combination therapy has been shown to decrease the frequency of exacerbations in patients with chronic obstructive pulmonary disease (COPD). In this population, adherence to treatment is associated with better disease control and lower risk of COPD-related exacerbations in the future. Using a treatment with a more convenient regimen or easier-to-use device could improve patient adherence, improve disease control, decrease the frequency of exacerbations and minimize the COPD-related economic burden. Real-world information on the impact on healthcare costs and exacerbation risk of initiating once-daily or twice daily ICS/LABA in this patient population is limited. The objective of this study was to assess COPD-related healthcare costs, adherence, and exacerbations in COPD patients initiating treatment with fluticasone furoate/vilanterol 100/25 (FF/VI) or budesonide/formoterol 160/4.5 (BUD/F) using a large managed care database in the US.

Methods: This was a retrospective cohort study among COPD patients initiating FF/VI or BUD/F between January 01, 2014 and June 30, 2016. The analysis used the Optum Research Database (ORD) which contains patients from commercial and Medicare Advantage Prescription Drug (MAPD) plans. The study included new initiators of ICS/LABA as either FF/VI or BUD/F for COPD, ≥40 years of age at index, ≥15 months of continuous enrollment (12 months pre-index and ≥3 months post-index). New users of FF/VI or BUD/F were matched on baseline characteristics using propensity score matching (PSM) methods. Multivariate models including ordinary least squares regression, Lin's regression, logistic regression, and Cox proportional hazards were used to assess differences between the cohorts on outcomes of interest.

Results: A total of 18,652 subjects met all inclusion and exclusion criteria with 5044 initiating FF/VI and 13,608 initiating BUD/F. Of these, 9026 subjects were matched at a 1:1 ratio (4513 patients in each cohort) and were included in the final analyses. Proportion of days covered (PDC), was significantly better for FF/VI (mean PDC [SD]: FF/VI: 0.46 [0.31], BUD/F: 0.41 [0.29], p < 0.001) while FF/VI was associated with a 9% lower risk (adj. hazard ratio (HR): 0.91, 95% CI: 0.85-0.96) of having a moderate or severe COPD-related exacerbation. However, COPD-related healthcare costs were not significantly different, $11,521 vs $10,986, p = 0.41 for FF/VI and BUD/F, respectively.

Conclusions: Patients initiating once-daily FF/VI were more adherent, and were associated with a lower risk of subsequent COPD-related exacerbations compared with twice-daily BUD/F, however this was not associated with a significant difference in costs. (GSK Study HO1617333/206702).