Comparable Clinical Outcomes with Tiotropium/Olodaterol or Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with COPD and Blood Eosinophil Count ≤300 Cells/μL

Sanjay Sethi,1 Brendan Clark,2 Erin K Buysman,3 Andrew Sargent,3 Lindsay GS Bengtson3 1Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA; 2HEOR Value Demonstration, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 3Health Economics and Outcomes Research, Optum Life Sciences, Eden Prairie, MN, USACorrespondence: Brendan Clark, HEOR Value Demonstration, Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT, 06877, USA, Email [email protected]: Assessment of blood eosinophil count (BEC) is recommended to guide the use of inhaled corticosteroids in chronic obstructive pulmonary disease (COPD), with BEC ≥ 300 cells/μL predictive of patients most likely to benefit.Objective: To compare outcomes between patients initiating dual bronchodilator therapy with tiotropium/olodaterol (TIO/OLO) versus triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in patients with COPD and BEC ≤ 300 cells/μL.Methods: A retrospective cohort study using claims data from the Optum Research Database. Patients with COPD initiated on TIO/OLO or FF/UMEC/VI between 01 June 2015 and 30 November 2019, with a baseline BEC were included. TIO/OLO initiators were 1:1 propensity score matched with FF/UMEC/VI initiators. Time to first exacerbation and pneumonia diagnosis were assessed using Kaplan-Meier analysis. COPD exacerbations and COPD and/or pneumonia-related healthcare resource utilization (HRU) and cost outcomes were presented as population annualized averages.Results: The study population included 3867 individuals with a baseline BEC result. Among these, 3168 (81.9%) had BEC ≤ 300 cells/μL. After matching, 1098 matched pairs with BEC ≤ 300 cells/μL were retained. The follow-up annualized count of moderate/severe exacerbations was not significantly different between TIO/OLO and FF/UMEC/VI initiators (1.05 vs 0.99, p=0.535). Annualized counts of COPD and/or pneumonia-related HRU were not significantly different, except for emergency department visits, which were lower for TIO/OLO than FF/UMEC/VI (0.59 vs 0.83, p=0.018). Annualized COPD and/or pneumonia-related emergency department ($370 vs $538, p=0.034) and pharmacy costs ($4692 vs $6573, p< 0.001) were lower for TIO/OLO versus FF/UMEC/VI initiators.Conclusion: Eight in ten patients with COPD who initiated FF/UMEC/VI had BEC ≤ 300 cells/μL. TIO/OLO and FF/UMEC/VI users with BEC ≤ 300 cells/μL experienced similar rates of COPD exacerbations. TIO/OLO initiators incurred lower pharmacy costs related to COPD and/or pneumonia than FF/UMEC/VI initiators. These results support treatment recommendations of reserving inhaled corticosteroids for frequent exacerbators and patients with elevated eosinophil counts.Plain Language Summary: Chronic obstructive pulmonary disease (COPD) is a condition caused by lung damage that makes breathing difficult. Patients with COPD have several inhaler options for treating their symptoms and preventing COPD flareups. Some inhalers include steroids, which can help reduce lung inflammation. However, inhaled steroids can also cause side effects such as pneumonia.To choose the best inhaler for COPD patients, a blood draw can be used to check the levels of eosinophils, a type of white blood cell. Patients with high blood eosinophil count are most likely to benefit from inhaled steroids. However, most patients with COPD do not have high eosinophil levels.This study included patients without high eosinophil levels and compared COPD flare-ups and pneumonia outcomes in patients who used an inhaler with two (no steroid) or three medications (including a steroid). It also examined how often these patients needed to be treated for COPD or pneumonia and how expensive it was.The study found that for patients without high eosinophil levels, the number of COPD flare-ups and pneumonia events was similar for those who received an inhaler containing a steroid and those who did not. It was also found that medication costs related to COPD treatment were lower in patients using an inhaler without steroids. These findings indicate that COPD patients without high eosinophil counts are less likely to benefit from inhaled steroids and may help encourage healthcare providers to check eosinophil levels when selecting inhaled medications for patients with COPD.Keywords: dual bronchodilator, triple therapy, eosinophil, claims, exacerbations, costs