Burden of Exacerbations in Patients Newly Initiating an Inhaled Regimen for COPD: A Claims Analysis

Background: Chronic obstructive pulmonary disease (COPD) is a progressive disease that has a great impact on healthcare resource utilization (HRU). Large-scale real-world evidence studies evaluating the clinical and economic impact of current maintenance inhaler therapies are scarce. Objective: To assess annual exacerbation rate and COPD-related HRU in patients with COPD before and after initiation of an inhaled treatment regimen. Methods: The Optum Clinformatics® Data Mart database was used to identify inpatient, outpatient, and pharmacy claims from patients aged ≥40 years with COPD in the United States from January 2016 to June 2023. The index date was the date of the first prescription claim for a new inhaled maintenance therapy after a 12-month maintenance treatment-free baseline period. The primary outcome was the proportion of patients with ≥1 moderate/severe exacerbation within 12 months post-index. The average number of moderate/severe exacerbations per patient and the proportion of patients with inpatient, emergency department (ED), office, and outpatient visits within 12 months post-index were also assessed. Results: Of the 137,691 included patients, 51.5% were female and 74.6% were White, with a mean (standard deviation [SD]) age of 70.9 (9.49) years and a mean (SD) Elixhauser Comorbidity Index of 5.67 (3.29). Most (48.3%) patients were initiated on long-acting beta-agonists/inhaled corticosteroids (LABA/ICS). The proportions of patients with exacerbations significantly decreased overall (preindex, 45.5%; post-index, 37.0%; P < 0.001). However, more than one-third of patients still experienced an exacerbation 12 months after initiating treatment. The proportion of patients with COPD-related HRU generally decreased; however, 5.0% and 2.9% of patients had inpatient and ED care post-index, respectively. Conclusion: Despite use of inhaled treatments for COPD, patients continue to experience exacerbations and HRU. Better implementation of guideline-based COPD care and novel therapies for persistent exacerbation burden are needed to improve care of the COPD population in real-world settings.