Outcomes of patients with COPD before and after initiation of treatment with budesonide/glycopyrrolate/formoterol fumarate: Results from the US ARCTOS study

Objective: To assess change in COPD exacerbations, healthcare resource utilization, and costs among patients diagnosed with COPD following initiation of budesonide/glycopyrrolate/formoterol fumarate (BGF), a single inhaler triple therapy for COPD. Methods: This study was a retrospective analysis of the Inovalon MORE2 Registry and 100% Medicare Fee-for-Service claims databases between 1/1/2021-3/31/2024. Inclusion criteria: 1) prescription claim for BGF and ≥1 refill within 60 days (earliest prescription = index date), 2) ≥12 months of health plan enrollment preceding and following the index date, 3) diagnosis of COPD, 4) age ≥40 years, 5) absence of cancer and select respiratory diseases, and 6) presence of ≥1 severe or ≥2 moderate COPD exacerbations during baseline. Subgroups were established based on treatment history, baseline blood eosinophil counts and asthma comorbidity. Outcomes included COPD exacerbations, healthcare resource utilization and costs, assessed for statistically significant differences between baseline and follow-up in the overall sample and subgroups. Results: A total of 2204 patients were included. Following initiation of BGF, mean per patient per year (PPPY) total COPD exacerbations decreased by 28.7% (3.0 ± 1.7 to 2.1 ± 2.2; p < 0.0001), while mean severe COPD exacerbations decreased by 43.9% (0.3 ± 0.6 to 0.2 ± 0.5; p < 0.0001). PPPY COPD exacerbation-related medical costs decreased by 35.7% ($4664±$9355 to $2998±$8723; p < 0.001). Pre-defined subgroups showed similar changes in outcomes. Conclusions: Results demonstrate that patients with COPD and a history of exacerbations had substantial reductions in exacerbations, healthcare resource utilization, and healthcare costs after initiating BGF across a variety of subgroups including patients treated with ICS/LABA during baseline and across a range of eosinophil counts.