Abstract Intro Patients with chronic obstructive pulmonary disease (COPD) may experience severe exacerbations which require emergency room visits and/or hospitalization, often despite maximal maintenance therapy. These severe exacerbations are associated with significant health care costs, and increased risk of future exacerbations, leading to worse outcomes. There is a need for treatment options that reduce severe exacerbations for patients with COPD. Ensifentrine, a first-in-class, dual inhibitor of phosphodiesterase (PDE) 3 and PDE4, was approved in June, 2024 for the maintenance of COPD in adults in the US. The aim of this research is to explore the real-world effect of ensifentrine on severe exacerbations and COPD-related health care resource utilization. Methods Patients were identified using the Komodo Research Database (KRD) for this pre/post analysis between June 26 and November 25, 2024 with an Index date as the day of ensifentrine initiation. Patients were required to have at least 12 months of continuous pharmacy/medical coverage and ≥1 COPD diagnosis during the baseline period, as well as 30+ days post-index follow-up through May 29, 2025. COPD-related outcomes such as severe exacerbations and healthcare resource utilization (HCRU) were annualized and reported in the pre- and post-index periods in patients taking ensifentrine and concurrent dual (long-acting beta-agonist LABA/ long-acting muscarinic antagonist LAMA, LABA/inhaled corticosteroid ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) therapy. Baseline demographics and clinical characteristics were also reported. Results Of 3,958 patients that initiated ensifentrine, 2,372 patients were on concomitant dual (n = 363) or triple (n = 2,009) therapy and were included in this analysis. 36.6% of patients were GOLD E at index, with a mean Elixhauser comorbidity score of 4.63. 16.5% of patients had concomitant asthma. Overall, the pre- to post-index annual severe exacerbation rate reduction was 11% (p 0.05). Annualized COPD-related emergency room (ER) visits were reduced 17%, with an increase in outpatient HCRU of 21% (p 0.05 for both). In the subgroup on triple therapy, the pre- to post-index rate of severe exacerbations was reduced 11%, COPD-related ER visits were reduced 17%, and outpatient HCRU increased 19% (p 0.05 for all). Conclusion In a population of patients with COPD taking dual/triple maintenance therapy, the addition of ensifentrine reduced resource-intensive severe exacerbation events and care, while increasing outpatient care suggesting a lessening of exacerbation severity. These real-world outcomes support the use of ensifentrine as an effective treatment for patients with COPD who need additional options to prevent severe outcomes. This abstract is funded by: Verona Pharma, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Siddharthan et al. (Fri,) studied this question.