A44-18 Demographic and Clinical Characteristics of Patients With COPD Initiating Treatment With Ensifentrine: A Real-World Claims Analysis

Abstract Rationale Chronic Obstructive Pulmonary Disease (COPD) is a progressive and heterogeneous condition, affecting a broad population of patients. In June 2024, ensifentrine, a first-in-class inhaled dual inhibitor of phosphodiesterase 3 and 4, was approved by the US Food and Drug Administration for the maintenance treatment of COPD in adults. Here, we use real-world claims data to characterize the demographic and clinical profiles of patients newly initiated on ensifentrine. Methods We conducted a retrospective analysis on patients who initiated ensifentrine between August 1st, 2024 and August 29th, 2025 using the Komodo Research Database. Patients were required to have at least 12 months of continuous enrollment before the index date (i.e., date of first ensifentrine prescription). We recorded demographic and baseline clinical characteristics, including age, sex, region, insurance type, background COPD medications (rescue therapy, maintenance therapy, biologics, antibiotics, oral steroids, etc.), comorbidities of interest, and Elixhauser scores. We additionally determined baseline Global Initiative for Chronic Obstructive Lung Disease (GOLD 2025) classification groups (i.e., A, B or E). Results The total eligible population included 13,848 ensifentrine-treated patients. The median age was 74 years, with 80% between the ages of 65-84, with a nearly equal sex distribution (female 51.6%). Most patients had Medicare (85.6%), followed by commercial insurance (11.6%) and Medicaid (2.6%). Nearly half of the patients (51.2%) were on concurrent triple inhaler therapy (LABA/LAMA/ICS), while 4.1% and 4.2% received concurrent dual long-acting beta-agonist (LABA)/ long-acting muscarinic antagonist (LAMA) and LAMA/inhaled corticosteroid (ICS) therapy, respectively. Other therapies of interest included roflumilast in 12.8%, and biologics in 7.8% (dupilumab, mepolizumab, benralizumab, and/or tezepelumab). Over a third of patients received home oxygen therapy (35.9%). The top comorbidities were cardiometabolic in nature including hypertension (56.7%), cardiac arrhythmias (31.1%), peripheral vascular disorders (24.4%), congestive heart failure (23.8%), and diabetes (21.2%), with a mean (SD) Elixhauser score of 4.62 (3.47). Additional comorbidities included asthma (15.2%) and osteoporosis (12.2%). 21.8% of the population also had a history of pneumonia within the prior 12 months. The GOLD stage of patients at the index date was A/B in 63.1% and E in 36.9%. Conclusion In the first year after FDA approval, ensifentrine was prescribed to a broad population of patients with COPD, encompassing diverse demographic and disease characteristics. Notably, ensifentrine was initiated in patients receiving various background regimens and in different GOLD groups (A/B and E). These findings suggest that providers utilize ensifentrine across the spectrum of COPD management. This abstract is funded by: Verona Pharma, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA