B24-20 Real-World COPD Assessment Test (CAT) Outcomes of Patients Initiating Ensifentrine: 3 Month Interim Analysis of the RELIEF Study

Rationale Patients with chronic obstructive pulmonary disease (COPD) report symptom and quality of life impacts despite stable maintenance therapy. There is a need for treatments that improve symptoms for patients with COPD. Ensifentrine is a dual inhibitor of phosphodiesterase (PDE)3 and PDE4 with bronchodilation and anti-inflammatory effects. This analysis describes changes in COPD Assessment Test (CAT) scores in patients initiating ensifentrine. Methods The RELIEF study is an observational, 6-month, longitudinal study conducted in the US. Adults with COPD on stable dual (long-acting beta-agonist [LABA]/long-acting muscarinic antagonist [LAMA]) or triple (LABA/LAMA/inhaled corticosteroid [ICS]) therapy for at least 3 months were eligible to enroll after their physicians initiated ensifentrine. CAT, St. George’s Respiratory Questionnaire Symptoms Domain, and Treatment Satisfaction Questionnaire for Medication 9 were collected via web-based survey at baseline and months 1, 3, and 6. CAT responders (change from baseline ≥ -2 units) were analyzed at 1 and 3 months in patients with a baseline CAT score ≥ 10. Here, CAT outcomes are presented through 3 months in an interim analysis. Results 132 patients were included in this study and completed baseline surveys. Patients were a median age of 72, had been diagnosed with COPD for an average of 10 years, and were equally split for gender. The population was primarily white (91.5%), with the majority covered by Medicare (88.5%). Roughly 1 in 5 patients were current smokers (18.9%). Over 95% of patients were stable on concomitant triple therapy (96.2%). Of the patients with a baseline CAT Score ≥ 10 (n = 114 at 1 month and n = 97 at 3 months), the mean baseline CAT score was 24.6. In this population, the mean CAT score declined to 20.3 at 1 month and 19.9 at 3 months. Domain-specific reductions were also observed at 1 and 3 months in Cough (Month 1= -0.5, Month 3= -0.7), and Phlegm (Month 1= -0.6, Month 3= -0.8). 64.9% were CAT responders at 1-month and 65% were CAT responders at 3 months. CAT Score results in CAT responders are presented in Figure 1. Conclusion Symptomatic patients on standard-of-care maintenance therapy reported rapid and durable reductions in symptoms after the initiation of ensifentrine. Ensifentrine is associated with improvements in CAT at 1 and 3 months, potentially through beneficial impacts on airway mucous dysfunction. These patient-reported data show that ensifentrine offers early, sustainable and clinically meaningful relief to patients with COPD who remain symptomatic, especially those on stable triple therapy.