Real-World Identification of Eosinophilic COPD Patients Potentially Eligible for Dupilumab: A Retrospective Observational Study.

PURPOSE: Despite optimized inhaled therapy, many patients with Chronic Obstructive Pulmonary Disease (COPD) continue to experience frequent exacerbations, lung function decline, and impaired quality of life, with severe exacerbations driving disease progression and increasing healthcare costs. Recently, BOREAS & NOTUS studies suggested that a subset of COPD patients with type 2 (T2) inflammation may benefit from biologic therapies. This study aimed to identify COPD patients exhibiting eosinophil-defined T2 inflammatory features potentially responsive to dupilumab among those treated at a tertiary-level hospital in Italy, characterizing them according to disease severity and biomarker profiles. PATIENTS AND METHODS: Real-world data were extracted from Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG) Hospital Information Systems through the implementation of the COPD DataMart. A multilevel RWE-based approach identified patients (2020-2023) aged ≥40 years on triple inhaled therapy with ≥2 moderate or ≥1 severe exacerbations. Patients were stratified according to their blood eosinophil levels (EOS), and healthcare pathways, comorbidities, symptoms, smoking status, and all-cause mortality were descriptively analyzed. RESULTS: Among 3,279 COPD patients, 224 met inclusion criteria. Eosinophil data were available for 179 patients, of whom, 87 (48.6%) had at least one EOS ≥300 cells/μL, corresponding to 38.8% (87/224) of the total cohort. Patients with EOS ≥300 had a median of 4 EOS measurements/year, with a median value of 210 [interquartile ranges 130-335] cells/μL. Compared with EOS <300, they showed a higher inpatient origin (23.0% vs 12.2%, p=0.005), greater comorbidity burden (71.3% cardiovascular, 59.8% metabolic, and 50.6% of other comorbidities), numerically higher all-cause mortality although not statistically significant (19.5% vs 13.0%, p=0.437), and higher annual hospital contacts (4.5 vs 3.0, p<0.001). CONCLUSION: This real-world exploratory study identified a subgroup of patients with severe COPD within a tertiary-care setting and suggested that eosinophil monitoring may contribute to guide targeted therapeutic strategies, including emerging biological therapies.