Unmet Needs and New Opportunities in Chronic Obstructive Pulmonary Disease in Italy: A Narrative Review with Insights from the GULP Study.

The "DescribinG bUrden of COPD and occurrence of mortaLity in a cohort of Italian Patients" (GULP) study was conducted to investigate the potential of biological treatments for patients with severe chronic obstructive pulmonary disease (COPD). The purpose of this article was to perform a narrative review highlighting the role of type 2 inflammation in the mechanism of disease for COPD, summarizing the efficacy data of the Phase III RCTs that investigated biologics in COPD, and exploring the potential role for biological treatment in this setting with a particular focus on Italian patients with COPD. To this end, we conducted an exploratory analysis of GULP study data to identify patients at high risk of exacerbations, with high symoptom burden and classify them based upon the eosinophilic counts, to provide further insights into the potential use of biologics in this cohort. Out of the 1111 patients of the GULP cohort, we retrieved in total 286 (25.7%) GULP participants with ≥2 moderate or ≥1 severe exacerbation per year. Of them, despite maintenance therapy with dual bronchodilators or triple therapy, a high symptom burden (dyspnea, cough and chronic sputum production) was present in between 51.1 and 74.8%, while patients that presented with eosinophilic COPD accounted for the 7.2% of the patients at risk. This indicates that biological agents, specifically those that target the type 2 inflammatory response in COPD, should be considered in symptomatic patients with COPD and unstable disease, but that careful and pro-active phenotyping through clinical and biomarker evaluation is mandatory. Dupilumab is currently approved in Italy for eosinophilc exacerbating COPD patients, and through its favorable efficacy and safety profile, could represent a valid opportunity for these patients.