Dupilumab improves lung function in non-exacerbators with moderate-to-severe COPD with type 2 inflammation in phase 3 BOREAS trial

<bold>BACKGROUND:</bold> IL-4 and IL-13 are key and central drivers in type 2 inflammation. Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for IL-4 and IL-13, reduced exacerbations and improved lung function in the phase 3 BOREAS trial (<ext-link>NCT03930732</ext-link>). This analysis evaluates the effect of dupilumab vs placebo on lung function in a subgroup of patients who did not experience an exacerbation (“non-exacerbators”) during BOREAS. <bold>METHODS:</bold> In BOREAS, patients with COPD with moderate-to-severe airflow limitation and type 2 inflammation (screening blood eosinophils ≥300 cells/µL), on triple therapy, received add-on dupilumab 300 mg q2w or placebo for 52 weeks. Pre-bronchodilator (BD) FEV1 was analyzed at Week 12 in the overall ITT population and in non-exacerbators. <bold>RESULTS:</bold> In the ITT population, dupilumab (n=468) improved pre-BD FEV1 at Week 12 (least squares [LS] mean difference 83 mL; <italic>P</italic><0.0001) compared to placebo (n=471). For non-exacerbators at Week 12, dupilumab (n=286) improved pre-BD FEV1 compared to placebo (n=259) (LS mean difference 85 mL; nominal <italic>P</italic>=0.0065) <bold>(Table)</bold>. Dupilumab demonstrated an acceptable safety profile in the ITT population. <bold>CONCLUSIONS:</bold> Regardless of exacerbations experienced during the 52-Week treatment period, dupilumab improved lung function compared to placebo in non-exacerbators and in the overall ITT population. <fig><object-id>erj;64/suppl_68/PA4785/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>