Dupilumab efficacy and safety in patients with moderate-to-severe COPD with type 2 inflammation: pooled analysis of BOREAS and NOTUS

<bold>Introduction:</bold> BOREAS (<ext-link>NCT03930732</ext-link>) and NOTUS (<ext-link>NCT04456673</ext-link>) were 52-Week, phase 3, randomized, double-blind, placebo-controlled trials demonstrating dupilumab efficacy and safety in patients with COPD and type 2 inflammation. <bold>Objective:</bold> To evaluate the safety and efficacy of dupilumab in a pooled analysis combining BOREAS and NOTUS. <bold>Methods:</bold> Patients with moderate-to-severe COPD and type 2 inflammation (blood eosinophils ≥300 cells/µL) on triple therapy received add-on dupilumab 300 mg q2w or placebo for 52 weeks. Both trials were pooled for the primary endpoint of annualized rate of moderate or severe exacerbations, key secondary endpoint of pre-BD FEV₁, and safety. <bold>Results:</bold> 1,874 participants were randomized (936 to placebo and 938 to dupilumab). There was a 31% reduction in the annualized rate of moderate-to-severe exacerbations (nominal <italic>P</italic><0.0001, <bold>Table</bold>). At Week 12, change from baseline in pre-BD FEV₁ was greater with dupilumab (LS mean difference 83 mL, nominal <italic>P</italic><0.0001) vs placebo. This improvement was maintained at Week 52 (LS mean difference 73 mL, nominal <italic>P</italic><0.0001). Dupilumab was well tolerated; treatment-emergent adverse events were balanced between arms across both groups (<bold>Table</bold>). <bold>Conclusions:</bold> Dupilumab reduces moderate-to-severe exacerbations, improves lung function, and has safety consistent with the known safety profile in patients with COPD and type 2 inflammation. <fig><object-id>erj;64/suppl_68/PA4787/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>