Dupilumab efficacy in patients with COPD and type 2 inflammation irrespective of mortality risk score

<bold>BACKGROUND:</bold> In the phase 3 BOREAS (<ext-link>NCT03930732</ext-link>) study dupilumab reduced exacerbations and improved lung function and quality of life in patients with moderate-to-severe COPD and type 2 inflammation (blood eosinophils ≥300 cells/µL). Here we explore dupilumab efficacy stratified by baseline body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index ≤/>4, a predictor of 5-year mortality in COPD. <bold>METHODS:</bold> Patients received add-on dupilumab 300 mg or placebo every 2 weeks for 52 weeks alongside standard-of-care treatment. Endpoints were adjusted annualized rates of moderate or severe acute exacerbation of COPD and least squares (LS) mean difference of change from baseline at Week 12 in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV₁). <bold>RESULTS:</bold> Of 468 patients randomized to receive dupilumab, 278 had BODE≤4 and 186 had BODE>4; of 471 patients receiving placebo, 299 had BODE≤4, and 171 had BODE>4. Dupilumab reduced exacerbation rates vs placebo by 28.2% (BODE≤4) and 34.4% (BODE>4). At Week 12, dupilumab improved pre-BD FEV1 from baseline vs placebo by 0.10 L (BODE≤4; 95% CI: 0.05–0.15) and 0.06 L (BODE>4; 95% CI: −0.01–0.14) (Table). <bold>CONCLUSION:</bold> Dupilumab reduced exacerbation rates and improved lung function in patients with COPD and type 2 inflammation irrespective of baseline BODE scores (including those with high scores). <fig><object-id>erj;64/suppl_68/PA4782/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>