6/27/23, 11:44 PM BOREAS Pathway Feedback Search Clinical Topics Home Studies BOREAS BOREAS Disease Chronic obstructive pulmonary Trial question What is the role of dupilumab in patients with COPD who had type 2 inflammation indicated by eosinophil counts? Study design Multi-center Double blinded RCT Population Characteristics of study participants 34.0% female N = 939 66.0% male 939 patients (319 female, 620 male) Inclusion criteria: patients with COPD who had a blood eosinophil count 300 cells/mL and an elevated exacerbation risk despite the use of standard triple therapy Key exclusion criteria: current diagnosis of asthma or a history of asthma Interventions N=468 dupilumab (subcutaneous injection of 300 mg every 2 weeks) N=471 placebo (matching placebo every 2 weeks) Primary outcome Annualized rate of moderate or severe exacerbations 1.1 1.1 0.8 0.78 https://web.pathway.md/studies/recoGNOSn5RCHsQf0 1/2 6/27/23, 11:44 PM BOREAS Pathway 0.6 0.3 Significant decrease 0.0 Dupilumab Placebo Significant decrease in annualized rate of moderate or severe exacerbations (0.78 vs. 1.1; RR 0.7, 95% CI 0.58 to 0.86) Secondary outcomes Significant increase in improvement in prebronchodilator FEV in 1 second at week 12 (160 mL vs. 77 mL; LSMD 83, 95% CI 42 to 125) Significant decrease in reduction in St. George's Respiratory Questionnaire Score at week 52 (-9.7 vs. -6.4; LSMD -3.4, 95% CI -5.5 to -1.3) Significant decrease in reduction in evaluating respiratory symptoms in COPD score (-2.7 vs. -1.6; LSMD -1.1, 95% CI -1.8 to -0.4) Safety outcomes No significant differences in adverse events leading to discontinuation of trial drug, serious adverse events, and adverse events leading to death. Conclusion In patients with COPD who had a blood eosinophil count 300 cells/mL and an elevated exacerbation risk despite the use of standard triple therapy, dupilumab was superior to placebo with respect to annualized rate of moderate or severe exacerbations. Reference Surya P Bhatt, Klaus F Rabe, Nicola A Hanania et al. Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. N Engl J Med. 2023 May 21. Online ahead of print. Open reference URL https://web.pathway.md/studies/recoGNOSn5RCHsQf0 2/2