TY - JOUR
T1 - Efficacy and Safety of Dupilumab in COPD with Type 2 Inflammation Guided by Blood Eosinophils: The BOREAS Study
AU - Bhatt, Surya
AU - Rabe, Claus
AU - Hanania, Nicolas
AU - Vogelmeier, Claus
AU - Cole, Jeremy
AU - Bafadhel, Mona
AU - Christenson, Stephanie
AU - Papi, Alberto
AU - Singh, Dave
AU - Laws, Elizabeth
AU - Mannent, Leda
AU - Patel , Naimish
AU - Staudinger, Heribert
AU - Yancopoulos, George
AU - Mortensen, Eric
AU - Akinlade, Bolanle
AU - Maloney, Jennifer
AU - Lu, Xin
AU - Bauer, Deborah
AU - Bansal, Ashish
AU - Robinson, Lacey
AU - Abdulai, Raolat
PY - 2024/3/1
Y1 - 2024/3/1
N2 - Background: Chronic obstructive pulmonary disease (COPD) is often associated with markedly reduced lung function and frequent exacerbations despite optimized inhaled treatment. Type 2 inflammation is hypothesized to play a role in a subset of patients with COPD and drive exacerbation risk. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation. Methods: BOREAS was a phase 3, 52-week, multi-center, randomized, double-blind trial of dupilumab (300mg) versus placebo administered subcutaneously once every two weeks in COPD participants with type 2 inflammation (blood eosinophils ≥300 cells/μL), who have high exacerbation risk despite standard-of-care triple inhaled medications. Primary endpoint: annualized rate of moderate or severe exacerbations. Additional endpoints: pre-bronchodilator (BD) FEV1 and St. George's Respiratory Questionnaire (SGRQ) and Evaluating Respiratory Symptoms in COPD (E-RS) scores. Results: 939 participants (468 dupilumab, 471 placebo) were randomized. The annualized rate of moderate or severe exacerbations was 30% lower with dupilumab (0.776; 95% confidence interval [CI], 0.645–0.934) than with placebo (1.101; 95% CI 0.931–1.301; rate ratio: 0.705; 95% CI, 0.581–0.857; p=0.0005). Dupilumab significantly increased pre-BD FEV1 at Week 12 vs placebo (least squares mean [LSM] 160mL vs 77mL, respectively; LSM difference: 83mL; p
AB - Background: Chronic obstructive pulmonary disease (COPD) is often associated with markedly reduced lung function and frequent exacerbations despite optimized inhaled treatment. Type 2 inflammation is hypothesized to play a role in a subset of patients with COPD and drive exacerbation risk. Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation. Methods: BOREAS was a phase 3, 52-week, multi-center, randomized, double-blind trial of dupilumab (300mg) versus placebo administered subcutaneously once every two weeks in COPD participants with type 2 inflammation (blood eosinophils ≥300 cells/μL), who have high exacerbation risk despite standard-of-care triple inhaled medications. Primary endpoint: annualized rate of moderate or severe exacerbations. Additional endpoints: pre-bronchodilator (BD) FEV1 and St. George's Respiratory Questionnaire (SGRQ) and Evaluating Respiratory Symptoms in COPD (E-RS) scores. Results: 939 participants (468 dupilumab, 471 placebo) were randomized. The annualized rate of moderate or severe exacerbations was 30% lower with dupilumab (0.776; 95% confidence interval [CI], 0.645–0.934) than with placebo (1.101; 95% CI 0.931–1.301; rate ratio: 0.705; 95% CI, 0.581–0.857; p=0.0005). Dupilumab significantly increased pre-BD FEV1 at Week 12 vs placebo (least squares mean [LSM] 160mL vs 77mL, respectively; LSM difference: 83mL; p
U2 - 10.1055/s-0044-1781407
DO - 10.1055/s-0044-1781407
M3 - Article
SN - 1533-4406
JO - The New England Journal of Medicine
JF - The New England Journal of Medicine
ER -