Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS)

TY - JOUR

T1 - Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema

T2 - Phase 3 randomized trial (BOREAS)

AU - Bhatt, Surya P.

AU - Rabe, Klaus F.

AU - Hanania, Nicola A.

AU - Vogelmeier, Claus F.

AU - Bafadhel, Mona

AU - Christenson, Stephanie A.

AU - Papi, Alberto

AU - Singh, Dave

AU - Laws, Elizabeth

AU - Dakin, Paula

AU - Maloney, Jennifer

AU - Lu, Xin

AU - Bauer, Deborah

AU - Bansal, Ashish

AU - Robinson, Lacey B.

AU - Abdulai, Raolat M.

N1 - Publisher Copyright: © 2024 The Authors

PY - 2025/1

Y1 - 2025/1

N2 - Background: Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, reduced exacerbations and improved lung function in patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation in the phase 3 BOREAS trial. Objective: To assess clinical outcomes in patients from BOREAS by emphysema status. Methods: Patients with COPD and type 2 inflammation (screening blood eosinophils ≥300 cells/μL) on maximal inhaled therapy were randomized to add-on dupilumab 300 mg or placebo every 2 weeks for 52 weeks. We assessed the annualized moderate/severe COPD exacerbation rates over 52 weeks and change from baseline to Week 12 in prebronchodilator forced expiratory volume in 1 s (FEV1) in patients with and without investigator-reported emphysema. Results: Investigator-reported emphysema was present in 306/939 patients (32.6 %) at baseline. Dupilumab reduced exacerbation rates vs placebo by 29 % (relative risk [RR] 0.71 [95 % CI 0.53–0.95]) and 31 % (RR 0.69 [95 % CI 0.53–0.89]) in patients with and without emphysema, respectively. Prebronchodilator FEV1 least squares mean difference from baseline to Week 12 for dupilumab vs placebo was 0.07 L ([95 % CI 0.002–0.14]) and 0.09 L ([95 % CI 0.04–0.14]) in patients with and without emphysema, respectively. No treatment by emphysema interaction effect was observed for the annualized rate of exacerbations (P value for interaction = 0.8296) or change in prebronchodilator FEV1 (P value for interaction = 0.6438). Conclusion: Dupilumab efficacy was similar in patients with COPD and type 2 inflammation, with or without investigator-reported emphysema.

AB - Background: Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4 and interleukin-13, reduced exacerbations and improved lung function in patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation in the phase 3 BOREAS trial. Objective: To assess clinical outcomes in patients from BOREAS by emphysema status. Methods: Patients with COPD and type 2 inflammation (screening blood eosinophils ≥300 cells/μL) on maximal inhaled therapy were randomized to add-on dupilumab 300 mg or placebo every 2 weeks for 52 weeks. We assessed the annualized moderate/severe COPD exacerbation rates over 52 weeks and change from baseline to Week 12 in prebronchodilator forced expiratory volume in 1 s (FEV1) in patients with and without investigator-reported emphysema. Results: Investigator-reported emphysema was present in 306/939 patients (32.6 %) at baseline. Dupilumab reduced exacerbation rates vs placebo by 29 % (relative risk [RR] 0.71 [95 % CI 0.53–0.95]) and 31 % (RR 0.69 [95 % CI 0.53–0.89]) in patients with and without emphysema, respectively. Prebronchodilator FEV1 least squares mean difference from baseline to Week 12 for dupilumab vs placebo was 0.07 L ([95 % CI 0.002–0.14]) and 0.09 L ([95 % CI 0.04–0.14]) in patients with and without emphysema, respectively. No treatment by emphysema interaction effect was observed for the annualized rate of exacerbations (P value for interaction = 0.8296) or change in prebronchodilator FEV1 (P value for interaction = 0.6438). Conclusion: Dupilumab efficacy was similar in patients with COPD and type 2 inflammation, with or without investigator-reported emphysema.

KW - BMI body mass index

KW - COPD

KW - Dupilumab

KW - Emphysema

KW - Eosinophils

KW - Exacerbations

KW - Type 2 inflammation

UR - http://www.scopus.com/inward/record.url?scp=85211056863&partnerID=8YFLogxK

U2 - 10.1016/j.rmed.2024.107846

DO - 10.1016/j.rmed.2024.107846

M3 - Article

C2 - 39481660

AN - SCOPUS:85211056863

SN - 0954-6111

VL - 236

JO - Respiratory medicine

JF - Respiratory medicine

M1 - 107846

ER -