TY - JOUR
T1 - Dupilumab reduces acute exacerbations and improves lung function in patients with COPD with type 2 inflammation irrespective of body mass index, airflow obstruction, dyspnea, and exercise capacity index scores
AU - Vogelmeier, Claus F.
AU - Rabe, Klaus F.
AU - Bhatt, Surya P.
AU - Hanania, Nicola A.
AU - Bafadhel, Mona
AU - Christenson, Stephanie A.
AU - Papi, Alberto
AU - Singh, Dave
AU - Laws, Elizabeth
AU - Maloney, Jennifer
AU - Dakin, Paula
AU - Lu, Xin
AU - Bauer, Deborah
AU - Bansal, Ashish
AU - Robinson, Lacey B.
AU - Abdulai, Raolat M.
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/5
Y1 - 2025/5
N2 - Background: The body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index predicts 5-year mortality risk in chronic obstructive pulmonary disease (COPD); higher scores predict worse outcomes. Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4/13, reduced exacerbations and improved lung function in patients with COPD in the phase 3 BOREAS trial (NCT03930732). We assessed dupilumab efficacy in patients with COPD and type 2 inflammation by baseline BODE index. Methods: Patients with COPD, moderate-to-severe airflow limitation, screening blood eosinophils ≥300 cells/μL, and high exacerbation risk, on triple therapy, received 300 mg add-on dupilumab or placebo every 2 weeks for 52 weeks. Annualized moderate or severe COPD exacerbation rate and change from baseline in pre-bronchodilator forced expiratory volume in 1 s (FEV1) at Weeks 12 and 52 were assessed by baseline BODE index, categorized as low (≤4) or high (>4). Results: Of 934 patients with reported baseline BODE index scores (dupilumab: 470; placebo: 464), 61.8 % had scores ≤4. Dupilumab reduced exacerbations versus placebo, regardless of baseline BODE index group. Exacerbation reductions were similar by BODE index group; relative risk (95 % confidence interval) for patients with BODE index >4 versus ≤4 was 0.656 (0.496–0.868) versus 0.718 (0.547–0.944). At Weeks 12 and 52, dupilumab consistently improved pre-bronchodilator FEV1 versus placebo, regardless of baseline BODE index group. Conclusion: Dupilumab reduced exacerbations and improved lung function in patients with COPD and type 2 inflammation irrespective of baseline BODE index score. Clinical trial registration number: BOREAS trial NCT03930732.
AB - Background: The body mass index, airflow obstruction, dyspnea, and exercise capacity (BODE) index predicts 5-year mortality risk in chronic obstructive pulmonary disease (COPD); higher scores predict worse outcomes. Dupilumab, a fully human monoclonal antibody that blocks the shared receptor component for interleukin-4/13, reduced exacerbations and improved lung function in patients with COPD in the phase 3 BOREAS trial (NCT03930732). We assessed dupilumab efficacy in patients with COPD and type 2 inflammation by baseline BODE index. Methods: Patients with COPD, moderate-to-severe airflow limitation, screening blood eosinophils ≥300 cells/μL, and high exacerbation risk, on triple therapy, received 300 mg add-on dupilumab or placebo every 2 weeks for 52 weeks. Annualized moderate or severe COPD exacerbation rate and change from baseline in pre-bronchodilator forced expiratory volume in 1 s (FEV1) at Weeks 12 and 52 were assessed by baseline BODE index, categorized as low (≤4) or high (>4). Results: Of 934 patients with reported baseline BODE index scores (dupilumab: 470; placebo: 464), 61.8 % had scores ≤4. Dupilumab reduced exacerbations versus placebo, regardless of baseline BODE index group. Exacerbation reductions were similar by BODE index group; relative risk (95 % confidence interval) for patients with BODE index >4 versus ≤4 was 0.656 (0.496–0.868) versus 0.718 (0.547–0.944). At Weeks 12 and 52, dupilumab consistently improved pre-bronchodilator FEV1 versus placebo, regardless of baseline BODE index group. Conclusion: Dupilumab reduced exacerbations and improved lung function in patients with COPD and type 2 inflammation irrespective of baseline BODE index score. Clinical trial registration number: BOREAS trial NCT03930732.
KW - BODE index
KW - COPD
KW - Dupilumab
KW - Exacerbations
KW - Lung function
KW - Type 2 inflammation
UR - http://www.scopus.com/inward/record.url?scp=105001997057&partnerID=8YFLogxK
U2 - 10.1016/j.rmed.2025.108015
DO - 10.1016/j.rmed.2025.108015
M3 - Article
C2 - 40024335
AN - SCOPUS:105001997057
SN - 0954-6111
VL - 241
JO - Respiratory medicine
JF - Respiratory medicine
M1 - 108015
ER -