Respiratory medicine · 2024
Dupilumab reduces exacerbations and improves lung function in patients with chronic obstructive pulmonary disease and emphysema: Phase 3 randomized trial (BOREAS).
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Bhatt Surya P, Rabe Klaus F, Hanania Nicola A, Vogelmeier Claus F, Bafadhel Mona, Christenson Stephanie A, Papi Alberto, Singh Dave, Laws Elizabeth, Dakin Paula, Maloney Jennifer, Lu Xin, Bauer Deborah, Bansal Ashish, Robinson Lacey B, Abdulai Raolat M
Аннотация
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.
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.