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On September 15, 2023, we reported on findings from the pivotal phase 3 BOREAS clinical trial presented at the European Respiratory Society International Congress.
The BOREAS phase 3, randomized, double blind clinical trial enrolled 939 adults aged 40 to 80 years who were current or former smokers with uncontrolled moderate-to severe COPD. All study participants had evidence of type 2 inflammation as indicated by a blood eosinophil count of ≥300 cells/µL.
All participants were receiving maximal standard of care, ie triple therapy comprised of an inhaled corticosteroid (ICS), long-acting β2-agonist (LABA), and long-acting muscarinic antagonist (LAMA). Investigators also accepted participants treated with a LABA/LAMA combination in cases where ICS was shown to be contraindicated.
Researchers randomly assigned participants receive dupilumab 300 mg (n=468) or placebo (n=471) every 2 weeks over the 52-week study period. The study’s primary endpoint evaluated the annualized rate of acute moderate or severe COPD exacerbations; key secondary endpoints included change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at 12 and 52 weeks; change from baseline at 52 weeks in QoL as measured by the St George’s Respiratory Questionnaire (SGRQ); and, change from baseline at 52 weeks in severity of COPD respiratory symptoms as measured by the Evaluation Respiratory Symptoms: COPD (E-RS: COPD) Scale.
Exacerbations down. Compared with participants who received placebo, BOREAS participants who received dupilumab experienced a 30% reduction in annualized moderate or severe acute COPD exacerbations over 52 weeks (P=.0005), the study’s primary endpoint.
Increased FEV1.Analyses of key secondary endpoints related to lung function also favored dupilumab, with an increase in prebronchodilator FEV1 from baseline to week 12 by least squares (LS) mean of 160 mL at 12 weeks compared to 77 mL for placebo (LS mean difference, 83 ml; 95% CI, 42 to 125; P<.001), with the benefit versus placebo sustained through week 52 (P=.0003).
“In this landmark phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic. These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease.”