The P-III trial (BOREAS) evaluating Dupixent vs PBO added to maximal SoC inhaled therapy in 939 adults aged 40-80yrs. with mod. to sev. COPD
The trial met its 1EPs & 2EPs i.e., 30% reduction in mod. or sev. acute COPD exacerbations over 52wks., improved lung function from baseline by 160mL vs 77mL @12wks. & the benefit was sustained through 52wks. The therapy also met all EPs incl. improvement in patient-reported health-related QoL & reduction in the severity of respiratory symptoms of COPD
The safety results were consistent with the known safety profile of Dupixent in its approved indications, and overall rates of AEs (77% vs 76%). The ongoing second, replicate P-III trial (NOTUS) results of Dupixent are expected in 2024
Ref: Regeneron | Image: Regeneron
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