Regeneron and Sanofi Presented P-III Trial (BOREAS) Results of Dupixent (dupilumab) for Chronic Obstructive Pulmonary Disease at ATS and Published in the NEJM
- The P-III trial evaluating Dupixent vs PBO added to maximal SoC inhaled triple therapy in 939 adult patients aged 40-80yrs.
- The trial met its 1EPs & 2EPs i.e., 30% reduction in mod. to sev. COPD exacerbations @52wks., numerical improvement as early as 2wks. & benefits were sustained @52wks., 9.7 vs 6.4-point improvement in health-related QoL from baseline with numerical improvements as early as 4wks. & reduction in respiratory symptom severity (2.7 vs 1.6-point) @52wks.
- The safety results were consistent with the known safety profile of Dupixent, overall rates of AEs (77% vs 76%), and AEs leading to deaths (1.5% vs 1.7%). The P-III trial (NOTUS) of Dupixent is ongoing for COPD with evidence of type 2 inflammation & results are expected in 2024
Ref: Globenewswire | Image: Regeneron
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