Efficacy and Safety of Dupilumab for COPD with Type 2 Inflammation Indicated by Elevated Eosinophils

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Introduction: Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL-4 and IL-13, key/central drivers of Type 2 (T2) inflammation. The objective is to determine efficacy/safety in patients with moderate-to-severe COPD with T2 inflammation. Methods: BOREAS (NCT03930732) was a 52-week (wk), phase 3, randomized, double-blind, placebo (PBO)-controlled trial of efficacy/safety of biweekly DPL 300mg in COPD pts with blood eosinophils ≥300cells/µL at screening, on triple therapy (an inhaled corticosteroid [ICS], long-acting β2-agonists [LABA], and long-acting muscarinic antagonists [LAMA]; or LABA/LAMA if ICS was contraindicated) without asthma diagnosis/history. Primary endpoint: annualized rate of moderate-severe exacerbations. Secondary/other endpoints: change from baseline (BL) in pre-bronchodilator FEV 1 at wk 12 and wk 52; cumulative exacerbations over time; safety. Results: 939 participants were randomized to PBO (N=471) or DPL (N=468). DPL reduced exacerbation rates by 30% vs PBO (p=0.0005). DPL significantly increased pre-BD FEV 1 at wk 12 (LSM difference vs PBO: 83mL, p<0.0001); sustained through wk 52 (83mL, p=0.0003). This trended towards reduced exacerbation-associated annualized total SCS treatment duration for DPL (13.57 days [SD 13.17] vs for PBO (19.09 days [SD 20.65]). Safety similar in DPL and PBO groups; TEAEs balanced. Conclusions: DPL significantly improved moderate-severe exacerbations, lung function, quality of life, and symptoms in COPD patients with T2 inflammation. The use of SCS days required for the treatment of AECOPD trended lower with DPL. Acknowledgments: *PD Dr. Henrik Watz is presenting on behalf of the original authors. Data first presented at the European Respiratory Society International Congress (ERS 2023); Milan, Italy; September 9-13, 2023. Research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Medical writing/editorial assistance was provided by Luke Ray, Ph.D., of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice guidelines . Publication History Article published online: 01 March 2024 © 2024. Thieme. All rights reserved. Georg Thieme Verlag Rüdigerstraße 14, 70469 Stuttgart, Germany

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