Dupilumab Efficacy and Safety in Patients with Moderate-to-Severe COPD with Type 2 Inflammation: Pooled Analysis of BOREAS and NOTUS Trials

Introduction: BOREAS (NCT03930732) and NOTUS (NCT04456673), 52-week, phase 3, randomized, double-blind, placebo-controlled trials demonstrating dupilumab efficacy and safety data in patients with COPD.

Objective: To evaluate the safety and efficacy of dupilumab in a pooled analysis combining both BOREAS and NOTUS.

Methods: Patients with moderate-to-severe COPD and type 2 inflammation (blood eosinophils≥300 cells/µL) on triple therapy (ICS+LABA+LAMA) received add-on dupilumab 300 mg q2w vs placebo for 52 weeks. Pooled primary endpoint included annualized rate of moderate or severe exacerbations, key secondary endpoint of pre-BD FEV₁, and safety.

Results: 1,874 participants were randomized (936 to placebo and 938 to dupilumab). There was a 31% reduction in the annualized rate of moderate-to-severe exacerbations (nominal P<0.0001, Table). At Week 12, change from baseline in pre-BD FEV₁ was greater with dupilumab (LS mean difference 83 mL, nominal P<0.0001) compared with placebo. This improvement was maintained at Week 52 (LS mean difference 73 mL, nominal P<0.0001). Dupilumab was well tolerated; treatment-emergent adverse events were balanced between arms across both groups (Table).

Conclusions: Dupilumab reduces moderate-to-severe exacerbations, improves lung function, and had safety consistent with the known safety profile in patients with COPD and type 2 inflammation.

Acknowledgments and funding sources Data first presented at the European Respiratory Society International Congress (ERS 2024); Vienna, Austria; September 7-11, 2024. Research sponsored by Sanofi and Regeneron Pharmaceuticals Inc. ClinicalTrials.gov Identifiers: NCT03930732/NCT04456673. Medical writing/editorial assistance was provided by Ricardo Estupinian, PhD, of Excerpta Medica, and was funded by Sanofi and Regeneron Pharmaceuticals Inc., according to the Good Publication Practice guidelines.

Fig. 1  

Publikationsverlauf

Artikel online veröffentlicht:
18. März 2025