Dupilumab Demonstrates Reduced COPD Exacerbations in Phase 3 Trials

A Closer Look at Type 2 Inflammation in COPD

Sanofi and Regeneron Pharmaceuticals have announced results from a pooled analysis of the Phase 3 BOREAS and NOTUS trials, evaluating dupilumab—a monoclonal antibody targeting IL-4 and IL-13 pathways—as an add-on therapy for patients with chronic obstructive pulmonary disease (COPD) marked by type 2 inflammation. The trials specifically focused on former or current smokers with symptomatic COPD and elevated blood eosinophil counts, a subgroup in need of innovative treatments due to their risk for frequent exacerbations despite standard therapy.

Phase 3 Analysis Highlights Efficacy in Hard-to-Treat Subgroup

The analysis included 1,874 participants randomized to receive either dupilumab or placebo, alongside standard inhaled triple therapy. Over 52 weeks, the dupilumab group experienced a significant reduction in the annualized rate of moderate or severe exacerbations compared with placebo (0.794 vs 1.156; incidence rate ratio 0.687, 95% CI 0.595-0.793; p<0.0001). Additionally, dupilumab extended the time to first severe exacerbation (p=0.016), though the reduction in annualized rate of severe exacerbations did not reach statistical significance (p=0.073). Safety outcomes were comparable between both groups, with similar rates of adverse and serious adverse events.

Building on Success: What’s Next for Dupilumab in COPD?

Phase 3 trials show dupilumab significantly lowers moderate or severe exacerbations in COPD patients with type 2 inflammation. Sanofi and Regeneron plan next steps based on these promising results.