Dupilumab (Dupixent®), a monoclonal antibody that inhibits interleukin-4 (IL-4) and 13 (IL-13), recently became the first biologic approved to treat COPD. Dupilumab also has indications for asthma, atopic dermatitis, nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. The COPD indication was based on two studies that found dupilumab reduced exacerbations and improved lung function, compared to placebo, in COPD patients with evidence of type 2 inflammation (defined as a blood eosinophil count ≥ 300 cells/mcl). In the
BOREAS study (N=939), the annualized rate of moderate or severe COPD exacerbations was lower with dupilumab (0.78 vs 1.10, p<0.001), and the pre-bronchodilator FEV1 increased more with dupilumab at 52 weeks (+153 ml vs +70 ml, p<0.001). Similar results were observed in the NOTUS study (N=935), which also showed lower exacerbation rates (0.86 vs 1.30) and improved FEV1 (+139 vs +82) with dupilumab. [
NOTUS abstract] Dosing in both studies was 300 mg every two weeks, and adverse events were similar to placebo.
Dupilumab, already a blockbuster drug for Regeneron and Sanofi, is now approved for COPD patients with an eosinophilic phenotype, typically defined as a blood eosinophil count consistently above 300 cells/mcl. For context, the average eosinophil count in the general adult population is 100 to 150 cells/mcl, and most labs consider a normal range to be 0 to 500 cells/mcl. Dupilumab is expensive but covered by most Medicare Part D plans, which may help many COPD patients access it.