Dupilumab Significantly Reduces Exacerbations in COPD Trial

Dupilumab was found to significantly reduce exacerbations in adults with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation, according to findings from the phase 3 BOREAS trial.

The randomized, double-blind, placebo-controlled BOREAS trial (ClinicalTrials.gov Identifier: NCT03930732) included 939 adults 40 to 80 years of age with COPD who were current or former smokers and were on maximal standard of care inhaled therapy (triple therapy). Patients were randomly assigned 1:1 to receive dupilumab or placebo subcutaneously every 2 weeks for 52 weeks, in addition to triple therapy. The primary endpoint was the annual rate of moderate to severe acute COPD exacerbations.

Over the 52-week study period, treatment with dupilumab led to a significant 30% reduction in moderate or severe acute COPD exacerbations compared with placebo (P =.0005). Dupilumab was also associated with improvements in lung function (change in pre-bronchodilator FEV₁ from baseline to week 12: 160mL vs 77mL for placebo; P <.0001) that were sustained through 52 weeks (P =.0003).

The safety profile of dupilumab was consistent with that observed in previous clinical trials. Adverse events more commonly seen with dupilumab compared with placebo were headache (8.1% vs 6.8%, respectively), diarrhea (5.3% vs 3.6%), and back pain (5.1% vs 3.4%).

Dupilumab, an interleukin-4 receptor alpha antagonist, is currently marketed under the brand name Dupixent for the treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

“In this landmark phase 3 trial, patients with uncontrolled COPD achieved clinical outcomes with Dupixent at a magnitude never before seen with a biologic,” said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. “These results also validate the role type 2 inflammation plays in driving COPD in these patients, advancing the scientific community’s understanding of the underlying biology of this disease. We look forward to discussing these exciting results with regulatory authorities.”