Sanofi and Regeneron’s Dupixent (dupilumab) was associated with significant improvements in uncontrolled chronic obstructive pulmonary disease (COPD), according to positive phase 3 results presented at the 2023 American Thoracic Society International Conference.
The results from the BOREAS trial, which met the primary and all secondary endpoints, were simultaneously published in the New England Journal of Medicine.
According to the results, patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations over 52 weeks compared to placebo when added to maximal standard-of-care inhaled triple therapy.
The study also showed a 160ml improvement in lung function from baseline at 12 weeks in the Dupixent-treated cohort versus 77ml in the control group.
Additionally, patients receiving Dupixent achieved a 9.7-point improvement in health-related quality of life from baseline at 52 weeks versus a 6.4-point improvement for those on placebo.
A 2.7-point reduction in respiratory symptom severity was also observed for Dupixent-treated patients at 52 weeks versus a 1.6-point reduction in the placebo group.
COPD is a chronic respiratory disease that causes progressive lung function decline. In the US, approximately 300,000 people live with uncontrolled COPD with evidence of type 2 inflammation.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central of the type 2 inflammation that plays a major role in multiple related and often comorbid diseases.
Co-principal investigator of the BOREAS trial, Surya Bhatt, said: “I’ve seen patients with uncontrolled COPD struggle for far too long with the debilitating symptoms of this progressive disease – with limited, incremental improvement on current treatment options.
“This trial showed that [Dupixent] has the potential to impact the vicious cycle of exacerbations and lung function decline in patients with uncontrolled COPD with type 2 inflammation, and significantly improve respiratory symptoms.”
The second, replicate phase 3 trial of Dupixent in COPD with evidence of type 2 inflammation is ongoing, the companies said, with data from the study expected next year.
Dupixent has already received regulatory approvals for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic oesophagitis and prurigo nodularis.