• DUPIXENT (dupilumab), a fully human monoclonal antibody, inhibits interleukin-4 and interleukin-13 pathways, crucial in type 2 inflammation, without being immunosuppressive. Phase III trials have shown its significant clinical benefits and reduction of type 2 inflammation, driven by these key pathways. Currently, it is under Priority Review by the FDA as an add-on treatment for uncontrolled Chronic Obstructive Pulmonary Disease (COPD) in adults.
• Recent data released from the significant BOREAS Phase III study further endorse DUPIXENT’s potential as a pioneering biologic therapy for specific adult individuals suffering from unmanaged COPD associated with type 2 inflammation.
• Fresh insights from the BOREAS trial assess the significance of biomarkers in anticipating enhancements in exacerbations and other treatment responses.

At the American Thoracic Society International Conference 2024, Sanofi, in collaboration with Regeneron, will present oral presentations on DUPIXENT data, evaluating its potential as a treatment for COPD from the Phase III BOREAS and NOTUS studies. The BOREAS trial (NCT03930732), concluded in February 2023, was a 52-week, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of Dupilumab in moderate-to-severe COPD with type 2 inflammation. Six abstracts from BOREAS will be presented at the ATS conference, including an analysis of treatment-by-biomarker interaction effects and lung function data, in an oral abstract session.

In some patients with COPD, type 2 inflammation may increase exacerbation risk and may be indicated by elevated blood eosinophil counts. Dupilumab inhibits IL-4 and IL-13, crucial drivers of this inflammation. In the Phase III BOREAS study of COPD patients with high FeNO levels (≥20 ppb), Dupilumab showed significant benefits. By Week 12, patients treated with Dupilumab had a notable lung function improvement, with an average FEV1 increase of 232 mL, compared to 108 mL in the placebo group, a statistically significant difference (p = 0.002). This improvement persisted through Week 52. Furthermore, the Dupilumab group experienced fewer moderate or severe exacerbations, indicating enhanced lung function and reduced COPD severity. Overall, patients with type 2 inflammation who received Dupilumab had better lung function, fewer exacerbations, improved quality of life, and reduced respiratory symptoms compared to those on placebo.

Dupixent, currently under priority review by the US FDA, offers promising potential as an adjunctive maintenance therapy for specific adults grappling with uncontrolled COPD. Clinical trials indicate its efficacy in mitigating type 2 inflammation, a pivotal factor in various interconnected and frequently co-existing conditions. Notably, patients with elevated FeNO levels at baseline experienced fewer COPD exacerbations and enhanced lung function when treated with Dupilumab compared to a placebo, aligning with the established role of IL-4 and IL-13 in type 2 inflammation. Dupilumab’s proposed mechanism suggests it could mitigate goblet-cell hyperplasia, mucus hypersecretion, and airway remodeling. 

If DUPIXENT receives approval, it has the potential to transform the landscape of COPD management significantly. This could lead to a paradigm shift in how healthcare professionals approach and manage COPD, potentially resulting in improved patient outcomes and quality of life. Moreover, the introduction of DUPIXENT may spur further innovation and competition in the COPD market, driving advancements in therapeutic options and enhancing overall patient care. 

Based on DelveInsight’s “Chronic Obstructive Pulmonary Disease (COPD) – Market Insight, Epidemiology And Market Forecast – 2034”, the COPD market in 2023 was estimated to be approximately USD 12.6 billion in the 7MM, which is likely to surge at a considerable CAGR during the forecast period.