Dupixent provides late-breaking results showing reduced airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma – Sanofi + Regeneron

Topline results from the VESTIGE Phase IV clinical trial evaluating the effect of Dupixent (dupilumab) on airway remodeling parameters through the use of functional respiratory imaging (FRI) in adults with uncontrolled moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma were presented in collaboration with Regeneron in a late-breaking poster session at the 2024 American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting . The study, the largest of its kind to utilize FRI to evaluate a biologic’s impact on the lungs, found that patients taking Dupixent achieved a significant reduction in airway inflammation, and had numerically greater reductions in mucus plug (mucus buildup in the lungs) scores and numerically greater improvements in airway volume and flow, indicating improvements in their ability to breathe more normally.

Mucus plugs in patients with asthma and other respiratory conditions are associated with type 2 inflammation and play a role in airflow obstruction, sometimes leading to persistent symptoms . Further utilization of novel FRI technologies has the potential to more accurately measure a biologic’s effect on mucus plugging in at-risk patients across multiple respiratory diseases.

Njira Lugogo, MD, MS, Division of Pulmonary & Critical Care Medicine’s Asthma Program Director, University of Michigan “By using functional respiratory imaging to produce 3D visualizations, we were able to track asthma disease progression and the biologic’s efficacy with much greater accuracy than with traditional methods like spirometry. These findings reinforce the efficacy of dupilumab in improving airflow in the lungs, and the importance of reducing mucus plugging when managing asthma. These data show the impact of dupilumab on the lungs of patients with moderate-to-severe asthma and further add to its ability to effectively treat respiratory diseases.”

Data presented at the 2024 AAAAI Annual Meeting showed that patients treated with Dupixent experienced the following changes compared to placebo at Week 24 : i. 56.9% of patients taking Dupixent achieved a significant reduction in airway inflammation as measured by fractional exhaled nitric oxide (FeNO) <25 parts per billion (ppb) compared to 10.8% of patients on placebo (P <0.001), a primary endpoint. ii. Numerically greater reductions in mucus plug scores compared to placebo in which Dupixent reduced mucus scores while an increase was observed in patients on placebo. The difference between Dupixent and placebo was -4.9 (nominal P<0.001). iii. Dupixent also reduced mucus volume by Week 24 vs placebo: -107·0 mL (p<0·001). The reductions in mucus plug count and volume are also clearly visible in the computed tomography. iv. Numerically greater improvements in lung function from baseline compared to placebo as defined by in airway volumes ([s]iVaw) at total lung capacity (TLC), the other primary endpoint, and airway resistance ([s]iRaw) at TLC, were also achieved.

The safety results were generally consistent with the known safety profile of Dupixent in moderate-to-severe asthma.The most common adverse events (AEs) observed with Dupixent (?1%) compared to placebo included cardiac disorders (Dupixent n=1/72, placebo n=2/37), vascular disorders (Dupixent n=3/72, placebo n=0/37), infections and infestations (Dupixent n=13/72, placebo n=10/37), injection site reaction (Dupixent n=7/72, placebo 2/37) and COVID-19 (Dupixent n=7/72, placebo n=2/37).