Topline results from the VESTIGE phase 4 clinical trial demonstrated that individuals with uncontrolled moderate-to-severe asthma with an eosinophilic phenotype or who were oral corticosteroid-dependent who took dupilumab (Dupixent; Sanofi) had a significant reduction in airway inflammation , according to a press release from the company. Additionally, the drug showed greater reductions of mucus buildup in the lung (mucus plugs) and greater improvements in airway volume and flow.
The data were presented as a late-breaking poster, in collaboration with Regeneron, in a session at the 2024 American Academy of Allergy, Asthma, and Immunology Annual Meeting.
“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,” Njira Lugogo, MD, MS, asthma program director of the Division of Pulmonary & Critical Care Medicine at the University of Michigan, said in the press release.
3 Key Takeaways
- Dupilumab was effective in reducing airways inflammation and functional changes in airways volume in individuals with uncontrolled moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid dependent asthma.
- The study used functional respiratory imaging to produce 3D visualizations, which allowed researchers to track asthma disease progression and the biologic's efficacy with much greater accuracy than with traditional methods like spirometry.
- The study included 109 individuals aged 21 to 70 years who had uncontrolled moderate-to-severe asthma and raised type 2 biomarkers. In the 24-week treatment period, investigators randomized treatment 2:1 for 300 mg of dupilumab or the matched placebo every 2 weeks, at 72 individuals and 37 individuals, respectively.
In the VESTIGE clinical trial, investigators conducted a phase 4 randomized, double-blind, placebo-controlled trial which evaluated the efficacy of dupilumab on lung inflammation and structural/functional changes in airway volume, according to the press release. They included 109 individuals aged 21 to 70 years who had uncontrolled moderate-to-severe asthma and raised type 2 biomarkers. In the 24-week treatment period, investigators randomized treatment 2:1 for 300 mg of dupilumab or the matched placebo every 2 weeks, at 72 individuals and 37 individuals, respectively.
The primary endpoint included the proportion of individuals who achieved fractional exhaled nitric oxide (FeNO levels of less than 25 parts per billion (ppb) and the percent change from baseline to 24 weeks in airway volumes at total lung capacity, according to the press release. For the secondary endpoints, investigators evaluated the percent change from baseline at 24 weeks in untrimmed distal airway resistance corrected for lung volume at total lung capacity as well as change from baseline at 24 weeks in global lung mucus score.
The results showed that approximately 56.9% of individuals taking dupilumab achieved a significant reduction in airway inflammation with FeNO less than 25 ppb compared to approximately 10.8% of individuals taking the placebo. There were also greater reductions in mucus plug scores with dupilumab and increases with the placebo. There was a -4.9 difference between dupilumab and the placebo, according to the press release.
Furthermore, dupilumab also reduced mucus volume at 24 weeks when compared to the placebo. According to the press release, the mucus plug count and volume could be clearly seen in the computed tomography. There were also improvements in lung function with dupilumab compared to the placebo in airway volumes at total lung capacity and airway resistance at total lung capacity, according to the results presented.
Additionally, the safety profile of dupilumab was consistent with what has been observed in moderate-to-severe asthma, with the most common adverse events being cardiac disorders, vascular disorders, infections and infestations, injection site reaction, and COVID-19, according to the press release.
References
Media Update: Dupixent continues scientific leadership with late-breaking results showing reduced airway inflammation and mucus plugging in adults with uncontrolled moderate-to-severe asthma. News release. February 24, 2024. Accessed March 1, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-02-24-13-00-00-2834714
