Study involving children aged six to 11 years with moderate-to-severe asthma reveals positive data
Results from a phase 3 extension trial have demonstrated the efficacy and safety profile of Dupixent – also known as dupilumab – as a maintenance therapy when added to other asthma medications.
The treatment – developed by Sanofi and Regeneron – was consistent for up to two years in children aged six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation.
The results were presented in a late-breaking session at the recent 2022 European Respiratory Society (ERS) International Congress. It also coincided with the notable milestone that more than 500,000 people around the world have been treated with Dupixent in its approved indications.
The results were from data in children who entered the extension trial after finishing active treatment or placebo during the phase 3 trial. Children in the extension trial were treated for up to an additional year with Dupixent, providing up to two years of data in total.
Leonard Bacharier, director of the Center for Pediatric Asthma Research, explained: “An established safety profile balanced with efficacy is always a priority when treating children with a chronic disease, such as those with uncontrolled moderate-to-severe asthma with an oeosinophilic phenotype or oral corticosteroid dependent asthma.”
“This new data further supports the consistent safety profile of long-term Dupixent – which is indicated for the treatment of uncontrolled moderate to severe asthma with an oeosinophilic phenotype or oral corticosteroid dependent asthma – and its ability to provide sustained improvements in lung function and reductions in asthma exacerbations in children as young as six years old,” he added.
Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have a higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They also may require the use of multiple courses of systemic corticosteroids that can carry significant risks.
