Sanofi and Regeneron have shared the latest positive Dupixent data for use in children aged six to 11 years old with asthma.
The late-breaking data was presented at the European Respiratory Society (ERS) 2022 congress and demonstrated a consistent safety profile and efficacy for up to two years for children in this age group with moderate-to-severe asthma and evidence of type 2 inflammation.
The results were taken from a global phase 3 open-label extension Liberty Asthma Excursion trial and the data showed a sustained improvement in lung function in this age group, as well as a low rate of asthma attacks and a consistent safety profile for up to two years. The data reinforces the well-established efficacy and safety profile of Dupixent across age groups.
The safety results of the trial were generally consistent with the established safety profile of Dupixent in its approved respiratory indications. Over the 52-week trial treatment period, the overall rates of adverse events identified were 61-68%.
The sharing of the data at ERS coincided with the milestone that more than 500,000 people worldwide have been treated with Dupixent in its approved indications.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development programme has demonstrated a significant clinical benefit, alongside a decrease in type 2 inflammation in phase 3 trials, further reinforcing that IL-4 and IL-13 act as central drivers of the type 2 inflammation that plays a major role in multiple related – and often co-morbid – diseases.
As one of the most common chronic diseases in children, asthma is a lung condition which, depending on its severity, can cause considerable breathing difficulties. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden.
Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, those with the condition may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. They may also need multiple courses of systemic corticosteroids, which can carry significant risks.
Leonard Bacharier, Professor of pediatrics, director of the Center for Pediatric Asthma Research, Monroe Carell Jr Children’s Hospital, Vanderbilt University Medical Center, said: “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.”