Dupilumab Shows Consistent Efficacy, Safety Profile for Approximately 2 Years in Children 6 to 11 Years of Age with Moderate-to-Severe Asthma

A new study analyzing the safety and efficacy of dupilumab (Dupixent, Regeneron Pharmaceuticals) shows sustained improvement in lung function and a low rate of severe asthma attacks in children between 6 and 11 years of age. These findings were presented at the 2022 European Respiratory Society International Congress.

Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. Both pathways are central drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis, atopic dermatitis, and eosinophilic esophagitis. Dupilumab is used as a maintenance therapy when added to other asthma medications.

"Children with uncontrolled moderate-to-severe asthma may experience long-term persistent coughing, difficulty breathing, unpredictable asthma attacks and impaired lung function, which can lead to complications later in life as they grow and develop," said principal study investigator Leonard B. Bacharier, MD, professor of Pediatrics and director of the Center for Pediatric Asthma Research, Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center in Nashville, Tennessee, in a press release. "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 eosinophilic phenotype or oral corticosteroid dependent asthma. These new data further support the consistent safety profile of long-term Dupixent, which is indicated for the treatment of uncontrolled moderate-to-severe asthma with an eosinophilic 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 6 years old."

Asthma is the most common chronic disease in children, with approximately 75,000 children between 6 and 11 years of age living with uncontrolled moderate-to-severe asthma in the United States. Although many receive treatment with standard-of-care inhaler corticosteroids and bronchodilators, many children continue to experience serious symptoms such as coughing, wheezing, and difficulty breathing.

Managing asthma can also require multiple courses of systemic corticosteroids that carry significant risks. Children who have asthma and underlying type 2 inflammation are more likely to have poor disease control, more frequent asthma attacks, and symptoms that interfere with their day-to-day activities.

The phase 3 LIBERTY ASTHMA EXCURSION trial is an open-label extension evaluating the long-term safety and efficacy of dupilumab in 365 children with uncontrolled moderate-to-severe asthma who had previously participated in the placebo-controlled VOYAGE trial when they were between 6 and 11 years of age. Patients in the open-label extension trial received dupilumab 100 mg or 200 mg every 2 weeks or dupilumab 300 mg every 4 weeks for 52 weeks based on their body weight.

The safety results were generally consistent with the known safety profile of dupilumab in its approved respiratory indications. The overall adverse events (AEs) were between 61% and 68%, with the most common AEs being nasopharyngitis, pharyngitis, upper respiratory tract infection, influenza, eosinophilia, allergic rhinitis, diarrhea, and injection site reactions.

REFERENCE

Late-Breaking Dupixent® (Dupilumab) Data At ERS 2022 Show Consistent Efficacy And Safety Profile For Up To Two Years In Children Aged 6 To 11 Years With Moderate-To-Severe Asthma. Regeneron. September 5, 2022. Accessed September 7, 2022. https://investor.regeneron.com/news-releases/news-release-details/late-breaking-dupixentr-dupilumab-data-ers-2022-show-consistent