Dupilumab is used as maintenance therapy when added to other asthma medications.
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 old. 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 type 2 inflammation which plays an important role in asthma, chronic rhinosinusitis with nasal polyps, atopic dermatitis and eosinophilic esophagitis. Dupilumab is used as maintenance therapy when added to other asthma medications.
“Children with uncontrolled moderate to severe asthma may experience persistent coughing, difficulty breathing, unpredictable asthma attacks, and decreased lung function, which can lead to complications later in life as they grow and develop,” said lead researcher 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 in balance with efficacy is always a priority when treating children with chronic disease, such as children 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 reduce asthma exacerbations in children as young as 6 years old.”
Asthma is the most common chronic disease in children, affecting approximately 75,000 children between the ages of 6 and 11 with uncontrolled moderate to severe asthma in the United States. While many are treated with standard inhaler corticosteroids and bronchodilators, many children continue to experience severe symptoms such as coughing, wheezing, and difficulty breathing.
Managing asthma may also require multiple courses of systemic corticosteroids that carry significant risks. Children with asthma and underlying type 2 inflammation are more likely to have poor disease control, more frequent asthma attacks, and symptoms that interfere with their daily activities.
The Phase 3 LIBERTY ASTHMA EXCURSION Study is an open-label extension to evaluate 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 study when they were aged between 6 and up. were years old. and 11 years old. Patients in the open-label extension study received dupilumab 100 mg or 200 mg every 2 weeks or dupilumab 300 mg every 4 weeks for 52 weeks based on body weight.
The safety results were generally consistent with the known safety profile of dupilumab in the approved respiratory indications. Overall adverse reactions (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.
Late-breaking Dupixent® (Dupilumab) data on ERS 2022 demonstrate a consistent efficacy and safety profile up to two years of age in children 6 to 11 years of age 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