A maintenance therapy from Sanofi and Regeneron, added to other asthma medications, has shown sustained improvement in lung function, low-rate of asthma attacks and a consistent safety profile for up to two years in children.
Results from the longest global phase 3 open-label extension trial in the age group six to 11 years old with moderate to severe asthma with evidence of type-2 inflammation.
Late-breaking Dupixent (dupilumab) data show consistent efficacy and safety profile for up to two years
Dupixent results presented
These results were presented today (September 5) in a late-breaking session at the 2022 European Respiratory Society (ERS) International Congress, which coincides with the milestone that more than 500,000 people around the world have been treated with Dupixent in its approved indications.
Leonard B. Bacharier, professor of pediatrics at Vanderbilt University Medical Center said: “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.
“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.”
Two years of data
The results are from data in children who entered the extension trial after finishing active treatment or placebo in the phase 3 trial (pivotal 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.
Children treated with Dupixent in the extension trial experienced a low-rate of severe asthma attacks and sustained improvement in lung function at 52 weeks.
Children who switched from placebo in the pivotal trial to Dupixent in the extension trial demonstrated improvement of 8.71 percentage points in lung function at two weeks.
The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved respiratory indications.
Chronic disease
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 higher disease burden.
The phase 3, multicenter, open-label extension trial evaluated the long-term safety and efficacy of Dupixent in 365 children with uncontrolled moderate-to-severe asthma who had previously participated in the placebo-controlled VOYAGE trial (the pivotal trial) when they were 6 to 11 years of age.
Patients in the open-label extension trial received Dupixent 100mg or 200mg every two weeks or Dupixent 300mg every four weeks, based on body weight, for 52 weeks.
The primary endpoint assessed the number of patients experiencing any treatment emergent adverse event. Secondary endpoints included the annualized rate of severe asthma exacerbations over one year.
In 2017, the European Commission has granted marketing authorization to Dupixent (dupilumab) for the treatment of atopic dermatitis in adults who are candidates for systemic therapy.