Dupixent Demonstrates Sustained Efficacy and Safety as Maintenance Therapy in Children Aged 6–11 with Moderate-to-Severe Type 2 Asthma

Dupixent (dupilumab) as a maintenance therapy, when used in combination with other asthma medications in children aged 6 to 11 with moderate to severe asthma and type 2 inflammation, demonstrated consistent efficacy and safety over a period of up to two years.

The results come from a multi-center, open-label, longest-running Phase III extension trial designed to evaluate the long-term safety and efficacy of dupilumab in children with moderate-to-severe asthma. In the extension trial, treatment with dupilumab was extended for an additional year, providing a total of two years of data. A total of 365 children aged 6-11 with moderate-to-severe asthma were enrolled, all of whom had previously participated in the placebo-controlled VOYAGE trial. Based on body weight, patients received injections of dupilumab 100mg or 200mg every two weeks, or dupilumab 300mg every four weeks, for a duration of 52 weeks.

The primary endpoint was the number of patients experiencing any treatment-emergent adverse event. Secondary endpoints included the annualized rate of severe asthma exacerbations within one year and the change from baseline in FEV1pp (percent predicted forced expiratory volume in 1 second) in the pivotal trial. FEV1pp is a commonly used measure of lung function in pediatric asthma patients.

The results showed that, over a two-year period, the pediatric patients experienced continuous improvement in lung function, low asthma attack rates, and stable safety. Specifically, the incidence of severe asthma attacks was low, with an average of 0.118 to 0.124 times per year, compared to the baseline of 2.16 to 2.56 times per year in key trials; at week 52, lung function was 9.43 to 12.6 percentage points lower than baseline. In the previous VOYAGE trial, pediatric patients who were on placebo switched to dupilumab in the extension trial and saw an 8.71 percentage point improvement in lung function after two weeks.

The safety results of the trial were generally consistent with previously approved respiratory indications. During the 52-week treatment period, the overall incidence of adverse events ranged from 61% to 68%. The most common adverse reactions were nasopharyngitis, pharyngitis, upper respiratory tract infection, influenza, eosinophilia, allergic rhinitis, diarrhea, and injection site reactions.