New phase 3 data will evidence an FDA application for the biologic as an add-on therapy for patients aged 6-11 years with AD.
New positive phase 3 pivotal trial data from Regeneron Pharmaceuticals and Sanofi show dupilumab (Dupixent) has efficacious and safe benefit for the treatment of atopic dermatitis (AD) in children aged 6-11 years old.
The findings—which according to the companies are the first of their kind for the patient population treated with a biologic—will headline a new indication application to the US Food and Drug Administration (FDA) later this year.
In the new data—to be presented at an upcoming medical meeting—children with severe AD reported significantly improved metrics for overall disease severity, skin clearing, itching, and quality of life (QoL) when adding dupilumab to standard-of-care topical corticosteroid (TCS) versus lone TCS.
Investigators also reported consistent safety data to that observed in older patient populations, as well as a lower rate of skin infections versus patients administered placebo.
The trial enrolled 367 patients aged 6-11 years old with severe AD whose disease was not controlled by topical medications. Another 92% of the observed patients also suffered from a concurrent condition including allergic rhinitis, asthma, and food allergy.
Investigators assessed for primary endpoints of proportion of patients to achieve Investigator’s Global Assessment (IGA) score of 0 or 1 (defining clear or almost clear skin), plus 75% improvement in Eczema Area and Severity Index (EASI-75) at 16 weeks.
A majority of patients administered 300 mg dupilumab every 4 weeks (70%) and patients administered 100 or 200 mg every 2 weeks (67%) reported achieving EASI-75 at 16 weeks, versus just 27% of placebo patients (P< .0001).
Another one-third of patients receiving dupilumab every 4 weeks, and 30% receiving it every 2 weeks, achieved IGA scores of 0 or 1—versus 11% administered placebo (P< .0001 and P= .0004, respectively).
Patients receiving dupilumab every 4 weeks improved on average by 82% weekly from baseline EASI score. Patients on bi-weekly treatment improved on average 78% per week, and placebo patients improved 49% (P< .0001).
Regeneron and Sanofi announced their intention to submit the data to the FDA in 4th quarter of 2019. Three years ago, the FDA had granted Breakthrough Therapy Designation to dupilumab for the treatment of moderate-to-severe AD in children aged 12-17 years old, as well as severe AD in children aged 6 months to 11 years old.
The interleukin-4 (IL4) and -13 (IL13) inhibitor monoclonal antibody has been approved for the treatment of patients aged 12 years and older with moderate-to-severe AD, patients with moderate-to-severe asthma, and adults with severe chronic rhinosinusitis with nasal polyposis (CRSwNP). The therapy’s capability in treating the pathways associated with type 2 inflammation has also made it a candidate therapy for chronic obstructive pulmonary disease (COPD), eosinophilic esophagitis, and food allergy—all of for which it is currently being assessed in clinical trials.
John Reed, MD, PhD, Global Head of Research and Development at Sanofi, emphasized the significance of treating the burdensome symptoms that comprise AD—particularly for a suffering pediatric population.
“Symptoms of severe atopic dermatitis can take a toll on children both physically and emotionally,” Reed said in a statement. “We are encouraged by these results, which demonstrate that Dupixent improved skin lesions, reduced itching, cleared the skin and importantly, improved health-related quality of life measures for these young patients.”