Dupixent may soon be available to younger patients if the treatment continues it trajectory in adolescent clinical trials. The news was announced at the annual meeting of the European Academy of Dermatology and Venerology (EADV) in September 2018.
EADV is a nonprofit membership organization consisting of medical professionals from around the world whose mission is to advance clinical care, research, education and training in the fields of dermatology and venereology. They convene yearly to present clinical trial results and other scientific advancements.
At the 2018 annual meeting held in Paris, researchers shared the results of a stage 3 clinical trial on Dupixent (dupilumab) for adolescents with moderate to severe atopic dermatitis (AD). The treatment is co-produced by pharmaceutical giants Sanofi and Regeneron.
Dupixent is the first biologic for adults with moderate to severe AD. Its active ingredient is an antibody (dupilumab) that binds to a protein called interleukin-4, which causes inflammation. By binding to this protein, Dupixent inhibits the inflammatory response that plays a role in AD flares.
The safety and efficacy of Dupixent was established in three placebo-controlled clinical trials with a total of 2,119 adult participants. After the medication was approved by the FDA and brought to market, researchers embarked on another clinical trial to determine whether the drug is safe and effective for adolescents between the ages of 12 and 18.
The study recruited 251 adolescents with AD ranging from 12 to 17 years old. Patients were randomized into one of three treatment groups for the controlled period of 16 weeks.
The first group was treated with Dupixent subcutaneous injection 200 mg or 300 mg every two weeks, based on weight (with an initial dose of 400 mg or 600 mg respectively). The second group was treated with 300 mg Dupixent every four weeks (with an initial dose of 600 mg), and the third group was treated with placebo every two weeks.
According to Dr. Eric Simpson, professor of dermatology at the Oregon Health and Science University in Portland and principal investigator on both studies, said the adolescent clinical trial saw better Eczema Area and Severity Index (EASI) scores than the adult clinical trial.
“Dupilumab treatment showed clinically meaningful and statistically significant improvements in atopic dermatitis signs and symptoms and quality of life in adolescents,” he said.