Thanks to the phase 3 study that led to dupilumab's approval in adolescent atopic dermatitis (AD), patients can avoid off-label treatments that may pose a risk of significant long-term toxicity, says the study's lead investigator.
Dupilumab gives physicians the first FDA-approved treatment for moderate-to-severe AD in adolescents who have failed topical therapy.
“It's been a godsend for us who see these suffering adolescent patients, and we previously had no FDA-approved therapies,” says Eric L. Simpson, M.D., professor of dermatology at Oregon Health & Science University (OHSU).
Previously, physicians commonly used off-label cyclosporine and methotrexate, which could lead to liver and kidney toxicity over time. Because families were concerned about the potential risks of these therapies, he says, many patients with moderate-to-severe disease remained undertreated and symptomatic.
“The advent of a new targeted therapeutic without the need for labs, and without any end-organ damage, has opened the door to more successful treatment of these kids,” Dr. Simpson says. “This enables patients who were concerned about side effects to get proper therapy and get their symptoms under control.”
Dr. Simpson has received personal fees from AbbVie, Boehringer Ingelheim, Dermavant, Dermira, Galderma, GlaxoSmithKline, Incyte, LEO Pharma, Lilly, Menlo Therapeutics, Pfizer, Pierre Fabre Dermo-Cosmetique, Regeneron, Sanofi Genzyme and Valeant. He also has received grants from AbbVie, Celgene, Dermira, Galderma, LEO, Lilly, Pfizer, Regeneron, Roivant and Sanofi Genzyme and nonfinancial support from Regeneron and Sanofi Genzyme.
Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156:44-56.