Children’s school performance, behavior and self-confidence tend to increase as well, adds Dr. Simpson.
“Some of the study's endpoints show that this is likely happening. Not only did we see the signs of the disease — the redness and excoriation — improve, but we also saw improvement in sleep scores as measured by various endpoints, which I believe is critical, especially for this age group.”
For example, week 16 mean SCORing Atopic Dermatitis (SCORAD) sleep-loss scores declined more than three points from baseline in both treatment groups, versus 1.2 points for placebo (p<0.001 in both analyses).
Regarding safety, dupilumab-treated patients had slightly elevated rates of conjunctivitis (9.8% and 10.8% for two-week and four-week dosing, versus 4.7% placebo) and injection-site reactions.
“With adolescents,” says Dr. Simpson, “this drug works very similarly in both efficacy and safety as it does in adults. We weren't sure if the underlying pathophysiology in adolescent atopic dermatitis is the same as in adult atopic dermatitis. But from the conclusions of this study, adolescents respond similarly in efficacy, and the safety is similar — the main, most clinically relevant side effect we saw in the adolescent trial was conjunctivitis.”
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.