In the LIBERTY AD ADOL trial, investigators randomized 251 patients aged 12-17 years to placebo or one of two dupilumab regimens (after loading doses):
- Every four weeks (300 mg)
- Every two weeks (200 mg for patients weighing <60 kg; 300 mg if weight ≥60 kg)
In both groups, a significantly higher proportion of patients reached Eczema Area and Severity Index (EASI) 75 at week 16: 41.5% and 38.1% in the two-week and four-week groups, respectively, versus 8.2% for placebo. Differences versus placebo were 33.2% and 29.9%, respectively (p<0.001 in both analyses).
Since dupilumab's approval in adolescents AD, Dr. Simpson says, OHSU dermatologists have been prescribing the drug frequently because they understand the long-term effects of inadequately treating AD.
“Children with atopic dermatitis, especially moderate-to-severe, are known to have more difficulty with attention and disrupted sleep. Disrupted sleep, even for a few days, can impact concentration. Over the years, unrelenting itch and poor sleep can often lead to other conditions such as attention-deficit/hyperactivity disorder, anxiety and depression.”
These changes are likely mediated by poor sleep, and possibly by inflammation, he says. “So the hypothesis is if you can treat more moderate-to-severe disease effectively, you can improve sleep and hopefully improve some of these mental-health comorbidities down the road.”
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.