Vtama safe, effective with minimal systemic exposure in children with atopic dermatitis
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Dermavant Sciences announced positive results from its maximal usage study of Vtama cream in the treatment of atopic dermatitis for children aged as young as 2 years, according to a company press release.
“This is the first time that we’ve explored tapinarof 1% cream in children down as young as 2 years of age. And we’ve done that under maximal use conditions, the exact same concentration that we utilize in our adult population that’s approved in psoriasis,” Philip M. Brown, MD, JD, chief medical officer of Dermavant, told Healio. “What these data tell us is that the drug performs in this very consistent fashion producing minimal to even no systemic exposures observed in these very young children despite the disruption in the skin barrier, as seen in atopic dermatitis.”
The open-label study evaluated the safety and pharmacokinetics of Vtama (tapinarof) 1%, an aryl hydrocarbon receptor agonist, under maximal use conditions in 36 pediatric patients with atopic dermatitis aged 2 to 17 years. Participants had an IGA score of 3 or greater with a mean 43% of body surface area (BSA) affected. Patients applied tapinarof once a day for 4 weeks.
Results showed a low incidence rate of adverse events and high tolerability in sensitive skin areas. In patients with up to 90% BSA affected, minimal to no systemic exposure was also confirmed under maximal use conditions.
“These results give us confidence that tapinarof 1% cream is predictable, consistent and provides a favorable safety profile as we move forward and complete our ADORING studies and eventually file our [supplemental new drug application] in the time to come,” Todd Zavodnick, CEO of Dermavant, told Healio. “We are excited for Dermavant to be able to provide the full immunodermatology set of indications of not only psoriasis, but also atopic dermatitis.”