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A recent discussion with Dr. Brown on the use of tapinarof, approved for adult plaque psoriasis, in patients with atopic dermatitis.
In an interview with HCPLive, Philip Brown, MD, JD, Chief Medical Officer at Dermavant Sciences, spoke on recent trial results for the use of tapinarof (VTAMA) for atopic dermatitis patients as young as 2-years-old.
Tapinarof is an aryl hydrocarbon receptor (AHR) agonist, and the topical therapy was approved for the treatment of adult plaque psoriasis in May of 2022, following positive data from the PSOARING 1 and PSOARING 2 trials.
This latest study used the same dose and frequency for tapinarof cream that was approved by the US Food and Drug Administration (FDA) for the topical treatment of adult plaque psoriasis.
“So, this was a maximal usage study, that is a required study by the FDA for topical products,” Brown explained. “And this particular study evaluated children, so individuals aged 2 to age 17, under maximal use conditions, so these are individuals with fairly significant degree of disease involvement based on body surface area.”
Brown went into some of the details of the study into tapinarof’s use in patients with atopic dermatitis.
“They applied tapinarof 1% cream, the exact same dose that's already approved for use in adults with plaque psoriasis, to their affected body surface area once daily, over the course of one month, and they had serial pharmacokinetic blood serial blood draws for pharmacokinetic analysis, both at baseline and then at day 28,” he said. “And what these data show is a very high degree of tolerability and excellent safety profile, as well as a confirmation of this minimal to no systemic exposure, very low systemic exposure.”
Brown also highlighted some of the surprising elements encountered by the researchers during the course of the study, as well as the significance of its findings.
“This study that we're reporting out today, this maximal use study, represents the first formal analysis that shows the consistency and the predictability tapinarof 1% cream, even in this disparate indication where we know there's barrier disruption of the skin,” he said. “And we see this very consistent profile of tapinarof with minimal to no systemic exposure, even in these very, very young children down to age 2.”
For more on the recent trial results, view the full interview with Dr. Brown.