Discussing FDA Approval of Tapinarof Cream for Atopic Dermatitis, with John Browning, MD

On December 16, an approval by the US Food and Drug Administration (FDA) was announced for tapinarof (Vtama) cream 1% treatment of individuals with atopic dermatitis aged 2 years and older.¹ The approval followed the conclusion of the ADORING trial program.

John Browning, MD, is a pediatric dermatologist in San Antonio, Texas, an adjunct assistant professor of pediatrics at Baylor College of Medicine, and an ADORING trial investigator. Browning spoke with the HCPLive editorial team about the tapinarof approval, the data behind it, and the move’s significance.

“The approval of tapinarof really represents a paradigm shift in how we can approach atopic dermatitis using the non-steroidal option,” Browning explained. “First of all, it's approved for ages 2 and up, which is incredible. But secondly, it's a completely new mechanism of action. So instead of it blocking inflammation, it’s acting as an aryl hydrocarbon receptor agonist. So we're turning on cellular machinery to improve your skin barrier, to improve your lipids, and to decrease inflammation, while it is improving your skin barrier.”

Browning was asked about the uniqueness of the medication’s formulation and its comparison to other options for atopic dermatitis.

“Topical steroids, which have been the main stray mainstay of treatment of atopic dermatitis for decades, do not help the skin barrier,” Browning said. “In fact, there's really a lot of thought now that they decrease your skin barrier. So to have a topical option that's going to be able to improve your skin barrier function and also decrease inflammation at the same time is very exciting. And really, that also explains the fact that people on it can often go for several months without treatment, and we refer that as a ‘remittive’ effect.”

The FDA approval of tapinarof for atopic dermatitis follows the positive results of the ADORING clinical trial program.² The topical cream was analyzed in patients as young as 2 years with moderate-to-severe disease, with the ADORING 3 trial specifically being an open-label, long-term extension study lasting 48 weeks.

More than 80% of participants in the age range of 2-17 in ADORING 3 achieved clear or almost clear skin after using tapinarof cream. ADORING investigators also found that 52% reported completely clear skin.

Browning was asked about some of his experiences in the ADORING trial and some of the most notable findings.

“...I got to see lots of disappointed trial patients when the trial came to an end because they couldn't continue to receive it,” Browning said. “And that was really disappointing for them, because they were very excited to have a topical treatment that decreased their itch rapidly. That would be one of the things that I noticed quickly was just how happy they were at their decreased amount of itch without having to be on a biologic medication or having to be on an antihistamine. Then also the fact that they could use it head to head to toe.”

To find out more about this interview, the findings, and their significance, view the full interview posted above.

The quotes contained in this article were edited for the purposes of clarity.

Browning has previously reported working as an investigator for Amryt, Brickell Biotech, Celgene, ChemoCentryx, Eli Lilly, Incyte, Lenus, LEO Pharma, Mayne, Novartis, Pfizer, Regeneron and Valeant; as a consultant for Dermavant (recently acquired by Organon) and LEO Pharma; and as a speaker for Regeneron, Dermira, Pfizer, and Galderma.

References

1. ^{FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. December 16, 2024. https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/. Date accessed: December 16, 2024.}
2. ^{Smith T. ADORING Trial Open-Label Extension: Tapinarof Cream 1% Results in Atopic Dermatitis. HCPLive. October 30, 2024. https://www.hcplive.com/view/adoring-trial-open-label-extension-tapinarof-cream-1-results-atopic-dermatitis. Date accessed: December 17, 2024.}