Impact of Tapinarof Cream Approval for Atopic Dermatitis, with Adelaide Hebert, MD

Few disease states have seen the same level of advancement in recent years as atopic dermatitis, with notable breakthroughs, such as the December 16, 2024, US Food and Drug Administration (FDA) approval of tapinarof cream 1% (Vtama).1

Tapinarof is an aryl hydrocarbon receptor agonist and its approval expands the range of available treatments for atopic dermatitis, 1 of the most prevalent dermatological disorders, providing a new option for patients managing this widespread condition. To discuss the approval’s significance, the HCPLive editorial team spoke with Adelaide A. Hebert, MD, a professor of dermatology and pediatrics at UTHealth Houston.

“One of the things I think is tremendously exciting is that tapinarof offers us a single dose strength to use either for atopic dermatitis or psoriasis across age groups,” Hebert said. “It's a 1-day application, and the drug is also steroid free, which is very appealing in this era of, unfortunately, steroid-phobia. We needed additional medications to help patients who suffer with a chronic relapsing disease, such as atopic dermatitis, but also psoriasis.”

The drug boasts prior approvals dating back to 2022 when the agent received approval for the treatment of plaque psoriasis in adults, and the latest approval for tapinarof cream indicates the agent for treatment of atopic dermatitis in patients aged 2 years and older. The FDA approval for Organon’s aryl hydrocarbon receptor agonist, which occurred more than 2 months prior to its scheduled March 12, 2025 PDUFA, was based on significant efficacy in the ADORING clinical trial program, including ADORING 3, a 48-week extension study.2

In ADORING 1 and 2, tapinarof cream 1% demonstrated robust efficacy for atopic dermatitis. In ADORING 1, 45.4% of patients treated with tapinarof achieved clear (0) or almost clear (1) skin with at least a 2-grade improvement on the Validated Investigator Global Assessment for AD (vIGA-AD) scale, compared to 13.9% in the placebo group. Similarly, in ADORING 2, 46.4% of tapinarof-treated patients met these criteria versus 18.0% with placebo (P < 0.0001 in both trials). According to a release from Organon, tapinarof cream also improved EASI 75 scores and reduced itch severity in participants aged 12 and older.1

With an interest in learning more about the approval and how it impacts the landscape of disease management for the dermatological condition, our editorial team asked Herbert about some of the treatment's potential advantages.

“One of the big advantages we have with tapinarof 1% is that the percentage that has been approved for about 2 years now for psoriasis in those patients aged 18 and above is exactly the same cream, both in formulation, tube size, everything," Hebert said. "We didn't have to really reinvent this. This drug is already on the shelf. We just now have a greater expansion of its indication in both the pediatric realm and into the realm of atop a dermatitis.”

For additional information, view the full interview posted above.

The quotes contained in this interview summary were edited for clarity.

Hebert's disclosures are as follows: Research grants paid to the medical school (Dermavant, Arcutis, Pfizer, Leo Pharma, Incyte), Honoraria (Dermavant, Arcutis, Pfizer, Leo Pharma, Incyte, Sun Pharma, Ortho Dermatology, Apogee), DSMB (Sanofi Regeneron, OrthoDermatologics, GSK, Apogee).

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. Update on FDA Review of VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organon. November 5, 2024. https://www.organon.com/news/update-on-fda-review-of-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.