Late-Breaking Data on Tapinarof Cream for Atopic Dermatitis, with Linda Stein Gold, MD

Once-daily treatment with tapinarof (Vtama) cream 1% led to atopic dermatitis activity remaining mild among individuals who had attained success with treatment and later entered a treatment-free interval that lasted an average of 80 days, according to late-breaking data presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando.1

These findings were released by Organon and resulted from the ADORING 3 trial—a 48-week open-label, long-term extension study. To address her team’s findings, head of the division of dermatology at the Henry Ford Health System and trial investigator Linda Stein Gold, MD, spoke with HCPLive.

“First of all, we know that when we do the long-term safety studies, there are safety first, we want to make sure that the drug is safe when using it for longer periods, and no new safety signals were identified,” Stein Gold said. “So that's a good thing, but we also learned some really important things about efficacy. As I mentioned, patients could be treated until they were completely clear, and then we took the drug away. One of the questions we have is, is there a durable remission that can occur off-drug?”

The study had assessed individuals who had been involved in the pivotal ADORING 1 and ADORING 2 phase 3 studies were assessed, as well as those involved in a 4-week maximal usage pharmacokinetics study. The study also involved tapinarof cream-naïve indiviudals aged 2-17 years with either mild, moderate, or severe disease who had also not met the inclusion criteria for ADORING 1 and ADORING 2.

Stein Gold was asked about some of these findings and their significance for patients with atopic dermatitis.

“What we found was, on average, is that they had about 80 consecutive days before they ended up having mild disease or worse and going back on drug,” Stein Gold said. “And this late breaker really helped us to understand what happens during that period. What we have come to understand is that at the end of that 80-day consecutive period when they're off treatment, it turns out, most of them have mild disease.”

Stein Gold pointed to the fact that this low disease activity had been noted by her team after a mean duration of 80 consecutive days off-treatment after success with the tapinarof cream. Stein Gold and colleagues found that there was a mean weekly Peak Pruritus Numerical Rating Scale (PP-NRS) score of 2.9 by the conclusion of the treatment-free interval.

For more information, view the video posted above and follow the rest of our conference coverage available here.

The quotes used in this summary were edited for clarity. Stein Gold has reported grants from Dermata and personal fees from Galderma as well as grants from Galderma and Dermata.

References

1. New Analysis of Organon’s VTAMA® (tapinarof) cream, 1% Phase 3 Data Shows Atopic Dermatitis Disease Activity Remained Low After Treatment-Free Interval in Adults and Children 2 Years of Age and Older. Organon. March 8, 2025. https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-shows-atopic-dermatitis-disease-activity-remained-low-after-treatment-free-interval-in-adults-and-children-2-years-of-ag/.