Safety Profile, Accessibility of Tapinarof Cream 1% for Atopic Dermatitis, with Adelaide Hebert, MD

The December 2024 US Food and Drug Administration (FDA) approval announced by Organon for tapinarof (Vtama) cream 1% expanded the drug’s indicated age range, with patients diagnosed with atopic dermatitis aged 2 years and older now approved to receive the medication.^1,2

In a previous interview, the FDA approval of this aryl hydrocarbon receptor agonist and the ADORING phase 3 clinical trial program leading to the approval were discussed between the HCPLive editorial team and ADORING investigator Adelaide A. Hebert, MD, a professor of dermatology and pediatrics at UTHealth Houston. In the above segment of her interview, Hebert was asked about the drug’s safety profile in her team’s findings.

“We had excellent results with long term safety,” Hebert explained. “We did not see new emergent adverse events in the long term safety study that would have suggested application over that duration, up to a full 52 weeks in a full year of treatment…[would] lead to any undue sequelae. It didn't raise any concerns and we didn't see anything we call a signal, which is something we would want to identify, and it remains one of the purposes of these long term safety evaluations.”

Overall, Hebert highlighted that in the ADORING trial, tapinarof cream 1% was well-tolerated among study subjects.

“One thing we learned in addition was many of the patients can develop time off medication because of the remitive effect of this drug,” Hebert said. “And the duration of that time off drug with disease control was as much as 80 days. That is really a remarkable interval of treatment-free time when you have a condition that's chronic, relapsing, and prone to flares. So this, again, was a very important learning arena for us, as we did this clinical trial out to the 52 week time point.”

Hebert highlighted that the ADORING investigators were pleased that the patients could go without medication during this brief period. Then, she was asked about any potential barriers to accessibility to this medication for patients aged 2 years and older with atopic dermatitis.

“I think 1 of the things for those of us, particularly in the pediatric realm, is to begin to generate awareness in our colleagues within pediatrics and family practice,” Hebert said. “Because they may or may not have heard of this drug, as it was only approved previously for those patients 18 above with psoriasis, so they will have had little opportunity to see patients who are on the drug, or to have prescribed it potentially themselves. We need to educate these colleagues, because it is once-a-day, it is steroid-free, and it can be used as a single drug over all body parts. I don't think many of our pediatric colleagues are aware of what we call this remitive effect.”

To find out more information about tapinarof 1% and its safety profile among patients aged 2 years and older with atopic dermatitis, view the full video posted above.

The quotes used in this summary were edited for the purposes of 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.}