Adults, children maintain mild AD during treatment-free period follow Vtama cream 1%
Key takeaways:
- Adults and children previously treated with Vtama cream 1% went through a treatment-free period of approximately 80 days.
- During that period, all patients maintained mild disease.
ORLANDO — Atopic dermatitis disease activity remained mild after patients treated with Vtama cream 1% achieved nearly 80 consecutive treatment-free days, according to a presentation at the American Academy of Dermatology Annual Meeting.
The late-breaking abstract included data from the ADORING 3 long-term extension trial which evaluated the efficacy and safety of nonsteroidal Vtama (tapinarof, Organon) cream 1% in adults and children aged as young as 2 years with mild, moderate and severe AD.
Of the 728 patients treated in the phase 3 trials, 378 achieved completely clear skin and were enrolled into the extension trial during which they stopped using Vtama cream to assess the drug’s ability to maintain disease clearance.
“We found that we could keep them under control over the long-term and even give them the possibility of a treatment-free holiday that lasts about 80 days,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health and one of the investigators, told Healio. “And at the end of those 80 days, on average, patients still just have mild disease.”
According to the presentation, 84% of patients had a validated IGA-AD score of 2 at the end of the first treatment-free interval without Vtama cream 1%, which lasted 79.8 consecutive days. The mean itch score, assessed by the Peak Pruritus Numerical Rating Scale, was 2.9 weekly, whereas the mean EASI score was 3.4 — all of which indicate mild disease.
“They seem to stay under control, even off treatment,” Stein Gold told Healio. “And even when their disease starts to come back it comes back pretty slowly.”
According to Stein Gold, the safety profile of Vtama cream 1% was similar among adults and children aged as young as 2 years with no new safety signals being identified since the ADORING 3 trial.
In the phase 3 study, discontinuations due to treatment-emergent adverse events were low at 2.6%. The most common treatment-emergent adverse events were folliculitis (12.1%), nasopharyngitis (6.9%) and upper respiratory tract infection (6.9%).
The adverse events of special interest resulted in very low to no trial discontinuations at just 1% for follicular events, 0.4% for contact dermatitis and 0% for headaches.
Approved by the FDA in December 2024 for adults and pediatric patients aged as young as 2 years, Vtama cream 1% helps “simplify” patients’ treatment regimen, according to Stein Gold.
“It’s important to investigate these novel, nonsteroidal drugs,” she said. “It allows us to give patients one medication that they can use on any body surface area for any duration of time, setting them up for success.”
Reference:
- 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. 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/. Published March 8, 2025. Accessed March 8, 2025.