Tapinarof Results in Mild Atopic Dermatitis Activity During Treatment-Free Period

Atopic dermatitis (AD) disease activity remained mild for patients that achieved treatment success with tapinarof (Vtama) and entered treatment-free interval for an average of 80 days, according to late-breaking data presented at the 2025 American Academy of Dermatology Annual Meeting.¹

“For patients with atopic dermatitis, the benefits of many topical treatments are often short-lived, and for some patients, their disease rapidly reappears after taking a break from topical treatments,” Jonathan Silverberg, MD, PhD, MPH, from the George Washington University School of Medicine and Health Sciences, said in a news release.¹ “As a physician, I’m encouraged that at the end of a break from treatment with Vtama cream, patients’ AD remained mild. I’m excited to see these data support the use of Vtama cream to potentially provide lasting results for itch, which is the universal and most burdensome symptom of AD.”

In the phase 3 open-label study, ADORING 3 (NCT05142774), investigators found that 84% of patients had a validated Investigator Global Assessment for AD (vIGA-AD) score of 2—indicating mild symptoms. Furthermore, itch remained low, with a 2.9 score reported on the Peak Pruritus Numerical Rating Scale, and the mean Eczema Area and Severity Index (EASI) score was 3.4, corresponding to mild severity.¹

In the initial studies, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), investigators evaluated the efficacy and safety of the drug compared to the vehicle cream once daily for patients 2 years or older with AD. The trials were identically designed as randomized, double-blind, multicenter phase 3 trials. There were 407 patients included in ADORING 1 and 406 in ADORING 2. Approximately 80% of patents were 18 years or younger. At week 8, the investigators found that vIGA-AD response in both trials included 45.4% and 46.4% in the drug group and 13.9% and 18% for the vehicle, respectively. Further, the EASI75 response was 55.8% and 59.1% for the drug group and 22.9% and 21.2% in the vehicle, respectively.²

At the conclusion of these studies, patients were qualified to enroll in the open-label extension, which took place for 48 weeks. In ADORING 3, there were 378 patients who were included and had clear skin and stopped using the treatment. The outcomes included the number of treatment-emergent adverse events (AEs), frequency of AEs, complete disease clearance, response during the long-term study, change from baseline for EASI score, and percent change from baseline in EASI score.³

The most frequent treatment-emergent AEs included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%).¹

“These data reinforce the efficacy of Vtama cream in atopic dermatitis, including the durability of effect among patients in the study, including children as young as 2 years old,” Juan Camilo Arjona Ferreira, MD, head of research and development and chief medical officer at Organon, said in a news release.¹ “Knowing the profound impact that atopic dermatitis can have on the lives of patients and oftentimes their caregivers, the possibility to receive over 2 months of relief without needing to reapply treatment is meaningful and speaks to our mission of creating a healthier every day.”

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. News release. Organon. March 8, 2024. Accessed March 11, 2025. https://www.businesswire.com/news/home/20250308653660/en/New-Analysis-of-Organon%E2%80%99s-VTAMA%C2%AE-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

2. Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024;91(3):457-465. doi:10.1016/j.jaad.2024.05.023

3. Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis. ClinicalTrial.gov identification: NCT05142774. Updated July 8, 2024. Accessed March 11, 2025. https://www.clinicaltrials.gov/study/NCT05142774