Tapinarof Cream 1% Maintains Clear Skin for 80 Days in Atopic Dermatitis, with David Rosmarin, MD

New data from the ADORING program demonstrate patients with atopic dermatitis can discontinue use of tapinarof cream 1% (Vtama) for nearly 80 days without recurrence after achieving completely clear skin.

Presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, results of the study offer insight into the long-term effects and can help guide use in real-world settings, according to study investigators.

“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,” said Jonathan Silverberg, MD, PhD, MPH, George Washington University School of Medicine and Health Sciences.2 “As a physician, I’m encouraged that at the end of a break from treatment with [tapinarof cream 1%] cream, patients’ [atopic dermatitis] remained mild. I’m excited to see these data support the use of [tapinarof cream 1%] cream to potentially provide lasting results for itch, which is the universal and most burdensome symptom of [atopic dermatitis].”

Initially approved for treatment of moderate to severe plaque psoriasis in adults in 2022, tapinarof cream 1% received approval for moderate to severe atopic dermatitis in patients aged 2 years or older in December 2024 based on data from the ADORING program. A long-term extension study, ADORING 3 aggregated patients from the ADORING 1 and ADORING 2 trials, patients from a 4-week maximal usage pharmacokinetics study, and VTAMA cream-naive patients 2 to 17 years of age with either mild, moderate, or severe atopic dermatitis that did not meet inclusion criteria in ADORING 1 and ADORING 2.1,2,3

Per study protocol, 378 patients achieving completely clear skin, which was defined as a score of 0 on the validated Investigator Global Assessment for AD (vIGA-AD), discontinued use of tapinarof cream 1% and were assessed for maintenance of vIGA-AD of 0 or 1 off-treatment.1,2

Results of the AAD 2025 analysis suggested 84% of patients had a vIGA-AD score of 2 at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days. Further analysis demonstrated this patient population achieved a mean weekly Peak Pruritus Numerical Rating Scale score of 2.9 and a mean Eczema Area and Severity Index score of 3.4.1,2

With an interest in learning more about how these new data might influence the treatment landscapes and unmet need within management of atopic dermatitis, particularly in pediatric patients, the editorial team of HCPLive Dermatology caught up with study presenter David Rosmarin, MD, chair of dermatology at Indiana University School of Medicine, and that conversation is the subject of the following Q&A.

Rosmarin on Tapinarof Cream 1% in Atopic Dermatitis

HCPLive: How does this new data add to the comfortability that clinicians and patients can have when it comes to using tapinarof cream 1%, particularly in such a young patient population?

Rosmarin: This late breaker is giving some of the results from the ADORING 3 long-term extension evaluating tapinarof cream for atopic dermatitis in patients 2 years of age and up. Just for a background, tapinarof is a nonsteroidal arrow hydrocarbon receptor agonist approved, first for adults in psoriasis, but now also FDA approved for atopic dermatitis in patients 2 years of age and older. The long-term extension basically accumulates patients from the pivotal phase 3 studies for of ADORING 1 and ADORING 2, the maximal use PK study, as well as a few people who were directly enrolled into the long-term extension as well.

So, it's a somewhat heterogeneous population. When they first started in the pivotal phase 3 program most of the patients had either moderate or severe atopic dermatitis and a majority of these patients were also pediatric patients. We know that tapinarof is effective at treating these patients, but the question we're trying to answer with the long-term extension is: What happens when you discontinue the treatment after achieving clearance?

So, what is the disease-free interval for these patients? In practical terms, it's helpful for patients to want to take a drug holiday and not be worried that their symptoms or their itch and their disease is going to immediately recur or rebound. That's what makes tapinarof a little bit unique in that nature.

The top line result is that it's about 80 days on average for the first disease-free interval for patients. So, quite a while, making this drug particularly unique. Additionally, when patients do get their disease back it's usually very mild in nature, meaning they're not super itchy—they're not getting a rip-roaring flare. It's usually coming back in a milder nature. The fact that this medicine as a monotherapy and being used once a day can achieve not only great efficacy results, but also this ability to have a long-term holiday.

HCPLive: How unique is this benefit among current management options and what type of impact could this have on quality of life?

Rosmarin: I think it's an added bonus there, and it is important information to have. I think in many ways more critical is the fact that it's once a day, which is fantastic for patients. It's nonsteroidal, which worry patients. There are no restrictions on an antibody surface area or locations or combining with other treatments. I think all of those really combine to make this treatment very advantageous to many of our atopic dermatitis patients and again, with a very favorable safety profile and no Boxed Warnings.

So, I think it's just an added bonus for some patients and it's nice to not have that burden of doing disease. Now there are some topicals, for example, corticosteroids, that can rebound and can do so rather quickly. So, to me, this is rather unique.

One of our strategies, with our current practices, is giving maintenance. So, we may give maintenance of a calcineurin inhibitor, such as tacrolimus, twice a week to maintain. Well, these are patients who were off treatment altogether. To me, it's a quite a nice feature, and it's unique amongst our topicals.

HCPLive: Are we able to further identify what baseline characteristics might predispose someone to see a greater benefit with tapinarof cream 1%?

Rosmarin: So, subgroup analysis has not been done. We don't know if there are certain prognostic factors that will lead to a longer disease-free interval. However, the fact that the population entering the study was heterogeneous—there were patients between the age of 2 all the way up to 81 years and so many pediatric patients in different disease severities, different body surface areas, different locations of disease—I think has me optimistic that it seems like many patients can experience this disease free interval, even though we don't yet know if there are particular differences amongst the population dependent on baseline characteristics.

HCPLive: What unmet needs still exist related to management of atopic dermatitis in pediatric patients?

Rosmarin: Well, right now we have data for two years of age and older, but it would be great if we had more options for below that that age because we have many patients who start to get atopic dermatitis at just a few months of age. So, given what we're seeing in the safety for the 2 years of age and up range, I'd love to have more data to give me confidence that I can use it in under 2 years of age.

So, I think that's still a need. Also, while this is a great option, there's still some patients who don't respond, and it would be helpful to know if we can predict that in advance? And we're always looking for new options. There are so many patients of ours that have eczema, we'd love to have more options in our armamentarium.

Relevant disclosures for Rosmarin include AbbVie, Abcuro, AltruBio, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Incyte, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio.

References:

1. Rosmarin D. Tapinarof Cream 1% Once Daily: Maintenance of Low Disease Activity Including Pruritus Through End of the Treatment-free Interval in a Long-term Extension Trial in Patients Down to 2 Years of Age. Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

2. Organon. 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. Accessed 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/.

3. Organon. 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. Accessed March 8, 2025. 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/.