TouchDERMATOLOGY coverage from AAD 2025:
Tapinarof cream 1% is a once-daily, nonsteroidal topical aryl hydrocarbon receptor (AhR) agonist, initially approved for adult plaque psoriasis and more recently for atopic dermatitis (AD) in patients aged 2 years and older. While the treatment is known to be highly effective, an important clinical question remains: can patients who achieve complete skin clearance take a break from treatment—often referred to as a “drug holiday”—and still maintain their results?
To explore this, researchers launched the long-term extension study of tapinarof cream, 1% for subjects with atopic dermatitis (ADORING 3 [NCT05142774]), building on earlier findings from the psoriasis program, where patients were able to sustain their response during treatment-free periods. The study aimed to determine how long patients with atopic dermatitis could remain off tapinarof cream 1% after achieving clear skin.
These findings, presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, offer valuable insight into the durability of response and real-world use of tapinarof. We spoke with study investigator Dr David Rosmarin (Indiana University School of Medicine, Indianapolis, IN, USA) to learn more about the study rationale, key results, and—importantly—what the findings reveal about the potential for patients with atopic dermatitis to take a treatment break from tapinarof cream 1%.
Associated abstract:
- 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. Late-breaking Research: Session 1. AAD, 7-11 March, 2025.
Disclosures: Dr David Rosmarin has nothing to disclose in relation to this video interview.
Cite: Rosmarin D. Tapinarof 1% in atopic dermatitis: Can patients take a drug holiday and maintain response? TouchDERMATOLOGY. 26 March, 2025
This content has been developed independently by Touch Medical Media for touchDERMATOLOGY and is not affiliated with the American Academy of Dermatology (AAD). Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. No endorsement of unapproved products or unapproved uses is either made or implied by mention of these products or uses by Touch Medical Media or any sponsor. Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
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Q. Could you briefly explain the rationale and design of the phase III ADORING 3 long-term study evaluating tapinarof cream 1% for atopic dermatitis?
Tapinarof is a aryl hydrocarbon receptor agonist (AhR), nonsteroidal cream used once a day. Originally approved for psoriasis in adults, and then later approved for atopic dermatitis in patients 2 years of age and older.
And while tapinarof as well as some other new creams can be quite effective for patients with atopic dermatitis, one outstanding question we have is, can patients take a drug holiday and still hold the response after they achieve complete clearance?
This is motivated by the fact that we saw patients in the psoriasis program able to take a drug holiday and maintain a response. Hence, we wanted to analyze this for the, long term extension study ADORING 3 tapinarof in atopic dermatitis.
Q. Could you describe the study methodology and highlight the key endpoints assessed?
Long term extension for tapinarof in atopic dermatitis, had patients enroll from the pivotal phase III program ADORING 1 and 2. That’s where most of the patients came from, as well as some patients from the maximal use study and then some patients directly enrolled.
It was somewhat of a heterogeneous population, and the study was designed such that either at enrollment or at some point, if patients achieved complete clearance, they would stop tapinarof until at which time at which the disease recurred with a, vIGA-AD of 2 or more, and then they would restart the tapinarof. And then once they cleared again, they would again hold off. And the length of the study was 48 weeks. The goal is to determine what the treatment-free interval is. So how long can patients go before the disease comes back?
Q. What were the observations regarding disease activity after the average 80-day treatment-free interval?
The first important point is that over half of the patients either are at enrollment or at some point during the study achieved complete clearance, and over 80 percent of patients achieved clear or almost clear at some point during the study. After the first treatment-free interval, we find that the patients, had disease that recurred that was very mild in nature, so people weren’t having rebound flares. Also, patients went on average 80 days for that first treatment free interval. So almost 2.5 months, which makes this medicine pretty unique amongst our armamentarium of topicals for atopic dermatitis.
Q. What have you observed in terms of safety across the patient population in this study?
Luckily, nothing new in terms of the side effects from the long term extension. The most common side effect is folliculitis.
Luckily, very few patients are discontinuing the medicine during the long term extension due to these, treatment related adverse events.
Only 2.6 percent, left the study due to an adverse event. So good thing that, that was low.
Q. In your view, how might these findings influence clinical practice in managing atopic dermatitis?
I think it’s more evidence that this is a really good option for patients. First, in its novel mechanism, the fact that it’s only once a day comes in a cream form and is highly effective, but also in this ability that if people are getting completely clear, well, maybe they don’t have to bring their tube of cream with them on vacation, and they can have this longer term remission and and not have the burden of having to put on a topical, constantly. And I think that’s a real advantage for for our patients.
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