New Tapinarof Data Promising for Children and Perhaps More

An analysis of the Phase 3 ADORING 3 study evaluating tapinarof cream, 1% once daily in adults and children 2 years of age and older with atopic dermatitis (AD) presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, demonstrated that AD disease activity remained mild in patients who had achieved treatment success and subsequently entered a treatment-free interval lasting on average 80 days.

“We are seeing exciting data,” Juan Camilo Arjona Ferreira, MD, Head of Research and Development and Chief Medical Officer at Organon, told Practical Dermatology. “VTAMA’s mechanism of action basically modifies the course of the disease, so we have seen a long remittive effect. Once you experience symptoms, you get treated, you get better, your skin clears, and you stop the treatment. With steroids, you typically see a flare in the next 48 hours after stopping treatment. Here, you have this time where you don’t need to do treatment, and the burden on patients and their families, particularly pediatric patients, is a lot less.”

ADORING 3 (N=728) was a 48-week open-label, long-term extension study that enrolled eligible patients from the pivotal Phase 3 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 AD that did not meet inclusion criteria in ADORING 1 and ADORING 2. In ADORING 3, those who entered with or achieved completely clear skin (n=378), defined as a validated Investigator Global Assessment for AD (vIGA-AD ™ ) score of 0, stopped using VTAMA cream and were assessed for maintenance of vIGA-AD of 0 (clear) or 1 (almost clear) off-treatment. Patients whose AD returned to a vIGA-AD of 2 or higher (mild or above) were retreated with VTAMA cream until complete disease clearance was achieved again or until study completion.

The new results demonstrate that, at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days, 84% of patients had a vIGA-AD score of 2 (mild). Itch, which was assessed with the patient-reported Peak Pruritus Numerical Rating Scale (PP-NRS) score ranging from 0 to 10, remained low with a mean weekly PP-NRS score of 2.9. The mean Eczema Area and Severity Index (EASI) score was 3.4, indicating mild disease.

The most frequent treatment-emergent adverse events (TEAEs) in ADORING 3 included folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%); trial discontinuations due to TEAEs were low (2.6%). Adverse events of special interests including follicular events, contact dermatitis, and headache were mostly mild or moderate and associated with low discontinuation rates (1.0%, 0.4%, and 0%, respectively).

“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, of George Washington University School of Medicine and Health Sciences said in a press release. “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 December 2024, the U.S. Food and Drug Administration (FDA) approved VTAMA (tapinarof) cream, 1% for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was also approved by the FDA on May 24, 2022, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults.

Dr. Arjona Ferreira said the hope is to expand on VTAMA’s indications in the future because the stabilizing aspect of the drug’s mechanism of action could be useful for various other inflammatory immunologicial conditions.

“We are big believers that we must maximize the impact that we have on patients with the drugs we develop,” Dr. Arjona Ferreira said. “It’s very hard to get a drug over the finish line. Once you get it there, how much more can you do with it to help more patients? One approach is to consider how much more new information we can generate so that physicians who are treating these patients today can understand it better and use it better. The other approach involves which other patients we can help. The label is pretty broad; we’re proud of the label because we have very good efficacy, a very clean safety profile, no warnings or precautions, no contraindications, and no drug interactions. You don’t get this every day when you're developing drugs, so it’s exciting—but where else can we go?”

This goal fits well into Organon’s position as a women’s health company, Dr. Arjona Ferreira added.

“We see dermatology as a very woman-centric therapeutic area because the burden of some dermatological conditions is greater in women as the primary caregivers of many of these children,” Dr. Arjona Ferreira said. “Furthermore, there are a lot of unmet needs in the gynecological side of the women's health, and one of them is that there are no treatments for atopic dermatitis during pregnancy even though incidences of AD increase during pregnancy. Because of the profile of VTAMA, that is something we are considering or exploring. There are conditions that happen in the vulvar skin for which there is no treatment and we believe that VTAMA could be an option. We are looking through a pretty broad lens of what else we can do to help more patients.”