Tapinarof Cream for Atopic Dermatitis: An Interim Analysis of Results in Adults, Children

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A new analysis of the phase 3 ADORING 3 extension trial involved a large, diverse population and the analysis showed that 91% of eligible participants from previous phases rolled over into this trial.

A pre-planned analysis of the ADORING 3 trial indicates that individuals with atopic dermatitis (AD) treated with tapinarof previously began with less severe disease than those who were treatment-naïve, with 91% of eligible subjects from the ADORING 1 and 2 trials choosing to roll over into the new trial.1

The data were shown at the 2024 American Academy of Dermatology (AAD) Annual Meeting. These findings and more were the conclusions of the interim analysis of the ADORING 3 extension study, an extension trial focusing on long-term efficacy and safety data observed in participants taking part in up to 48 weeks of open-label tapinarof therapy.

The investigators developed an overview of the baseline characteristics and outcomes of the trial, looking at long-term safety and efficacy of up to 48 weeks of treatment.

This new analysis was led by Robert Bissonnette, MD, Chief Executive Officer and medical director of Innovaderm Research, and Linda Stein Gold, MD, the head of the Division of Dermatology for the Henry Ford Health System and vice president of the American Academy of Dermatology.

The previous 2 phase 3 studies titled ADORING 1 and 2 indicated that once-per-day tapinarof cream 1% demonstrated significant effectiveness compared to vehicle, as it was demonstrated to be well-tolerated among patients with AD. Participants included children as young as 2 years of age, with moderate to severe AD.

There were 728 total participants involved in ADORING 3, and this represented a substantial and varied population of AD patients. The trial ended up with 91% of eligible individuals from the previous 2 ADORING trials, with 28 subjects drawn from a different 4-week maximal usage pharmacokinetic study.

Additionally, ADORING 3 featured another 76 tapinarof-naive individuals in the age range of 2-17 years with distinct disease severities. These participants had not been eligible for the preceding studies.

The investigators reported that the majority of subjects featured in ADORING 3 were children, adding that 26.6% were in the age range of 2-6 years, 27.1% in the range of 7-11 years, 29.3% in the range of 12-17 years, and 17.0% in the adult category. As far as demographics, the team noted that 46.6% of those in the study were male, 52.6% were reported to be White, 30.1% Black/African American, 11.1% Asian, and 4.4% from other unmentioned racial groups.

Individuals known to have AD are also characterized by their exhibition of diverse phenotypes and responses to different therapies. The investigators of the ADORING 3 interim analysis pointed out that a considerable amount of primarily pediatric patients chose to continue from the previous ADORING trials, and concluded that the diverse population recruited for ADORING 3 indicates this type of wide range of affected body surface area (up to 95%), disease severity, and demographics.

Lastly, the research team pointed out that there were new safety concerns appearing during the interim analysis of long-term treatment. Additional data regarding safety as well as efficacy with tapinarof cream 1% is slated for a full analysis and scheduled for 2024.

In a prior interview with HCPLive, JiaDe (Jeff) Yu, MD, MS, of Massachusetts General Hospital, spoke with the editorial team about tapinarof’s potential for eczema patients and its potential approval, describing its benefits in the eyes of some patients or clinicians.2

“You know, some people after years of putting creams on their body, really do not want to put a cream on twice a day, especially when we're talking about a sticky ointment,” Yu explained. “Thankfully, some of the newer ones that are coming out some come out as foam, some coming out as cream. These are going to go on a little bit more aesthetically, delicately, instead of thick ointments. But I think a once-daily application is huge for people.”

This element to tapinarof, coupled with the recent ADORING trial findings and their upcoming extension study results, could allow the treatment to become more widespread for AD patients.

References

  1. Bissonnette R, Stein Gold L, et al. Tapinarof Cream 1% Once Daily: Interim Analysis of ADORING 3 Phase 3 Long-term Extension Trial in Adults and Children Down to 2 Years of Age with Atopic Dermatitis. American Academy of Dermatology (AAD) Congress, San Diego, California, March 8–12, 2024. https://eposters.aad.org/abstracts/53928. Date accessed: March 8, 2024.
  2. Smith T. What Would FDA Approval of Tapinarof Mean for Patients with Eczema? HCPLive. October 26, 2023. https://www.hcplive.com/view/what-would-fda-approval-tapinarof-mean-patients-with-eczema-. Date accessed: March 8, 2024.
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