Atopic Dermatitis: Final ADORING 3 Open-Label Extension Trial Findings with Tapinarof Cream, 1% Announced

Dermavant presented final data from the ADORING 3 open label long-term extension (LTE) trial on complete skin clearance and treatment-free interval with use of tapinarof cream 1% for atopic dermatitis (AD) at the 2024 Fall Clinical Dermatology Conference, October 24-27, in Las Vegas, NV.

Results of the phase 3 trial showed that more than 80% of study participants aged 2 to 17 years achieved clear or almost clear skin with tapinarof cream while more than half (52%) achieved complete disease clearance over 48 weeks. Moreover, after achieving clear skin and discontinuing treatment, participants experienced a mean of 80 consecutive days of clear or almost clear skin before relapse, according to a news release from Dermavant Sciences.¹

The ADORING Trials

_{^{©New Africa/stock.adobe.com}}

ADORING 1 and ADORING 2 were identical, double-blind, randomized, vehicle-controlled phase 3 studies that evaluated the efficacy and safety of tapinarof cream, 1% in adults and children as young as 2 years old with AD. Study participants had a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 (moderate) to 4 (severe) at baseline.²

ADORING 3 was a 48-week open-label, long-term extension (LTE) study and enrolled participants from:

• ADORING 1, ADORING 2
• A 4-week maximal usage pharmacokinetics study
• Tapinarof cream-naive individuals aged 2 to 17 years with either mild, moderate or severe AD that did not meet inclusion in ADORING 1 and ADORING 2.

During the 48 weeks, researchers pursued safety and tolerability endpoints that included treatment emergent adverse events, adverse events of special interest, investigator-assessed and patient/caregiver-assessed local tolerability, according to Dermavant. The efficacy endpoints of interest included achievement of complete disease clearance (vIGA-AD=0), and of clear or almost clear skin (vIGA-AD=0 or 1).¹

ADORING 3 participants who entered the study with any disease activity were provided with tapinarof treatment until they reached complete disease clearance. Researchers followed any participant who entered already at vIGA-AD=0 to evaluate the length of a treatment-free interval, which they defined as “maintenance of clear or almost clear skin (vIGA-AD = 0, 1) for consecutive days while they were no longer receiving any treatment for AD."¹ Re-treatment with tapinarof was initiated for any participant whose disease severity relapsed to mild or greater (vIFA-AD ≥ 2) and continued until complete clearance was established again.¹

FINDINGS

The final ADORING 3 LTE enrollment was 728, of which 83% were aged 2 to 17 years. Slightly more than one-half (51.9%) of the participants entered with complete disease clearance or achieved that status at least once during the 48 weeks. The proportion that entered with or achieved clear or almost clear skin at least once reached 81.6%, according to the company news release.¹

Among the 378 participants who entered the study with completely clear skin or achieved it during the study and discontinued treatment with tapinarof, the average length of the first treatment-free interval was 79.8 consecutive days—nearly 3 months. The investigators reported no evidence of tachyphylaxis among study participants who received continuous or intermittent tapinarof therapy for up the 48-week end of the trial. All adverse events (AEs) were assessed as mild or moderate and there were no AE-related study discontinuations.¹

Tapinarof cream is a novel, aryl hydrocarbon receptor agonist that, if approved, will be indicated for both acute treatment and long-term management of AD. The original approval of tapinarof for plaque psoriasis in May 2022 made it the first non-steroidal, novel chemical entity topical agent available to treat psoriasis in the US in more than 25 years.²

In April, the US FDA accepted Dermavant’s supplemental new drug application for tapinarof cream 1% for the treatment of atopic dermatitis (AD) in adults and children aged 2 years and older. The FDA has assigned a PDUFA date in the fourth quarter of 2024.²

References
1. Dermavant presents ADORING 3 LTE final data on complete skin clearance and treatment-free interval for Vtama (tapinarof) cream 1% in adults and children as young as 2 years old with atopic dermatitis at 2024 Fall Clinical Dermatology Conference. News release. Dermavant. https://www.biospace.com/press-releases/dermavant-presents-adoring-3-lte-final-data-on-complete-skin-clearance-and-treatment-free-interval-for-vtama-tapinarof-cream-1-in-adults-and-children-as-young-as-two-years-old-with-atopic-dermatitis-at-2024-fall-clinical-dermatology-conference
2. Halsey G. Dermavant: FDA accepts sNDA for tapinarof cream 1% for treatment of adults, children with atopic dermatitis. Patient Care. April 29, 2024. https://www.patientcareonline.com/view/dermavant-fda-accepts-snda-for-tapinarof-cream-1-for-treatment-of-adults-children-with-atopic-dermatitis