FDA approves tapinarof cream, 1% for atopic dermatitis patients 2 years and up
"I really hope this becomes a first-line agent that people are comfortable prescribing whether they are in dermatology, pediatric dermatology, or primary care."
Organon's tapinarof cream, 1% (VTAMA), an aryl hydrocarbon receptor agonist, once-daily, steroid-free topical cream, has been approved by the FDA to treat atopic dermatitis in patients aged 2 years and up, according to a press release from Organon.1,2
"It's rare to first of all, have a steroid free option, but also to have something that's going to work in a completely different mechanism," John Browning, MD, FAAD, FAAP, in the above interview with Contemporary Pediatrics.
Browning is a board-certified pediatric and adult dermatologist in San Antonio, Texas, and is an assistant professor at the Baylor College of Medicine, as well as the chief of Dermatology at the Children's Hospital of San Antonio.
"Instead of just blocking inflammation, with tapinarof we're actually seeing the epidermal barrier, so your skin integrity improves with it," said Browning. "The other thing that's unique is the ability to go through these disease free intervals, [basically] a time when the skin clears up. It's very exciting to have a steroid free option for treating atopic dermatitis aged 2 and up."
The supplemental New Drug Application and subsequent approval by the federal agency was based on data from the ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) phase 3 trials. The trials are identical, double-blind, randomized, and vehicle-controlled, with a primary endpoint being a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at week 8.2
In ADORING 1, adult and pediatric participants aged 2 years and up with moderate to severe AD were randomized (2 to 1) to receive once-daily tapinarof or vehicle cream. By week 8, 45.4% of participants that received tapinarof achieved the primary endpoint of a vIGA-AD score of 0 or 1 with at least a 2-grade improvement from baseline. In the trial, 55.8% of tapinarof users achieved the key secondary endpoint of the proportion of participants with a 75% or greater improvement in the Eczema Area and Severity Index (EASI75) from baseline at week 8 (P < 0.0001).3
A significant improvement in itch was observed in study participants 12 years and older that received tapinarof. Of these participants with a Peak Pruritus Numeric Rating Scale (PP-NRS) score of 4 or greater at baseline, 61.1% achieved a 4-point or greater reduction in the PP-NRS at week 8 (P = 0.0366), another key secondary endpoint of the study.3
“VTAMA cream approval in AD is important because it can be prescribed for children as young as 2 years old. VTAMA cream has the potential to bring much needed relief to a significant number of children suffering from this disease,” said Adelaide A. Hebert, MD, Professor and Chief of Pediatric Dermatology at McGovern Medical School at UTHealth Houston and Children’s Memorial Hermann Hospital and lead investigator for the ADORING program, in a press release.1
"Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition’s most prevalent symptoms with use of VTAMA cream," said Hebert.1
In January of 2024, Organon announced data from an interim analysis of the ADORING 3 open-label, long-term extension study to evaluate the safety and efficacy of tapinarof cream 1% in AD patients for up to 48 weeks, as well as an integrated analysis of data that included 711 patients from the ADORING 1 and 2 trials.4
In the integrated analysis, 73% (519/711) of patients achieved a vIGA-AD™ score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline.5
Interim analysis for ADORING 3 revealed that 51.2% achieved complete disease clearance (vIGA-AD score: 0).4
In October 2023, Dermavant released new pruritus data for tapinarof cream, 1% that revealed a greater reduction in itch as early as 24 hours after first application in children as young as 2 years of age with AD.4
"Overall, these results show a rapid reduction in itch as early as 24 hours after first application of tapinarof, with a consistent improvement in itch through week 8," Eric Simpson, MD, MCR, professor, Frances J. Storrs Medical Dermatology, director, CLEAR Eczema Center, Oregon Health & Science University, told Contemporary Pediatrics at the time.4
"Itch remains the most burdensome and prevalent symptoms of atopic dermatitis, and these results highlight the potential of tapinarof as a clinically meaningful therapy with the ability to reduce itch for adults and children living with atopic dermatitis," said Simpson.4
Click here for full 24-hour application results and full commentary from Simpson.
"I've had patients that looked like they really needed a systemic agent, one of the injectable biologics, and they were able to go into the study, and it was incredible to see the results at the end of the study in terms of having clear skin, itch reduction, and just having happy patients," said Browning.
"I really hope that this can become a first line agent that people are comfortable prescribing, whether they're dermatology, pediatric dermatology, or primary care, and that's because of the great safety profile and efficacy that it provides," concluded Browning.
Tapinarof cream, 1% was approved by the FDA to treat plaque psoriasis in adults in May of 2022.1
References:
1. FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older. Organan. Press release. December 16, 2024. Accessed December 16, 2024. 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/
2. Fitch, J. FDA accepts sNDA for tapinarof cream, 1% to treat AD in children 2 years and up. Contemporary Pediatrics. April 29, 2024. https://www.contemporarypediatrics.com/view/fda-accepts-snda-for-tapinarof-cream-1-to-treat-ad-in-children-2-years-and-up
3. Fitch, J. Tapinarof cream 1% demonstrates positive topline results for treating pediatric AD. Contemporary Pediatrics. May 16, 2023. https://www.contemporarypediatrics.com/view/tapinarof-cream-1-demonstrates-positive-topline-results-for-treating-pediatric-ad
4. Fitch, J. New topline phase 3 data for tapinarof cream 1% to treat AD in children. Contemporary Pediatrics. January 11, 2024. https://www.contemporarypediatrics.com/view/new-topline-phase-3-data-for-tapinarof-cram-1-to-treat-ad-in-children
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