Tapinarof Shows Early, Sustained Benefits in Pediatric Atopic Dermatitis, With Druhan Howell, MD

New findings from a subanalysis of the phase 3 ADORING 1 and ADORING 2 trials demonstrated the efficacy and safety of 1% tapinarof (VTAMA) cream in pediatric patients with atopic dermatitis (AD). In an interview with HCPLive at the 2025 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in Orlando, Florida, investigator Druhan Howell, MD, an internal medicine and pediatrics-trained allergist practicing in Mobile, Alabama, reviewed the clinical significance of these results for everyday practice.

“A lot of the patients that we are seeing in clinical practice have more than one thing going on in the allergic world, so they'll have atopic dermatitis, allergic rhinitis, and asthma,” Howell said. “What we saw in the sub-analysis was that these patients had the same clinical improvement as patients who only had atopic dermatitis, which is important so that we know that when we are treating all of these patients, they will see the same sort of results.”

Tapinarof, an aryl hydrocarbon receptor (AhR) agonist, works by restoring skin barrier homeostasis, decreasing inflammation, and reducing oxidative stress—mechanistic features that distinguish it from existing topical options. The US Food & Drug Administration (FDA) approved this drug in December 2024 for adults and children aged ≥ 2 years with AD.

The pooled subanalysis evaluated 654 children aged 2 – 17 years with moderate to severe AD, including those with comorbid allergic conditions, such as asthma, allergic rhinitis, and food allergies. The data revealed early and sustained improvements in key clinical and patient-reported outcomes, regardless of comorbidity status.

By week 1, children treated with tapinarof cream showed measurable improvements in skin clearance and appearance, with vIGA-AD™ response rates of 42.3% in those with comorbidities and 49.5% in those without (P <.0001). These effects persisted through week 8. Improvements in eczema severity, measured by EASI-75, were seen as early as week 2 and maintained through week 8 (54.5% with comorbidities vs. 21.8% with vehicle; 63.1% without comorbidities vs. 20.4% with vehicle; P <.0001).

Patient-reported outcomes followed a similar pattern. Sleep and overall symptom burden, measured by POEM scores, improved significantly by week 1 and continued through week 8. Children also experienced meaningful itch reduction, with ≥ 4-point improvements on the Peak Pruritus–Numeric Rating Scale (PP-NRS) at week 2 (55.6% with comorbidities vs. 36.3% with vehicle; 63.3% without comorbidities vs. 29.2% with vehicle).

Investigators observed no new safety signals in the pediatric subgroup. The most common treatment-emergent adverse events included folliculitis (7.8%), upper respiratory tract infection (4.6%), and headache (3.7%).

“VTAMA is a new and novel mechanism of action. The aryl hydrocarbon receptor agonist goes in, and it is really leading to homeostasis and a disrupted skin barrier, so it improves the skin barrier, it decreases inflammation, and it decreases oxidative stress, all of which lead to improvement of the skin,” Howell said. “That really is new in the atopic dermatitis space. It’s nice to have something new and different to provide to our patients.”

Reported disclosures for Howell include Dermavant Sciences, Inc., AstraZeneca Pharmaceuticals LP, Actelion Pharmaceuticals US, Inc., GENZYME CORPORATION, Regeneron Healthcare Solutions, Inc., CSL Behring, Takeda Pharmaceuticals U.S.A., Inc., Blueprint Medicines Corporation, Amgen Inc., Philips North America LLC, Pulmonx Corporation, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme LLC, Grifols USA, LLC, Baxter Healthcare, Vifor Pharma, Inc., Mylan Specialty L.P., and more.

References

1. Howell D. Sub-analysis of pooled data from its ADORING 1 and ADORING 2 clinical trials demonstrating early and consistent response to VTAMA® (tapinarof) cream, 1%, across key measures, regardless of comorbidity status, in children aged 2-17 years with atopic dermatitis (AD). Presented at ACAAI in Orlando, Florida, from November 6 – November 10, 2025.

2. New Data Show Early and Consistent Response to VTAMA® (tapinarof) Cream, 1%, in Children Aged 2+ with Atopic Dermatitis, Including Those With Associated Comorbidities | Organon. Organon. Published November 13, 2025. Accessed November 13, 2025. https://www.organon.com/news/new-data-show-early-and-consistent-response-to-vtama-tapinarof-cream-1-in-children-aged-2-with-atopic-dermatitis-including-those-with-associated-comorbidities/