Tapinarof Cream 1% Improves Sleep in Atopic Dermatitis, With Druhan Howell, MD

A post hoc pooled analysis of the phase 3 ADORING 1 and ADORING 2 trials suggests that once-daily tapinarof cream 1% is associated with early and sustained improvements in sleep-related outcomes in children aged 2 to 17 years with moderate to severe atopic dermatitis (AD).1 Improvements were observed as early as week 1 in some patients. In an interview with HCPLive at the 2026 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in Philadelphia, Druhan Howell, MD, an allergist and immunologist in Mobile, Alabama, discussed how these findings may inform clinical conversations with families managing chronic disease.

“Week 1 [sleep] improvements are really meaningful for our patients,” Howell said. “Many of them who have shown up in the office have been dealing with atopic dermatitis and the unseen impacts of that for a long period of time, and so they are sleep-deprived. To get a good night's sleep after you haven't been sleeping is just kind of revolutionary.”

Tapinarof cream 1% (VTAMA) is a nonsteroidal topical aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration (FDA) for the treatment of AD in patients aged ≥ 2 years and older.2 The ADORING 1 and ADORING 2 trials were identical, randomized, double-blind, vehicle-controlled phase 3 studies evaluating once-daily tapinarof for 8 weeks in pediatric patients with moderate to severe AD.3

The newly reported sleep data derive from a pooled post hoc analysis of 654 tapinarof-treated children. Baseline disease burden was substantial, with mean Patient-Oriented Eczema Measure (POEM) scores ranging from 16.4 to 17.4, consistent with moderate to severe symptoms. Mean Dermatitis Family Impact (DFI) scores were between 7.7 and 9.1, reflecting moderate family burden.1

At week 8, mean improvements in POEM sleep scores favored tapinarof over vehicle across all age cohorts: –1.9 vs –0.9 in children aged 2 to 6 years (P <.0001), –1.5 vs –1.0 in those aged 7 to 11 years (P =.0029), and –1.2 vs –0.6 in adolescents aged 12 to 17 years (P <.0001).1 DFI sleep scores similarly demonstrated statistically significant improvements with tapinarof compared with vehicle: –1.1 vs –0.6 in children aged 2 to 6 years (P =.0002), –0.6 versus –0.4 in those aged 7 to 11 years (P =.0049), and –0.4 versus –0.2 in adolescents aged 12 to 15 years (P =.0283).1

Howell emphasized that although the primary endpoints of the ADORING trials focused on investigator-assessed skin clearance, the sleep findings capture a dimension of disease burden frequently highlighted in clinic but less often foregrounded in trial reporting. In her view, the ability to counsel families that measurable improvements in both itch and sleep may occur within the first week of therapy provides a concrete and clinically meaningful expectation.

The absolute differences in sleep score improvements between tapinarof and vehicle, although statistically significant, were modest. Whether these numeric changes correspond to clinically meaningful improvements at the individual level remains uncertain.

The consistency of improvement across pediatric age groups suggests that sleep and family impact may represent important adjunctive outcomes when evaluating therapeutic benefit in AD. As Howell described, incorporating sleep data into shared decision-making discussions may help contextualize treatment goals beyond lesion clearance alone, particularly in families coping with chronic nocturnal symptoms.

“I think all of us understand how important sleep is, and in our atopic dermatitis patients,” Howell said. “Disruption of sleep leads to problems…in children. That's behavior, that's [the] ability to function at school. This data [is] important because if we improve their sleep score, we can see those invisible burdens of atopic dermatitis improve for our patients and their families.”

Reported disclosures for Howell include Organon, 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. Boguniewicz M, Eichenfield L, Kwong P, Hebert A. Improvement In Sleep And Family Impact For Pediatric Patients Down To 2 Years Of Age With Atopic Dermatitis Treated With Tapinarof Cream 1% Once Daily In Two Pivotal Phase 3 Trials. Journal of Allergy and Clinical Immunology. 2026;157(2):AB5. doi:https://doi.org/10.1016/j.jaci.2025.12.019

2. FDA Approves VTAMA® (tapinarof) cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older | Organon. Organon. Published January 20, 2025. 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/

3. Howell D. Tapinarof Shows Early, Sustained Benefits in Pediatric Atopic Dermatitis, With Druhan Howell, MD. HCPLive. Published on November 13, 2026. Accessed on February 27, 2026. https://www.hcplive.com/view/tapinarof-shows-early-sustained-benefits-in-pediatric-atopic-dermatitis-with-druhan-howell-md