an internal medicine and pediatrics-trained allergist practicing in Mobile, Alabama.

Druhan Howell, MD

What to Expect for Sleep Improvement With Tapinarof in AD, With Druhan Howell, MD

Counseling families about treatment timelines in pediatric 

often centers on when meaningful itch relief can be expected, but emerging data on tapinarof cream now allows clinicians to incorporate anticipatory guidance around sleep improvement into those early discussions as well.

At the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in Philadelphia from February 27 - March 2, HCPLive spoke with Druhan Howell, MD, an allergist from Mobile, Alabama, on a recent pooled analysis of ADORING 1 and ADORING 2 examining sleep outcomes of once-daily tapinarof for 8 weeks in pediatric patients with moderate to severe AD.

The analysis showed that once daily tapinarof cream 1% (VTAMA), an US Food & Drug Administration (FDA)-approved nonsteroidal topical aryl hydrocarbon receptor agonist for AD, was associated with early and sustained improvements in sleep-related outcomes in children aged 2 – 17 years.

Investigators observed sleep improvements as early as 1 week. By week 8, children treated with tapinarof demonstrated greater mean improvements in POEM and DFI scores compared with those who received vehicle. This was observed across age groups 2 – 6 years (

For Howell, this alignment between itch reduction and sleep improvement provides a practical framework for expectation-setting. Families frequently present after prolonged periods of nocturnal scratching and fragmented sleep. Being able to counsel that both itch and sleep may begin to improve within the first week offers a tangible and time-bound treatment goal. She emphasized that sustained improvement through 8 weeks, along with a safety and tolerability profile consistent with earlier analyses, supports incorporating sleep into routine counseling.

Howell said the findings match up to what she sees in clinical practice, with tapinarof cream improving sleep.

“I've had patients who we are seeing, and they come back, and we're talking about how nice it is now that the kids are not up all night, scratching and itching, waking parents up, waking other siblings up that they share bedrooms with,” Howell said. “Those discussions [of sleep improvement] were already happening on the side in my clinic, but now I have some meaningful data that is representative of that clinical impact that I was already seeing.”

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.

Boguniewicz M, Eichenfield LF, 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. J Allergy Clin Immunol. 2026;157(2). 

https://www.jacionline.org/article/S0091-6749(25)XXXX-X/fulltext

Howell D. Tapinarof Cream 1% Improves Sleep in Atopic Dermatitis, With Druhan Howell, MD. HCPLive. Published on February 27, 2026. Accessed on February 27, 2026. 

https://www.hcplive.com/view/tapinarof-cream-1-improves-sleep-atopic-dermatitis-druhan-howell-md

Videos

Once-daily VTAMZA delivers week-one sleep gains and lasting itch control in atopic dermatitis, with safety consistent across studies.

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

 Improvements were observed as early as week 1 in some patients. In an interview with 

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.

 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.

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.

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 (

<.0001), –1.5 vs –1.0 in those aged 7 to 11 years (

 =.0029), and –1.2 vs –0.6 in adolescents aged 12 to 17 years (

 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 (

 =.0002), –0.6 versus –0.4 in those aged 7 to 11 years (

 =.0049), and –0.4 versus –0.2 in adolescents aged 12 to 15 years (

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.”

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

doi:https://doi.org/10.1016/j.jaci.2025.12.019

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/

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

Post hoc pooled data from ADORING 1 and 2 demonstrate statistically significant improvements in patient and family sleep scores in children aged 2–17 years

HCPLive Five at ACAAI 2025

American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting

 in Orlando, leading clinicians from UT Health Houston, the University of Alberta, Johns Hopkins University School of Medicine, and community allergy practices presented pivotal updates in asthma, immunology, dermatology, and anaphylaxis care. This HCPLive Five highlights emerging data across eosinophilic disorders, chronic rhinosinusitis, hereditary angioedema (HAE), anaphylaxis management, and atopic dermatitis, each offering clinicians new insights into rapidly evolving therapeutic landscapes.

Benralizumab Reduces HES Flare in Phase 3 Trial, With Princess Ogbogu, MD

Benralizumab significantly reduced flare events and fatigue in patients with hypereosinophilic syndrome (HES), according to phase 3 NATRON results presented at ACAAI 2025. In an interview with HCPLive, Princess Ogbogu, MD, of the University of Hospitals Rainbow Babies & Children’s Hospital, highlighted the therapy’s impact on time to first flare, annualized flare rates, and hematologic relapse, noting patients on benralizumab did significantly better than those on placebo. Improvements in PROMIS Fatigue scores emerged by week 4. Safety findings aligned with prior benralizumab data, with mostly mild adverse events.

Dupilumab Shows Promise for Allergic Fungal Rhinosinusitis in Phase 3 Trial, With Amber Luong, MD, PhD

Dupilumab demonstrated strong efficacy for allergic fungal rhinosinusitis (AFRS) in the phase 3 LIBERTY AIMS trial, offering a potential new option for this challenging CRSwNP subtype. Amber Luong, MD, PhD, from UT Health Houston, presented data at ACAAI 2025 showing significant improvements in sinus opacification, nasal polyp size, and congestion by weeks 24 and 52, with dupilumab reducing the need for oral steroids or surgery by 92%. The year-long study enrolled 62 rigorously diagnosed patients and met all primary and secondary endpoints. Safety findings aligned with dupilumab’s known profile.

Sebetralstat Shows Promise for On-Demand HAE Treatment in Children, With Adil Adatia, MD

Adil Adatia, MD, from the University of Alberta, presented interim KONFIDENT-KID findings showing that oral sebetralstat safely and rapidly reduced symptoms of hereditary angioedema (HAE) attacks in children aged 2 - 11 years. The oral plasma kallikrein inhibitor, already approved for patients ≥12, was administered within 30 minutes of symptom onset, with a median time to first improvement of four hours. No treatment-emergent adverse events were reported, and pharmacokinetic data aligned with adult studies. Adatia emphasized the promise of a fast-dissolving oral option for young children, noting its potential to replace challenging IV therapies and transform timely, at-home pediatric HAE management.

Sublingual Epinephrine Film Rapidly Works in Children, With David Golden, MD

David Golden, MD, from Johns Hopkins, presented phase 1 data showing that AQST-109 (Anaphylm), a sublingual epinephrine film, rapidly reaches therapeutic levels in children, triggering cardiovascular effects within 2 minutes. In 32 participants aged 7 – 17 years, pharmacokinetics and pharmacodynamics closely mirrored adult findings, with therapeutic plasma levels achieved by 5 - 8 minutes and peak concentrations at 10 minutes. Heart rate and blood pressure rose early, confirming fast onset. Golden emphasized that the needle-free film performed comparably to adult data and may offer an effective alternative to intranasal and injectable epinephrine options for children at risk of severe allergic reactions.

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

Druhan Howell, MD, a pediatrics-trained allergist practicing in Mobile, Alabama, highlighted sub-analysis data from the ADORING 1 and 2 trials showing that 1% tapinarof cream delivers early, sustained benefits in children aged 2–17 with atopic dermatitis (AD). Across 654 pediatric patients, including those with asthma, allergic rhinitis, or food allergies, tapinarof improved skin clearance, eczema severity, itch, sleep, and overall symptom burden as early as week 1, with effects maintained through week 8. EASI-75 and vIGA-AD™ response rates were significantly higher than vehicle, regardless of comorbidities. Safety was consistent with prior findings, with no new signals.

This HCPLive Five features advancements in asthma, immunology, and allergy that were presented at the ACAAI 2025 meeting in Orlando.

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

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, and an Organon Health Partner, 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 (

 <.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; 

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 ... leading to homeostasis and improved skin barrier, which leads 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 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 

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.

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/

At ACAAI 2025, Howell discussed sub-analytical data showing early itch and skin improvements with tapinarof cream in children with AD aged 2–17 years.

Druhan Howell, MD

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