Allergists Debate Newer Nonsteroidal Topicals for Atopic Dermatitis

Atopic dermatitis management has shifted considerably since the 2023 publication of the American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology (AAAAI/ACAAI) Joint Task Force (JTF) guidelines, which remain a common reference point for allergists but predate 3 nonsteroidal topical agents now central to practice: tapinarof, roflumilast, and ruxolitinib.¹

Tapinarof, an aryl hydrocarbon receptor agonist, and roflumilast, a phosphodiesterase-4 (PDE4) inhibitor, both received FDA approval with subsequent label expansions down to age 2 years.2,3 Moreover, ruxolitinib, a topical Janus kinase (JAK) inhibitor, carries similar age-based labeling for mild-to-moderate disease.4

New Topical Options Reshape Guideline-Directed Atopic Dermatitis Treatment

This accelerating pace of approval and guideline revision has outstripped the JTF's most recent formal update, creating a gap between codified recommendations and day-to-day allergy practice. The American Academy of Dermatology (AAD) updated its adult AD topical therapy guidance with strong recommendations added for roflumilast and tapinarof, and in April 2026, published its first-ever pediatric-specific AD guideline, issuing strong recommendations across topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), crisaborole, roflumilast, ruxolitinib, and tapinarof.5

Long-term extension data have also continued to accumulate for each of the newer agents. In the ADORING 3 tapinarof trial, the mean first treatment-free interval after complete skin clearance was 79.8 consecutive days.6 Additionally, the FDA accepted a supplemental application on July 8, 2026, to extend roflumilast cream (0.05%) to infants as young as 3 months, based on the open-label INTEGUMENT-INFANT trial.3

A group of practicing allergists convened for a peer discussion forum in the Los Angeles area on July 13, 2026, moderated by Greg Bensch, MD, a PI at Bensch Clinical Research in Stockton, California. The discussion, framed around AD as often the first diagnosis in the broader atopic march, focused on how newer nonsteroidal topical therapies are being integrated into pediatric and adult treatment sequencing relative to legacy TCS and TCI regimens.

“One of the magic questions is: Can you stop the atopic march by intervening early?" Bensch asked.

Itch Control and Access Barriers Drive Real-World Nonsteroidal Prescribing Decisions

Panelists described a consistent referral pattern: patients typically arrive already exposed to topical corticosteroids, most often low-to-mid-potency formulations initiated by primary care, with calcineurin inhibitor exposure more common among dermatology referrals.

Persistent barriers to sustained use of these legacy therapies included steroid phobia, burning and stinging associated with TCIs, and long-standing safety concerns such as skin atrophy, striae, telangiectasia, and growth suppression. Most panelists said they proactively discuss these risks with patients or caregivers.

Panelists also identified body surface area and practical prescribing constraints, including tube-quantity limits and prior authorization burden, as frequent drivers of early escalation to systemic therapy independent of formal severity thresholds. The panel broadly agreed that itch remains the most consequential patient-reported outcome and often determines both initial agent selection and perceived treatment success. This is consistent with itch's role as a primary or secondary endpoint across pivotal trials for all 3 newer agents, including ruxolitinib's TRuE-AD3 pediatric study, in which 56.5% of children aged 2 to 11 years achieved Investigator's Global Assessment treatment success with 1.5% ruxolitinib cream (P <.0001).⁷

Discussing the newer nonsteroidal agents, panelists rated ruxolitinib as offering the most consistently favorable itch response in their clinical experience. They distinguished tapinarof by its lack of systemic absorption, absence of a boxed warning, and inclusion of severe AD patients in its ADORING 1 and 2 pivotal trials. Roflumilast, despite regulatory momentum toward younger pediatric indications, was described as more variably effective in their hands.

Unmet needs raised included the lack of real-world, non-fixed-duration data on tapinarof's remittive effect and continued uncertainty about comparative long-term efficacy among the 3 agents outside controlled trial settings, with panelists closing on the broader observation that an expanding nonsteroidal topical armamentarium now requires more individualized, patient-specific decision-making than in prior years.

Panelists cited unmet needs, including real-world data on tapinarof's remittive effect outside fixed trial durations and continued uncertainty about comparative long-term efficacy among the 3 agents. They noted that an expanding nonsteroidal topical armamentarium now demands more individualized, patient-specific decision-making than in prior years.

The panel repeatedly cited access and insurance coverage as the dominant real-world barrier across all 3 agents. When Bensch posed the question, “If there [were] 0 access problems at all, would you even use topical steroids anymore?” a panelist responded with, “I am probably skipping the topical steroids altogether.”

References

1. Chu DK, Schneider L, Asiniwasis RN, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE- and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol. 2024;132(3):274-312. https://www.annallergy.org/article/S1081-1206(23)01455-2/fulltext

2. Smith T. FDA Approves Tapinarof 1% Cream for Adult, Pediatric Patients with Atopic Dermatitis. HCPLive. Published on December 16, 2024. Accessed on July 20, 2026. https://www.hcplive.com/view/fda-approves-tapinarof-cream-adult-pediatric-patients-atopic-dermatitis

3. Brooks A. FDA Approves Roflumilast (Zoryve) Cream 0.05% for Atopic Dermatitis in Children Aged 2-5 Years. HCPLive. Published on October 6, 2025. Accessed July 20, 2026. https://www.hcplive.com/view/fda-approves-roflumilast-zoryve-cream-0-05-for-atopic-dermatitis-in-children-aged-2-5-years

4. Smith T. FDA Approves Ruxolitinib Cream for Pediatric Patients with Atopic Dermatitis. HCPLive. Published September 18, 2025. Accessed July 20, 2026. https://www.hcplive.com/view/fda-approves-ruxolitinib-cream-for-pediatric-patients-with-atopic-dermatitis

5. Davis DMR, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in pediatric patients. J Am Acad Dermatol. Published online April 7, 2026. https://www.jaad.org/article/S0190-9622(26)00343-9/fulltext

6. Bissonnette R, Stein Gold L, et al. Skin clearance, duration of treatment-free interval, and safety of tapinarof cream 1% once daily: results from ADORING 3, a 48-week phase 3 open-label extension trial in adults and children down to 2 years of age with atopic dermatitis. J Am Acad Dermatol. Published online May 16, 2025. https://www.jaad.org/article/S0190-9622(25)02130-9/fulltext

7. Eichenfield LF, Armstrong AW, Stein Gold LF, et al. Efficacy and safety of ruxolitinib cream in children aged 2 to 11 years with atopic dermatitis: results from TRuE-AD3, a phase 3, randomized double-blind study. J Am Acad Dermatol. Published online May 14, 2025. https://www.jaad.org/article/S0190-9622(25)02124-3/fulltext