To reflect the latest evidence and FDA approvals, the American Academy of Dermatology has updated its clinical guidelines for managing atopic dermatitis in adults. This focused update, developed through systematic review and GRADE methodology, integrates guidance on two new topical therapies—tapinarof and roflumilast—and two new biologics—lebrikizumab and nemolizumab. Each treatment showed favorable efficacy and safety profiles based on high-certainty evidence from multiple randomized controlled trials.

Tapinarof 1% cream and roflumilast 0.15% cream demonstrated moderate improvements in dermatitis severity and pruritus with low adverse event rates in short-term trials. The biologics lebrikizumab and nemolizumab, both used with or without topical therapy, produced large improvements in disease control and quality of life over 16–52 weeks, with mild to moderate adverse events and low discontinuation rates. While cost remains a concern, these therapies are recommended as part of individualized, shared decision-making approaches. Pediatric guidance will follow in a separate update.

"The workgroup recommends the use of tapinarof cream, roflumilast cream, lebrikizumab, and nemo- lizumab with concomitant topical therapy for the management of AD in adults," write the authors. "Additional, long-term efficacy and safety data, and data on patient-reported outcomes in real-world settings are needed to pro- vide additional insights into the efficacy, effective- ness, and safety of these therapies for the management of AD."

Reference: Davis DMR, Frazer-Green L, Alikhan A, et al. Focused update: Guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025: In Press.

DRUG AT A GLANCE

Tapinarof (Vtama®)
A nonsteroidal topical aryl hydrocarbon receptor agonist approved in December 2024 for patients aged ≥2 years with AD. Once-daily application over 8–12 weeks showed meaningful improvements in pruritus and disease severity. Mild to moderate side effects such as folliculitis and headache were reported.
FDA Approval: December 2024 | Route: Topical | Indication: AD (≥2 years)

Roflumilast (Zoryve®)
A topical phosphodiesterase-4 inhibitor approved in July 2024 for mild to moderate AD in patients ≥6 years old. Daily use over 4 weeks led to moderate clinical benefit with limited adverse events, mainly mild GI symptoms.
FDA Approval: July 2024 | Route: Topical | Indication: AD (≥6 years)

Lebrikizumab (Ebseleku®)
An IL-13–targeting monoclonal antibody approved for moderate to severe AD in individuals ≥12 years. Administered subcutaneously every 2 weeks, it showed large improvements in IGA scores, EASI-75, pruritus, and quality of life. FDA Approval: October 2023 | Route: Subcutaneous | Indication: Atopic dermatitis (adults)

Nemolizumab (Lyxumia®)
A subcutaneous IL-31 receptor A antagonist approved in June 2024 for prurigo nodularis in adults. Shown to rapidly reduce itch and skin lesions, with a favorable safety profile in clinical trials.
FDA Approval: June 2024 | Route: Subcutaneous | Indication: Prurigo nodularis (adults)

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