Roflumilast Cream 0.15% for Atopic Dermatitis Receives Strong Recommendation in Updated AAD Guidelines

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The American Academy of Dermatology (AAD) has recently published a focused update of its guidelines of care for the management of atopic dermatitis (AD) in adults. With this update, a strong, evidence-based recommendation has been given to Arcutis Biotherapeutics’ roflumilast cream 0.15% (Zorvye) for disease management.¹

The recommendation emphasizes roflumilast’s ability to reduce pruritus and disease severity in a safe and tolerable manner for adult and pediatric patients 6 years of age and older. The non-steroid is suitable for the daily treatment of mild to moderate AD. The AAD guidelines are regularly updated to include new topicals and biologic therapies approved by the US Food and Drug Administration (FDA), allowing patients and clinicians to have the most current options for this condition. Roflumilast cream 0.15% is 1 of 4 new recommendations included in this update, including tapinarof cream, lebrikizumab, and nemolizumab with concomitant topical therapy.

“The AAD’s focused update highlights therapies that meet rigorous standards for efficacy, safety, and tolerability for adults living with AD,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “The inclusion of ZORYVE in these recommendations validates what healthcare professionals have already experienced with ZORYVE in their practice – a next-generation, steroid-free topical that delivers meaningful improvement for people with AD. It marks important progress in providing individuals with AD and their healthcare providers evidence-based choices that are suitable for all areas, including sensitive and hard-to-treat areas of the body.”

Roflumilast cream 0.15% is the only treatment with a strong recommendation for adults with mild to moderate AD in AAD’s focused guideline update. The targeted mechanism of this drug addresses AD’s inflammatory pathways in a new way, reducing inflammation while minimizing potential adverse effects. Roflumilast is the first FDA-approved branded topical phosphodiesterase-4 (PDE4) inhibitor indicated for AD, plaque psoriasis, and seborrheic dermatitis. Recently, it became the first prescription therapy to be given the National Psoriasis Foundation’s Seal of Recognition.²

Arcutis is currently working to expand FDA-approved access to roflumilast in pediatric patients. In February, the FDA accepted a supplemental New Drug Application to treat children aged 2 to 5 with mild to moderate disease. The application is supported by promising data from pivotal phase 3 trials, long-term extension studies, and pharmacokinetic research, including results from the INTEGUMENT-PED and INTEGUMENT-OLE clinical trials. A Prescription Drug User Fee Act (PDUFA) target action date has been set for October 13, 2025. Furthermore, the upcoming phase 2 INTEGUMENT-INFANT study will evaluate the safety and efficacy of roflumilast in infant patients between the ages of 3 months to less than 2 years.

“AD presents unique challenges in this youngest age group, not only because the skin is more sensitive, but also because the condition often covers a greater percentage of their total body surface area compared to older children and adults. In addition, long-term management of AD requires treatment that can deliver rapid relief of itch, sustained symptom improvement over time, and that is tolerable when applied to the skin,” Burnett said in a recent press release. “Our goal is to address this unmet need by providing advanced targeted topical therapies that can manage symptoms effectively over the long-term, while also improving the quality of life for individuals and their families living with this chronic condition."³

References

1. Arcutis’ ZORYVE® (roflumilast) Cream 0.15% Receives Strong Recommendation in American Academy of Dermatology Updated Guidelines for Adult Atopic Dermatitis. News release. Globe Newswire. June 26, 2025. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2025/06/26/3105808/0/en/Arcutis-ZORYVE-roflumilast-Cream-0-15-Receives-Strong-Recommendation-in-American-Academy-of-Dermatology-Updated-Guidelines-for-Adult-Atopic-Dermatitis.html

2. NPF expands Seal of Recognition to FDA-approved treatments and awards its first to Arcutis’ Zoryve (roflumilast). News release. Arcutis Biotherapeutics. June 2, 2025. Accessed June 26, 2025. https://www.arcutis.com/npf-expands-seal-of-recognition-to-fda-approved-treatments-and-awards-its-first-to-arcutis-zoryve-roflumilast/

3. Arcutis to Present New Long-Term Results of ZORYVE® (roflumilast) Cream at the 2025 Revolutionizing Atopic Dermatitis Conference. Arcutis Biotherapeutics, Inc. June 6, 2025. Accessed June 6, 2025. https://www.globenewswire.com/news-release/2025/06/06/3095048/0/en/Arcutis-to-Present-New-Long-Term-Results-of-ZORYVE-roflumilast-Cream-at-the-2025-Revolutionizing-Atopic-Dermatitis-Conference.html