AAD Posters Highlight Positive Data for Roflumilast

Arcutis Biotherapeutics, Inc., announced new data from two posters shared at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

The first poster presentation details the positive efficacy, patient-reported outcomes, and tolerability for the use of once-daily roflumilast (ZORYVE) cream 0.15% in adults and children 6 years and older with mild-to-moderate atopic dermatitis (AD) from the INTEGUMENT 1-2 trials (n=1,337) who reported a prior inadequate response, intolerance, or contraindication to topical corticosteroids (TCS; 60.8%), topical calcineurin inhibitors (TCI; 18.1%), or crisaborole (7.3%). At all timepoints assessed during the 4-week trial, more than 91% of participants reported no or mild sensation at the application site and investigators reported no irritation or minimal erythema (redness) in ≥ 97% of participants in these subgroups. Improvement in AD was observed across multiple efficacy endpoints and safety was consistent with the overall study population.

A second poster presentation shares results from the Phase 3 ARRECTOR trial that outlines improvements in patient-reported outcomes with investigational ZORYVE foam 0.3% compared with vehicle in adults and children 12 and older with psoriasis of the scalp and body. ZORYVE foam significantly improved quality of life across the 23-component Scalpdex assessment throughout the 8-week study period. Individuals reported an improvement in symptoms as well as a reduction in how psoriasis impacted their daily life (eg, embarrassment, stress, affecting clothing choices, or hair styles).

“While topical therapies are the first line of therapy for millions of people with atopic dermatitis, there are many who are contraindicated or have an inadequate or intolerant response to topical therapies, which have previously been considered the standard of care. These data add to the large body of evidence that highlights the effectiveness, safety, and tolerability of ZORYVE cream 0.15% across diverse patient types, making it a suitable targeted topical and alternative to steroids for adults and children with atopic dermatitis,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in a press release. “In addition, the patient-reported outcome data being shared at AAD underscores our team’s commitment to finding meaningful innovations for immuno-dermatologic conditions like psoriasis that can have a significant physical and emotional impact on the individuals that live with these chronic conditions and their caregivers.”