Arcutis presents Zoryve and corticosteroid data at dermatology meetings

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) presented clinical and real-world data on its Zoryve (roflumilast) portfolio at two dermatology conferences: the 35th European Academy of Dermatology and Venereology Congress, held Sept. 30–Oct. 3 in Vienna, Austria, and the Fall Clinical Dermatology Conference, held Oct. 8–11 in Las Vegas, Nevada.

Among the presentations, data from the Phase 2 INTEGUMENT-INFANT study evaluated investigational once-daily Zoryve cream 0.05% in 101 infants aged 3 to less than 24 months with atopic dermatitis. Of the 96 infants who completed four weeks of treatment, 34.4% achieved Validated Investigator Global Assessment success, defined as a score of clear or almost clear with at least a two-grade improvement from baseline. The treatment was reported to be well tolerated, with no serious adverse events. Zoryve cream 0.05% is currently under FDA review for this age group, with a PDUFA target action date of February 23, 2027.

Analyses from the Phase 3 ARRECTOR trial showed that more patients treated with Zoryve foam 0.3% achieved clear or almost clear skin at week 8 compared to vehicle foam, on both the scalp (66.4% vs. 27.8%) and body (45.5% vs. 20.1%). A separate analysis from the DERMIS-1/2 and ARRECTOR trials found that Zoryve cream 0.3% and foam 0.3% improved psoriasis signs, quality of life, and patient-reported sexual function and personal relationships through week 8.

Collaborative research from Mount Sinai, also presented at EADV, used proteomic analysis of tape strips and skin biopsies to characterize inflammatory pathways and barrier impairment in seborrheic dermatitis, identifying it as a primarily Th17-mediated disease.

Arcutis also presented real-world survey research conducted with the National Eczema Association and the National Psoriasis Foundation. In a survey of 1,000 adults and 500 caregivers of children prescribed topical corticosteroids, 78.8% of adults and 77.6% of caregivers said treatment focused on reacting to flares rather than long-term control. Nearly half of respondents said they hesitated to raise concerns about long-term steroid use with their provider.

A targeted literature review of 42 case reports covering 83 patients found that skin effects such as atrophy appeared in 69% of publications, while Cushing's syndrome or features were the most common systemic side effect at 47.6%.

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