Arcutis Biotherapeutics, Inc. announced new results from the INTEGUMENT-OLE long-term open-label study of investigational once-daily roflumilast cream 0.15% in adults and children ages 6 years and older with AD presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. In the study, roflumilast cream was well-tolerated, with no new safety signals observed over 56 weeks of treatment. Efficacy was not only maintained but improved over time, with 56.6% of participants who continued use of roflumilast cream from the initial trial and 53.8% of participants who switched to roflumilast cream0.15% from vehicle after the initial trial achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at Week 56.

56.9% and 50.0% of participants who rolled over from or switched to once-daily roflumILast cream 0.15% treatment achieved a significant reduction (4-point) in itch based on daily worst Itch Numeric Rating Scale (WI-NRS) (among patients aged 12 years with baseline WI-NRS 4) at Week 56, respectively. These long-term study results provide further support for the safety and tolerability profile of roflumilast Cream already seen in the pivotal INTEGUMENT-1 and INTEGUMENT-2 clinical trials, with no new safety signals reported up to 56 weeks. Overall incidence of adverse events was low, with most being mild to moderate in severity.

PDE4 - an established target in dermatology - is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®?) is approved by the Food and Drug Administration (FDA) for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Investigational roflumilast cream were evaluated at lower doses for AD: 0.15% for adults and children 6 years of age and older and 0.05% for children aged 2 to 5 years.

RoflumilAST cream 0.15% is under review at the FDA for the treatment of adults and children 6 years of ages 2 to 5 years with a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024. Arcutis intends to submit a supplemental new drug application (sNDA) for roflumilast Cream 0.05% in ages 2 to 5 following the potential approval of roflumilast cre 0.15%.