Arcutis Announces Positive Long-Term Results of Roflumilast Cream 0.15%

Arcutis Biotherapeutics recently announced the interim results of its phase 3, long-term extension trial of roflumilast cream 0.15% for the treatment of atopic dermatitis (AD) in adults and children 6 years and older.


INTEGUMENT-OLE, an open-label study, included 658 patients from the company’s other phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2, which also evaluated roflumilast. Participants received monotherapy with roflumilast with no rescue treatment. Starting at week four, those patients who had achieved a validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of clear (0) switched to twice weekly maintenance dosing. Patients who reached vIGA-AD of mild (2) or if signs or symptoms were not adequately controlled were to resume once-daily dosing. Results demonstrated that over two-thirds of participants who switched to maintenance dosing remained on the twice-weekly schedule for more than half of their time in the study.

At weeks 28 and 56, 46.1% and 51% of patients achieved a vIGA-AD of 0 or 1, plus a 2-point improvement from baseline, respectively. Additionally, 61.5% and 66.2% achieved a 75% improvement from baseline in the Eczema Area and Severity Index after 28 and 56 weeks, respectively.

The interim results demonstrated that roflumilast cream was well-tolerated for up to 56 weeks in duration with no new safety signals observed.  The overall incidence of adverse events was low, with most being mild to moderate. The most frequently reported adverse events included COVID-19, upper respiratory tract infection, nasopharyngitis, and headache.

The results of this long-term study only served to reinforce the safety profile of roflumilast cream already seen in the short-term INTEGUMENT-1 and INTEGUMENT-2 clinical trials.

According to Eric Simpson, MD, MCR, FAAD, professor of dermatology at Oregon Health & Science University in Portland, Oregon, and INTEGUMENT trial investigator, 

“When determining a treatment plan for an adult or child with a chronic, burdensome skin condition such as atopic dermatitis, long-term efficacy and safety are both incredibly important considerations. These results build upon the positive findings from the pivotal Phase 3 trials of roflumilast cream 0.15% in atopic dermatitis demonstrating rapid efficacy within the first 4 weeks of treatment, and further validate the long-term durable efficacy and tolerability of roflumilast cream, with continued improvement over the course of the long-term study. Importantly, individuals who reached clear were able to switch to a twice weekly dosing and maintain control of their disease through this schedule.”

Arcutis has since submitted roflumilast cream 0.15% for a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration.

With October marking the all-important Eczema Awareness Month, this is a prime opportunity to dive into LiVDerm’s free AD resources. Head over to our AD Digital Education Hub now and tune in to our dedicated podcasts, earn CMEs from our complimentary activities, view our past conference slides, and much more.


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