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


Roflumilast maintained disease control when patients switched to twice-weekly dosing.



Arcutis Biotherapeutics recently announced interim results from its phase 3 INTEGUMENT-OLE (NCT04804605) long-term open-label study of roflumilast cream 0.15% in adults and children ages 6 years and older with atopic dermatitis (AD).1 Roflumilast was well-tolerated and had no new safety signals during treatment for up to 56 weeks in duration. Most notably, efficacy improved over time, with 46.1% and 51.0% of adult and pediatric patients who rolled over from the roflumilast cream treatment arm in INTEGUMENT-1 or -2 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 weeks 28 and 56.

At the start of week 4 of INTEGUMENT-OLE, patients who achieved a vIGA-AD score of clear (0) switched to twice weekly maintenance dosing. Patients would continue once-daily dosing if vIGA-AD reached mild (2) or if their signs or symptoms of AD were not adequately controlled. Over two-thirds of patients who switched to maintenance dosing remained on the twice-weekly schedule for more than half of their time in the study, post-week 4.

Additionally, 61.5% and 66.2% of patients who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 demonstrated a 75% improvement from baseline in Eczema Area and Severity Index (EASI-75) after 28 weeks and 56 weeks. According to Arcutis, “The long-term study results reinforce the safety profile of roflumilast cream already seen in the short-term INTEGUMENT-1 and INTEGUMENT-2 clinical trials.”

The overall incidence of adverse events was low, with most being recorded as mild to moderate. The most frequently reported adverse events (≥2%) included COVID-19, upper respiratory tract infection, nasopharyngitis, and headache. Overall, 3% of patients discontinued the study due to adverse events.

Arcutis has announced it plans to submit a supplemental New Drug Application in the third quarter of 2023 for roflumilast cream 0.15% for the treatment of mild to moderate AD in individuals ages 6 years and older.

“Roflumilast cream is uniquely formulated to deliver treatment without sensitizing excipients and irritants, which can often disrupt the skin barrier. We are excited by these results, which demonstrate the long-term efficacy and the safety and tolerability profile of our next generation phosphodiesterase type 4 (PDE4) inhibitor for the treatment of atopic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, in the news release. “Based on the positive results we have seen, we are convinced that, if approved, roflumilast cream will provide individuals with atopic dermatitis with an important new long-term treatment option that is designed with their specific needs in mind.”


INTEGUMENT-OLE is a phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% in adults and children ages 6 years and older with AD and roflumilast cream 0.05% in children ages 2 to 5 years. Patients who completed the INTEGUMENT-1 or INTEGUMENT-2 phase 3 trials were eligible to enroll (n=658) for either 24 or 52 weeks. The primary end point of the study was to assess the long-term safety of roflumilast after either 24 or 52 weeks of treatment. Key secondary end points included a vIGA-AD score of 0 or 1 at each assessment, Worst Itch Numeric Scale score over time, and EASIscore over time.


1. Arcutis announces positive long-term results of roflumilast cream 0.15% showing durable and improved efficacy over time and favorable safety profile in treatment of mild to moderate atopic dermatitis. Arcutis Biotherapeutics. News release. September 7, 2023. Accessed September 7, 2023. https://investors.arcutis.com/news-releases/news-release-details/arcutis-announces-positive-long-term-results-roflumilast-cream

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