Arcutis Reveals Long-Term Data on Roflumilast Cream for Mild to Moderate AD at Dermatology Conference

Investigational roflumilast cream 0.15% has shown promising results in alleviating the symptoms of atopic dermatitis (AD) over a prolonged period of 56 weeks. According to Arcutis Biotherapeutics, Inc., a company dedicated to advancing treatments in immuno-dermatology, the once-daily application of roflumilast cream led to significant improvements in the condition of participants.

In an extended study known as INTEGUMENT-OLE, 66.2% of individuals who continued using roflumilast cream from an initial 4-week trial and 53.8% of those who switched from a placebo achieved a 75% improvement in the Eczema Area and Severity Index (EASI-75) by Week 56. Participants also showed a reduction in itchiness, a common and distressing symptom of AD.

The study highlighted that the cream was well-tolerated with no new safety concerns over the 56-week period. The efficacy of the treatment not only persisted but improved over time. Additionally, participants who reached disease clearance after the initial trial and switched to a proactive twice-weekly application managed to maintain control of their symptoms for an average of 281 days.

Dr. Melinda Gooderham, a medical director at SKiN Centre for Dermatology and lead investigator, emphasized the chronic nature of AD and the need for long-term treatment solutions. She noted that roflumilast cream could offer a steroid-free option that maintains disease control and improves treatment adherence. Dr. Emma Guttman-Yassky from Mount Sinai Health System also pointed out that the study's design, which included proactive treatment strategies, represents a shift from reactive to proactive disease management.

The investigational use of roflumilast cream went beyond initial expectations, as 66.2% of the participants from the roflumilast arm and 64.6% from the vehicle arm achieved a 75% improvement from baseline in their EASI scores. Additionally, both groups saw a significant decrease in itch severity, with more than half reporting a reduction of at least four points on the Worst Itch Numeric Rating Scale (WI-NRS).

Safety profiles from the study further support the use of roflumilast cream, consistent with findings from earlier trials (INTEGUMENT-1 and INTEGUMENT-2). Adverse events were generally mild to moderate, with the most common being COVID-19, upper respiratory infections, nasopharyngitis, and headaches. Only 3.0% of participants discontinued the study due to adverse events.

Dr. Patrick Burnett, Chief Medical Officer at Arcutis, highlighted the unique formulation of roflumilast cream, which includes a non-greasy emollient base that absorbs quickly and avoids skin barrier disruption. The cream does not contain potential irritants or allergens like propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

The INTEGUMENT-OLE study assessed the long-term safety and efficacy of roflumilast cream in individuals aged 6 years and older, with a lower dose version tested in younger children. The study aimed to evaluate the sustained impact of the cream without rescue treatments, focusing on maintaining disease control with proactive twice-weekly applications once disease clearance was achieved.

Atopic dermatitis affects millions in the United States, presenting as a red, itchy rash that can appear anywhere on the body. The condition varies widely among individuals and can be influenced by environmental factors. The investigational 0.15% roflumilast cream formulation is under FDA review for treating AD in individuals aged 6 and older, with a decision expected by July 2024.

If approved, roflumilast cream could offer a significant step forward in the long-term management of AD, providing a steroid-free, effective treatment option that maintains symptom control and improves the quality of life for patients.