Arcutis Biotherapeutics (ARQT) Announces New Long-Term Data of Roflumilast Cream 0.15%

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) today 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 cream 0.15% 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.

Starting at Week 4 of INTEGUMENT-OLE, participants who achieved a vIGA-AD score of clear (0), switched to proactive twice-weekly application (130 participants; 19.8% of study population). For these participants, after their first switch to twice-weekly application, the median duration of disease control (maintaining vIGA-AD of 0 or 1 with adequate control of signs and symptoms on the twice-weekly schedule application) was 281 days (95% CI: 147, not evaluable). In addition, 57.7% of these participants maintained disease control on the twice weekly schedule through their final study day.

“AD is a chronic, burdensome skin condition that requires clinicians and patients to seek a treatment option that can be safely and effectively used long-term for an adult or child,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, investigator with Probity Medical Research, and study presenter. “Importantly, investigational roflumilast cream 0.15% showed continued improvement through the course of the study, demonstrating that once approved, roflumilast cream may be an effective long-term, steroid-free treatment option that can be used for proactive flare-free disease control. These results also reinforce the durable efficacy and tolerability of roflumilast cream in AD, which could translate to improved treatment adherence.”

“Adults and children with AD deserve treatment standards that focus on maintaining long-term disease control, rather than reactively managing flares. This novel pivotal study design evaluated proactive twice-weekly application with a targeted topical treatment, and demonstrates that after achieving disease clearance, patients can maintain disease control for at least 281 days,” said Emma Guttman-Yassky, MD, PhD, Waldman Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai, chair of the Kimberly and Eric J. Waldman Department of Dermatology, Mount Sinai Health System, and director of the Laboratory for Inflammatory Skin Diseases at Mount Sinai. “These results provide support for shifting the paradigm from reactively chasing flares to long-term flare-free disease management.” Dr. Guttman-Yassky is a paid consultant with Arcutis Biotherapeutics.

Additional results presented include:

• 66.2% and 64.6% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 or switched to once-daily roflumilast cream 0.15% from the vehicle arm demonstrated a 75% improvement from baseline in EASI-75 after 56 weeks, respectively.
• 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 observed up to 56 weeks. Overall incidence of adverse events was low, with most being mild to moderate in severity. The most frequently reported adverse events (≥2%) included: COVID-19, upper respiratory tract infection, nasopharyngitis, and headache. Overall, only 3.0% of trial participants discontinued the study due to adverse events.

“Investigational roflumilast cream 0.15% is designed to provide clinicians and individuals with AD with a long-term treatment option that is formulated free of known ingredients or allergens that may disrupt and compromise skin barrier integrity,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Based on these positive results, individuals can expect long-term efficacy and improvement in the signs and symptoms of AD, including itch, from roflumilast cream. If approved, we believe that roflumilast cream offers patients with AD an important steroid-free topical option that can provide lasting symptom relief which is maintained over time.”

Roflumilast cream is uniquely formulated as a non-greasy emollient cream that absorbs quickly and does not disrupt the skin barrier. In addition, roflumilast cream does not include sensitizing excipients or irritants, such as propylene glycol, polyethylene glycol, isopropyl alcohol, ethanol, or fragrances.

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