Arcutis Presents Positive Patient-Reported Outcome Data for ZORYVE® (Roflumilast) Cream 0.15% in Atopic Dermatitis at American College of Allergy, Asthma and Immunology 2024 Annual Scientific Meeting

• New patient-reported outcome data from INTEGUMENT-1 and -2 demonstrate that ZORYVE cream 0.15% rapidly decreased the impact of atopic dermatitis (AD), including sleep loss and daily activities, on patients and families
• ZORYVE cream 0.15% resulted in significant improvements across all efficacy endpoints, including validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Success and rapid itch reduction within 24-hours of first application
• Data presented as an oral presentation at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 Annual Scientific Meeting

WESTLAKE VILLAGE, Calif., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new patient-reported outcome data demonstrating that ZORYVE cream 0.15% improved the impact of AD on patients, families, and caregivers. These results, along with efficacy, safety, and tolerability data from Phase 3 INTEGUMENT-1 and -2, will be shared in an oral presentation at the ACAAI 2024 Annual Scientific Meeting held October 24-28, 2024, in Boston, MA.

Improvement with ZORYVE cream 0.15% was seen across multiple patient-reported outcomes including SCORing AD (SCORAD) total scorei, Patient-Oriented Eczema Measure (POEM), and Dermatitis Family Impact (DFI) compared to vehicle at 4 weeks, with improvement reported as early as Week 1, the first timepoint measured. These assessments score the improvement of physical symptoms such as redness and itchiness, as well as impact on loss of sleep, emotional distress, and daily activities (such as schoolwork, housework, or social activities).

“AD is a chronic, complex disease that can negatively affect the individual and the broader family unit, impacting relationships, sleep, and basic functions in life, like school attendance, housework, food preparation, and more,” said Mark Boguniewicz, MD, professor in the Division of Allergy-Immunology, Department of Pediatrics, at National Jewish Health and University of Colorado School of Medicine , and presenting author. “These new data show that treatment with ZORYVE not only provides rapid disease clearance and significant reduction in itch for the patient, but extends beyond that, reducing the impact of quality of life challenges that families and caregivers experience as a result of having a loved one living with a chronic skin disease like AD.”

Treatment with ZORYVE improved all patient-reported outcomes measured compared to vehicle including:

• 64.2% of individuals treated with ZORYVE cream achieved a clinically meaningful improvement in SCORAD Total Score compared to 36.3% treated with vehicle at Week 1 i,ii (P