New Data Shows ZORYVE (Roflumilast) Cream 0.3% Provided Measurable Improvement of Plaque Psoriasis in Nearly All Individuals in DERMIS Trials

• Individual patient response data highlights 95% of individuals treated with ZORYVE had a measurable improvement in Psoriasis Area and Severity Index (PASI) at Week 8
• Over 85% achieved measurable improvement by Week 2 (the earliest timepoint measured)
• Separately reported new data confirms ZORYVE is well tolerated according to both investigator and patient local tolerability assessments

WESTLAKE VILLAGE, Calif., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new individual patient response data showing nearly all individuals (95%) treated with ZORYVE (roflumilast) cream 0.3% had a measurable improvement in Psoriasis Area and Severity Index (PASI). Separately reported investigator and patient local tolerability assessment data confirms again that ZORYVE was well tolerated from first application. New analyses from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) were presented in two posters at the 43^rd Annual Fall Clinical Dermatology Conference held October 19-22, 2023, in Las Vegas, Nevada. ZORYVE is a once-daily, steroid-free cream for individuals with plaque psoriasis down to 6 years of age that can be used for any duration across all affected areas of the body.

At Week 8, a statistically significant greater percentage of patients achieved a 50% reduction in PASI scores (PASI-50), with 72.1% of patients treated with ZORYVE compared to 25.5% of those treated with vehicle (P<0.0001). At the same 8 week endpoint, a 75% reduction in PASI scores (PASI-75) was achieved in 40.3% of roflumilast-treated patients compared to 6.5% of vehicle-treated patients (P<0.0001). PASI-90 was observed in 19.7% of patients treated with ZORYVE compared to 2.3% of vehicle-treated patients (P<0.0001) and a 100% reduction (PASI-100) was observed in 12.3% of patients treated with ZORYVE compared to 0.8% of vehicle-treated patients (P<0.001).

“Data reported from clinical trials generally show results within the overall study population which is certainly important. However, what it does not show clinicians is the range or pattern of clinical response they can anticipate in the individual patient they are treating. This information is clinically relevant during each office visit with every patient as it directly provides the range of individual patient responses, in this case using PASI scores as the measure of response,” said James Q. Del Rosso, D.O., FAOCD, FAAD, research director and principal investigator, JDR Dermatology Research, and lead author on the individual patient response presentation. “It is impressive that 95% of individual patients treated with ZORYVE cream showed measurable improvement in PASI scores within eight weeks, with an increased magnitude of efficacy noted progressively over the eight weeks duration of treatment. It is also very clinically relevant that 85% showed measurable improvement as early as two weeks. Collectively, this information highlights the efficacy, consistency, and importance of ZORYVE cream as a corticosteroid-free topical treatment for the vast majority of children and adults with plaque psoriasis.”