Arcutis Presents Positive Patient-Reported Outcome Data from the Pivotal ARRECTOR Phase 3 Trial in Scalp and Body Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress

• Once-daily, steroid-free roflumilast foam 0.3% demonstrated significant improvements in both scalp and body psoriasis across all efficacy endpoints compared to vehicle
• New data highlights a significant reduction in scalp itch observed as early as 24 hours following the first application of roflumilast foam, as measured by change in baseline in Scalp Itch-Numeric Rating Score (SI-NRS)
• Patients reported a significant improvement in scaling, itch, and pain at Week 8, with significantly more individuals treated with roflumilast foam achieving a Psoriasis Symptom Diary (PSD) score of 0, or clear, compared to vehicle
  

WESTLAKE VILLAGE, Calif., Oct. 13, 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 data from its pivotal ARRECTOR Phase 3 trial of roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis. Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor being developed to treat inflammatory dermatoses, particularly in hair-bearing areas of the body such as the scalp, face, and trunk. The results, including new patient-reported outcome data, were presented at the EADV Congress held October 11-14, 2023, in Berlin.

New data presented in Berlin demonstrate improvements in both scalp and body itch. Two thirds (65.3%) of roflumilast-treated patients achieved a clinically significant reduction in itch compared to 30.3% of vehicle-treated patients at Week 8 (P<0.0001) as measured by a four-point (4-pt) change from baseline in SI-NRS. Importantly, a rapid and significant improvement in scalp itch was observed 24 hours following first application as measured by SI-NRS (P=0.0164).

“Scalp psoriasis, which presents in about 40 percent of people with psoriasis, is often associated with itch and is the most burdensome symptom of the disease,” said Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology, and investigator with Probity Medical Research. “These data show that roflumilast foam significantly improved scalp psoriasis across multiple efficacy endpoints, including a notably rapid and significant reduction in itch as early as the first treatment. Coupled with a favorable safety and tolerability profile, these efficacy data demonstrate the potential for roflumilast foam as a treatment option designed to overcome the limitations of traditional creams and ointments for hair-bearing areas of the body.”