At week 8, 65.3% of roflumilast-treated patients achieved a clinically significant reduction in itch.
Today, Arcutis Biotherapeutics announced new positive data from its pivotal phase 3 ARRECTOR trial (NCT05028582) of roflumilast foam 0.3% for the treatment of adults and adolescents with scalp and body psoriasis. The results, including new patient-reported outcome data, were presented at the European Academy of Dermatology and Venereology (EADV) Congress in Berlin, Germany.1
Key findings from the study include:
According to the study, patient-reported outcomes, reported by the Psoriasis Symptom Diary (PSD), also improved. Patients were given a 16-item PSD questionnaire to assess efficacy by asking them to rate the severity and burden of their psoriasis-related symptoms in the past 24 hours. Findings from the questionnaire include:
In total, 432 adults and adolescents ages 12 and over were enrolled in ARRECTOR. The extent of scalp involvement of patients was approximately one-third of the scalp surface area (34.4% for patients treated with roflumilast foam, 36.0% for patients treated with a vehicle foam). The previous use of a topical steroid was reported by 81.9% of patients, and 58.6% of patients reported inadequate response, intolerance, or contraindication to topical steroids.
“These data from the ARRECTOR trial show once-daily topical roflumilast foam achieved early and significant improvements in psoriasis signs and symptoms on both the scalp and body, including in patients who have already failed standard-of-care topical steroids, suggesting investigational roflumilast foam may be an important topical treatment option,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis, in the news release. “We are pleased to share these results with the medical dermatology community at EADV as we further explore the potential of roflumilast foam in patients with psoriasis in hair-bearing areas of the body, which are traditionally challenging to treat.”