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 - Seite 2

In addition, improvement in body itch as measured by the Worst Itch Numeric Rating Scale (WI-NRS) was also observed at Week 8, with 63.1% of those treated with roflumilast foam achieving a WI-NRS 4-pt response compared to 30.1% of those treated with vehicle (P<0.0001).

Patient-reported outcomes, as reported by the PSD, also improved. Patients in the study were given a 16-item PSD questionnaire to assess efficacy by asking participants to rate the severity and burden of their psoriasis-related symptoms in the past 24 hours.

• At Week 8, a statistically significantly greater percentage of patients achieved an aggregate PSD score of 0 (i.e., no symptoms) for scaling, itch, and pain, with 19.6% of patients treated with roflumilast foam reporting no scaling, itch, or pain compared to 7.1% of those treated with vehicle (P=0.0012).
• Regarding severity of scaling, 41.5% of roflumilast-treated patients achieved a PSD score of 0 vs. 13.6% of vehicle-treated patients (P<0.0001). For severity of itch, 31.7% of roflumilast-treated patients achieved a PSD score of 0 vs. 10.0% of vehicle-treated patients (P<0.0001).
• Similarly, regarding severity of pain, 64.9% of individuals treated with roflumilast foam achieved a PSD score of 0 compared to 40.3% of individuals treated with vehicle (P<0.0001).
  

A total of 432 adults and adolescents ages 12 and over were enrolled in the study. In the study, the extent of scalp involvement of study participants was approximately one-third of the scalp surface area (34.4% for those treated with roflumilast foam, 36.0% in those treated with a vehicle foam). Previous use of a topical steroid was reported by 81.9% of study participants, and 58.6% of participants in the study 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. “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.”