Arcutis presents positive patient-reported outcome data from the pivotal ARRECTOR phase III trial in scalp and body psoriasis at European Academy of Dermatology and Venereology Congress.

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)."></0.0001)>

“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 Dr. Melinda Gooderham, 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.”

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).></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. i. 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). ii. 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). iii. 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).></0.0001).></0.0001).></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 Dr. Patrick Burnett, 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.”

As previously reported, ARRECTOR met both co-primary endpoints of Scalp-Investigator Global Assessment (S-IGA) Success and Body-Investigator Global Assessment (B-IGA) Success (S-IGA and B-IGA of Clear [0] or Almost Clear plus greater than 2-grade improvement from baseline) at Week 8 and all secondary endpoints. Specifically, 66.4% of individuals treated with roflumilast foam achieved S-IGA Success compared to 27.8% of individuals treated with a vehicle foam at Week 8 (P<0.0001) and 45.5% of individuals treated with roflumilast foam achieved b-iga success compared to 20.1% of individuals treated with a matching vehicle foam at week 8 (p><0.0001).></0.0001).></0.0001)>

Roflumilast foam 0.3% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse events in the study population (greater than 2%) included headache (4.6%), diarrhea (3.2%), COVID-19 (2.8%) and nausea (2.1%). Rates of discontinuation due to adverse events were low and similar among roflumilast-treated (1.8%) and vehicle-treated (1.3%) patients.

About ARRECTOR The “A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis” (ARRECTOR) study was a parallel group, double blind, vehicle-controlled pivotal Phase III study of the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once-daily in subjects with scalp and body psoriasis ages 12 and older. A total of 432 subjects were enrolled in the study. The co-primary endpoints of the study were the proportion of subjects achieving S-IGA Success and the proportion of subjects achieving B-IGA Success, with IGA Success defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement from baseline after eight weeks.