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.

Arcutis’ roflumilast foam 0.3% demonstrated significant improvements in both scalp and body psoriasis across all efficacy endpoints when compared to vehicle, according to patient-reported outcome data from the pivotal ARRECTOR Phase 3 trial in scalp and body psoriasis presented at the European Academy of Dermatology and Venereology Congress in Berlin, Germany.

Roflumilast foam is a once-daily topical foam phosphodiesterase type 4 inhibitor.

A total of 432 adults and adolescents ages 12 and older 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.

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 as measured by a four-point (4-pt) change from baseline in Scalp Itch-Numeric Rating Score (SI-NRS). Importantly, a rapid and significant improvement in scalp itch was observed 24 hours following first application as measured by SI-NRS, the study showed.

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.

 “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,” says Melinda Gooderham, MSc, MD, FRCPC, medical director, SKiN Centre for Dermatology in Canada and an investigator with Probity Medical Research, in a news release. “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.”

“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,” says Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. 

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 [1] plus ≥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, 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.

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 (≥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.