Results from Arcutis Biotherapeutics’ pivotal Phase 3 study (ARRECTOR) evaluating roflumilast foam 0.3% in scalp and body psoriasis demonstrated benefit in psoriasis patients.1 Arcutis already plans to submit a New Drug Application (NDA) for roflumilast foam for the treatment of seborrheic dermatitis in Q1 2023 and believes the positive ARRECTOR results will provide enough data to also support a supplemental NDA for scalp and submit body psoriasis.2
The primary endpoints of the study were Scalp Investigator Global Assessment (S-IGA) success, defined as an IGA score of clear or almost clear plus a 2-point improvement at week 8, and Body Investigator Global Assessment (B – IGA) success, defined as an IGA score of “clear” or “almost clear” plus a 2-point improvement at week 8. ARRECTOR met both primary endpoints, as 67.3% of roflumilast foam-treated participants achieved a S-IGA success was achieved compared to 28.1% of participants treated with matching carrier foam at week 8 (P<0.0001) and 46.5% of participants treated with roflumilast foam achieved a B- IGA success compared to 20.8% of participants treated with a matched support foam at week 8 (P<0.0001).
“As Derm PA, I’m usually the first in line to treat psoriasis patients who usually have a lot of discomfort from plaques on their scalp. Your quality of life is affected by extreme itching and even hair loss. What saddens me is that they spend years on the subject before even being seen. I am excited to see the Phase III studies of a cosmetically elegant, once-a-day, non-steroidal option showing promising endpoints for efficacy, safety and tolerability. The data showing that over 65% of people experience a reduction in itch will change the game,” said Renata Block, MMS and PA-C at Advanced Dermatology & Aesthetic Medicine, LLC, in Chicago, Illinois.
Some secondary endpoints included baseline scalp itch-numeric rating score (SI-NRS) success defined as a pruritis score ≥4 at week 8, baseline worst itch-numeric rating score (WI-NRS) success as a ≥ 4 point improvement at week 8 and a Psoriasis Area and Severity Index-75 (PASI-75) score at week 8. Roflumilast foam demonstrated statistically significant improvements in all secondary endpoints, including scalp itch, compared to vehicle , measured by SI-NRS, and total pruritus, measured by WI-NRS at week 8.
According to Arcutis, roflumilast foam was well tolerated and the overall safety and tolerability profile was consistent with other previous studies of roflumilast cream 0.3% and foam. The incidence of treatment-emergent adverse events (TEAEs) was low and similar between roflumilast and vehicle, with most TEAEs recorded as mild to moderate in severity. Some common side effects included headache, diarrhea, and COVID-19.
ARRECTOR is a phase 3, double-blind, vehicle-controlled, parallel-group study evaluating the safety and efficacy of roflumilast foam 0.3% or matched vehicle administered once daily in participants with scalp and body psoriasis 12 years of age and older becomes. 432 participants were included in the study.
About 9 million people in the US have plaque psoriasis, and about 40% of people with psoriasis also have plaques on the scalp.1 Scalp psoriasis can severely impact a patient’s quality of life as many feel insecure about the appearance of their scalp. Roflumilast foam is a selective and potent PDE4 inhibitor designed as a water-based emollient, moisturizing foam that can be used on the scalp and body.
- Topical roflumilast for treatment of scalp and psoriasis (ARRECTOR). ClinicalTrials.gov. Identifier: NCT05028582. Updated August 8, 2022. Accessed September 26, 2022. https://clinicaltrials.gov/ct2/show/NCT05028582?term=ARRECTOR&draw=2&rank=1
- Arcutis Announces Positive Top-Line Results from the Pivotal Phase 3 ARRECTOR Study of Roflumilast Foam 0.3% in Scalp and Body Psoriasis. Arcutis biotherapeutics. Published September 26, 2022. Accessed September 26, 2022. https://www.arcutis.com/arcutis-announces-positive-topline-results-from-arrector-pivotal-phase-3-trial-of-roflumilast- foam- 0-3-in-scalp-and-body-psoriasis/