New Study Data of Roflumilast Foam for Scalp and Body Psoriasis

Results from Arcutis Biotherapeutics’ pivotal phase 3 trial (ARRECTOR) evaluating roflumilast foam 0.3% for scalp and body psoriasis showed success among psoriasis patients.¹ Arcutis already plans to submit a New Drug Application (NDA) for roflumilast foam for the treatment of seborrheic dermatitis in the first quarter of 2023 and believes the positive ARRECTOR results will provide enough data to also submit a supplemental NDA for scalp and 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 participants treated with roflumilast foam achieved S-IGA Success compared to 28.1% of participants treated with a matching vehicle foam at week 8 (P<0.0001), and 46.5% of participants treated with roflumilast foam achieved B-IGA Success compared to 20.8% of participants treated with a matching vehicle foam at week 8 (P<0.0001).

“As a Derm PA, I am usually the first in line to see psoriasis patients who most have major discomfort from their plaques to their scalp. Their quality of life is affected by extreme itch and even hair loss. What saddens me is that they have been dealing with the issue for years before they are even seen. I am thrilled to see the phase III studies of a cosmetically elegant, once-daily, non-steroid option showing promising endpoints for efficacy, safety, and tolerability. The data showing over 65% of people experience a reduction in itch will be a game changer,” 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 pruritis score ≥4 at week 8, baseline Worst Itch-Numeric Rating Score (WI-NRS) Success defined as a ≥ 4-point improvement at week 8, and a Psoriasis Area and Severity Index- 75 (PASI-75) score at week 8. Roflumilast foam showed statistically significant improvements compared to the vehicle on all secondary endpoints, including scalp itch as measured by SI-NRS and overall itch as 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 severity. Some common adverse effects included headache, diarrhea, and COVID-19.

ARRECTOR is a parallel group, double blind, vehicle-controlled phase 3 study evaluating the safety and efficacy of roflumilast foam 0.3% or a matching vehicle administered once a day to participants with scalp and body psoriasis aged 12 years and older. 432 participants were enrolled in the study.

Approximately 9 million people in the US have plaque psoriasis, and approximately 40% of patients with psoriasis also have plaques on the scalp.¹ Scalp psoriasis can have a severe impact on a patient’s quality of life, as many feel self-conscious over the appearance of their scalp. Roflumilast foam is a selective and potent PDE4 inhibitor designed as an emollient, water-based, moisturizing foam that can be used on the scalp and body.

References:

1. Topical roflumilast to treat 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
2. Arcutis announces positive topline results from ARRECTOR pivotal phase 3 trial 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/