Roflumilast Foam Improves Symptoms of Scalp, Body Psoriasis
The therapy is currently under FDA review and has a PDUFA action date of May 22, 2025.
Roflumilast foam (Zoryve) 0.3% improved signs and symptoms of psoriasis on the scalp and body in patients 12 years of age and older, according to data published in the journal JAMA Dermatology.1 The therapy is currently under FDA review and has a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025.
Roflumilast Foam Improves Symptoms of Scalp, Body Psoriasis / Ilia - stock.adobe.com
Results from the ARRECTOR trial (NCT05028582) showed that roflumilast foam met its coprimary efficacy endpoints of Scalp Investigator Global Assessment (S-IGA) score change and Body Investigator Global Assessment (B-IGA) score change. The therapy also met several key secondary endpoints.
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“Plaque psoriasis is a chronic and burdensome disease that often leaves people searching for relief from thick scales, itch, and discomfort – especially when it affects the scalp, where treatment can be particularly challenging,” Melinda Gooderham, MD, MSc, FRCPC, lead author on the study, said in a release.2 “These compelling results demonstrate that ZORYVE foam 0.3% may provide rapid and significant relief of plaques anywhere on the body and is well-tolerated according to both investigator and patient-reported assessments.”
ARRECTOR was a parallel group, double blind, vehicle-controlled phase 3 study evaluating the safety and efficacy of roflumilast foam 0.3% as a once-daily monotherapy treatment for psoriasis of the scalp and body. The study cohort included 432 patients aged 12 years and older who had plaque psoriasis affecting the scalp and body across 49 sites in the US and Canada. Patients received either roflumilast foam or an active comparator once daily for 8 weeks.
The study found that 65.3% of patients treated with roflumilast foam achieved a clinically significant reduction in itch at 8 weeks, compared to 30.3% of patients who received the active comparator. For body itch, 63.1% of patients treated with roflumilast achieved a 4-point or greater reduction in Worst Itch-Numeric Rating Scale, compared to 30.1% treated with the active comparator at 8 weeks.
At Week 8, 70.9% of patients treated with roflumilast achieved at least 75% improvement in Psoriasis Scalp Severity Index, and 50.1% achieved at least 75% improvement in Psoriasis Area and Severity Index. A greater improvement in itch was also observed within 24 hours in patients who received roflumilast compared to the active comparator.
Additionally, roflumilast foam was seen to be well tolerated, with a low and similar incidence of adverse events across both study cohorts. The most frequent adverse events in the roflumilast group included headache, diarrhea, and nausea.
“These data demonstrate that investigational Zoryve foam rapidly relieved psoriasis symptoms, including the most troublesome symptom of itch,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis Biotherapeutics, who developed roflumilast foam, said in a release.2 “As an effective, safe, and well-tolerated once-daily treatment, Zoryve foam 0.3%, if approved, will offer those living with psoriasis a potential new treatment option for use anywhere on the body with no limitations on duration of use.”
READ MORE: Dermatology Resource Center
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