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Roflumilast Foam 0.3% Update: Pivotal Phase 3 Trial Outcomes Published in JAMA Dermatology, Arcutis Announces
Publication of the phase 3 ARRECTOR trial findings precede an anticipated PDUFA date of May 22, 2025, for the investigational foam, now under FDA review.
Findings from the pivotal phase 3 ARRECTOR trial of roflumilast foam 0.3% for treatment of psoriasis affecting the scalp and body were published in the journal JAMA Dermatology,1 according to a May 7 announcement from Arcutis. The company has submitted a supplemental New Drug Application (sNDA) for investigational treatment to the US FDA that is under review, with a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2025.2
Courtesy of the International Psoriasis Council
The ARRECTOR trial evaluated roflumilast foam 0.3% in 432 adults and adolescents 12 years and older with plaque psoriasis across 49 sites in the United States and Canada. Researchers found that 66.4% of participants treated with roflumilast foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at week 8 compared to 27.8% for vehicle (P <.001). The study also showed 45.5% of those treated with roflumilast foam achieved Body-Investigator Global Assessment (B-IGA) Success at Week 8 compared to 20.1% for vehicle (P <.001).1
The clinical need for the next generation topical phosphodiesterase-4 (PDE4) inhibitor is significant, Arcutis stated in the announcement, citing an estimate that nearly half of the 9 million Americans with plaque psoriasis experience scalp involvement.1
"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," ARRECTOR lead author Melinda Gooderham, MD, MSc, dermatologist and medical director at the SKIN Centre for Dermatology in Ontario, Canada, said in a statement.2 Gooderham, who is also principal investigator at the SKIN Research Centre, added, "These compelling results demonstrate that [roflumilast] 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."2
Roflumilast foam treats both hair-bearing and non-hair-bearing skin, a benefit Gooderham said could help patients adhere to their treatment.
ARRECTOR researchers reported that roflumilast foam rapidly improved itch symptoms, with 65.3% of treated individuals achieving a clinically significant reduction in scalp itch compared to 30.3% with vehicle at week 8 (P <.001). Notably, researchers observed improvement in itch within 24 hours of the first application (P =.0164). They reported similar improvements in body itch, with 63.1% of those treated with roflumilast foam 0.3% achieving a 4-point or greater reduction in Worst Itch-Numeric Rating Scale compared to 30.1% with vehicle (P <.001).1
Additional efficacy measures showed that 70.9% of study participants treated with roflumilast foam vs 31.3% with vehicle achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) at week 8 (P<.001). Similarly, 50.1% of people treated with roflumilast foam 0.3% achieved at least 75% improvement in Psoriasis Area and Severity Index (PASI-75) compared to 16.8% with vehicle (P<.001).1
Safety outcomes were similar to those reported in previous trials of roflumilast cream 0.3% in individuals with psoriasis. The majority of treatment-emergent adverse events (TEAEs) were mild or moderate in both treatment and vehicle groups (96.0% and 92.0%, respectively). Just 5.7% and 2.0% of the of TEAEs were considered related to study treatment, respectively, according to Arcutis. Discontinuations of the study due to TEAEs similar between the roflumilast (n=5 [1.8%]) and vehicle (n=2 [1.3%]) groups and were described as “limited.”1
"As an effective, safe, and well-tolerated once-daily treatment, [roflumilast] 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. Having a single agent that effectively treats psoriasis on both the scalp and body, with a safe and tolerable profile, is an important therapeutic benefit for both clinicians and the people they treat," Patrick Burnett, MD, PhD, chief medical officer at Arcutis said in the statement.2
The foam formulation of the PDE4 inhibitor is already FDA-approved for seborrheic dermatitis in patients 9 years and older; roflumilast cream formulations are approved for plaque psoriasis (0.3%) and atopic dermatitis (0.15%) in patients 6 years and older.2
