New Insights into Roflumilast Foam 0.3% for Scalp and Body Psoriasis: ARRECTOR Trial Patient Reported Outcomes

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A poster¹ presented at the 2024 Elevate-Derm West Conference highlighted data from the phase 3 ARRECTOR trial,² providing insights on the effectiveness and tolerability of roflumilast (Zoryve; Arcutis) foam 0.3% in patients with moderate to severe scalp and body psoriasis. The data involved patient reported outcomes, including itch and pain measures.

Roflumilast, a selective phosphodiesterase-4 inhibitor, has shown promise in addressing inflammation and other psoriasis symptoms without the adverse effects often associated with corticosteroids, according to poster authors Gooderham et al. ARRECTOR, or A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis, was conducted to further understand the safety and efficacy of this nonsteroidal option in a controlled clinical setting.

The trial was a double-blind, randomized, placebo-controlled study conducted over 8 weeks. A total of 453 adult patients with moderate to severe plaque psoriasis, including scalp involvement, participated in the study. Patients were randomly assigned to receive either roflumilast foam 0.3% or a vehicle foam in a 2:1 ratio.

Key inclusion criteria included a Scalp Investigator's Global Assessment (S-IGA) score of 3 or 4 (indicating moderate or severe psoriasis), a Psoriasis Area and Severity Index score less than 5, and an affected Body Surface Area ranging from 2% to 20%.

The study’s primary endpoint was the proportion of patients achieving a clear or almost clear status (S-IGA score of 0 or 1) by week 8. Secondary endpoints included improvements in pruritus, overall symptom severity, quality of life as measured by the Dermatology Life Quality Index (DLQI), and patient-reported outcomes.

As a result of the study, roflumilast demonstrated significant improvements in psoriasis severity and symptom management with roflumilast foam 0.3%, particularly in the scalp and body regions. A significantly higher percentage of patients treated with roflumilast achieved success in both scalp and body IGA scores (clear or almost clear) by week 8 compared to those receiving the vehicle.

At week 8, 65.1% of patients in the roflumilast treatment group achieved a score of 0 (clear) or 1 (almost clear) for scalp involvement, compared to only 31.3% in the vehicle group. This difference was statistically significant.

For body involvement, 49.8% of patients in the roflumilast group achieved a Body Investigator's Global Assessment, or B-IGA, score of clear or almost clear, versus 21.1% in the vehicle group, with a similar statistically significant difference.

Additionally, patients in the roflumilast group reported significant quality of life improvements, as shown by reductions in DLQI scores. Symptom improvement was also notable, particularly for scalp symptoms such as itch, redness, and scaliness.

The reduction in scaliness was -12.18 for roflumilast versus -7.36 for the vehicle; redness reduction was -11.96 for roflumilast versus -6.49 for the vehicle; and itch reduction was -12.36 for roflumilast versus -7.58 for the vehicle. Additionally, 70.3% of patients in the roflumilast group achieved a 75% improvement in Psoriasis Area and Severity Index, compared to 32.5% in the vehicle group, a difference that was also statistically significant.

In terms of safety, 26.3% of patients in the roflumilast group experienced treatment-emergent adverse events, compared to 20.2% in the vehicle group. Both groups reported low rates of serious adverse events, with 0.7% of patients in the roflumilast group and 0.8% in the vehicle group experiencing serious events. The most common adverse events were application site reactions, diarrhea, and nausea, though application site reactions were infrequent, suggesting good local tolerability.

Patient-rated local tolerability assessments at baseline, week 2, and week 8 indicated low levels of irritation and discomfort, with average scores remaining below 0.5 across all assessments.

“In patients with scalp and body psoriasis, treatment with once-daily roflumilast foam 0.3% demonstrated greater improvement compared with vehicle across multiple patient-reported efficacy endpoints,” wrote Gooderham et al.

References

1. Gooderham M, Bagel J, Forman S, et al. Patient-reported outcomes with roflumilast foam 0.3% in patients with scalp and body psoriasis in the phase 3 ARRECTOR trial. Poster presented at: Elevate-Derm West Conference; November 7-10, 2024; Scottsdale, Arizona.
2. Gooderham M, Bagel J, Kircik SB, et al. Patient-reported outcomes with roflumilast foam 0.3% in patients with scalp and body psoriasis in the phase 3 ARRECTOR trial. J Amer Acad Dermatol. Accessed November 7, 2024. https://www.jaad.org/article/S0190-9622(24)02140-6/fulltext

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