Roflumilast Foam .3% Demonstrates Significant, Rapid Improvement in Scalp, Body Psoriasis

Melinda Gooderham, MD

Credit: SKiN Centre for Dermatology

Patients with scalp and body psoriasis receiving once-daily, nonsteroidal roflumilast foam .3% showed significant improvement in symptoms, as early as 2 weeks, according to research presented at the 2023 Fall Clinical Dermatology Conference.¹ Additionally, improvements in pruritus were observed at 24 hours following the initial dose.

“Foam formulations are able to be applied through the hair more easily to reach lesions on the skin of the scalp and other hair-bearing areas,” wrote lead investigator Melinda Gooderham, MD, medical director at the SKiN Centre for Dermatology and the Principal Investigator for the SKiN Research Centre in Peterborough, Ontario, and colleagues.

The US Food and Drug Administration (FDA)-approved roflumilast cream, a selective nonsteroidal, phowsphodiesterase-4 (PDE4) inhibitor, is used to treat plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. This foam version of the high-water content formulation of roflumilast cream .3% and stands out from other topical foams as it does not contain skin-irritating fragrances, propylene glycol, or ethanol. The treatment works by decreasing the conversion of cyclic adenosine monophosphate (cAMP) and decreasing the expression of pro-inflammatory cytokines.

The parallel-group, double-blind, vehicle-controlled, multicenter phase 3 ARRECTOR trial enrolled patients aged ≥12 years with scalp and body plaque psoriasis. Patients were required to have at least a moderate psoriasis severity on the scalp, as assessed using the scalp-specific Investigator’s Global Assessment scale (S-IGA), and mild severity for the body, as determined using the body-specific IGA scale (B-IGA), a Psoriasis Scalp Severity Index (PSSI) score of ≥6, Psoriasis Area and Severity Index (PASI) score of ≥2, and ≥10% of scalp involvement. Patients were randomized 2:1 to receive either roflumilast foam .3% one daily (n = 281) or the vehicle foam once daily (n = 153).

The primary endpoints were S-IGA and B-IGA success at week 8, as well as safety and tolerability. For both endpoints, success was defined as clear or almost clear with a ≥2-grate improvement from baseline. Secondary endpoints included S-IGA score of 0, PASI 75, PSSI, and the Psoriasis Symptom Diary.

Baseline characteristics and demographics were comparable among patients in both treatment arms. Most (90%) patients in the roflumilast foam cohort completed the trial.

Patients treated with roflumilast foam reported greater efficacy when compared with the vehicle treatment in multiple endpoints. At week 2, 30.4% of patients in the roflumilast group achieved S-IGA success compared with only 11.7% of those in the vehicle cohort. This percentage continued to increase through the study period, with 66.4% of those in the foam cohort achieving pre-defined success compared with 27.8% in the vehicle group at week 8. Additionally, 40.0% of those obtained an S-IGA of clear at the 8-week mark, compared with 9.1% in those receiving the vehicle.

These improvements were similar in body psoriasis symptoms, as 45.5% treated with roflumilast obtained the B-IGA success criteria, compared with 20.1% in the vehicle cohort. A larger proportion of patients in the roflumilast group reported a B-IGA of clear (27.8% vs 11.0%, respectively). Continuing with this pattern, a significantly larger proportion of patients achieved PASI 75 and PSSI 75 (70.9% and 50.1%, respectively) when compared with the vehicle (31.3% and 16.8%, respectively). Regarding improvement in scalp and body pruritus, more than twice as many patients in the roflumilast group achieved pre-defined Worst Itch Numeric Rating Scale (WI-NRS) success (63.1% vs 30.1%, respectively).

Low rates of adverse events and treatment-related discontinuation (1.8%, n = 5) were observed among subjects and local tolerability was favorable. The most common reasons for discontinuation included lack of efficacy (n = 3) and being lost to follow-up (n = 11).

References

1. ^{Gooderham M, Bagel J, DuBois J, Kircik L, et al. Efficacy and Safety of Roflumilast Foam 0.3% in Patients with Scalp and Body Psoriasis in the Phase 3 ARRECTOR Trial. Presented at: Fall Clinical Dermatology 2023 Conference. Las Vegas, NV. October 19 – 22, 2023.}