Roflumilast foam 0.3%, a topical phosphodiesterase-4 inhibitor formulation, shows greater efficacy than vehicle control for the treatment of scalp and body psoriasis, plaque psoriasis, and seborrheic dermatitis, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
In a phase 2b study, treatment with roflumilast foam 0.3% in 200 patients with scalp and body psoriasis was generally well tolerated and associated with a similar overall adverse event (AE) profile as a vehicle foam (n=104) control (2.5% vs 1.9%, respectively).1 A higher percentage of patients in the roflumilast foam group achieved clear/almost clear status and a ≥2-grade reduction from baseline to 8 weeks, as assessed by the static Investigator’s Global Assessment (S-IGA), compared with patients who received vehicle (59.1% vs 11.4%, respectively; P <.0001). In addition, the 8-week body IGA success rate was higher in patients who received roflumilast foam (40.3% vs 6.8%; P <.0001).
Another randomized, phase 2b study found that treatment with roflumilast foam 0.3% was also safe and well tolerated in patients with seborrheic dermatitis.2 More patients in the roflumilast foam group (n=154), compared with those randomly assigned to vehicle (n=72), achieved IGA success by week 8 (P <.0001). A significantly greater percentage of patients in the roflumilast foam group also achieved an erythema score of 0 by week 8 (P =.0013) and scaling score of 0 by week 8 (P =.0006). Approximately 24% and 18.1% of patients in the active treatment and vehicle form groups, respectively, experienced a treatment-related AE.
In another study, the use of roflumilast foam significantly improved measures of chronic plaque psoriasis compared with a once-daily vehicle in patients with steroid-sensitive area involvement (IGA score of clear or almost clear plus 2-grade improvement from baseline to 12 weeks, P <.05).3 The active foam treatment also significantly reduced symptom burden (P <.05) and itch (P <.05) compared with vehicle. And in a longer-term phase 2b trial, treatment with roflumilast foam for 52 weeks was associated with durable efficacy and a safety profile consistent with that reported in previous trials.4
A post-hoc analysis of a phase 2b study presented at AAD VMX also shows that the use of a new, modified disease measure may be helpful for assessing disease severity in patients treated with roflumilast cream.5 Researchers found that the Psoriasis Area and Severity Index (PASI) HD was more precise compared with gold-standard PASI for scoring disease severity in areas of the body with less than 10% disease involvement in patients with mild to moderate plaque psoriasis treated with roflumilast cream for 8 weeks. In this analysis, the median 8-week score was lower and standard deviation was higher for PASI-HD vs PASI across erythema, induration, and desquamation PASI domains.
Disclosure: This clinical trial was supported by Arcutis Biotherapeutics. Please see the original reference for a full list of authors’ disclosures.
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1. Kircik LH, Moore A, Bhatia N, et al. Once-daily roflumilast foam 0.3% for scalp and body psoriasis: A randomized, double-blind, vehicle-controlled phase 2b study. Presented at: AAD VMX 2021; April 23-25, 2021.
2. Zirwas M, Draelos ZD, DuBois J, et al. Efficacy and safety of roflumilast foam 0.3% in patients with seborrheic dermatitis in a randomized, double-blind, vehicle-controlled phase 2 study.
3. Draelos ZD, Lebwohl MG, Lynde CW, et al. Roflumilast cream significantly improves chronic plaque psoriasis in patients with steroid-sensitive area involvement.
4. Gold LS, Gooderham MJ, Papp KA, et al. Long-term safety and efficacy of roflumilast cream 0.3% in adult patients with chronic plaque psoriasis: Results from a 52-week, phase 2b open-label study.
5. Papp KA, Lebwohl M, Kircik L, et al. The PASI-HD improved precision in measuring disease severity in subjects with mild-to-moderate plaque psoriasis treated with roflumilast cream, a phosphodiesterase-4 inhibitor.