Once-daily roflumilast foam may bring relief in psoriasis

Treatment with once-daily roflumilast foam appears to improve the signs and symptoms of psoriasis of the scalp and body, with low rates of adverse events (AEs), according to the results of the phase III ARRECTOR trial.

After 8 weeks of treatment, Investigator Global Assessment (IGA) success, defined as complete or near complete skin clearance plus a ≥2-grade improvement, occurred in significantly more patients on roflumilast foam vs vehicle. Specifically, 66.4 percent vs 27.8 percent of patients achieved IGA success for the scalp (p<0.001), and 45.5 percent vs 20.1 percent achieved IGA success for the body (p<0.001). [JAMA Dermatol 2025;161:698-706]

Notably, treatment success with roflumilast appeared early in the treatment course. Compared with vehicle-treated patients, those who received the foam were more likely to achieve IGA success for the scalp at weeks 2 (30.4 percent vs 11.7 percent; p<0.001) and 4 (53.8 percent vs 19.5 percent; p<0.001). The same was true for IGA success for the body at week 4 (32.8 percent vs 12.1 percent; p<0.001).

Itchiness muted

“Most patients with psoriasis report substantial itch, with itch of the scalp being a predominant and bothersome site,” the investigators said. [J Eur Acad Dermatol Venereol 2019;33:1465-1476]

In the study, roflumilast foam was associated with a greater likelihood of achieving success on the Scalp Itch−Numeric Rating Scale (SI-NRS) and the Worst Itch−NRS (WI-NRS), defined as a ≥4-point improvement in patients with baseline scores of ≥4, compared with vehicle. Improvements in itch were observed as early as 24 hours after initiation and throughout the 8 weeks of treatment, they added.

The proportion of patients in the roflumilast foam and vehicle arms with SI-NRS success was 25.2 percent vs 8.0 percent at week 2 (p<0.001), 46.2 percent vs 16.8 percent at week 4 (p<0.001), and 65.3 percent vs 30.3 percent at week 8 (p<0.001). The corresponding proportion of patients with WI-NRS success was 23.3 percent vs 10.9 percent at week 2, 46.5 percent vs 18.1 percent at week 4, and 63.1 percent vs 30.1 percent at week 8 (p<0.001 for all).

This finding holds important implications, given that “patients with plaque psoriasis who report persistent itch have significant increases in overall work impairment and reduced quality of life. In addition, patients with plaque psoriasis and moderate to severe itch report significantly more sleep disturbance than those with mild itch,” the investigators pointed out. [Br J Dermatol 2018;179:173-181]

“[Furthermore], early improvement in patient-reported outcomes is advantageous because patient satisfaction with therapy can enhance adherence to treatment, particularly when the areas affected by psoriasis are difficult to treat,” they added. [Psoriasis (Auckl) 2016;6:33-40; Expert Opin Pharmacother 2018;19:561-575; J Eur Acad Dermatol Venereol 2017;31:1876-1883]

Well tolerated

As for safety, roflumilast foam was well tolerated, according to the investigators.

Treatment-emergent AEs occurred in 26.7 percent of patients in the roflumilast arm and in 16.6 percent of those in the vehicle arm, with most being mild to moderate in intensity. Treatment-related AEs were documented in 5.7 percent and 2.0 percent in the respective treatment arms.

The incidence of treatment-emergent serious AEs was low and similar between the roflumilast foam and vehicle arms (0.7 percent for both), as was that of AEs leading to discontinuation of the trial (1.8 percent and 1.3 percent, respectively).

“Roflumilast foam and vehicle had similar investigator- and patient-rated local tolerability assessments,” the investigators noted.

Easier application

Roflumilast foam 0.3% was adapted from the high-water content formulation (approximately 48 percent water) of roflumilast cream 0.3% and includes addition of a propellant. What sets apart this foam formulation from other topical foam formulations are the distinct excipients that maintain the skin barrier, the investigators explained.

“Foam formulations are intended to make application to the scalp and other hair-bearing areas easier. In addition, using a single topical product suitable for both hair-bearing and nonhair-bearing regions is more convenient than using separate products for different body parts,” they said. “The investigator- and patient-reported outcomes suggest that the foam formulation should help improve patient satisfaction, adherence to therapy, and quality of life.”

ARRECTOR population

The trial included 432 patients (mean age 47.3 years, 56.3 percent female) aged 12 years and older with plaque psoriasis affecting up to 25 percent of the scalp and body, at least 10 percent of the scalp, and up to 20 percent of nonscalp areas.

The patients were randomly assigned to receive treatment with roflumilast foam (n=281) or vehicle (n=151), which was identical to the foam but without the active ingredient. Treatment was applied to all affected body areas, including the face, scalp, palms, soles, genitals, and intertriginous regions, for 8 weeks. Baseline patient characteristics were generally similar between the two treatment arms.