More than 65% of patients using once-daily roflumilast foam, 0.3%, achieved significant scalp itch relief within 8 weeks—some as early as 24 hours after the first application, according to a recent study.

"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," noted Melinda J. Gooderham, MD, and colleagues. Their phase 3 randomized clinical trial assessed the safety and efficacy of once-daily roflumilast foam, 0.3%, for the treatment of psoriasis involving the scalp and body.

The ARRECTOR trial enrolled 432 adolescents and adults aged 12 years and older with plaque psoriasis affecting up to 25% of the body surface area, at least 10% of the scalp, a Scalp Investigator Global Assessment (S-IGA) score of at least 3, and a Body-IGA (B-IGA) score of at least 2. Participants were randomized in a 2:1 ratio to receive roflumilast foam or vehicle once daily for 8 weeks.

The co-primary endpoints were the proportions of patients achieving S-IGA and B-IGA success, defined as a score of clear (0) or almost clear (1) with a minimum two-grade improvement from baseline, noted Dr. Gooderham, of Queen's University in Ontario, and colleagues

At week 8, 66.4% of patients in the roflumilast group achieved S-IGA success, compared with 27.8% in the vehicle group. B-IGA success was achieved in 45.5% of patients treated with roflumilast, compared with 20.1% in the vehicle group. Additionally, 40% of roflumilast-treated patients achieved a clear S-IGA score, and 27.8% achieved a clear B-IGA score.

Pruritus outcomes also favored roflumilast. Scalp Itch Numeric Rating Scale success, defined as a 4-point or greater reduction from baseline, was achieved by 65.3% of the roflumilast group versus 30.3% of the vehicle group at week 8. Improvement in scalp itch was observed as early as 24 hours after the first application. Worst Itch-NRS success was reported in 63.1% of the roflumilast group versus 30.1% of the vehicle group by week 8.

Additional outcomes included higher rates of PASI-75 (50.1% vs 16.8%) and PSSI-75 (70.9% vs 31.3%) in the roflumilast group. Treatment-emergent adverse events were reported in 26.7% of roflumilast-treated patients and 16.6% of vehicle-treated patients, with most events being mild or moderate in severity. Discontinuations due to adverse events occurred in 1.8% and 1.3% of patients, respectively.

Full disclosures can be found in the published study.

Source: JAMA Dermatology