Findings from an extension study of the phase 3 STYLE trial suggest apremilast may be an effective therapy for scalp psoriasis, including for patients with scalp psoriasis that is poorly controlled by other treatments. Findings from the study were published online in the British Journal of Dermatology.
In the extension phase of the STYLE study, 76 patients with moderate to severe plaque psoriasis of the scalp who initially received placebo during the 16-week study period were switched to twice-daily 30 mg apremilast (placebo/apremilast). A total of 140 patients initially randomly assigned to apremilast (apremilast/apremilast) continued on the therapy during the extension study. Treatment lasted from 16 weeks through 32 weeks in the extension phase.
The study’s primary endpoint was achievement of the Scalp Physician’s Global Assessment (ScPGA) response score of 0 (clear) or 1 (almost clear) with a 2-point or greater reduction from baseline. A significantly greater percentage of patients in the apremilast group achieved the ScPGA response by 16 weeks (43.3% vs 13.7%; P <.0001).
Patients initially assigned to apremilast sustained their ScPGA response (45.5%) by 32 weeks, and more patients initially assigned to placebo and switched to apremilast in the extension phase experienced the ScPGA response (63.1%) at follow up.
Approximately 49.3% in the apremilast/apremilast group and 49.3% of patients in the placebo/apremilast group achieved Scalp Itch numeric rating scale (NRS) response at 32 weeks. In addition, 45.7% and 59.7% of patients, respectively, achieved the Whole Body Itch NRS response at the 32-week follow up. The mean improvement in the Dermatology Life Quality Index (DLQI) total score was -6.8 in the apremilast/apremilast arm and -8.0 in the placebo/apremilast group by 32 weeks.
The majority of adverse events (AEs) experienced by patients while on apremilast were mild or moderate and considered consistent with the therapy’s known safety profile. The most common AEs that occurred during the apremilast-exposure period included diarrhea (26.8%), nausea (19.4%), headache (9.9%), and vomiting (5.3%).
A primary limitation of this extension study was the inclusion of only a small number of participants.
The STYLE phase 3 supports apremilast, the investigators concluded, as an effective treatment for scalp psoriasis in different patients, including “those with scalp psoriasis inadequately controlled by other therapies.”
Disclosure: This clinical trial was supported by Amgen. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Van Voorhees AS, Stein Gold L, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results up to 32 weeks from a randomised, phase 3 study. Br J Dermatol. Published online March 24, 2021. doi:10.1111/bjd.20083