Efficacy and Safety of Apremilast in Patients With Moderate to Severe Plaque Psoriasis of the Scalp: Results of a Phase 3b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study.

Many psoriasis patients are bothered by symptoms in highly visible, pruritic areas, such as the scalp.Evaluate efficacy and safety of apremilast for moderate to severe scalp psoriasis.This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to ≥1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was proportion of patients who achieved Scalp Physician Global Assessment (ScPGA) response, defined as score of 0 (clear) or 1 (almost clear) with ≥2-point reduction, at Week 16. Secondary endpoints included ≥4-point improvement from baseline in Whole Body Itch and Scalp Itch numeric rating scales (NRS) and mean improvement in Dermatology Life Quality Index (DLQI) at Week 16.There were 303 randomized patients (placebo: n=102; apremilast: n=201). With apremilast, significantly more patients achieved ScPGA (43.3% vs. 13.7%), Scalp Itch NRS (47.1% vs. 21.1%), and Whole Body Itch NRS (45.5% vs. 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs. -3.8; all P<0.0001). Common AEs with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%).Patients with mild disease were not enrolled.Apremilast demonstrated efficacy for treatment of moderate to severe scalp psoriasis.