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
Van Voorhees AS, Stein Gold L, Lebwohl M, Strober B, Lynde C, Tyring S, Cauthen A, Sofen H, Zhang Z, Paris M, and Wang Y. 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. J Am Acad Dermatol 2020; 83(1):96-103.
Journal of the American Academy of Dermatology
BACKGROUND: Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp.
OBJECTIVE: To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis.
METHODS: This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16.
RESULTS: There were 303 randomized patients (placebo: n = 102; apremilast: n = 201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (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 < .0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%).
LIMITATIONS: Patients with mild disease were not enrolled.
CONCLUSION: Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.