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

Abby S. Van Voorhees, Linda Stein Gold, Mark Lebwohl, Bruce Strober, Charles Lynde, Stephen Tyring, Ashley Cauthen, Howard Sofen, Zuoshun Zhang, Maria Paris, Yao Wang

Research output: Contribution to journalArticlepeer-review

37 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)96-103
Number of pages8
JournalJournal of the American Academy of Dermatology
Volume83
Issue number1
DOIs
StatePublished - Jul 2020

Keywords

  • apremilast
  • itching
  • pruritus
  • psoriasis
  • quality of life
  • scalp

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