Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial

Authors

Linda F. Stein Gold, Henry Ford HealthFollow
Kim Papp
David Pariser
Lawrence Green
Neal Bhatia
Howard Sofen
Lorne Albrecht
Melinda Gooderham
Mindy Chen
Maria Paris
Yao Wang
Kristina Callis Duffin

Recommended Citation

Stein Gold L, Papp K, Pariser D, Green L, Bhatia N, Sofen H, Albrecht L, Gooderham M, Chen M, Paris M, Wang Y, and Callis Duffin K. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol 2022; 86(1):77-85.

Document Type

Article

Publication Date

1-1-2022

Publication Title

Journal of the American Academy of Dermatology

Abstract

BACKGROUND: Patients with mild-to-moderate psoriasis may have substantial quality-of-life impairment.

OBJECTIVE: To evaluate apremilast 30 mg twice daily for mild-to-moderate psoriasis.

METHODS: Phase 3, double-blind, placebo-controlled study in adults with mild-to-moderate psoriasis inadequately controlled or intolerant to ≥ 1 topical psoriasis therapy (NCT03721172). The primary endpoint was the achievement of static Physician Global Assessment score of 0 (clear) or 1 (almost clear) and ≥ 2-point reduction at week 16.

RESULTS: Five hundred ninety-five patients were randomized (apremilast: 297; placebo: 298). The primary endpoint was met, with a significantly greater static Physician Global Assessment response rate observed at week 16 in the apremilast group compared with the placebo group (21.6% vs 4.1%; P < .0001). All secondary endpoints were met with the achievement of body surface area-75 (33.0% vs 7.4%), body surface area ≤ 3% (61.0% vs 22.9%), ≥ 4-point reduction in Whole Body Itch Numeric Rating Scale (43.2% vs 18.6%), Scalp Physician Global Assessment 0 or 1 and ≥ 2-point reduction (44.0% vs 16.6 %), and changes from baseline in body surface area, Psoriasis Area and Severity Index, and Dermatology Life Quality Index (all P < .0001). The most commonly reported adverse events (≥ 5%) with apremilast were diarrhea, headache, nausea, nasopharyngitis, and upper respiratory tract infection, consistent with prior studies.

LIMITATIONS: The study lacked an active-comparator arm.

CONCLUSION: Apremilast demonstrated efficacy in mild-to-moderate psoriasis and safety consistent with the established safety profile of apremilast.

PubMed ID

34343599

Volume

86

Issue

1

First Page

77

Last Page

85