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 Stein Gold, Henry Ford Health System, West Bloomfield, Michigan. Electronic address: LSTEIN1@hfhs.org.
Kim Papp, Probity Medical Research, Inc., Waterloo, Ontario, Canada; K Papp Clinical Research, Waterloo, Ontario, Canada.
David Pariser, Eastern Virginia Medical School and Virginia Clinical Research, Inc., Norfolk, Virginia.
Lawrence Green, Department of Dermatology, George Washington University School of Medicine, Washington, DC.
Neal Bhatia, Therapeutics Clinical Research, San Diego, California.
Howard Sofen, UCLA School of Medicine, Los Angeles, California; Dermatology Research Associates, Los Angeles, California.
Lorne Albrecht, Probity Medical Research, Inc., Waterloo, Ontario, Canada; Enverus Medical, Surrey, British Columbia, Canada; University of British Columbia, Vancouver, British Columbia, Canada.
Melinda Gooderham, Probity Medical Research, Inc., Waterloo, Ontario, Canada; SKiN Centre for Dermatology, Peterborough, Ontario, Canada; Queen's University, Kingston, Ontario, Canada.
Mindy Chen, Amgen Inc, Thousand Oaks, California.
Maria Paris, Amgen Inc, Thousand Oaks, California.
Yao Wang, Amgen Inc, Thousand Oaks, California.
Kristina Callis Duffin, University of Utah, Salt Lake City, Utah.

Document Type

Journal Article

Publication Date

1-1-2022

Journal

Journal of the American Academy of Dermatology

Volume

86

Issue

1

DOI

10.1016/j.jaad.2021.07.040

Keywords

apremilast; clinical trial; mild-to-moderate psoriasis; pruritus; quality-of-life; scalp

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.

APA Citation

Stein Gold, Linda; Papp, Kim; Pariser, David; Green, Lawrence; Bhatia, Neal; Sofen, Howard; Albrecht, Lorne; Gooderham, Melinda; Chen, Mindy; Paris, Maria; Wang, Yao; and Callis Duffin, Kristina, "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" (2022). GW Authored Works. Paper 457.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/457

Department

Dermatology