Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Jan;86(1):77-85.
doi: 10.1016/j.jaad.2021.07.040. Epub 2021 Jul 31.

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

Linda Stein Gold  1 , Kim Papp  2 , David Pariser  3 , Lawrence Green  4 , Neal Bhatia  5 , Howard Sofen  6 , Lorne Albrecht  7 , Melinda Gooderham  8 , Mindy Chen  9 , Maria Paris  9 , Yao Wang  9 , Kristina Callis Duffin  10
Affiliations
Clinical Trial

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

Linda Stein Gold et al. J Am Acad Dermatol. 2022 Jan.

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.

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

PubMed Disclaimer

Conflict of interest statement

Conflicts of interest Dr Gold received honoraria, grants, and/or research funding as a speaker, investigator, and/or advisory board member for AbbVie, Amgen Inc, Arcutis, Celgene Corporation, Dermira, Dermavant, Eli Lilly, Galderma, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Valeant. Dr Papp was a steering committee member for PSLOAR and PURE and received honoraria, grants, and/or research funding as a speaker, investigator, advisory board member, data safety monitoring board member, and/or consultant for AbbVie, Actelion, Amgen Inc, Astellas Pharma US, Boehringer Ingelheim, Bausch Health, Celgene Corporation, Dermira, Dow Pharmaceuticals, Eli Lilly, Frontier, Galderma, Janssen, Kyowa Hakko Kirin Pharma, LEO Pharma, MedImmune, Merck & Co, Inc, Novartis, Pfizer, Regeneron, Roche Laboratories, Sanofi Genzyme, Takeda Pharmaceuticals, UCB, and Valeant. Dr Pariser received honoraria or was an investigator, advisory board member, or data monitoring board member for Amgen Inc, AO Biome, Asana, Brickel Biotech, Celgene Corporation, Dermavant, Dermira, Eli Lilly, Menlo Therapeutics, Merck, Novartis, Ortho, Regeneron, Atacama, Biofrontera, Bristol Myers Squibb, LEO Pharma, Pfizer, Sanofi, and Valeant. Dr Green was an investigator, speaker, and/or consultant for AbbVie, Amgen Inc, Arcutis, Dermavant, MC2, Novartis, Lilly, OrthoDerm, SunPharma, and UCB. Dr Bhatia was an advisor, consultant, investigator, and/or speaker for AbbVie, Actavis, Allergan, Amgen Inc, Aqua, Bayer, Biofrontera, BiopharmX, Castle, Cipher, Dermira, Encore, Exeltis, Ferndale, Foamix, Galderma, Intraderm, ISDIN, LaRoche-Posay, LEO Pharma, Novan, Novartis, PharmaDerm, Pfizer, Promius, Regeneron, Sanofi, Sun Pharma, and Valeant. Dr Sofen received honoraria, grants, and/or research funding as an investigator and/or advisory board member for AbbVie, Amgen Inc, Celgene Corporation, Dermira, Dermavant, Eli Lilly, Galderma, LEO Pharma, Novartis, Pfizer, and UCB. Dr Albrecht received honoraria, grants, and/or research funding as a speaker, investigator, advisory board member, and/or consultant for AbbVie, Amgen Inc, Arcutis, Boehringer Ingelheim, Bausch Health/Valeant, Celgene Corporation, Dermira, Dermavant, Eli Lilly, Galderma, Janssen, LEO Pharma, MedImmune, Merck & Co, Novartis, Pfizer, Regeneron, Roche Laboratories, Sanofi Genzyme, and UCB. Dr Gooderham received honoraria, grants, and/or research funding as a speaker, investigator, advisory board member, data safety monitoring board member, and/or consultant for AbbVie, Amgen Inc, Akros, Arcutis, Bausch/Valeant, Boehringer Ingelheim, Celgene Corporation, Dermira, Dermavant, Eli Lilly, Galderma, Janssen, Kyowa Hakko Kirin Pharma, LEO Pharma, MedImmune, Merck & Co, Novartis, Pfizer, Regeneron, Roche Laboratories, Sanofi Genzyme, Takeda Pharmaceuticals USA Inc, and UCB. Author Chen and Dr Paris are employees of Amgen Inc. Dr Wang was employed by Amgen Inc at time of the study. Dr Callis Duffin received honoraria, grants, and/or research funding as an investigator, advisory board member, consultant, and/or non-promotional speaker for AbbVie, Amgen Inc, Boehringer Ingelheim, Celgene Corporation, Eli Lilly, Janssen, Novartis, Pfizer, Regeneron, and UCB.

Publication types

Associated data