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Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial - 10/02/24

Doi : 10.1016/j.jaad.2023.10.020 
Joseph F. Merola, MD, MMSc a, , Lawrence Charles Parish, MD, MD (Hon) b, Lyn Guenther, MD c, Charles Lynde, MD d, e, Jean-Philippe Lacour, MD f, Petra Staubach, MD g, Sue Cheng, MD, PhD h, Maria Paris, MD i, Hernan Picard, MD, PhD h, Cynthia Deignan, PhD j, Shauna Jardon, PharmD j, Mindy Chen, MS h, Kim A. Papp, MD, PhD k, l
a Division of Rheumatology, Department of Dermatology and Department of Medicine and Associate Program Director, Combined Medicine-Dermatology Residency Program, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 
b President, Paddington Testing Company, Inc, Philadelphia, Pennsylvania 
c Guenther Research Inc, London, Ontario, Canada 
d Chief Medical Director, Lynde Institute for Dermatology, Markham, Ontario, Canada 
e Probity Medical Research, Markham, Ontario, Canada 
f Department of Dermatology, CHU de Nice - Hôpital l'Archet, Nice, France 
g Department of Dermatology, University Medical Center, Mainz, Germany 
h Global Development, Amgen Inc, Thousand Oaks, California 
i Global Patient Safety, Amgen Inc, Thousand Oaks, California 
j Medical Affairs, Amgen Inc, Thousand Oaks, California 
k Alliance Clinical Trials and Probity Medical Research, Waterloo, Ontario, Canada 
l Division of Dermatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada 

Correspondence to: Joseph F. Merola, MD, MMSc, Associate Professor, Harvard Medical School, Vice Chair of Clinical Trials and Innovation, Dermatology, Director, Center for Skin and Related Musculoskeletal Diseases (SARM), Director, Clinical Unit for Research Innovation and Trials (CUReIT), Department of Dermatology and Department of Medicine, Division of Rheumatology and Associate Program Director, Combined Medicine-Dermatology Residency Program, Brigham and Women's Hospital, 41 Ave Louis Pasteur, 319, Boston, MA 02115.Department of Dermatology and Department of MedicineDivision of Rheumatology and Associate Program DirectorCombined Medicine-Dermatology Residency ProgramBrigham and Women's Hospital41 Ave Louis Pasteur319BostonMA02115

Abstract

Background

Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment.

Objective

To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis.

Methods

DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented.

Results

Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis.

Limitations

Lack of active-comparator.

Conclusions

Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.

Le texte complet de cet article est disponible en PDF.

Key words : apremilast, efficacy, genital psoriasis, moderate to severe, safety, systemic

Abbreviations used : AE, BSA, CI, DLQI, DLQI-Q9, G-PsO, GPI-NRS, GPSS, IL, LS, PGA, QoL, sPGA, sPGA-G, TEAE


Plan


 Funding source: This study was sponsored by Amgen Inc.
 Prior presentation: A poster with results from the DISCREET study was presented at the AAD 2023 Annual Meeting (March 17-21, 2023), New Orleans, LA.
 IRB approval status: Institutional review board/ethics committee approval was obtained prior to study onset.
 Data sharing: Qualified researchers may request data from Amgen clinical studies. Complete details are available at datasharing.


© 2023  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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