Improvement of Nail and Scalp Psoriasis Using Apremilast in Patients With Chronic Psoriasis: Phase 2b and 3, 52-Week Randomized, Placebo-Controlled Trial Results

March 2016 | Volume 15 | Issue 3 | Original Article | 272 | Copyright © 2016

Catherine M. Nguyen BS,a Argentina Leon MD,b Melissa Danesh BS,c Kourosh Beroukhim BS,d Jashin J. Wu MD,e and John Koo MDb

aUniversity of California, Irvine School of Medicine, Irvine, CA
bUniversity of California, San Francisco Psoriasis Center, San Francisco, CA
cUniversity of California, San Francisco School of Medicine, San Francisco, CA
dDavid Geffen School of Medicine at UCLA, Los Angeles, CA
eKaiser Permanente Los Angeles Medical Center, Department of Dermatology, Los Angeles, CA

Abstract

INTRODUCTION: A significant portion of patients with psoriasis have scalp and nail involvement. It has been reported that 40% to 45% of patients with psoriasis have nail psoriasis, and up to 80% have scalp involvement. Nail and scalp psoriasis have often been found to be difficult to treat, due to the poor penetration and poor compliance of topical medication. Oral and biologic therapies have shown significant efficacy but often with undesirable side effects. Herein, we analyze the efficacy of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor, in the treatment of nail and scalp psoriasis at 16-, 32-, and 52 weeks.
METHODS: We reviewed the results of the phase IIb and phase III clinical trials for apremilast in treating nail and scalp psoriasis.
RESULTS: In ESTEEM 1, patients on apremilast showed a 22.5%, 43.6%, and 60.2% improvement in NAPSI at weeks 16, 32, and 52. 33.3%, 45.2%, and 63% of patients achieved NAPSI-50, respectively. In ESTEEM 2, patients on apremilast showed a 29%, 60%, and 59.7% improvement in NAPSI at weeks 16, 32, and 52, with 44.6%, 55.4%, and 68.6% of patients achieving NAPSI-50. In PSOR-005 at week 16, patients on a dose of 30 mg twice weekly had a 42.9% improvement in NAPSI with 45.5% reaching NAPSI-50. For scalp psoriasis, 46.5%, 37.4%, and 73% of patients achieved an Sc-PGA of 0 or 1 at weeks 16, 32, and 52 in ESTEEM 1. In ESTEEM 2, 40.9%, 32.4%, and 62.5% of patients achieved an Sc-PGA of 0 or 1 at weeks 16, 32, and 52.
CONCLUSION: With its limited safety profile of only diarrhea and headache and no additional lab requirements, apremilast may be a safer and more convenient alternative for patients with severe nail and scalp psoriasis.

J Drugs Dermatol. 2016;15(3):272-276.

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INTRODUCTION

Psoriasis is a chronic, inflammatory skin condition that affects 3.2% of the US population.1 A significant portion of patients with psoriasis have scalp and nail involvement. It has been reported that 40% to 45% of patients with psoriasis have nail psoriasis, and up to 80% have scalp involvement.2 In patients with psoriatic arthritis, 90% have nail involvement.2 Nail psoriasis often presents with alterations in the nail plate, such as pitting leukonychia, red spots in the lunula, and crumbling. 2 Nail bed involvement may lead to onycholysis, oil-drop patches, splinter hemorrhages, and nail bed hyperkeratosis.2 Scalp psoriasis has a presentation similar to that of general psoriasis, and can range from mild symptoms of slight, fine scaling to severe disease with thick, crusted plaques covering the entire scalp.3

It has been well documented in the literature that psoriasis has a negative effect on the quality of life of its patients in the physical, psychological, and social domains. Patients with nail psoriasis have been shown to have increased psychosocial impairment correlating to symptom severity, and are most affected in the social dimension.4 Similarly, scalp psoriasis has been shown using the Short Form-36 (SF-36) to significantly worsen the quality of life of patients when compared to healthy controls.5 The significant, but often underestimated, impact of both nail and scalp psoriasis on a patient’s quality of life may be due to the unique location and high visibility of the disease.

Because of the high burden that nail and scalp psoriasis pose to its patients, adequately aggressive treatment is often desired. However, nail and scalp psoriasis have often been found to be difficult to treat. Topical treatments are often ineffective due to its “time-consuming” nature and poor compliance of patients.2,3 Systemic therapy is recommended for patients with recalcitrant scalp and nail disease, and for patients who also have skin and joint involvement.6,7

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