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

• Published in: Journal of drugs in dermatology Vol. 15; no. 3; p. 272
• Main Authors: Nguyen, Catherine M, Leon, Argentina, Danesh, Melissa, Beroukhim, Kourosh, Wu, Jashin J, Koo, John
• Format: Journal Article
• Language: English
• Published: United States 01.03.2016
• Subjects: Administration, Oral; Chronic Disease; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Double-Blind Method; Humans; Nail Diseases - drug therapy; Phosphodiesterase 4 Inhibitors - administration & dosage; Phosphodiesterase 4 Inhibitors - adverse effects; Phosphodiesterase 4 Inhibitors - therapeutic use; Psoriasis - drug therapy; Scalp Dermatoses - drug therapy; Severity of Illness Index; Thalidomide - administration & dosage; Thalidomide - adverse effects; Thalidomide - analogs & derivatives; Thalidomide - therapeutic use; Treatment Outcome
• ISSN: 1545-9616

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. We reviewed the results of the phase IIb and phase III clinical trials for apremilast in treating nail and scalp psoriasis. 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. 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.