Nguyen Catherine M, Leon Argentina, Danesh Melissa, Beroukhim Kourosh, Wu Jashin J, Koo John
J Drugs Dermatol. 2016 Mar;15(3):272-6.
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.
引言：很大一部分银屑病患者有头皮和指甲受累情况。据报道，40%至45%的银屑病患者有指甲银屑病，高达80%有头皮受累。由于局部用药的渗透性差和依从性差，指甲和头皮银屑病常常难以治疗。口服和生物疗法已显示出显著疗效，但往往伴有不良副作用。在此，我们分析了口服磷酸二酯酶-4（PDE-4）抑制剂阿普斯特在治疗指甲和头皮银屑病16周、32周和52周时的疗效。 方法：我们回顾了阿普斯特治疗指甲和头皮银屑病的IIb期和III期临床试验结果。 结果：在ESTEEM 1试验中，服用阿普斯特的患者在第16周、32周和52周时指甲银屑病严重程度指数（NAPSI）改善率分别为22.5%、43.6%和60.2%。分别有33.3%、45.2%和63%的患者达到NAPSI改善50%。在ESTEEM 2试验中，服用阿普斯特的患者在第16周、32周和52周时NAPSI改善率分别为29%、60%和59.7%，分别有44.6%、55.4%和68.6%的患者达到NAPSI改善50%。在第16周的PSOR-005试验中，每周两次服用30毫克剂量的患者NAPSI改善率为42.9%，45.5%的患者达到NAPSI改善50%。对于头皮银屑病，在ESTEEM 1试验中，第16周、32周和52周时分别有46.5%、37.4%和73%的患者头皮医师全面评估（Sc-PGA）达到0或1。在ESTEEM 2试验中，第16周、32周和52周时分别有40.9%、32.4%和62.5%的患者Sc-PGA达到0或1。 结论：阿普斯特安全性有限，仅出现腹泻和头痛，且无需额外的实验室检查，对于重度指甲和头皮银屑病患者可能是一种更安全、更方便的选择。
J Eur Acad Dermatol Venereol. 2015-2-18
Curr Allergy Asthma Rep. 2018-8-31
J Clin Aesthet Dermatol. 2016-9
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