阿普司特在中度斑块状银屑病初治患者中的疗效和安全性：UNVEIL研究的52周结果
Efficacy and Safety of Apremilast in Systemic- and Biologic-Naive Patients With Moderate Plaque Psoriasis: 52-Week Results of UNVEIL.
作者信息
Stein Gold Linda, Bagel Jerry, Lebwohl Mark, Jackson J Mark, Chen Rongdean, Goncalves Joana, Levi Eugenia, Duffin Kristina Callis
出版信息
J Drugs Dermatol. 2018 Feb 1;17(2):221-228.
BACKGROUND: Many patients with moderate plaque psoriasis are undertreated despite broadening treatment options. In the phase IV UNVEIL study, oral apremilast demonstrated efficacy and safety in systemic-naive patients with chronic moderate plaque psoriasis with lower psoriasis-involved body surface area (BSA; 5%-10%) during the 16-week, double-blind, placebo-controlled phase. We describe efficacy and safety of apremilast in this population through week 52 in UNVEIL.
METHODS: Patients with moderate plaque psoriasis (BSA 5%-10%; static Physician's Global Assessment [sPGA] score of 3 [moderate]) and naive to systemic therapies for psoriasis were randomized (2:1) to receive apremilast 30 mg twice daily or placebo for 16 weeks. At week 16, patients continued on apremilast (apremilast/apremilast) or were switched from placebo to apremilast (placebo/apremilast) through week 52 (open-label apremilast treatment phase). Efficacy assessments included the product of sPGA and BSA (PGAxBSA) (mean percentage change from baseline; ≥75% reduction from baseline [PGAxBSA-75]), sPGA response (achievement of score of 0 [clear] or 1 [almost clear]), and the Dermatology Life Quality Index (DLQI; mean change from baseline).
RESULTS: A total of 136 patients completed the 52-week analysis period (placebo/apremilast, n=50/64; apremilast/apremilast, n=86/121). At week 52, improvements in all efficacy end points observed at week 16 were maintained in the apremilast/apremilast group (mean percentage change from baseline in PGAxBSA: -55.5%; PGAxBSA-75: 42.1%; sPGA response: 33.1%; mean change from baseline in DLQI score: -4.4); similar improvements emerged in the placebo/apremilast group after switching to apremilast. The most common adverse events (≥5% of patients) through week 52 were diarrhea (28.0%), nausea (19.0%), headache (15.2%), nasopharyngitis (10.4%), upper respiratory tract infection (7.1%), vomiting (5.7%), and decreased appetite (5.2%).
CONCLUSIONS: Apremilast was effective in systemic-naive patients with moderate plaque psoriasis with BSA 5%-10%; efficacy was sustained through week 52. No new safety signals emerged with continued apremilast exposure.
ClinicalTrials.gov: NCT02425826
J Drugs Dermatol. 2018;17(2):221-228.
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尽管治疗选择不断增加，但许多中度斑块状银屑病患者仍未得到充分治疗。在IV期UNVEIL研究中，口服阿普斯特在16周的双盲、安慰剂对照阶段，对慢性中度斑块状银屑病且银屑病累及体表面积（BSA；5%-10%）较低、未接受过系统治疗的患者显示出疗效和安全性。我们通过UNVEIL研究中52周的观察，描述了阿普斯特在该人群中的疗效和安全性。
方法
中度斑块状银屑病患者（BSA 5%-10%；静态医师整体评估[sPGA]评分为3[中度]）且未接受过银屑病系统治疗，随机（2:1）接受阿普斯特30mg每日两次或安慰剂治疗16周。在第16周时，患者继续接受阿普斯特治疗（阿普斯特/阿普斯特组），或从安慰剂转换为阿普斯特治疗（安慰剂/阿普斯特组）直至52周（开放标签阿普斯特治疗阶段）。疗效评估包括sPGA与BSA的乘积（PGAxBSA）（相对于基线的平均百分比变化；相对于基线降低≥75%[PGAxBSA-75]）、sPGA反应（达到0分[清除]或1分[几乎清除]）以及皮肤病生活质量指数（DLQI；相对于基线的平均变化）。
结果
共有136例患者完成了52周的分析期（安慰剂/阿普斯特组，n = 50/64；阿普斯特/阿普斯特组，n = 86/121）。在第52周时，阿普斯特/阿普斯特组在第16周观察到的所有疗效终点均得以维持（PGAxBSA相对于基线的平均百分比变化：-55.5%；PGAxBSA-75：42.1%；sPGA反应：33.1%；DLQI评分相对于基线的平均变化：-4.4）；安慰剂/阿普斯特组在转换为阿普斯特治疗后也出现了类似的改善。至52周时最常见的不良事件（≥5%的患者）为腹泻（28.0%）、恶心（19.0%）、头痛（15.2%）、鼻咽炎（10.4%）、上呼吸道感染（7.1%）、呕吐（5.7%）和食欲下降（5.2%）。
结论
阿普斯特对中度斑块状银屑病且BSA为5%-10%、未接受过系统治疗的患者有效；疗效持续至52周。持续使用阿普斯特未出现新的安全信号。
ClinicalTrials.gov：NCT02425826
《皮肤药物学杂志》2018年；17(2)：221 - 228。
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