Del Rosso James Q, Kircik Leon
Adjunct Clinical Professor (Dermatology), Touro University Nevada, Henderson, Nevada; Lakes Dermatology and Del Rosso Dermatology Research, Las Vegas, Nevada.
J Clin Aesthet Dermatol. 2016 Sep;9(9):43-48. Epub 2016 Sep 1.
This article provides an update on the use of oral apremilast, a phosphodiesterase-4 (PDE4) inhibitor, for the treatment of plaque psoriasis. Emphasis is placed on safety evaluations, although efficacy considerations are also addressed. Both two-year and three -year data analyses support the favorable safety profile reported in pivotal trials with this agent. Although effective in many study subjects despite baseline characteristics, higher response rates were noted in those with a baseline psoriasis area and severity index (PASI) score <20 and in subjects not previously treated with systemic therapy for psoriasis. Gastrointestinal (GI) side effects are the most common adverse events (AEs) reported, especially during the first few weeks of use; recommendations on management of GI AEs are discussed. Psychological AEs appear to be rare, including with prolonged durations of use, and are not clearly associated with the drug itself as depression and suicidal behaviors are common in individuals with psoriasis. Data reported through up to 182 weeks of exposure to apremilast do not support an association with cardiac AEs, emergence of malignancies, enhanced predilection to develop significant opportunistic infections, or reactivation of occult infection, such as tuberculosis.
本文提供了关于口服阿普米司特(一种磷酸二酯酶-4(PDE4)抑制剂)用于治疗斑块状银屑病的最新情况。重点在于安全性评估,不过也讨论了疗效方面的考量。两年和三年的数据分析均支持在该药物的关键试验中所报告的良好安全性。尽管无论基线特征如何,该药物在许多研究对象中都有效,但在基线银屑病面积和严重程度指数(PASI)评分<20的患者以及先前未接受过银屑病系统治疗的患者中,观察到了更高的缓解率。胃肠道(GI)副作用是报告中最常见的不良事件(AE),尤其是在用药的最初几周;文中讨论了胃肠道不良事件的管理建议。心理方面的不良事件似乎很少见,包括长期用药时,且与药物本身并无明确关联,因为抑郁症和自杀行为在银屑病患者中很常见。截至暴露于阿普米司特长达182周所报告的数据并不支持其与心脏不良事件、恶性肿瘤的发生、发生严重机会性感染的易感性增加或潜伏感染(如结核病)的重新激活有关联。