Abdulrahim Hunar, Thistleton Samuel, Adebajo Adewale O, Shaw Tim, Edwards Christopher, Wells Alvin
Barnsley Hospital NHS Foundation Trust, Department of Rheumatology , Barnsley , UK
Expert Opin Pharmacother. 2015 May;16(7):1099-108. doi: 10.1517/14656566.2015.1034107. Epub 2015 Apr 11.
The evidence base for disease-modifying anti-rheumatic drugs used in psoriatic arthritis (PsA) is surprisingly weak, with most having little robust evidence to support their clinical use. Furthermore, there remain safety and tolerability concerns with both these and more recently available biological therapies. Apremilast , a novel, small molecule, represents the first oral therapy specifically developed for PsA.
This review describes the pharmacokinetic properties of apremilast and available data demonstrating significant benefits to both clinical and histological features of inflammatory arthritis. The key findings from a large Phase III clinical program will also be discussed, including short- and long-term efficacy outcomes and, importantly, the safety profile. Indications other than PsA will also be briefly reviewed. Given the recent nature of much of the data, published literature as well as information available only in the abstract format are included in this review.
Studies show that treatment with apremilast results in significant improvement in both skin psoriasis and PsA symptoms. Apremilast has been approved by both the United States FDA and European Medicines Agency for treatment of PsA. Use of this medication is recommended in active PsA patients, according to local licensing.
用于治疗银屑病关节炎（PsA）的改善病情抗风湿药物的证据基础出人意料地薄弱，大多数药物几乎没有有力证据支持其临床应用。此外，这些药物以及最近可用的生物疗法仍存在安全性和耐受性问题。阿普斯特是一种新型小分子药物，是首个专门为治疗PsA开发的口服疗法。
本综述描述了阿普斯特的药代动力学特性以及现有数据，这些数据表明其对炎性关节炎的临床和组织学特征均有显著益处。还将讨论一项大型III期临床项目的主要发现，包括短期和长期疗效结果，以及重要的安全性概况。还将简要回顾PsA以外的适应症。鉴于大部分数据的时效性，本综述纳入了已发表的文献以及仅以摘要形式提供的信息。
研究表明，使用阿普斯特可显著改善皮肤银屑病和PsA症状。阿普斯特已获得美国食品药品监督管理局（FDA）和欧洲药品管理局的批准，用于治疗PsA。根据当地许可，建议在活动性PsA患者中使用此药物。
