Abstract：
The safety and efficacy of apremilast in psoriatic disease has been demonstrated in clinical trials, including in Japanese patients. This post-marketing surveillance study was conducted after approval of apremalast in Japan in 2016 to evaluate the safety and effectiveness of the drug in Japanese patients with plaque psoriasis (PsO) and psoriatic arthritis (PsA) in routine clinical practice. Patients (enrolled between September 1, 2017, and August 31, 2019), were observed for 12 months after apremilast treatment initiation or until discontinuation or withdrawal. Safety was assessed by evaluating adverse reactions (ARs) and serious ARs. Effectiveness measures in PsO included the proportion of patients who achieved global improvement and Physician\'s Global Assessment (PGA) scores of 0/1 and the change from baseline in the Dermatology Life Quality Index (DLQI) after 6 and 12 months treatment. The safety analysis set included 1063 patients (PsO, n = 992; PsA, n = 127). ARs and serious ARs were reported in 29.4% and 0.7% of patients, respectively; most occurred <1 month after apremilast initiation. There were no reports of fatal ARs, serious infections, hypersensitivity, or vasculitis. No new safety signals were identified. Among the key survey items, gastrointestinal disorders were the most common ARs (21.3%). In patients with PsO, after 6 and 12 months of treatment, effectiveness rates of achieving highly effective or effective global improvement of were 90.9% and 93.8%; PGA 0/1 was achieved by 42.7% and 58.1% of patients; mean decrease from baseline in total DLQI score was 4.2 (p < 0.0001) and 5.7 (p < 0.0001), respectively. Effectiveness was evaluated in a small number of patients with PsA for some measures; after 6 and 12 months of treatment, improvements were observed in global improvement effectiveness rates, Disease Activity Score in 28 Joints score, Visual Analog Scale score, and DLQI score. We conclude that orally administered apremilast was well tolerated and effective in Japanese patients with PsO and/or PsA enrolled in this post-marketing surveillance study.
摘要：
临床试验证明了阿普瑞司特治疗银屑病的安全性和有效性,包括日本患者。这项上市后监测研究是在2016年日本批准apremalast后进行的，目的是在常规临床实践中评估该药物在日本斑块状银屑病（PsO）和银屑病关节炎（PsA）患者中的安全性和有效性。患者（在2017年9月1日至2019年8月31日之间注册），在apremilast治疗开始或直至停药或停药后观察12个月。通过评估不良反应（ARs）和严重ARs来评估安全性。PsO的有效性指标包括在治疗6个月和12个月后，实现全球改善和医师全球评估（PGA）评分为0/1的患者比例以及皮肤病生活质量指数（DLQI）相对于基线的变化。安全性分析集包括1063名患者(PsO，n=992；PsA，n=127）。在29.4%和0.7%的患者中报告了ARs和严重ARs，分别；大多数发生在apremilast开始后<1个月。没有致命AR的报告，严重感染,超敏反应，或者血管炎.没有发现新的安全信号。在关键调查项目中，胃肠道疾病是最常见的ARs(21.3%).在PsO患者中，经过6个月和12个月的治疗，实现高效或有效整体改善的有效率分别为90.9%和93.8%；42.7%和58.1%的患者实现PGA0/1；总DLQI评分从基线平均下降为4.2(p<0.0001)和5.7(p<0.0001)，分别。在少数PsA患者中进行了一些措施的有效性评估；治疗6个月和12个月后，观察到全球改善有效率的改善，28关节评分中的疾病活动评分，视觉模拟量表评分,和DLQI得分。我们得出的结论是，口服apremilast在本上市后监测研究中招募的日本PsO和/或PsA患者中具有良好的耐受性和有效性。
