Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.
J Dermatol. 2018 Nov;45(11):1345-1348. doi: 10.1111/1346-8138.14617. Epub 2018 Aug 31.
Apremilast is a novel oral phosphodiesterase 4 inhibitor effective for psoriasis. It regulates the production of pro-inflammatory mediators. Apremilast was approved in December 2016 in Japan; however, its efficacy and safety in a real-world setting among Japanese patients have not been reported. We report on 44 patients treated with apremilast between March and October 2017. The median treatment duration was 25 weeks (range, 2-33). Thirty-five patients (79.5%) continued the drug for at least 23 weeks, and five (11.4%) achieved a Psoriasis Area and Severity Index 100 response within 12 weeks. Nine patients discontinued the drug within 24 weeks mainly due to insufficient efficacy (n = 3) and adverse events (n = 4). Seven patients continued their previous systemic therapies such as cyclosporin (n = 1), methotrexate (n = 1), etretinate + methotrexate (n = 1) and biologics (n = 4) combined with apremilast. Of these patients, 55.9% had at least one adverse event although no severe adverse events. The most common adverse event was diarrhea (31.8%), followed by nausea (25.0%), headache (13.6%), abdominal discomfort (6.8%) and vomiting (6.8%). The proportion of diarrhea in our patients was higher than those of previous clinical trials. Among 10 patients with psoriatic arthritis, apremilast did not improve joint pain in nine (90%). To investigate the relationship between treatment efficacy and plaque size, we defined a small plaque as an individual rash diameter of 1 inch or less. The efficacy of apremilast was greater in patients with small plaques than in patients with large plaques.
阿普米司特是一种新型口服磷酸二酯酶 4 抑制剂，对银屑病有效。它可调节促炎介质的产生。阿普米司特于 2016 年 12 月在日本获得批准；然而，其在日本患者中的真实世界疗效和安全性尚未有报道。我们报告了 2017 年 3 月至 10 月间接受阿普米司特治疗的 44 例患者。中位治疗时间为 25 周（范围，2-33 周）。35 例（79.5%）患者至少继续治疗 23 周，5 例（11.4%）患者在 12 周内达到银屑病面积和严重程度指数 100 缓解。9 例患者在 24 周内停用该药，主要是因为疗效不足（n=3）和不良反应（n=4）。7 例患者继续使用以前的系统治疗药物，如环孢素（n=1）、甲氨蝶呤（n=1）、阿维 A+甲氨蝶呤（n=1）和生物制剂（n=4），联合使用阿普米司特。这些患者中有 55.9%发生至少一种不良反应，尽管无严重不良反应。最常见的不良反应是腹泻（31.8%），其次是恶心（25.0%）、头痛（13.6%）、腹部不适（6.8%）和呕吐（6.8%）。我们患者的腹泻比例高于以往的临床试验。在 10 例患有银屑病关节炎的患者中，阿普米司特未能改善 9 例（90%）患者的关节疼痛。为了研究治疗效果与斑块大小的关系，我们将单个皮疹直径 1 英寸或以下定义为小斑块。与大斑块患者相比，小斑块患者的阿普米司特疗效更好。
