Safety and Efficacy of Methotrexate for Chinese Adults With Psoriasis With and Without Psoriatic Arthritis
Safety and Efficacy of Methotrexate for Chinese Adults With Psoriasis With and Without Psoriatic Arthritis
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甲氨蝶呤治疗中国成人银屑病（伴或不伴银屑病关节炎）的安全性和疗效
DOI：
10.1001/jamadermatol.2018.5194
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发表时间：
2019-03-01
期刊：
影响因子：
10.9
通讯作者：
Xu, Jinhua
中科院分区：
文献类型：
--
作者：
Yan, Kexiang;Zhang, Yuanjing;Xu, Jinhua
重要性：有必要确定银屑病患者和无银屑病关节炎患者对甲氨蝶呤的反应是否相同。目的评价甲氨蝶呤治疗伴有和不伴有银屑病关节炎的银屑病患者的有效性和安全性。设计、环境和参与者在这项前瞻性、单臂、介入研究中，从中国一所大型大学的医院门诊部招募了2015年4月1日至2017年12月31日期间接受甲氨蝶呤治疗的235例银屑病患者，107例无银屑病关节炎患者和128例银屑病关节炎患者。除糖尿病外，亚组之间没有显著的人口统计学或临床差异。干预措施：低剂量口服甲氨蝶呤12周疗程（每周7.5-15mg）。主要结局和测量疾病严重程度、不良事件、血细胞计数和肝肾功能的变化。结果235例银屑病患者接受甲氨蝶呤治疗12周，其中男性166例[66.0%]，平均年龄49.6[15.1]岁。在第8周和第12周，银屑病关节炎患者比无银屑病关节炎患者的基线银屑病区域严重性指数（Psoriasis Area Severity Index）降低90% (128 / 4 [3.1%]vs 107 / 12 [11.2%], P = 0.02), （128 / 19 [14.8%] vs 107 / 27 [25.2%], P = 0.049）。此外，银屑病关节炎患者的不良事件发生率，包括头晕（128例中12例[9.4%]vs 107例中1例[0.9%],P =.007）、胃肠道症状（128例中32例[25.0%]vs 107例中13例[12.1%],P =.01）和肝毒性（128例中34例[26.6%]vs 107例中16例[15.0%],P =.04）均显著高于无银屑病关节炎患者。甲氨蝶呤引起的丙氨酸转氨酶水平升高与体重指数（平均[SD]体重指数，银屑病关节炎患者26 [4][P =.04] vs无银屑病关节炎患者26 [4][P =.005]）和吸烟（34例银屑病关节炎患者17例[50.0%]vs 16例无银屑病关节炎患者9例[P =.04][56.3%]）相关。结论和相关性在本研究中，甲氨蝶呤对银屑病具有良好的耐受性和疗效。它对没有银屑病关节炎的银屑病患者比同时患有银屑病和银屑病关节炎的患者更有效，副作用更少。因此，甲氨蝶呤可推荐作为无关节炎银屑病的一线治疗。
IMPORTANCE It is necessary to determine whether psoriasis responds to methotrexate in the same manner in patients with and without psoriatic arthritis.OBJECTIVE To evaluate the effectiveness and safety of methotrexate in treating patients with psoriasis with and without psoriatic arthritis.DESIGN, SETTING, AND PARTICIPANTS In this prospective, single-arm, interventional study, a total of 235 patients with psoriasis, 107 without psoriatic arthritis and 128 with psoriatic arthritis who were receiving methotrexate therapy from April 1, 2015, to December 31, 2017, were recruited from the outpatient department of a hospital at a large Chinese university. There were no significant demographic or clinical differences between the subgroups with the exception of diabetes.INTERVENTIONS A 12-week course of low-dosage oral methotrexate (7.5-15mg weekly).MAIN OUTCOMES AND MEASURES Changes in disease severity, adverse events, blood cell counts, and liver and renal function.RESULTS A total of 235 patients with psoriasis (166 male [66.0%]; mean [SD] age, 49.6 [15.1] years) received methotrexate treatment for 12 weeks. The 90% reduction from baseline Psoriasis Area Severity Index response was significantly lower in patients with psoriatic arthritis than in patients without psoriatic arthritis at week 8 (4 of 128 [3.1%] vs 12 of 107 [11.2%]; P =.02) and week 12 (19 of 128 [14.8%] vs 27 of 107 [25.2%]; P =.049). Furthermore, the incidence of adverse events, including dizziness (12 of 128 [9.4%] vs 1 of 107 [0.9%]; P =.007), gastrointestinal symptoms (32 of 128 [25.0%] vs 13 of 107 [12.1%]; P =.01), and hepatoxicity (34 of 128 [26.6%] vs 16 of 107 [15.0%]; P =.04), was significantly higher in patients with psoriatic arthritis than in patients without psoriatic arthritis. Methotrexateinduced elevation of alanine aminotransferase levels was associated with body mass index (mean [SD] body mass index, 26 [4] in patients with [P =.04] vs 26 [4] in those without [P =.005] psoriatic arthritis) and smoking (17 of 34 [50.0%] in patients with [P =.02] vs 9 of 16 [56.3%] in those without [P =.04] psoriatic arthritis).CONCLUSIONS AND RELEVANCE In this study, methotrexate was well tolerated and effective in treating psoriasis. It was more effective, with fewer adverse effects, in patients with psoriasis who did not have psoriatic arthritis than in patients who presented with both psoriasis and psoriatic arthritis. Therefore, methotrexate can be recommended as first-line treatment for psoriasis without arthritis.