Shanghai Institute of Dermatology, Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.
Institute of Dermatology, Department of Dermatology, First Affiliated Hospital, Anhui Medical University, Hefei, Anhui, China.
JAMA Dermatol. 2019 Mar 1;155(3):327-334. doi: 10.1001/jamadermatol.2018.5194.
It is necessary to determine whether psoriasis responds to methotrexate in the same manner in patients with and without psoriatic arthritis.
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.
A 12-week course of low-dosage oral methotrexate (7.5-15 mg weekly).
Changes in disease severity, adverse events, blood cell counts, and liver and renal function.
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 0f 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. Methotrexate-induced 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).
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.
重要性：有必要确定银屑病关节炎患者和非银屑病关节炎患者的甲氨蝶呤治疗反应是否相同。
目的：评估甲氨蝶呤治疗银屑病关节炎患者和非银屑病关节炎患者的疗效和安全性。
设计、地点和参与者：这是一项前瞻性、单臂、干预性研究，共招募了 235 名银屑病患者，其中 107 名无银屑病关节炎，128 名有银屑病关节炎，他们均于 2015 年 4 月 1 日至 2017 年 12 月 31 日在一家中国大型大学医院的门诊接受甲氨蝶呤治疗。除了糖尿病之外，两个亚组之间在人口统计学和临床方面没有显著差异。
干预措施：为期 12 周的低剂量口服甲氨蝶呤（每周 7.5-15mg）。
主要结局和测量指标：疾病严重程度、不良反应、血细胞计数、肝肾功能的变化。
结果：共有 235 名银屑病患者（166 名男性[66.0%]；平均[SD]年龄，49.6[15.1]岁）接受了 12 周的甲氨蝶呤治疗。在第 8 周（4/128[3.1%]比 12/107[11.2%]；P=0.02）和第 12 周（19/128[14.8%]比 27/107[25.2%]；P=0.049），银屑病关节炎患者的从基线银屑病面积严重程度指数反应 90%的降低明显低于无银屑病关节炎患者。与无银屑病关节炎患者相比，银屑病关节炎患者的不良反应发生率更高，包括头晕（12/128[9.4%]比 1/107[0.9%]；P=0.007）、胃肠道症状（32/128[25.0%]比 13/107[12.1%]；P=0.01）和肝毒性（34/128[26.6%]比 16/107[15.0%]；P=0.04）。甲氨蝶呤引起的丙氨酸氨基转移酶水平升高与体重指数（银屑病关节炎患者的平均[SD]体重指数为 26[4]，而无银屑病关节炎患者的为 26[4]；P=0.04）和吸烟（34 名患者中有 17 名[50.0%]有银屑病关节炎，P=0.02，而 16 名患者中有 9 名[56.3%]无银屑病关节炎，P=0.04）有关。
结论：在这项研究中，甲氨蝶呤治疗银屑病的耐受性良好且有效。在无银屑病关节炎的银屑病患者中，它比同时患有银屑病和银屑病关节炎的患者更有效，不良反应更少。因此，甲氨蝶呤可被推荐为无关节炎银屑病的一线治疗药物。
