Department of Dermatology, Medical University of Graz, Graz, Austria.
J Eur Acad Dermatol Venereol. 2013 Jul;27(7):861-6. doi: 10.1111/j.1468-3083.2012.04596.x. Epub 2012 Jun 2.
To compare the clinical efficacy of methotrexate (MTX) vs. fumaric acid esters (FAE) in psoriasis treated under daily life conditions.
Data were extracted from a registry (http://www.psoriasisregistry.at) of 272 adult patients with moderate-to-severe chronic plaque psoriasis treated primarily with MTX (n = 72) or FAE (n = 200) between 2004 and 2011. Data from all patients, including those who did not complete at least 3 months of monotherapy, were included in an intention-to-treat (ITT) worst-case analysis.
Thirty of 72 (41.7%) patients treated with MTX and 85 of 200 (42.5%) patients treated with FAE discontinued early, mainly due to side-effects or lack of response. Among patients who completed at least 3 months of treatment, the response to primary treatment with MTX vs. FAE did not differ significantly at any time point. In the ITT worst-case analysis at month 3, complete remission rate, PASI90, PASI75 and PASI50 rates were 6%, 7%, 24% and 39% in MTX-treated patients vs. 1%, 5%, 27% and 44% in FAE-treated patients. Overall mean PASI reduction score improved significantly in response to primary MTX and FAE treatment (by 10.6% and 12.6%, respectively) between 3 and 6 months (P = 0.0005; exact Wilcoxon test), but not between 6 and 12 months (P = 0.16). A subset of 32 patients who did not respond satisfactorily to primary treatment with FAE responded better to subsequent MTX therapy (P < 0.0001; paired Wilcoxon test).
As shown by retrospective analysis, the primary efficacy of FAE was similar to that of MTX under daily life conditions.
比较甲氨蝶呤（MTX）与富马酸酯（FAE）在日常生活条件下治疗银屑病的临床疗效。
从 2004 年至 2011 年期间，一项包含 272 例中重度慢性斑块型银屑病成年患者的登记处（http://www.psoriasisregistry.at）中提取数据，这些患者主要接受 MTX（n=72）或 FAE（n=200）治疗。对所有患者的数据（包括未完成至少 3 个月单药治疗的患者）进行意向治疗（ITT）最差情况分析。
72 例接受 MTX 治疗的患者中有 30 例（41.7%）和 200 例接受 FAE 治疗的患者中有 85 例（42.5%）提前停药，主要是由于副作用或无反应。在至少完成 3 个月治疗的患者中，MTX 与 FAE 作为初始治疗的反应在任何时间点均无显著差异。在 ITT 最差情况分析中，第 3 个月时 MTX 治疗患者的完全缓解率、PASI90、PASI75 和 PASI50 率分别为 6%、7%、24%和 39%，而 FAE 治疗患者分别为 1%、5%、27%和 44%。在 3 至 6 个月期间，接受 MTX 和 FAE 初始治疗后，总平均 PASI 降低评分均显著改善（分别为 10.6%和 12.6%，P=0.0005；确切 Wilcoxon 检验），但在 6 至 12 个月期间无显著改善（P=0.16）。32 例对 FAE 初始治疗反应不佳的患者中，有一部分对后续 MTX 治疗反应更好（P<0.0001；配对 Wilcoxon 检验）。
通过回顾性分析，FAE 的主要疗效与日常生活条件下的 MTX 相似。
