Leonardi Craig L, Powers Jerold L, Matheson Robert T, Goffe Bernard S, Zitnik Ralph, Wang Andrea, Gottlieb Alice B
Saint Louis University School of Medicine, St. Louis, USA.
N Engl J Med. 2003 Nov 20;349(21):2014-22. doi: 10.1056/NEJMoa030409.
Inflammatory cytokines such as tumor necrosis factor (TNF) have been implicated in the pathogenesis of psoriasis. We evaluated the safety and efficacy of etanercept, a TNF antagonist, for the treatment of plaque psoriasis.
In this 24-week, double-blind study, 672 patients underwent randomization and 652 either received placebo or received etanercept subcutaneously at a low dose (25 mg once weekly), a medium dose (25 mg twice weekly), or a high dose (50 mg twice weekly). After 12 weeks, patients in the placebo group began twice-weekly treatment with 25 mg of etanercept. The primary measure of clinical response was the psoriasis area-and-severity index.
At week 12, there was an improvement from base line of 75 percent or more in the psoriasis area-and-severity index in 4 percent of the patients in the placebo group, as compared with 14 percent of those in the low-dose--etanercept group, 34 percent in the medium-dose--etanercept group, and 49 percent in the high-dose-etanercept group (P<0.001 for all three comparisons with the placebo group). The clinical responses continued to improve with longer treatment. At week 24, there was at least a 75 percent improvement in the psoriasis area-and-severity index in 25 percent of the patients in the low-dose group, 44 percent of those in the medium-dose group, and 59 percent in the high-dose group. The responses as measured by improvements in the psoriasis area-and-severity index were paralleled by improvements in global assessments by physicians and the patients and in quality-of-life measures. Etanercept was generally well tolerated.
The treatment of psoriasis with etanercept led to a significant reduction in the severity of disease over a period of 24 weeks.
肿瘤坏死因子（TNF）等炎性细胞因子与银屑病的发病机制有关。我们评估了TNF拮抗剂依那西普治疗斑块状银屑病的安全性和有效性。
在这项为期24周的双盲研究中，672例患者被随机分组，652例患者接受安慰剂治疗，或分别接受皮下注射低剂量（25mg，每周1次）、中剂量（25mg，每周2次）或高剂量（50mg，每周2次）的依那西普治疗。12周后，安慰剂组患者开始接受每周2次、每次25mg依那西普的治疗。临床反应的主要衡量指标为银屑病面积和严重程度指数。
在第12周时，安慰剂组4%的患者银屑病面积和严重程度指数较基线改善了75%或更多，相比之下，低剂量依那西普组为14%，中剂量依那西普组为34%，高剂量依那西普组为49%（与安慰剂组的所有三项比较P均<0.001）。随着治疗时间延长，临床反应持续改善。在第24周时，低剂量组25%的患者、中剂量组44%的患者和高剂量组59%的患者银屑病面积和严重程度指数至少改善了75%。银屑病面积和严重程度指数的改善所衡量的反应与医生和患者的整体评估以及生活质量指标的改善相平行。依那西普总体耐受性良好。
依那西普治疗银屑病在24周内可显著降低疾病严重程度。
