Gottlieb Alice B, Leonardi Craig L, Goffe Bernard S, Ortonne Jean-Paul, van der Kerkhof Peter C M, Zitnik Ralph, Nakanishi Arline, Jahreis Angelika
Clinical Research Center, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ 08901-0019, USA.
J Am Acad Dermatol. 2006 Mar;54(3 Suppl 2):S92-100. doi: 10.1016/j.jaad.2005.10.053.
Etanercept, a tumor necrosis factor antagonist, is an approved treatment in the United States and Europe for plaque psoriasis.
To further examine the safety profile of etanercept in patients with chronic, moderate to severe plaque psoriasis.
Safety data from an integrated database of 1347 patients from 3 randomized, double-blind, placebo-controlled clinical trials were analyzed. Safety end points included incidence rates of adverse events, serious adverse events, infections, serious infections, injection site reactions, and routine laboratory assessments. Pooled safety results from the first 12 weeks of each trial are reported here.
Rates of adverse events, serious adverse events, infections, and serious infections in the first 12 weeks of the 3 trials were similar among all active groups as well as each active group, compared with the placebo group. No dose-related toxicities were reported.
This report includes a relatively short (12-week) time frame; data from patients exposed to etanercept for longer periods are needed.
Etanercept was generally safe in a large cohort of patients with moderate to severe plaque psoriasis.
肿瘤坏死因子拮抗剂依那西普在美国和欧洲被批准用于治疗斑块状银屑病。
进一步研究依那西普在慢性中重度斑块状银屑病患者中的安全性。
分析了来自3项随机、双盲、安慰剂对照临床试验的1347例患者综合数据库的安全性数据。安全终点包括不良事件、严重不良事件、感染、严重感染、注射部位反应的发生率以及常规实验室评估。本文报告了每项试验前12周的汇总安全结果。
与安慰剂组相比，3项试验前12周所有活性组以及各活性组的不良事件、严重不良事件、感染和严重感染发生率相似。未报告与剂量相关的毒性。
本报告的时间框架相对较短（12周）；需要长期使用依那西普患者的数据。
在一大群中重度斑块状银屑病患者中，依那西普总体上是安全的。
