Gordon Kenneth B, Langley Richard G, Leonardi Craig, Toth Darryl, Menter M Alan, Kang Sewon, Heffernan Michael, Miller Bruce, Hamlin Regina, Lim Liberata, Zhong Jianhua, Hoffman Rebecca, Okun Martin M
Division of Dermatology, Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Skokie, IL 60077, USA.
J Am Acad Dermatol. 2006 Oct;55(4):598-606. doi: 10.1016/j.jaad.2006.05.027. Epub 2006 Aug 10.
Tumor necrosis factor is pivotal in the pathogenesis of psoriasis. Adalimumab is a fully human monoclonal immunoglobulin G1 antibody that neutralizes tumor necrosis factor.
We sought to assess the efficacy and safety of adalimumab in patients with moderate to severe plaque psoriasis.
In this multicenter, randomized, double-blind, placebo-controlled study, 147 patients received adalimumab (40 mg every other week or 40 mg/wk) or placebo. After 12 weeks of blinded therapy, patients taking adalimumab could continue their assigned dosages in a 48-week extension trial; patients taking placebo were switched to adalimumab (40 mg every other week).
At week 12, 53% of patients taking adalimumab every other week, 80% of patients taking adalimumab weekly, and 4% of patients taking placebo achieved 75% improvement in Psoriasis Area and Severity Index score (P < .001). Responses were sustained for 60 weeks. No new safety signals were noted compared with the existing adalimumab clinical safety database.
The study was insufficiently powered to detect rare adverse events associated with adalimumab.
Adalimumab significantly improved psoriasis and was well tolerated for 60 weeks.
肿瘤坏死因子在银屑病的发病机制中起关键作用。阿达木单抗是一种完全人源化的单克隆免疫球蛋白G1抗体，可中和肿瘤坏死因子。
我们旨在评估阿达木单抗治疗中度至重度斑块状银屑病患者的疗效和安全性。
在这项多中心、随机、双盲、安慰剂对照研究中，147例患者接受阿达木单抗（每两周40mg或每周40mg）或安慰剂治疗。在12周的盲法治疗后，接受阿达木单抗治疗的患者可在一项为期48周的延长期试验中继续使用指定剂量；服用安慰剂的患者改用阿达木单抗（每两周40mg）。
在第12周时，每两周服用一次阿达木单抗的患者中有53%、每周服用一次阿达木单抗的患者中有80%以及服用安慰剂的患者中有4%的银屑病面积和严重程度指数评分改善了75%（P<0.001）。疗效持续了60周。与现有的阿达木单抗临床安全数据库相比，未发现新的安全信号。
该研究的样本量不足以检测与阿达木单抗相关的罕见不良事件。
阿达木单抗显著改善了银屑病，且在60周内耐受性良好。
