Papp K A, Tyring S, Lahfa M, Prinz J, Griffiths C E M, Nakanishi A M, Zitnik R, van de Kerkhof P C M, Melvin Linda
Probity Medical Research, Waterloo, Ontario N2J 1C4, Canada.
Br J Dermatol. 2005 Jun;152(6):1304-12. doi: 10.1111/j.1365-2133.2005.06688.x.
In previous studies, etanercept significantly improved plaque psoriasis and was well tolerated.
To examine further the efficacy and safety of etanercept and to assess maintenance of treatment effect after dose reduction of etanercept.
In this multicentre 24-week study in the U.S.A., Canada and Western Europe, patients were at least 18 years old; had active, clinically stable plaque psoriasis involving at least 10% of body surface area; had a minimum Psoriasis Area and Severity Index (PASI) of 10 at screening; and had received or were a candidate to receive systemic psoriasis therapy or phototherapy. During the first 12 weeks of the study, patients were randomly assigned to receive by subcutaneous injection etanercept twice weekly (BIW) at a dose of 50 mg or 25 mg, or placebo BIW in a double-blind fashion. During the second 12 weeks, all patients received etanercept 25 mg BIW. The primary endpoint was a 75% or greater improvement from baseline in PASI (PASI 75) at 12 weeks.
Five hundred and eighty-three subjects were randomized and received at least one dose of study drug. At week 12, a PASI 75 was achieved by 49% of patients in the etanercept 50 mg BIW group, 34% in the 25 mg BIW group, and 3% in the placebo group (P < 0.0001 for each etanercept group compared with placebo). At week 24 (after 12 weeks of open-label 25 mg etanercept BIW), a PASI 75 was achieved by 54% of patients whose dose was reduced from 50 mg BIW to 25 mg BIW, by 45% of patients in the continuous 25 mg BIW group, and by 28% in the group that received placebo followed by etanercept 25 mg BIW. Etanercept was well tolerated throughout the study.
Etanercept provided clinically meaningful benefit to patients with chronic plaque psoriasis, with no apparent decrease in efficacy after dose reduction.
在先前的研究中，依那西普能显著改善斑块状银屑病，且耐受性良好。
进一步研究依那西普的疗效和安全性，并评估依那西普剂量减少后治疗效果的维持情况。
在美国、加拿大和西欧进行的这项为期24周的多中心研究中，患者年龄至少18岁；患有累及至少10%体表面积的活动性、临床稳定的斑块状银屑病；筛查时银屑病面积和严重程度指数（PASI）至少为10；且已接受或有资格接受全身性银屑病治疗或光疗。在研究的前12周，患者被随机分配以双盲方式皮下注射依那西普，每周两次（BIW），剂量为50毫克或25毫克，或安慰剂BIW。在第二个12周期间，所有患者接受依那西普25毫克BIW。主要终点是12周时PASI较基线改善75%或更多（PASI 75）。
583名受试者被随机分组并接受了至少一剂研究药物。在第12周时，依那西普50毫克BIW组中49%的患者达到PASI 75，25毫克BIW组中为34%，安慰剂组中为3%（依那西普各治疗组与安慰剂组相比，P均<0.0001）。在第24周（开放标签的依那西普25毫克BIW治疗12周后），剂量从50毫克BIW减至25毫克BIW的患者中有54%达到PASI 75，持续接受25毫克BIW治疗组中的患者为45%，接受安慰剂后再接受依那西普25毫克BIW治疗组中的患者为28%。在整个研究过程中，依那西普耐受性良好。
依那西普为慢性斑块状银屑病患者提供了具有临床意义的益处，剂量减少后疗效无明显下降。
