作者
Ulrich Mrowietz, Craig L Leonardi, Giampiero Girolomoni, Darryl Toth, Akimichi Morita, Shyamal A Balki, Jacek C Szepietowski, Pascaline Regnault, Helen Thurston, Charis Papavassilis, SCULPTURE Study Group
发表日期
2015/7/1
期刊
Journal of the American Academy of Dermatology
卷号
73
期号
1
页码范围
27-36. e1
出版商
Mosby
简介
Background
Secukinumab has demonstrated high, sustained efficacy in psoriasis to 52 weeks on a fixed-interval regimen.
Objective
We sought to compare a retreatment-as-needed versus a fixed-interval regimen.
Methods
In this double-blind study, adults with moderate to severe plaque psoriasis were randomized 1:1 to subcutaneous secukinumab at 300 mg (n = 484) or 150 mg (n = 482) weekly from baseline until week 4, and at week 8. At week 12, patients achieving 75% or more improvement from baseline Psoriasis Area and Severity Index score (PASI 75) were rerandomized to 2 dose levels of secukinumab retreatment as needed (n = 217, 300 mg; n = 206, 150 mg) or fixed interval (n = 217; n = 203). Primary end point was noninferiority of retreatment as needed versus fixed interval for maintaining PASI 75 to week 52.
Results
Secukinumab induced high responses by week 12 (84.4%-91.1% PASI 75 responders …
引用总数
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