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Etanercept as Monotherapy in Patients with Psoriasis

Authors :
Bernard S. Goffe
Robert Matheson
Alice B. Gottlieb
Craig L. Leonardi
Ralph Zitnik
Jerold Powers
Andrea Wang
Source :
New England Journal of Medicine. 349:2014-2022
Publication Year :
2003
Publisher :
Massachusetts Medical Society, 2003.

Abstract

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 (P0.001 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.

Details

ISSN :
15334406 and 00284793
Volume :
349
Database :
OpenAIRE
Journal :
New England Journal of Medicine
Accession number :
edsair.doi.dedup.....e657fec43a8878a0994645dddc72c894
Full Text :
https://doi.org/10.1056/nejmoa030409