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Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial.

Abstract：

BACKGROUND:Efalizumab inhibits multiple T-cell-mediated processes. OBJECTIVE:To evaluate 12- and 24-week efalizumab therapy for psoriasis. METHODS:In this phase III, randomized, double-blind trial, 498 patients received subcutaneous 1 or 2 mg/kg/wk efalizumab or placebo for 12 weeks. Efalizumab-treated patients who achieved <75% Psoriasis Area and Severity Index improvement (PASI-75) were re-randomized to a second 12-week course of treatment. Results At week 12, 39% and 27% of efalizumab-treated patients (1 and 2 mg/kg, respectively) achieved PASI-75 (vs 2% placebo; P < .001, both dose groups). At week 24, an additional 20% of efalizumab-treated patients achieved PASI-75 (vs placebo 7%, P = .018). Efalizumab was well tolerated. CONCLUSION:Twelve-week efalizumab treatment resulted in significant improvement; extension of therapy to 24 weeks resulted in additional improvement in patients who initially had not achieved PASI-75. There were no significant changes in safety profile during weeks 13-24.

journal_name

J Am Acad Dermatol

journal_title

Journal of the American Academy of Dermatology

authors

Leonardi CL,Papp KA,Gordon KB,Menter A,Feldman SR,Caro I,Walicke PA,Compton PG,Gottlieb AB,Efalizumab Study Group.

doi

10.1016/j.jaad.2004.09.029

subject

Has Abstract

pub_date

2005-03-01 00:00:00

pages

425-33

issue

3 Pt 1

eissn

0190-9622

issn

1097-6787

pii

S0190962204025113

journal_volume

52

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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