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J Am Acad Dermatol. 2005 Mar;52(3 Pt 1):425-33.

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

Author information

1
Saint Louis University School of Medicine, St. Louis, Missouri, USA. leonardi@centralderm.com

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.

PMID:
15761420
DOI:
10.1016/j.jaad.2004.09.029
[Indexed for MEDLINE]

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