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

Craig L. Leonardi*, Kim A. Papp, Kenneth B. Gordon, Alan Menter, Steven R. Feldman, Ivor Caro, Patricia A. Walicke, Peter G. Compton, Alice B. Gottlieb

*Corresponding author for this work

Research output: Contribution to journalArticle

214 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)425-433
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume52
Issue number3 Pt 1
DOIs
StatePublished - Mar 2005

ASJC Scopus subject areas

  • Dermatology

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    Leonardi, C. L., Papp, K. A., Gordon, K. B., Menter, A., Feldman, S. R., Caro, I., Walicke, P. A., Compton, P. G., & Gottlieb, A. B. (2005). Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. Journal of the American Academy of Dermatology, 52(3 Pt 1), 425-433. https://doi.org/10.1016/j.jaad.2004.09.029