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

Research output: Contribution to journalArticlepeer-review

223 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
Pages (from-to)425-433
Number of pages9
JournalJournal of the American Academy of Dermatology
Volume52
Issue number3 Pt 1
DOIs
StatePublished - Mar 2005
Externally publishedYes

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