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

Autor: Peter Compton, Ivor Caro, Steven R. Feldman, Kim A. Papp, Alice B. Gottlieb, Alan Menter, Patricia A. Walicke, Craig L. Leonardi, Kenneth B. Gordon
Rok vydání: 2005
Předmět:
Zdroj: Journal of the American Academy of Dermatology. 52:425-433
ISSN: 0190-9622
Popis: Efalizumab inhibits multiple T-cell-mediated processes.To evaluate 12- and 24-week efalizumab therapy for psoriasis.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 achieved75% 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.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.
Databáze: OpenAIRE