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

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-randornized 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.