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 receivedsubcutaneous 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.
RCT Entities:
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-treatedpatients 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-treatedpatients (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-treatedpatients 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.
Authors: María Denise Takahashi; Edgardo Néstor Chouela; Gladys Leon Dorantes; Ana Maria Roselino; Jesùs Santamaria; Miguel Angel Allevato; Tania Cestari; Maria Eugenia Manzanera de Aillaud; Fernando Miguel Stengel; Daiana Licu Journal: Arch Drug Inf Date: 2010-03
Authors: Torello Lotti; Sergio Chimenti; Andreas Katsambas; Jean-Paul Ortonne; Louis Dubertret; Daiana Licu; Jan Simon Journal: Arch Drug Inf Date: 2010-03
Authors: Fernando M Stengel; Valeria Petri; Gladys Am Campbell; Gladys Leon Dorantes; Magdalina López; Ricardo L Galimberti; Raúl P Valdez; Lucia F de Arruda; Mario Amaya Guerra; Edgardo N Chouela; Daiana Licu Journal: Arch Drug Inf Date: 2009-12