TY - JOUR
T1 - Extended efalizumab therapy improves chronic plaque psoriasis
T2 - results from a randomized phase III trial.
AU - Leonardi, Craig L.
AU - Papp, Kim A.
AU - Gordon, Kenneth B.
AU - Menter, Alan
AU - Feldman, Steven R.
AU - Caro, Ivor
AU - Walicke, Patricia A.
AU - Compton, Peter G.
AU - Gottlieb, Alice B.
PY - 2005/3
Y1 - 2005/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=17144388751&partnerID=8YFLogxK
U2 - 10.1016/j.jaad.2004.09.029
DO - 10.1016/j.jaad.2004.09.029
M3 - Article
C2 - 15761420
AN - SCOPUS:17144388751
SN - 0190-9622
VL - 52
SP - 425
EP - 433
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 3 Pt 1
ER -