Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol 2005 Mar;52(3 Pt 1):425-33
Date
03/12/2005Pubmed ID
15761420DOI
10.1016/j.jaad.2004.09.029Scopus ID
2-s2.0-17144388751 (requires institutional sign-in at Scopus site) 223 CitationsAbstract
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.
Author List
Leonardi CL, Papp KA, Gordon KB, Menter A, Feldman SR, Caro I, Walicke PA, Compton PG, Gottlieb AB, Efalizumab Study GroupAuthor
Kenneth Brian Gordon MD Chair, Professor in the Dermatology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdultAged
Antibodies, Monoclonal
Antibodies, Monoclonal, Humanized
CD11 Antigens
Dermatologic Agents
Double-Blind Method
Female
Humans
Immunologic Factors
Male
Middle Aged
Psoriasis
