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-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.


CONCLUSIONS
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.
Leonardi
Craig L
CL
Saint Louis University School of Medicine, St. Louis, Missouri, USA. leonardi@centralderm.com
Papp
Kim A
KA
Gordon
Kenneth B
KB
Menter
Alan
A
Feldman
Steven R
SR
Caro
Ivor
I
Walicke
Patricia A
PA
Compton
Peter G
PG
Gottlieb
Alice B
AB
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; D003879:Dermatologic Agents; D007155:Immunologic Factors; C472181:efalizumab