title: Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial.
abstract: 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.
authors.affiliation: Saint Louis University School of Medicine, St. Louis, Missouri, USA. leonardi@centralderm.com
authors.forename: Craig L
authors.initials: CL
authors.lastname: Leonardi
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.forename: Kenneth B
authors.initials: KB
authors.lastname: Gordon
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.forename: Steven R
authors.initials: SR
authors.lastname: Feldman
authors.forename: Ivor
authors.initials: I
authors.lastname: Caro
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Walicke
authors.forename: Peter G
authors.initials: PG
authors.lastname: Compton
authors.forename: Alice B
authors.initials: AB
authors.lastname: Gottlieb
mesh_terms: 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*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018845:CD11 Antigens; D003879:Dermatologic Agents; D007155:Immunologic Factors; C472181:efalizumab