title: An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis.
abstract: BACKGROUND
  Alefacept, human lymphocyte function-associated antigen 3/immunoglobulin 1 fusion protein, binds to CD2 molecules on the surface of activated T cells, selectively targeting memory-effector (CD45RO+) T cells, which comprise more than 75% of T cells in psoriatic plaques.
  
  
  OBJECTIVE
  To examine the efficacy and tolerability of intramuscular alefacept.
  
  
  METHODS
  International, randomized, double-blind, placebo-controlled, parallel-group trial.
  
  
  METHODS
  A total of 507 patients with chronic plaque psoriasis.
  
  
  METHODS
  Placebo, 10 mg of alefacept, or 15 mg of alefacept administered once weekly for 12 weeks followed by 12 weeks of observation.
  
  
  METHODS
  Psoriasis Area Severity Index (PASI).
  
  
  RESULTS
  Alefacept treatment was associated with dose-related significant improvements in PASI from baseline. Throughout the study, a greater percentage of patients in the 15-mg group than in the placebo group achieved a significant reduction in PASI. Of patients in the 15-mg group who achieved at least 75% PASI reduction 2 weeks after the last dose, 71% maintained at least 50% improvement in PASI throughout the 12-week follow-up. There were no opportunistic infections and no cases of disease rebound.
  
  
  CONCLUSIONS
  Intramuscular administration of alefacept was a well-tolerated and effective therapy for chronic plaque psoriasis and thus represents a convenient alternative to intravenous dosing.
authors.affiliation: Mount Sinai School of Medicine, New York, NY 10029, USA. lebwohl@aol.com
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.forename: Enno
authors.initials: E
authors.lastname: Christophers
authors.forename: Richard
authors.initials: R
authors.lastname: Langley
authors.forename: Jean P
authors.initials: JP
authors.lastname: Ortonne
authors.forename: Janet
authors.initials: J
authors.lastname: Roberts
authors.forename: Christopher E M
authors.initials: CE
authors.lastname: Griffiths
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077944:Alefacept; D002170:Canada; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014481:United States
chemical_list: D011993:Recombinant Fusion Proteins; D000077944:Alefacept