An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis.
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.
Lebwohl
Mark
M
Mount Sinai School of Medicine, New York, NY 10029, USA. lebwohl@aol.com
Christophers
Enno
E
Langley
Richard
R
Ortonne
Jean P
JP
Roberts
Janet
J
Griffiths
Christopher E M
CE
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
D011993:Recombinant Fusion Proteins; D000077944:Alefacept