An International, Randomized, Double-blind, Placebo-Controlled Phase 3 Trial of Intramuscular Alefacept in Patients With Chronic Plaque Psoriasis.
Lebwohl, Mark MD; Christophers, Enno MD; Langley, Richard MD; Ortonne, Jean P. MD; Roberts, Janet MD; Griffiths, Christopher E. M. MD; for the Alefacept Clinical Study Group
[Miscellaneous Article]
Archives of Dermatology.
139(6):719-727, June 2003.
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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.
Design: International, randomized, double-blind, placebo-controlled, parallel-group trial.
Patients: A total of 507 patients with chronic plaque psoriasis.
Intervention: Placebo, 10 mg of alefacept, or 15 mg of alefacept administered once weekly for 12 weeks followed by 12 weeks of observation.
Main Outcome Measure: 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.
Conclusion: Intramuscular administration of alefacept was a well-tolerated and effective therapy for chronic plaque psoriasis and thus represents a convenient alternative to intravenous dosing.
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