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Mark Lebwohl, MD; Enno Christophers, MD; Richard Langley, MD; Jean P. Ortonne, MD; Janet Roberts, MD; Christopher E. M. Griffiths, MD; for the Alefacept Clinical Study Group

Arch Dermatol. 2003;139:719-727.

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.

From the Mount Sinai School of Medicine, New York, NY (Dr Lebwohl); Klinikum an der Universität Kiel, Kiel, Germany (Dr Christophers); Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia (Dr Langley); Hôpital L'Archet II, Nice, France (Dr Ortonne); Northwest Cutaneous Research Specialists, Portland, Ore (Dr Roberts); Dermatology Centre, The University of Manchester, Hope Hospital, Manchester, England (Dr Griffiths). A complete list of the members of the Alefacept Clinical Study Group appears below. The authors have served as investigators for Biogen. Dr Lebwohl is a consultant for Biogen.

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