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Arch Dermatol. 2003 Jun;139(6):719-27.

An international, randomized, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis.

Author information

1
Mount Sinai School of Medicine, New York, NY 10029, USA. lebwohl@aol.com

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.

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.

PMID:
12810502
DOI:
10.1001/archderm.139.6.719
[Indexed for MEDLINE]

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