Document Detail

Alefacept: a novel biologic in the treatment of psoriasis.
MedLine Citation:
PMID:  15645008     Owner:  NLM     Status:  MEDLINE    
Recognition of psoriasis as a T-cell-mediated immune disease has led to the development of various therapeutic approaches directed against the T cell and T-cell processes such as activation, trafficking and cytokine release. The novel and selective biologic agent alefacept, with an effect of selective apoptotic reduction in memory-effector T cells, has been given FDA approval for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The clinical profile of this novel biologic agent is presented here. Two pivotal multicenter, randomized, placebo-controlled, double-blind studies enrolling 1060 patients were designed to support the efficacy and safety of alefacept in the treatment of moderate to severe chronic plaque psoriasis. With either intramuscular or intravenous administration, well over half of patients treated with a single course of alefacept achieved a 50% reduction in PASI (Psoriasis Area and Severity Index), and a second course of therapy provided further benefit by increasing response rates and providing long-lasting off-treatment responses regardless of the route of administration. In all studies, alefacept was well tolerated. There was no evidence of an increased risk of infections or malignancies and no opportunistic infections were reported. Consistent with its composition as a fully human fusion protein, alefacept had a low incidence of immunogenicity and no evidence of an increased rate of antibody development over time. There was no evidence that primary or secondary responses to a new antigen or memory response to a recall antigen were blunted in patients treated with alefacept. In conclusion, alefacept is the first biologic therapy to demonstrate positive effects in an immune-mediated disease while maintaining immune responses to novel and recall antigens. This selective effect on the immune system distinguishes alefacept from immunosuppressive therapies that are nonselective.
Clive M Liu; Jeffrey K McKenna; Gerald G Krueger
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Drugs of today (Barcelona, Spain : 1998)     Volume:  40     ISSN:  1699-3993     ISO Abbreviation:  Drugs Today     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2005-01-12     Completed Date:  2005-10-20     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  101160518     Medline TA:  Drugs Today (Barc)     Country:  Spain    
Other Details:
Languages:  eng     Pagination:  961-74     Citation Subset:  IM    
Copyright Information:
(c) 2004 Prous Science. All rights reserved
Department of Dermatology, University of Utah, 30 North 1900 East #4B454, Salt Lake City, UT 84132, USA.
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MeSH Terms
Dermatologic Agents / adverse effects,  pharmacology,  therapeutic use
Double-Blind Method
Drug Administration Schedule
Injections, Intramuscular
Injections, Intravenous
Psoriasis / diagnosis,  drug therapy*,  immunology
Radiotherapy, Adjuvant
Recombinant Fusion Proteins / adverse effects,  pharmacology,  therapeutic use*
Severity of Illness Index
Treatment Outcome
Reg. No./Substance:
0/Dermatologic Agents; 0/Recombinant Fusion Proteins; ELK3V90G6C/alefacept

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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