Document Detail

Alefacept for moderate to severe atopic dermatitis: a pilot study in adults.
MedLine Citation:
PMID:  18395294     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Atopic dermatitis is a common inflammatory skin condition with acute and chronic phases showing a prevalence of memory T cells. Alefacept is a fully human LFA-3/IgG1 fusion protein that inhibits T-cell activation and selectively reduces memory T cells, which may prove to be effective in the treatment of atopic dermatitis.
OBJECTIVE: We sought to evaluate clinical response of alefacept intramuscular (IM) injection for 16 weeks in adults with atopic dermatitis.
METHODS: This was an open-label study of a 16-week treatment regimen of alefacept IM injection in adults with moderate to severe inflammatory atopic dermatitis. Patients received alefacept (30 mg IM) weekly for the first 8 weeks. At week 9, patients who did not achieve a 50% reduction in their Eczema Area Severity Index (EASI) score continued on alefacept (30 mg IM) weekly; those patients with a 50% reduction in their EASI (EASI 50) score or higher had their weekly dose decreased (15 mg IM) for the remaining 8 weeks.
RESULTS: Nine patients with moderate to severe atopic dermatitis were enrolled and treated. At the primary end point, week 18, 1 patient achieved EASI 50 score and 1 patient achieved EASI 90 score; 4 patients had a decrease in EASI score of less than 50%, 1 patient had an increase in EASI score, and 2 patients withdrew early before the primary end point because of worsening disease. A Physician Global Assessment score of mild was achieved in 2 patients and 1 patient achieved a Physician Global Assessment score of almost clear. Minimal pruritus was reported by 3 patients and 1 patient reported no pruritus. The 16-week course of alefacept was well tolerated.
LIMITATIONS: The study was inherently limited by its small sample size, concomitant use of antihistamines, and open-label design, which increases the likelihood of observer and self-assessment bias.
CONCLUSION: The treatment regimen of alefacept for 16 weeks was well tolerated by our patients. Although, in this study, only 2 of the 9 patients with atopic dermatitis responded to treatment with alefacept, the study was inherently limited by the small sample size. Additional studies with a larger sample size, continued weekly use, or concomitant use of ultraviolet-B light therapy may be warranted to evaluate the possibility of alefacept as a therapy for patients with chronic atopic dermatitis.
Danielle K Moul; Shannon B Routhouska; Maria R Robinson; Neil J Korman
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-04-18
Journal Detail:
Title:  Journal of the American Academy of Dermatology     Volume:  58     ISSN:  1097-6787     ISO Abbreviation:  J. Am. Acad. Dermatol.     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-05-19     Completed Date:  2008-07-24     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  7907132     Medline TA:  J Am Acad Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  984-9     Citation Subset:  IM    
Department of Dermatology, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA.
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MeSH Terms
Dermatitis, Atopic / drug therapy*
Middle Aged
Pilot Projects
Recombinant Fusion Proteins / therapeutic use*
Severity of Illness Index
Reg. No./Substance:
0/Recombinant Fusion Proteins; ELK3V90G6C/alefacept

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

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