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.
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 humanLFA-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.
Authors: Michael E Wechsler; Patricia C Fulkerson; Bruce S Bochner; Gail M Gauvreau; Gerald J Gleich; Tim Henkel; Roland Kolbeck; Sameer K Mathur; Hector Ortega; Jatin Patel; Calman Prussin; Paolo Renzi; Marc E Rothenberg; Florence Roufosse; Dagmar Simon; Hans-Uwe Simon; Andrew Wardlaw; Peter F Weller; Amy D Klion Journal: J Allergy Clin Immunol Date: 2012-09 Impact factor: 10.793
Authors: Ulf Darsow; Andreas Wollenberg; Dagmar Simon; Alain Taïeb; Thomas Werfel; Arnold Oranje; Carlo Gelmetti; Ake Svensson; Mette Deleuran; Anne-Marie Calza; Francesca Giusti; Jann Lübbe; Stefania Seidenari; Johannes Ring Journal: World Allergy Organ J Date: 2013-03-14 Impact factor: 4.084
Authors: Andrea Montes-Torres; Mar Llamas-Velasco; Alejandra Pérez-Plaza; Guillermo Solano-López; Javier Sánchez-Pérez Journal: J Clin Med Date: 2015-04-03 Impact factor: 4.241