Alefacept for moderate to severe atopic dermatitis: a pilot study in adults.
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.


CONCLUSIONS
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.


CONCLUSIONS
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.
Moul
Danielle K
DK
Department of Dermatology, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA.
Routhouska
Shannon B
SB
Robinson
Maria R
MR
Korman
Neil J
NJ
D000077944:Alefacept; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012720:Severity of Illness Index
D011993:Recombinant Fusion Proteins; D000077944:Alefacept