An International, Randomized, Double-blind, Placebo-Controlled Phase 3 Trial of Intramuscular Alefacept in Patients With Chronic Plaque Psoriasis

Abstract

Background: Alefacept, human lymphocyte functionassociated 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.

Rapid response to alefacept given to patients with steroid resistant or steroid dependent acute graft-versus-host disease: a preliminary report

“…alefacept once weekly as previously reported. 1 He responded quickly (see below) but exacerbation of the GVHD was seen after 5 days, the dose was repeated and he again responded ( Figure 1). Following this patient, pediatric patients were treated with i.m.…”

“…for study 2) of placebo or alefacept in adults with chronic plaque psoriasis, the response to alefacept was significantly better. 19,20 In both studies, onset of response to alefacept treatment (defined as at least 50% reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after the initiation of therapy. I.m.…”

“…It is successfully used in psoriasis, a T-cell-dependent autoimmune disease. 1,2 Onset of response to alefacept treatment was shown to begin 60 days after initiation of therapy while the median duration of response was 3.5 months.…”

Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

“…20,674 articles were found, of which 20,592 were excluded, resulting in 82 articles in which 41 clinical trials comparing biologics with placebo (six adalimumab 17,18,19,20,21,22,23,24,25,26,27 , three alefacept 28,29,30,31,32,33,34,35,36,37 , one briakinumab 38,39 , one certolizumab 40 , seven efalizumab 41,42,43,44,45,46,47,48,49,50,51 , eight etanercept 52,53,54,55,56,57,58,59,60,61,62,63,64 , one golimumab 65,66 , eight infliximab …”

Alefacept treatment for refractory chronic extensive GVHD

“…It is successfully used in psoriasis 1,2 and is being used (off label) in a variety of other disorders. 3 In addition, in psoriatic patients, it was already reported that alefacept causes a selective reduction in circulating effector memory T cells 4 and that there is a reduction in the total number of conventional memory T and natural killer (NK)-T cells, whereas no statistically significant changes were seen in NK cells and CD4 þ 25 þ .…”