Amevive^® (Alefacept)

Content:

EFFICACY

This can be measured in different ways:

1. Reduction in PASI (does not always correlate well with reduction in disease)

Psoriasis area and severity index
% surface area involved, redness, thickness and severity of scaling is measured for each body area

Example of PASI reduction:


Baseline PASI 14.2	2 Weeks After Last Dose PASI 9.5	12 Weeks After Last Dose PASI 4.8

2. Reduction in QoL index

A measure of the reduction in the quality of life index which may accompany clinical improvement

One 12 week course (phase III trial)

PASI reduction with 15mg im. weekly for 12/52
75%+ reduction in 33% of patients after 1 course of therapy
50%+ reduction in 57% of patients after 1 course of therapy

[Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J, and Griffiths CEM for the Alefacept Clinical Study Group. An international, randomized, double-blind, placebo-controlled Phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol. 2003; 139:719-727.]

Second Course

Second course of Alefacept increases efficacy without increased side effects

75%+ reduction in 43% of patients after 2nd course of therapy
50%+ reduction in 69% of patients after 2nd course of therapy
Gordon KB and Langley R. Remittive effects of intramuscular alefacept in psoriasis. J Drugs Dermatol. 2003;2(5):494-500

7 out of 10 patients achieved a reduction in PASI score of > 50% after two courses of therapy

Baseline	2 Weeks After 1st Course	2 Weeks After 2nd Course	12 Weeks After 2nd Course Reduction

PASI 12.8	PASI 5 61% PASI Reduction	PASI 1.3 90% PASI Reduction	PASI 0.5 96% PASI Reduction

Median duration of response in the PASI 75% improvement group was 209 days for 1 course and 245 days for those with an almost clear response
After a second course remissions lasted for over 1 year on average in patients that achieved a PASI 75% reduction
No rebound or flare ups were seen in psoriasis on stopping therapy
Clinical meaningful results shown to last 7 months after one course of Alefacept

Dermatology QoL index

Dermatology life quality index
70% improvement in DLQI in the groups with PASI reduction of 75% as well as in the almost clear and clear patients
It is significant that the 50% PASI reduction patients also displayed a 60% improvement in DLQI scores

Psoriatic Arthritis

Preliminary results of phase II trials show Alefacept is effective
All patients on stable doses of methotrexate (12.5–15 mg/wk)
67% ACR 20 (p = 0.036)
Adverse events were the same in the placebo and Alefacept groups
Schneider M. Presented at: European League Against Rheumatism; June 18-21, 2003; Lisbon, Portugal.

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