Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter

 

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:


Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter
   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
Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter Amevive® (Alefacept) - A - Detailing from Skin Therapy Letter
   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.

Next:   Compliance