Efficacy:
Efficacy 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.
