Safety and Efficacy of 16 Weeks of 30 mg/Week Intramuscular Alefacept in the Treatment of Chronic Plaque Psoriasis

Abstract

Background

The biological agent alefacept (Amevive) induces sustained clinical improvement in patients with chronic plaque-type psoriasis.¹ Multiple or extended courses of therapy are associated with higher response rates and an increased duration of results.^2,3

Objective

To obtain pilot information on the safety and efficacy of a 16-week course of intramuscular alefacept in doses of 30 mg per week.

Methods

All subjects in this open-label, single-center study received a starting dose of 15 mg intramuscular (IM) alefacept, followed by 30 mg per week for 15 weeks. Outcomes were assessed every two weeks throughout the 16-week drug administration phase and every four weeks during the 12-week follow-up phase using the Psoriasis Area and Severity Index (PASI), the Physician Global Assessment (PGA), Subject's Global Assessment (SGA), pruritus visual analog scale (VAS), measurement of CD4 counts and adverse event reporting.

Results

Of the 19 enrolled subjects, 17 completed treatment and 16 completed 12-week follow-up. PASI, PGA, SGA, and VAS scores improved from baseline to week 16 with 59% of subjects achieving a 50% reduction in PASI (PASI 50), and 18% achieving a 75% reduction (PASI 75). Clinical improvement occurred during the treatment phase and continued into follow-up. CD4 counts decreased significantly from week 2 to week 16, but a linear trend was not seen. No adverse events occurred that required discontinuation of treatment. One subject had a CD4 count < 250 cells/μL for 4 consecutive weeks, leading to the discontinuation of treatment in accordance with the protocol.

Conclusion

A16-week extended course of higher dose (30 mg) IM alefacept was well-tolerated and may offer additional therapeutic benefit to some patients. However, the higher dose and extended course did not dramatically improve efficacy seen with lower doses in previous trials.