Background: The efficacy and safety of one and two courses of alefacept have been demonstrated in phase 2 and 3 clinical trials, with a course of alefacept defined as 12 weeks of once-weekly treatment followed by 12 weeks of observation.
Methods: This randomized, single-center study compared the safety and efficacy of a standard 12-week versus extended 16-week alefacept dosing period in 20 patients with chronic plaque psoriasis.
Results: Both dose groups showed marked improvement in mean Psoriasis Area and Severity Index (PASI) score from baseline through week 24 (between-group difference: not significant). In each group, 60% of patients achieved PASI 50 (> or =50% reduction from baseline PASI score) at any time between weeks 12 and 24. For patients who received 16 weeks of alefacept, the mean percentage change from week-12 PASI score was higher and continued to increase through week 24 compared with that for patients who received 12 weeks of alefacept (P < .05). Adverse events were similar between the two groups and comparable with those observed in phase 2 and 3 clinical studies of alefacept.
Conclusions: This was an open-label, single-center study of 20 patients. Further study is warranted to assess the effect of alefacept when administered for more than 12 weeks. Extended dosing with alefacept appeared to have a similar safety profile to 12-week dosing and may offer further benefit to some patients for disease improvement.