Open label trial of alefacept in palmoplantar pustular psoriasis

BACKGROUND: Palmoplantar pustular psoriasis (PPP) is difficult to treat. We assessed the effectiveness of alefacept in PPP and the safety of a 30 mg/week dose. METHODS: Fifteen individuals with PPP were started on 15 mg/week intramuscularly (IM) alefacept. Efficacy was measured by the PPP severity instrument (PSI). Treatment was continued for 16 weeks, and the alefacept dose was increased to 30 mg/week IM at week 9 if the PSI did not decrease by at least 25%. Other outcomes included physician's global assessment (PGA), reported adverse events and CD4+ T-lymphocyte counts. Clinical response was observed for 12 weeks after the last injection. RESULTS: The severity of PPP improved in both the PSI and the PGA (p<0.0001 and p = 0.0009, respectively). Much of the improvement occurred after 10 weeks of therapy. Nail severity scores improved (p = 0.0003). CD4+ counts decreased, but all remained >250 cells/mm3. There were no severe adverse effects or discontinuations due to adverse events. CONCLUSIONS: Alefacept in doses up to 30 mg/week was well tolerated in patients with PPP and appeared to have some efficacy. The use of concomitant therapy, the lack of a comparator, and the small sample size are limitations of the study.