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Safety profile of siplizumab for the treatment of psoriasis


The results of two multicenter, randomized, double-blind, placebo-controlled phase II studies provided data on the safety profile of i.v. and s.c. siplizumab (SIP; Medimmune LLC) in a total of 554 randomized patients (aged 18-65 years) with plaque psoriasis. The i.v. study assessed doses of 0.012 and 0.04 mg/kg SIP or placebo every 2 weeks for 8 weeks. The s.c. study tested 3 regimens of SIP (5 mg x 12 weeks; 5 mg x 6 weeks; 7 mg x 4 weeks or placebo x 12 weeks). Adverse events (AEs) and laboratory values were monitored. The most common acute AEs reported by > 10% of all SIP patients were chills, headache, hypertension, ...

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