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November 4, 2012
11:02 EDTALXNAlexion:Data show substantial improvement with Soliris in patients with STEC-HUS
Alexion Pharmaceuticals announced the presentation of 28-week data from all enrolled patients in a multi-center trial of eculizumab, Soliris, in patients who developed Shiga-toxin-producing E. coli hemolytic uremic syndrome, STEC-HUS, during an outbreak in Germany from May 2011 to July 2011. In the study, eculizumab therapy was associated with rapid and sustained clinical improvements in thrombotic microangiopathy, TMA, and systemic organ complications. The study met its primary endpoint of global assessment of efficacy at 8 weeks with 94% of patients achieving a complete or partial response in systemic TMA and vital organ involvement. Key secondary endpoints were also met with high clinical and statistical significance, including global assessment of efficacy at 28 weeks as well as improvement in hematologic, renal and neurologic functions. Preliminary findings from an exploratory post hoc, matched-control analysis of patients with severe STEC-HUS receiving eculizumab versus other patients who received current best supportive care during the German epidemic were also reported, and showed that eculizumab treatment was associated with consistently higher rates of renal and neurological function improvement at weeks 8 and 28.1
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