Abstract
The recombinant humanized monoclonal antibody eculizumab (Soliris®) is a complement inhibitor that is indicated for use in the treatment of atypical haemolytic uraemic syndrome (aHUS). In two open-label, single-arm, multinational, 26-week, phase II trials, intravenous eculizumab inhibited complement-mediated thrombotic microangiopathy in patients aged ≥12 years with aHUS. At 26 weeks, the platelet count was significantly increased in patients with progressing thrombotic microangiopathy, and thrombotic microangiopathic event-free status was achieved in 80 % of patients with a long disease duration and chronic kidney disease who had received previous long-term plasma exchange/infusion. The beneficial effects of eculizumab on renal function were maintained long term and the proportion of patients meeting criteria for improvement in renal function increased over 2 years of therapy. Intravenous eculizumab was generally well tolerated. In conclusion, eculizumab is a valuable new agent for use in the treatment of aHUS.
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