Safety issue puts daclizumab in doubt for MS
Posted: Mon Oct 15, 2012 12:08 pm
Daclizumab, a biologic drug targeting the interleukin-2 pathway, showed sustained efficacy in the second year of a phase II trial in multiple sclerosis, but serious autoimmune issues also emerged, researchers said here.
In a randomized extension study of high-yield process daclizumab called SELECTION, efficacy according to most measures was maintained or even increased in relapsing-remitting MS patients who had participated in the one-year SELECT trial, according to Gavin Giovannoni, MD, of Queen Mary University in London.
But one patient died from autoimmune hepatitis and two others developed autoimmune conditions affecting vital organs, he reported at a late-breaking abstract session at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis.
Hepatic monitoring in the daclizumab clinical program was stepped up after the potential for such effects was recognized, Giovannoni said. Nevertheless, other researchers suggested that the problem was serious enough to jeopardize the drug's future in MS.... Read More -
http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1502