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Natalizumab, initially introduced for treatment of relapsing forms of multiple sclerosis (MS) in November 2004, was abruptly withdrawn 3 months later when three clinical trial participants were found to have developed progressive multifocal leukoencephalopathy (PML). Two participants had MS and had received the combination of natalizumab and interferon beta-1a. The drug was subsequently reintroduced in a carefully controlled program.
Now, Kappos and colleagues have reviewed the clinical results of treatment with natalizumab and its association with PML to provide risk-management guidelines. The authors are MS neurologists and PML experts, some of whom were investigators in the original clinical trials. These authors highlight the inability t…