Abstract
Natalizumab is the first monoclonal antibody approved for the treatment of relapsing forms of multiple sclerosis (MS). After its initial approval, three patients under natalizumab therapy were diagnosed with progressive multifocal leukoencephalopathy (PML). The agent was later reapproved, and its use restricted to monotherapy in patients with relapsing forms of MS. Based on its potency, natalizumab has changed expectations among neurologists about which end points can be achieved with modern immunotherapies today. On the other hand, natalizumab prompted a new era of weighing risks and benefits in MS treatment, an ongoing discussion for most of the recently approved MS therapies. With the increasing knowledge about PML, its early detection by magnetic resonance imaging as well as the risk stratification by measuring anti-John Cunningham virus antibodies, active pharmacovigilance is becoming part of the daily routine when treating MS patients.
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