Best practice recommendations for the selection and management of patients with multiple sclerosis receiving natalizumab therapy

Natalizumab, a humanized monoclonal antibody directed against alpha(4)-integrin is a first-in-class disease-modifying therapy for the treatment of relapsing multiple sclerosis. Natalizumab is highly effective but has been associated with a risk of progressive multifocal leukoencephalopathy. Since the efficacy of natalizumab in relapsing forms of multiple sclerosis is viewed as superior to first-line agents, a growing number of neurologists are using natalizumab as the treatment of choice for patients with worsening MS. Owing to the recently reported cases of progressive multifocal leukoencephalopathy, a panel of neurologists met in February 2009 to discuss best practices for the use of natalizumab, with the goal of developing consensus-based recommendations on patient management to minimize the risk of progressive multifocal leukoencephalopathy. The panel consisted of a cross section of academic and community neurologists from the United States who treat multiple sclerosis in large centers and have extensive experience with natalizumab (approximating 2000 patient-years combined experience). This paper summarizes the panel's recommendations on the following: (1) appropriate patient selection for natalizumab; (2) routine monitoring and management of adverse events during natalizumab therapy; and (3) clinical vigilance monitoring and risk reduction for progressive multifocal leukoencephalopathy.