Abstract
I read with interest the analysis by Thompson et al.1 that assessed the risks and benefits of natalizumab in relapsing multiple sclerosis (MS). The study is based on an incorrect assumption and does not consider another fatal complication besides progressive multifocal leukoencephalopathy (PML). Following reports of the development of PML under natalizumab therapy, it is currently approved in a subgroup of patients with MS who “have had an inadequate response to, or are unable to tolerate, alternate therapies.”2 However, this indication is based on the observed effect of natalizumab in two studies that did not examine its impact in the selective subgroup of patients with MS who already had not responded to immunosuppressive therapy.3 Ironically, it seems that natalizumab is indicated for a clinical setting in which it was not tested. The current therapeutic approach in MS is based on the unproven assumption that relapses in MS are due to acute CNS inflammation and therefore immunomodulating or immunosuppressive therapies are aimed at preventing the immune …
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