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Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

Natalizumab is a monoclonal antibody that acts as an α4 integrin antagonist to prevent leukocyte trafficking into the central nervous system (1)

Natalizumab (branded and biosimilar) has a marketing authorisation as a single disease-modifying therapy in highly active relapsing-remitting multiple sclerosis for the following groups (2):

  • patients with rapidly evolving severe relapsing–remitting multiple sclerosis defined by 2 or more disabling relapses in 1 year, and 1 or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared with a previous MRI. This patient group is referred to as the 'RES group'
  • patients with high disease activity despite treatment with beta interferon
    • group is defined as patients who have failed to respond to a full and adequate course of a beta interferon
    • patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintensive lesions in cranial MRI or at least 1 gadolinium-enhancing lesion
    • this patient group is referred to as the 'suboptimal therapy group'

NICE state (2):

  • natalizumab (branded or biosimilar) is recommended as an option for the treatment only of rapidly evolving severe relapsing - remitting multiple sclerosis (RES‑RRMS) in adults. RES‑RRMS is defined by 2 or more relapses in the previous year, and baseline MRI evidence of disease activity


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