2.1
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.
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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'.
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Patients with high disease activity despite treatment with beta interferon. This 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'.