Natalizumab is the first monoclonal antibody licensed for the treatment of relapsing-remitting multiple sclerosis (RRMS) 1. Natalizumab was licensed by the European Medicines Agency in 2006 with a restricted indication 2. Mainly, natalizumab is used for patients with insufficient response to alternative first-line disease-modifying therapies (DMTs), i.e. p-interferon (IFN-P) or glatiramer acetate (GA), or for patients with aggressive MS. Intolerance of other DMTs may occasionally also account for switching to natalizumab.No prospective, randomized placebo-controlled trials have been conducted to provide class I or II evidence-based guidance for treatment decisions in patients with insufficient response to first-line DMTs. Also, it is unclear how to treat patients who discontinue natalizumab treatment. However, discontinuation occurs in approximately 10 in clinical practice due to hypersensitivity, neutralizing antibodies (NABs) against natalizumab, insufficient response or a combination of these 3. Considering that about 60,000 patients worldwide have had exposure to natalizumab (of whom 6,000 will not continue this treatment) 4, it is of clinical relevance to investigate strategies for patients who were eligible for natalizumab treatment but who have to discontinue it.
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