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  • Title: Natalizumab: safety and risk in patients with relapsing-remitting multiple sclerosis.
    Author: Rodríguez de Castro B, Barbosa CM, Ayastuy Ruiz A, Fernández González B.
    Journal: Eur J Hosp Pharm; 2021 Mar; 28(2):112-114. PubMed ID: 33608441.
    Abstract:
    OBJECTIVE: To estimate the risk of progressive multifocal leukoencephalopathy (PML) and the safety of natalizumab administration in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: A descriptive retrospective observational study including all patients with RRMS treated with natalizumab followed-up after 10 years.The likelihood of developing PML was estimated based on three risk factors: anti-John Cunningham virus antibody index, previous immunosuppressive therapy, and duration of treatment. Patients were classified into five categories: minimum probability (<0.1/1000); low (0.1/1000); medium-low (0.2-0.6/1000); medium-high (0.8-3/1000); high probability (3-10/1000). RESULTS: 34 patients were included. The probability of PML in the last cycle was: 55.9% minimum, 8.8% low, 11.8% medium-low, 3% medium-high, and 20.5% high. 12 patients continue with active treatment with natalizumab. No cases of PML have been confirmed. Adverse effects were detected in 50% of patients. CONCLUSIONS: Quantifying risk factors allows us to estimate the probability of PML appearance, thus assessing the maintenance or suspension of natalizumab.
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