4CPS-137 Natalizumab: a review of its use in the management of multiple sclerosis, experience in a university hospital

BackgroundNatalizumab is the first licensed treatment, given by infusion, monthly, for highly active relapsing-remitting multiple sclerosis or rapidly evolving severe MS. It is not a cure, its safety issues represent a relevant limitation and impose strict clinical surveillance mainly because of the risk of progressive multi-focal leukoencephalopathy (PML), (a potentially lethal brain disorder.PurposeReview of use: effectiveness, safety, reason for start or switch.Material and methodsRetrospective observational study 2015–2018.Treatment history, demographic and clinical data were collected from medical recordsWe assessed effectiveness by the change in expanded disability status scale (EDSS), defined by Fernandez et al: improvement, a decrease of ≥1 point, stability, a change of 2 years, prior immunosuppressive treatment and positive serum JC virus antibodies.ResultsFifty-six patients, 57% female, mean age at diagnosis 26.4.Eleven patients received Natalizumab as first option and 45 were switched because of lack of efficacy with one or two immunomodulatory drugs prior to Natalizumab.Most patients were still ambulatory when they began treatment (median EDSS 2.00).Mean treatment duration was 3.3 years (1–10 years).Over the study period, the age of starting natalizumab has decreased and the total number of treated patients has increased from 31 to 56. Natalizumab was generally well tolerated, as only four left for the reason of inefficacy and one for PML.Stabilisation of EDSS was achieved for 70% of patients:; only 10% showed worsening.Forty patients showed no risk for PML (