Baseline characteristics associated with NEDA-3 status in fingolimod-treated patients with relapsing-remitting multiple sclerosisReportar como inadecuado

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Multiple Sclerosis and Demyelinating Disorders

, 2:10

First Online: 26 June 2017Received: 08 March 2017Accepted: 28 April 2017


BackgroundFingolimod is an efficacious treatment for relapsing-remitting multiple sclerosis RRMS and there is class I evidence that it is superior to standard care in reducing relapse rate. However, real-world data investigating its effectiveness and potential predictors of response are still scarce.

ObjectiveTo estimate i the proportion of fingolimod-treated patients who achieved the no evidence of disease activity NEDA-3 status; and ii to determine which baseline i.e. at treatment start clinical and magnetic resonance imaging MRI variables were associated with better outcomes.

MethodsWe collected clinical and MRI data of RRMS patients treated with fingolimod and followed-up for 24 months. The proportion of patients who had NEDA-3 - i.e. absence of relapses, sustained Expanded Disability Status Scale EDSS worsening and radiological activity on MRI - was estimated. A Cox proportional hazard model was carried out to investigate which baseline characteristics were associated with the NEDA status at follow-up.

ResultsWe collected data of 201 patients who started fingolimod. Of them, 24 12% were treatment-naïve, 115 58% were switched after failing a self-injectable drug, and 60 30% switching from natalizumab. Five patients who discontinued fingolimod early within 3 months bradycardia, n = 2; leukopaenia, n = 2; macular oedema, n = 1 were removed from the analysis. At follow-up, 118 60% patients achieved the NEDA-3 status, while 78 experienced clinical and-or MRI activity. The risk of not achieving the NEDA-3 status was associated with higher baseline EDSS score hazard ratio HR = 1.18, p = 0.024 and more relapses in the 12 months prior to fingolimod start HR = 1.61, p = 0.014.

ConclusionOur findings suggest that fingolimod may lead to a better control of the disease if started in patients with a less aggressive disease i.e. fewer pre-treatment relapses and milder disability level, thus supporting its possible role as an early treatment for MS.

KeywordsMultiple sclerosis 190 Clinical outcome measures 40 Therapeutics 360 Fingolimod  Download fulltext PDF

Autor: Manuela Giuliani - Alessandra Logoteta - Luca Prosperini - Maria Neve Hirsch - Carlo Pozzilli


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