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Treatment of relapsing-remitting multiple sclerosis with fingolimod in routine clinical practice

C. Alcalá-Vicente, F.C. Pérez-Miralles, F. Gascón-Giménez, I. Boscá-Blasco, A. Navarré-Gimeno, F. Coret-Ferrer, B. Casanova-Estruch [REV NEUROL 2017;64:445-453] PMID: 28497440 DOI: https://doi.org/10.33588/rn.6410.2016359

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Volumen 64 | Number 10 | Nº of views of the article 8.345 | Nº of PDF downloads 490 | Article publication date 16/05/2017

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ABSTRACT

INTRODUCTION Fingolimod is a selective immunosuppressant that targets the S1P receptor, and is indicated in the treatment of aggressive relapsing-remitting multiple sclerosis (RRMS) and following treatment failure with first-order drugs.

AIM To investigate the safety and effectiveness of fingolimod under the conditions of routine clinical practice.

PATIENTS AND METHODS We conducted an observational study with prospective follow-up of patients with RRMS who received fingolimod from January 2011 until February 2014. Data assessed were the annualised relapse rate (ARR), disability measured by the Expanded Disability Status Scale (EDSS), magnetic resonance activity and the appearance of side effects.

RESULTS Our sample consisted of 122 patients, 79.5% of them females and with a mean age of 26.8 years. They were classified, according to the last treatment received, as being: naïve (aggressive RRMS; n = 17), previous treatment failure (n = 67) and withdrawal of natalizumab due to risk of progressive multifocal leukoencephalopathy (n = 38). After a mean follow-up of 29.9 ± 15.9 months, the ARR and the appearance of new lesions with gadolinium enhancement were reduced in both the naïve and the previous treatment failure groups. There were no differences between the various subgroups as regards the progression of EDSS or the time elapsed until the first attack or treatment failure. The risk of treatment failure is higher with a baseline EDSS > 3 (hazard ratio: 4.24; p = 0.001) and presence of IgM oligoclonal bands (hazard ratio: 2.45; p < 0.022).

CONCLUSIONS Fingolimod is an effective and well-tolerated drug under conditions of routine clinical practice. Having a baseline EDSS > 3 and IgM oligoclonal bands is predictive of a poor response to fingolimod. KeywordsFingolimod IgM oligoclonal bands Relapsing-remitting multiple sclerosis Treatment CategoriesEsclerosis múltiple

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Original

Treatment of relapsing-remitting multiple sclerosis with fingolimod in routine clinical practice