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Usefulness of electronic drug registers: Spanish register of patients treated with fingolimod (Gilenya ®)

Ó. Fernández, A. Rodríguez-Antigüedad, C. Oreja-Guevara, M. Garcia-Garcia, X. Montalbán, e.r. [REV NEUROL 2014;58:77-83] PMID: 24399624 DOI: https://doi.org/10.33588/rn.5802.2013076

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Volumen 58 | Number 02 | Nº of views of the article 6.104 | Nº of PDF downloads 334 | Article publication date 16/01/2014

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ABSTRACT

INTRODUCTION This study outlines the design of an electronic register of patients with multiple sclerosis who began treatment with fingolimod in Spain. The system is intended to serve as a tool to monitor its utilisation in daily clinical practice and thus allow optimisation of the way it is used. AIMS. To establish the profile of patients with multiple sclerosis undergoing treatment with fingolimod and to determine the effectiveness and safety of this treatment in daily clinical practice. DEVELOPMENT. An observation-based, retrospective and prospective, multi-centre registry is set up, which will be active for five years. Forty neurologists working in Spain will participate in the project. Patients treated with fingolimod who fulfil the selection criteria will be included in the study. The effectiveness variables that will be evaluated are: disability measured by means of the Expanded Disability Status Scale, the rate of attacks, T1 gadolinium-enhancing lesions and new lesions in T2, and the percentage of patients who were free of activity and those who require concomitant treatments. The tolerability variables that will be evaluated are: the rate of patients who present events and adverse reactions, respectively, with a separate analysis of those presenting after the first dose or that are related to the fingolimod risk management plan and the treatment dropout rate.

CONCLUSIONS New pharmaceuticals that have only recently been commercialised require more information about their effectiveness and safety, beyond the controlled environment of a clinical trial. Initiatives involving electronic registries such as the Gilenya register are a solution that can respond to such needs by providing information in the shortest possible time about the most suitable management in order to be able to make the best and most efficient use of it. KeywordsClinical-epidemiological profile Electronic case registry Fingolimod Multiple sclerosis Treatment CategoriesEsclerosis múltiple

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Usefulness of electronic drug registers: Spanish register of patients treated with fingolimod (Gilenya ®)