Time for change - Evolution of real-world evidence outcome measures in multiple sclerosis exemplified by fingolimod

Mefkure Eraksoy, Helmut Butzkueven, Tjalf Ziemssen, Robert Zivadinov

Research output: Contribution to journalArticleOtherpeer-review

8 Citations (Scopus)


Real-world evidence provides important information concerning the long-term effectiveness and safety of disease-modifying treatments (DMTs) for multiple sclerosis (MS) in clinical practice in a large number of patients. These data enhance and extend the results from randomised clinical trials and include information that cannot easily be obtained in trials such as treatment efficacy in non-trial populations (e.g. those with co-morbidities, older patients and children) and long-term safety analyses. Such data are compatible with specialist clinical practice and, when accumulated in multicentre databases using an agreed minimum dataset, these data can provide invaluable information on long-term disease progression and treatment. Real-world evidence in terms of fingolimod is reviewed and clearly demonstrates its long-term effectiveness and safety. Currently, imaging data are not systematically collected but the development of improved standard magnetic resonance imaging (MRI) protocols and automated procedures now makes this a realistic option in the near future. Automated (or largely automated) MRI analytics are likely to greatly enhance and further strengthen real-world evidence for outcomes of different treatment algorithms incorporating more sophisticated MRI measures.

Original languageEnglish
Pages (from-to)136-142
Number of pages7
JournalEuropean Neurological Review
Issue number2
Publication statusPublished - 1 Jan 2014
Externally publishedYes


  • Databases
  • Effectiveness
  • Fingolimod
  • Multiple sclerosis
  • Real-world data
  • Real-world evidence
  • Registries

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