Position and practical use of fingolimod in Europe

Research output: Contribution to journalArticle

Abstract

Approval of fingolimod in 2011 heralded the era of oral therapies for multiple sclerosis (MS) in the European Union. Uptake of fingolimod across Europe was widespread, even though its indication was predominantly second-line; that is, for patients with a lack of response to interferon beta or those with highly active relapsing-remitting MS (RRMS). Safety concerns raised with the European Medicines Agency culminated in the revision of the European Union labeling for first-dose management in 2012. However, in addition to evidence from the pivotal clinical trials, cumulating real-world fingolimod experience in Europe provides reassurance on its safety and efficacy. Studies show that switching to fingolimod from approved first-line injectable therapies is beneficial for patients who might otherwise switch to another interferon beta or glatiramer acetate. Furthermore, in several recent European studies of patients who switched to fingolimod from natalizumab, disease control was improved compared with drug withdrawal and no immunomodulatory treatment, or withdrawal and first-line treatment, including the Disease Control and Safety in Patients with RRMS Switching from Natalizumab TO FINGOlimod (TOFINGO) study, which supported a shorter washout period before switching. The safety profile shown in clinical trials is supported by post-marketing observations; any first-dose effects on heart rate are managed easily, and severe complications as a result of herpes viral infections are rare. The use of newer oral drugs remains a key topic of discussion, in light of the recognized importance of an early shift of suboptimal responders to another therapy. The information on fingolimod summarized in the present review may contribute to define its role further in RRMS treatment in Europe.

Original languageEnglish
Pages (from-to)19-33
Number of pages15
JournalClinical and Experimental Neuroimmunology
Volume5
Issue number1
DOIs
Publication statusPublished - 2014

Fingerprint

Interferon-beta
European Union
Safety
Therapeutics
Pragmatic Clinical Trials
Relapsing-Remitting Multiple Sclerosis
Virus Diseases
Patient Safety
Fingolimod Hydrochloride
Marketing
Pharmaceutical Preparations
Multiple Sclerosis
Heart Rate
Clinical Trials
Injections
Natalizumab
Glatiramer Acetate

Keywords

  • Europe
  • fingolimod
  • multiple sclerosis

ASJC Scopus subject areas

  • Clinical Neurology
  • Immunology and Microbiology (miscellaneous)
  • Neuroscience (miscellaneous)
  • Immunology

Cite this

Position and practical use of fingolimod in Europe. / Comi, Giancarlo.

In: Clinical and Experimental Neuroimmunology, Vol. 5, No. 1, 2014, p. 19-33.

Research output: Contribution to journalArticle

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