Long-term results from a phase 2 extension study of fingolimod at high and approved dose in relapsing multiple sclerosis

Xavier Montalban*, Giancarlo Comi, Jack Antel, Paul O’Connor, Ana de Vera, Malika Cremer, Nikolaos Sfikas, Philipp von Rosenstiel, Ludwig Kappos

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

15 Citations (Scopus)


Fingolimod safety and efficacy data in relapsing–remitting multiple sclerosis (RRMS) are available up to 5 years, from an extension of a randomized, placebo-controlled, double-blind, phase 2 study, at a dose higher (5.0/1.25 mg) than the approved dose of 0.5 mg. The objective of the study is to present the end-of-study data (>7 years) from the open-label extension of the phase 2 study. In the core phase (6 months), patients (N = 281) were randomized to placebo or fingolimod 1.25/5 mg. In the extension, placebo patients were randomized to fingolimod 1.25/5 mg. All patients received open-label 1.25 mg fingolimod after month 24 and 0.5 mg after month 60. Clinical visits were performed every 3 months, expanded disability status scale (EDSS) every 6 months and magnetic resonance imaging (MRI) annually. 122 (48.8 %) patients completed the extension study; overall fingolimod exposure was 1230.7 patient-years. The most common (>10 %) reasons for study discontinuation were adverse events (19.6 %) and consent withdrawal (16.4 %). Fingolimod treatment for >7 years was associated with sustained low clinical and MRI disease activity. Over 60 % of patients remained relapse free and about 80 % were free from any MRI activity. Overall annualized relapse rate was 0.18. Long-term fingolimod treatment was not associated with new safety concerns. Long-term fingolimod was well tolerated and associated with a sustained low level of disease activity.

Original languageEnglish
Pages (from-to)2627-2634
Number of pages8
JournalJournal of Neurology
Issue number12
Publication statusPublished - 1 Dec 2015


  • Disease-modifying therapy
  • Fingolimod
  • Long term
  • Phase 2
  • Relapsing–remitting multiple sclerosis
  • Sphingosine 1-phosphate receptor modulator


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