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

Research output: Contribution to journalArticlepeer-review


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 - Dec 1 2015


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

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology


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