Relapses in patients treated with fingolimod after previous exposure to natalizumab

Mult Scler. 2015 May;21(6):786-90. doi: 10.1177/1352458514549404. Epub 2014 Sep 25.


In post hoc analyses of an open-label, phase 3b study (FIRST), relapse rates during 4 months of fingolimod therapy were compared in patients with and without previous natalizumab exposure. Reductions in the proportion of patients experiencing relapses and annualized relapse rates (ARRs) from years 1 and 1-2 pre-study were evident between months 1 and 2 of fingolimod treatment, and were most pronounced in natalizumab-naïve patients and those who discontinued natalizumab >6 months pre-study. Patients who discontinued natalizumab 3-6 months pre-study had a peak ARR during month 1 of fingolimod treatment, followed by a decrease during months 2-4. These data indicate that fingolimod has the potential to reduce disease reactivation but that timing of treatment initiation may be critical for achieving an optimal effect.

Keywords: ARR; FIRST; Fingolimod; multiple sclerosis; natalizumab; relapse control.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Clinical Trials, Phase III as Topic
  • Female
  • Fingolimod Hydrochloride / administration & dosage
  • Fingolimod Hydrochloride / adverse effects
  • Fingolimod Hydrochloride / pharmacology*
  • Humans
  • Immunologic Factors / administration & dosage
  • Immunologic Factors / adverse effects
  • Immunologic Factors / pharmacology*
  • Male
  • Middle Aged
  • Multiple Sclerosis, Relapsing-Remitting / drug therapy*
  • Natalizumab / therapeutic use*
  • Time Factors
  • Treatment Outcome


  • Immunologic Factors
  • Natalizumab
  • Fingolimod Hydrochloride