Fingolimod: A Review of Its Use in Relapsing-Remitting Multiple Sclerosis

@article{Sanford2014FingolimodAR,
  title={Fingolimod: A Review of Its Use in Relapsing-Remitting Multiple Sclerosis},
  author={Mark Rep Sanford},
  journal={Drugs},
  year={2014},
  volume={74},
  pages={1411-1433}
}
  • M. Sanford
  • Published 26 July 2014
  • Medicine, Psychology
  • Drugs
Fingolimod (Gilenya®) is an orally administered disease modifying agent (DMA) for use in relapsing-remitting multiple sclerosis (RRMS). In placebo-controlled trials in patients with RRMS with active disease, fingolimod 0.5 mg/day significantly reduced the annualized relapse rate (ARR) by approximately one-half over 2-year trial periods. It also significantly increased the proportion of patients with no disability progression, reduced deterioration from baseline in the Extended Disability Status… 

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References

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A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis.

Both doses of oral fingolimod improved the relapse rate, the risk of disability progression, and end points on MRI and were superior to placebo with regard to MRI-related measures.

Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.

This trial showed the superior efficacy of oral fingolimod with respect to relapse rates and MRI outcomes in patients with multiple sclerosis, as compared with intramuscular interferon beta-1a.

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Fingolimod was generally well tolerated in these trials of up to 2 years' duration, with most adverse events being manageable and of mild to moderate severity; there were two deaths from opportunistic infections, albeit these occurred with fingolIMod 1.25 mg/day (higher than the recommended dosage).

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Fingolimod therapy significantly increased the proportion of patients with MS who were free of disease activity compared with IFN beta-1a IM over 12 months.
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