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Area of Science:

  • Neurology
  • Pharmacology

Background:

  • Fingolimod is an oral sphingosine-1-phosphate receptor modulator used for multiple sclerosis (MS).
  • Real-world data on fingolimod's effectiveness and tolerability in clinical practice are valuable for understanding its use beyond controlled trials.

Purpose of the Study:

  • To evaluate the clinical experience with fingolimod in a real-world academic medical center setting.
  • To assess adverse events, clinical outcomes, MRI findings, and quality of life in patients treated with fingolimod.

Main Methods:

  • A cohort of 317 patients initiated on fingolimod between October 2010 and August 2011 was identified.
  • Patients were followed for 12 months, with data collected on adverse effects, clinical relapses, MRI activity, and quality of life.

Main Results:

  • Fingolimod was discontinued by 24.8% of patients, primarily due to adverse effects (40 patients) or breakthrough disease (22 patients).
  • Among patients with 12-month follow-up, 87.3% remained relapse-free, and 83.7% had no relapses or gadolinium enhancement.
  • Quality of life measures remained stable throughout the follow-up period.

Conclusions:

  • Fingolimod discontinuation rates in clinical practice were higher than observed in clinical trials.
  • Adverse effects and breakthrough disease were the main reasons for treatment cessation.
  • The study confirms fingolimod's efficacy in controlling disease activity for most patients, consistent with phase 3 trial findings, while highlighting common tolerability issues in clinical practice.