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Half-dose fingolimod for treating relapsing-remitting multiple sclerosis: Observational study.

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Fingolimod every other day (FTY-EOD) in multiple sclerosis patients showed increased risk of relapses and new lesions compared to daily dosing (FTY-ED). Caution is advised for FTY-EOD, particularly in younger patients or those with prior natalizumab treatment.

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Area of Science:

  • Neuroscience
  • Immunology
  • Pharmacology

Background:

  • Fingolimod (FTY) is a sphingosine-1-phosphate receptor modulator used to treat multiple sclerosis (MS).
  • Dosage adjustments, such as every-other-day (FTY-EOD) administration, are explored to optimize treatment strategies.
  • Understanding the comparative efficacy and safety of different dosing regimens is crucial for MS management.

Purpose of the Study:

  • To compare the efficacy and safety of fingolimod 0.5 mg administered every other day (FTY-EOD) versus every day (FTY-ED) in patients with multiple sclerosis.
  • To identify factors associated with switching to FTY-EOD and assess the risk of disease reactivation.

Main Methods:

  • Multicentre retrospective observational study involving 60 FTY-EOD and 63 FTY-ED patients.
  • Propensity score-adjusted Cox and linear regressions were used to analyze efficacy in preventing relapses and demyelinating lesions.
  • Baseline characteristics, including weight, sex, and lymphocyte count, were compared.

Main Results:

  • Patients on FTY-EOD had a significantly higher risk of relapses (HR=2.98) and a combined outcome of relapses or new MRI lesions (HR=2.07) compared to FTY-ED.
  • Lower weight was associated with switching to FTY-EOD; female sex and lower lymphocyte counts were linked to switching due to lymphopenia.
  • In the FTY-EOD group, prior natalizumab treatment and younger age increased the risk of relapses and new lesions.

Conclusions:

  • FTY-EOD is associated with increased disease activity, including relapses and new demyelinating lesions, compared to FTY-ED.
  • Disease reactivation was observed in a significant proportion of patients on FTY-EOD.
  • Neurologists should exercise caution when considering FTY-EOD, especially in younger patients and those with a history of natalizumab treatment.