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Drug-associated progressive multifocal leukoencephalopathy in multiple sclerosis patients

Yasuo Oshima1, Tetsuya Tanimoto2, Koichiro Yuji1

  • 1The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|July 10, 2018
PubMed
Abstract

Insights

This study examined multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients using disease-modifying drugs (DMDs). Fingolimod, dimethyl fumarate, and rituximab showed increased PML risk compared to natalizumab.

Area of Science:

  • Neurology
  • Pharmacovigilance
  • Immunology

Background:

  • Multiple sclerosis (MS) is treated with various disease-modifying drugs (DMDs).
  • Progressive multifocal leukoencephalopathy (PML) is a rare but serious adverse event associated with some MS treatments.
  • Limited data exists on PML characteristics with DMDs other than natalizumab.

Purpose of the Study:

  • To investigate the characteristics of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients.
  • To assess the risk of PML associated with DMDs used for MS, beyond natalizumab.

Main Methods:

  • Descriptive observational study using the FAERS database (July 2015 - June 2017).
  • Analysis of 100,921 MS patients, with 786 developing PML.
  • Calculation of adjusted odds ratios for PML associated with specific DMDs.

Main Results:

  • The adjusted odds ratio for PML was highest for natalizumab (115.72), followed by fingolimod (4.98), rituximab (3.22), and dimethyl fumarate (1.77).
  • Median time to PML onset was significantly shorter for non-natalizumab DMDs (178 days) compared to natalizumab (1463 days).
  • PML reporting proportion was higher in Japan (2.4%) than in the United States (0.24%).

Conclusions:

  • Fingolimod, dimethyl fumarate, and rituximab are associated with an increased reporting proportion of PML in MS patients.
  • Characteristics of PML, including time to onset and geographical variations, differ among DMDs.
  • Continued pharmacovigilance is crucial for monitoring PML risk with various MS therapies.
Keywords:
Progressive multifocal leukoencephalopathydemographyfingolimodmultiple sclerosisnatalizumabrituximabtime to onset

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