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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
Summary
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.
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