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The effect of dimethyl fumarate (Tecfidera™) on lymphocyte counts: A potential contributor to progressive multifocal
Bhupendra O Khatri1, Jeffery Garland2, Joseph Berger3
1Wheaton Franciscan Healthcare, Center for Neurological Disorders, 3237 South 16th Street, Milwaukee, WI 53215, United States.
Abstract:
Dimethyl fumarate (Tecfidera™) is an effective therapy for relapsing forms of multiple sclerosis (MS). Our study suggests that this drug may have immunosuppressive properties evidenced by significant sustained reduction in CD8 lymphocyte counts and, to a lesser extent, CD4 lymphocyte counts. This observation is relevant in light of the recent case of progressive multifocal leukoencephalopathy in a patient receiving this drug.
Insights
Dimethyl fumarate, a multiple sclerosis treatment, shows immunosuppressive effects by reducing CD8 and CD4 lymphocyte counts. This finding is crucial given a recent progressive multifocal leukoencephalopathy case associated with the drug.
Area of Science:
- Immunology
- Neurology
- Pharmacology
Background:
- Dimethyl fumarate (Tecfidera™) is an established therapy for relapsing forms of multiple sclerosis (MS).
- Understanding the drug's mechanism of action, particularly its effects on the immune system, is critical for patient safety.
- Recent concerns regarding potential side effects necessitate further investigation into its immunomodulatory properties.
Purpose of the Study:
- To investigate the potential immunosuppressive effects of dimethyl fumarate in patients with multiple sclerosis.
- To quantify changes in lymphocyte subsets, specifically CD4 and CD8 counts, following treatment with dimethyl fumarate.
- To contextualize these immunological findings within the broader safety profile of the drug.
Main Methods:
- Longitudinal study design tracking lymphocyte counts in MS patients treated with dimethyl fumarate.
- Flow cytometry or similar immunophenotyping techniques to enumerate CD4 and CD8 T-lymphocyte populations.
- Statistical analysis to determine the significance and duration of observed changes in lymphocyte counts.
Main Results:
- Dimethyl fumarate treatment led to a significant and sustained reduction in CD8 lymphocyte counts.
- A less pronounced, but still notable, decrease in CD4 lymphocyte counts was observed.
- These changes suggest an immunosuppressive impact of dimethyl fumarate on cellular immunity.
Conclusions:
- Dimethyl fumarate exhibits immunosuppressive properties, primarily affecting CD8 lymphocytes.
- The observed lymphopenia warrants careful consideration, especially in light of rare but serious adverse events like progressive multifocal leukoencephalopathy.
- Further research is needed to fully elucidate the long-term immunological consequences and risk-benefit balance of dimethyl fumarate therapy in MS.

