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Laatste wijziging: 24 January 2022
Immune regulation using dimethylfumarate in patients with relapse-remitting multiple sclerosis
Principal Investigator: Prof. Dr. Veerle Somers, Researcher: Gwendoline Montes Diaz
Dimethylfumuraat (DMF) is an orally administered fumarate derivative with immunomodulating and neuroprotective effects in relapsing remitting multiple sclerosis (RRMS). An imbalance in the immune system of MS patients, leads to a pro-inflammatory state. This is probably partly due to a change in immune regulation. MS is characterized by less functionally active regulatory T cells (Treg) and there is a reduction in the amount of regulatory B cells (Breg). The mechanism of DMF is still not entirely known, but it may include effects on T- and B-cells, and more specifically on regulatory T- and B-cells.
The primary objective of this study is to determine the effect of DMF treatment on the number and functionality of T- and B-cells. Furthermore, changes in clinical outcome (EDSS, MSFC, FSMC and relapse ratio) will be determined and associated with changes in T and B cells. This study will be a cohort study with a prospective design. 30 RRMS patients, who are 18 years or older and are not diagnosed with RRMS for more than 5 years, will participate. They will start with the first-line treatment DMF (BG-12; Tecfidera®).
The first endpoint will be the effect of DMF treatment on T and B-cell number and function. A second endpoint will be the effect of DMF treatment on clinical outcome and this linked to T and B cell changes. Besides the follow-up study of 30 patients, 50 patients with MS which have been treated with DMF will participate in the study as part of the regular patient care. As control group 50 non-treated MS patients and 50 MS patients treated with a different immunomodulatory therapy than DMF, will be included. In this cross-sectional study T- and B-cell functions will be examined. For the follow-up study, there are three additional visits to the clinic for medical examination and blood sampling. No risk is expected for the patient. This study will provide valuable evidence on the effect of DMF on the immune system in MS. Moreover, the underlying mechanisms resulting in the beneficial effect of the therapy will be demonstrated in phase III trials.