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Objective  Immunological studies have demonstrated a plethora of beneficial effects of dimethyl fumarate ( DMF ) on various cell types. However, the cellular and molecular targets are incompletely understood and response markers are scarce. Here, we focus on the relation between nuclear factor (erythroid‐derived 2)‐like 2 ( NRF 2) pathway induction under  DMF  therapy and the composition of the blood immune cell compartment and clinical efficacy in relapsing‐remitting multiple sclerosis ( MS ) patients.    Methods  We explored effects of  DMF  on peripheral immune cell subsets by flow cytometric and transcriptional analysis of serial blood samples obtained from 43  MS  patients during the first year of therapy.    Results  Gene expression analysis proved activation of  NRF 2 signaling under  DMF  therapy that was paralleled by a temporal expansion of FoxP3 +  regulatory T cells,  CD 56 bright  natural killer cells, plasmacytoid dendritic cells, and a decrease in  CD 8 +  T cells, B cells, and type 1 myeloid dendritic cells. In a subgroup of 28 patients with completely available clinical data, individuals with higher levels of the  NRF 2 target gene  NAD (P)H quinone dehydrogenase 1 ( NQO 1) 4–6 weeks after  DMF  therapy initiation were more likely to achieve no evidence of disease activity status 1 year later. The degree of  NQO 1 induction further correlated with patient age.    Interpretation  We demonstrate that positive effects of  DMF  on the clinical outcome are paralleled by induction of the antioxidant  NRF 2 transcriptional pathway and a shift toward regulatory immune cell subsets in the periphery. Our data identify a role of the  NRF 2 pathway as potential biomarker for  DMF  treatment in  MS .

The NRF 2 pathway as potential biomarker for dimethyl fumarate treatment in multiple sclerosis