Dimethyl fumarate halts radiologic progression of multiple sclerosis: Study

A new study published in Annals of Neurology suggests that the advantage of a disease-modifying treatment in radiologically isolated syndrome (RIS) patients in averting a first acute clinical episode.

For people with relapsing remitting multiple sclerosis (RRMS), dimethyl fumarate (DMF) is a disease-modifying medication (DMT) that has been shown to be effective in lowering clinical and MRI activity as well as disease progression. The earliest discernible pre-clinical stage of multiple sclerosis (MS) is represented by the radiologically isolated condition. Therefore, This study was conducted by Darin T. Okuda and team, which assessed how therapeutic intervention affected delaying the onset of the initial symptoms at this point in the illness spectrum.

People with RIS participated in a multi-center, double-blinded, randomized, placebo-controlled trial. These participants had incidental brain MRI abnormalities associated with CNS demyelination but no clinically evident MS symptoms and were randomized 1:1 to receive placebo or oral dimethyl fumarate, 240 mg twice a day, across 12 MS facilities in the US. The start of clinical symptoms linked to a CNS demyelinating event within a 96-week follow-up period was the main objective. All participants in the main and safety investigations underwent an intention-to-treat analysis.

The key findings of this study were:

1. Between March 9, 2016, and October 31, 2019, participants from 12 sites were enlisted, with 44 being randomly assigned to dimethyl fumarate and 43 to a placebo.

2. The uncorrected Cox proportional-hazards regression model showed that after DMF therapy, the probability of a first clinical demyelinating episode throughout the 96-week study period was significantly decreased (hazard ratio (HR)=0.18, 95% confidence interval (CI)=0.05-0.63, p=0.007).

3. There were more mild adverse reactions in the DMF (34 (32%) than in the placebo groups (19 (21%) but similar numbers of severe events (DMF, 3 (5%); placebo, 4 (9%)).

Reference:

Okuda, D. T., Kantarci, O., Lebrun‐Frénay, C., Sormani, M. P., Azevedo, C. J., Bovis, F., Hua, L. H., Amezcua, L., Mowry, E. M., Hotermans, C., Mendoza, J., Walsh, J. S., Okai, A., Pardo, G., Repovic, P., … Pelletier, D. (2022). Dimethyl fumarate delays multiple sclerosis in radiologically isolated syndrome. In Annals of Neurology. Wiley. https://doi.org/10.1002/ana.26555