Treatment with Tecfidera (dimethyl fumarate) significantly reduces the risk of experiencing the first multiple sclerosis (MS) symptoms in adults with radiologically isolated syndrome (RIS), according to data from a Phase 4 clinical trial which may lead to changes in practice.
RIS is a condition in which patients have MS-like lesions on MRI scans, but lack typical symptoms of the disease.
This is the first clinical trial demonstrating the benefit of disease-modifying therapies (DMTs) in people with RIS — the “earliest detectable pre-clinical phase of multiple sclerosis,” Darin Okuda, MD, the trial’s principal investigator, said in an oral presentation at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Okuda is a Professor of Neurology and the Director of the MS and Neuroimmunology Imaging Programme, as well as Director of the Neuroinnovation Programme, at University of Texas Southwestern Medical Center, in Dallas, US.
The trial’s results, “Multi-center, randomized, double-blinded assessment of dimethyl fumarate in extending the time to a first clinical demyelinating event in radiologically isolated syndrome (ARISE),” were shared by Okuda at the ECTRIMS 2022 Congress, held October 26–28, both virtually and in Amsterdam, Netherlands. Biogen, which developed and markets Tecfidera as a DMT, funded the trial.