Kelli Whitlock Burton
October 31, 2022
Dimethyl fumarate (DMF) could delay — or even prevent — clinical symptoms in patients with radiologically isolated syndrome (RIS), the earliest detected pre-clinical phase of multiple sclerosis.
Researchers found that DMF reduced the risk of a first acute or progressive event related to CNS demyelination by more than 80% compared with placebo.
Patients with RIS have incidental MRI abnormalities typical of multiple sclerosis (MS) but have no symptoms of the disease. The condition is usually detected when a patient seeks treatment for another issue, such as migraines or head trauma.
The study is the first randomized clinical trial to examine efficacy of a disease-modifying therapy in delaying symptoms in RIS.
“It really supports the concept of the benefit of early treatment intervention within this given MS disease spectrum,” lead investigator Darin Okuda, MD, professor of neurology at The University of Texas Southwestern Medical Center in Dallas, told delegates attending the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Amsterdam.
Topic of Debate
RIS was first identified by Okuda in 2008. Increased use of brain imaging led to the detection of patients with incidental white-matter pathology in the central nervous system on MRI. Some of the findings were nonspecific, but others were highly suggestive of demyelinating pathology based on their location and morphology in the central nervous system.
Although the prevalence of RIS is unknown, incidentally discovered white matter lesions resembling demyelination occur in an estimated 0.1%–0.7% of the general population. Up to half patients with RIS experience a first clinical MS event within 10 years.
Diagnostic criteria and whether to treat patients with RIS prophylactically has long been a topic of debate among neurologists and radiologists.
Researchers conducted the multicenter, randomized, double-blinded, placebo-controlled ARISE study in 2016, recruiting 87 patients with RIS. The majority of participants were women, and most were diagnosed in their early 40s.
Patients received oral DMF at 240 mg twice daily or placebo and were followed for 96 weeks (1 year, 10 months). Clinical assessments were completed at baseline, at weeks 48 and 96, and at the time of the first clinical event. MRI scans were performed only at the beginning and end of the study.
The study was funded by Biogen. Okuda has received support from Biogen and EMD Serono/Merck; and consulting fees from Alexion, Biogen, EMD Serono, Genzyme, Novartis, RVL Pharmaceuticals, TG Therapeutics, Viela Bio, Celgene/Bristol Myers Squibb, Genentech, Janssen Pharmaceuticals, and Osmotica Pharmaceuticals. Giesser reports no relevant financial relationships.
38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2022: Abstract 0179.
Presented October 28, 2022.
Leave a Reply