Presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, held April 22-27, in Boston, Massachusetts, findings from the phase 3 TERIS study (NCT03122652) showed that treatment with teriflunomide (Aubagio; Sanofi) significantly reduced the time to first clinical event in patients with radiologically isolated syndrome (RIS), often considered the presymptomatic phase of multiple sclerosis (MS).
Introduced in 2009, RIS refers to an entity in which white matter lesions fulfilling the criteria for MS occur in individuals without a history of clinical demyelinating attack or alternative etiology. Some have argued that RIS is not truly a clinical diagnosis and instead is part of a continuum from health to disease that cannot be distinguished on the basis of imaging and clinical features.
The study, led by Christine Lebrun-Frenay, MD, PhD, FAAN, head of CRCSEP and coordinator of the Neurosciences Research Unit at Paris City University, enrolled 124 individuals and randomized 89 who fulfilled the 2009 RIS criteria. Comprised of mostly females (70.8%), the cohort was randomly assigned 1:1 to either 14 mg of teriflunomide, an FDA-approved immunomodulatory agent for relapsing MS, or placebo, with time to first event from study entry as the primary outcome measure.
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