AAN: Teriflunomide Reduces Clinical Events in Radiologically Isolated Syndrome
23 Apr 2023
Clinical ResultPhase 3
FRIDAY, April 21, 2023 -- For adults with radiologically isolated syndrome (RIS), teriflunomide is associated with a reduction in the first clinical demyelinating event compared with placebo, according to a study presented at the annual meeting of the American Academy of Neurology, held from April 22 to 27 in Boston.
Christine Lebrun Frenay, M.D., from the University Hospital of Nice in France, and colleagues randomly assigned 89 patients with RIS to teriflunomide or placebo in a phase III study. Participants underwent follow-up at weeks 48 and 96.
The researchers detected 28 clinical events during follow-up (20 with placebo; eight with teriflunomide). The superiority of teriflunomide was demonstrated in unadjusted and adjusted analyses (hazard ratios, 0.38 and 0.34, respectively). The teriflunomide arm had a reduction in the number of patients with gadolinium+ lesions and the cumulative number of new or enlarging T2 lesions, although these results were not statistically significant.
"Our findings suggest that early intervention with teriflunomide may be beneficial to those diagnosed with radiologically isolated syndrome, the presymptomatic phase of multiple sclerosis," Lebrun Frenay said in a statement. "However, more research is needed in larger groups of people to confirm our findings. Additionally, it is important that medical professionals are cautious when using MRI expertise to diagnose this condition, selecting only patients at risk of developing multiple sclerosis and not increasing MRI misdiagnoses."
The study was funded by Sanofi, which manufactures teriflunomide.
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Posted April 2023
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