Teriflunomide shows promise as a potential treatment for radiologically isolated syndrome

Christine Lebrun-Frenay, MD, PhD, FAAN

Results from the Phase 3 TERIS trial (NCT03122652), presented at the 2023 American Academy of Neurology (AAN) Annual Meeting in Boston, Massachusetts, April 22-27, show that treatment with teriflunomide (Aubagio; Sanofi) First clinical event in a patient with radiologically isolated syndrome (RIS), often considered the preclinical stage of multiple sclerosis (MS).

Introduced in 2009, RIS refers to the entity in which white matter lesions meeting criteria for MS occur in individuals with no history of clinical demyelinating attacks or another etiology. Some argue that RIS is not a true clinical diagnosis, but rather part of a continuum from health to disease that is indistinguishable based on imaging and clinical features.

Led by Christine Lebrun-Frenay, MD, PhD, FAAN, director of CRCSEP and coordinator of the Neuroscience Research Unit at the City University of Paris, the study enrolled 124 people and met the 2009 RIS criteria89. Randomized people. A cohort composed mostly of women (70.8%) was randomly assigned her 1:1 to either 14 mg teriflunomide, an FDA-approved immunomodulatory drug for relapsing MS, or placebo. rice field. .

“The results are positive. We are pleased to announce that teriflunomide demonstrated a 63% risk reduction,” Lebrun-Frenay said. neurology live®“After adjusting for RIS, sex, and age at diagnosis for MRI metrics, the risk increased to 72% in favor of the active arm. is a prescription for the disease – changing treatment is effective in preventing multiple sclerosis.”

Standardized MRI studies of the brain and spinal cord were performed at 0, 48, 96 weeks, and clinical events. Upon entry into the study, patient index MRI motivations included headache (47%), follow-up neurological disease (18%), dizziness/dizziness (13.5%), ophthalmology (7%), and other (14.5%). I was.

During follow-up, 28 clinical events were detected, 20 in the placebo group and 8 in the teriflunomide group. Unadjusted results (HR, 0.38; 95% CI, 0.17-0.88; P. = .025) and adjusted (HR, 0.34; 95% CI, 0.14–0.82; P. = .016) model further demonstrated the superiority of teriflunomide in preventing first clinical events. Number of patients with gadolinium-enhancing lesions, although not statistically significant (OR, 0.31; 95% CI, 0.08-1.18; P. = .087) and cumulative number of new or expanding T2 lesions (risk ratio, 0.69; 95% CI, 0.34–1.40; P. = .31) decreased in the teriflunomide group compared to the placebo group.

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“There have been no safety issues. It’s very safe. It’s a well-known drug in the multiple sclerosis field,” added Lebrun-Frenay. “Now he has two drugs that have shown efficacy in phase 3 trials. [of RIS]Recommendations need to be voiced to clinical neurologists to know who is at risk and who will benefit from early prescription.”

TERIS is a sister study to ARISE (NCT02739542) and the first study to demonstrate disease-modifying effects in patients with RIS. Led by Darin Okuda, M.D., her cohort of 87 patients who met the 2009 RIS criteria were randomly assigned to receive either dimethyl fumarate (Techfidera, Biogen) or placebo for a 96-week treatment period. I was. A total of 59 (68%) participants completed the trial, and dimethyl fumarate reduced the risk of a first clinical demyelination event by 82% during his 96-week treatment period (HR, 0.18; 95%). %CI, 0.05-0.63; P. = .007).

After 96 weeks, 33% of patients in the placebo group and 7% of patients in the active group had their first acute neurological symptoms related to central nervous system demyelination. The effect of dimethyl fumarate on patients was evaluated using an adjusted Cox proportional hazards regression model, even after adjusting for sex, age at diagnosis, family history of MS, diastolic disability status scale (EDSS) score, and T2-weighted hyperintensity. But it was clear. , and presence of gadolinium-enhancing lesions (HR, 0.07; 95% CI, 0.01–0.45; P. = .005). Using a Bayesian approach, the HR for the risk of first clinical event during the 96-week treatment period was 0.20 (95% confidence interval, 0.11-0.35) for dimethyl fumarate and placebo.

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1. Lebrun-Frenay C, Siva A, Sormani MP, et al. Teriflunomide (Aubagio) prolongs time to onset of multiple sclerosis in radiologically isolated syndromes: the TERIS study. Announcement Location: 2023 AAN Annual Meeting. April 22-27. Boston, Massachusetts. ES2
2. Okuda DT, Kantarci O, Lebrun-Frenay C, et al. Dimethyl fumarate delays radiologically isolated syndromes of multiple sclerosis. Anne Nellore. Published online November 18, 2022. doi:10.1002/ana.26555

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