Teriflunomide prevents conversion to MS in patients with RIS

In people with radiologically isolated syndrome (RIS), treatment with teriflunomide resulted in a 62% risk reduction compared with a placebo for a first clinical event related to the CNS. These outcomes add evidence for the benefit of early intervention with disease-modifying treatment (DMT) in the demyelinating spectrum of multiple sclerosis (MS).

RIS represents the earliest detectable pre-clinical phase of MS. MRI features of RIS subjects are highly similar to MS without clinical symptoms. In a previous study (NCT02739542), the use of dimethyl fumarate (DMF) to prevent the clinical onset of MS was associated with a risk reduction of >80% [2]. The phase 3 TERIS study (NCT03122652) aimed to evaluate the efficacy and safety of the DMT teriflunomide, with a different mechanism of action, in a cohort of participants with RIS from Europe and Turkey.

First author Dr Christine Lebrun-Frenay (Centre Hospitalier Universitaire de Nice, France) presented the results [1]. She explained that the TERIS study included 89 participants of 18 years or older who fulfilled the 2009 RIS criteria. Participants were randomised 1:1 to teriflunomide (14 mg daily) or a placebo. The primary outcome measure was the time-to-onset of a first clinical symptom that can be attributed to a CNS demyelinating event over 96 weeks. Of randomised participants, 63 (71%) were women, the mean age was 40 years, and the age at index MRI was 38 years.

During 96 weeks of follow-up, 28 clinical events were detected: 8 in the teriflunomide, and 20 in the placebo group. This difference was significant in both the unadjusted and adjusted analysis. In the unadjusted analysis, the hazard ratio (HR) was 0.37 (95% CI 0.16–0.84; P=0.018). In the adjusted analysis, the HR was 0.28 (0.11–0.71; P=0.007).

Though not statistically significant, the number of MRI lesions was also lower in the treatment group compared to placebo. For the cumulative number of Gd+ lesions, the adjusted rate ratio (RR) was 0.33 (0.09–1.37; P=0.086). For new or enlarging T2 lesions, the adjusted RR was 0.57 (0.27–1.20; P=0.139).

1. 1. Lebrun-Frenay C, et al. Teriflunomide (Aubagio) extends the time to multiple sclerosis in radiologically isolated syndrome: The TERIS study. Session ES2.010, AAN 2023 Annual Meeting, 22–27 April, Boston, USA.
   2. Okuda DT, et al. Ann Neurol 2023;93(3):604–614.

 

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Posted on 1 May, 202314 May, 2023