Ponesimod Compared with Teriflunomide in Patients with Relap
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In this study, the efficacy of ponesimod was superior to teriflunomide, and ponesimod had a safety profile consistent with sphingosine-1-phosphate modulators without any new safety signals.

The Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial is the first phase 3 study comparing 2 oral disease-modifying therapies for relapsing multiple sclerosis (RMS). The study was aimed to compare the efficacy of ponesimod, a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator with teriflunomide, a pyrimidine synthesis inhibitor, approved for the treatment of patients with RMS.

This multicenter, double-blind, active-comparator, superiority randomized clinical trial enrolled patients, who were aged 18 to 55 years and had been diagnosed with multiple sclerosis per 2010 McDonald criteria, with a relapsing course from the onset, Expanded Disability Status Scale (EDSS) scores of 0 to 5.5, and recent clinical or magnetic resonance imaging disease activity.

~~For 1133 patients (567 receiving ponesimod and 566 receiving teriflunomide), the relative rate reduction for ponesimod vs teriflunomide in the annualized relapse rate was 30.5%; the mean difference in FSIQ-RMS, ?3.57; the relative risk reduction in combined unique active lesions per year, 56%; and the reduction in time to 12-week and 24-week confirmed disability accumulation risk estimates, 17%, and 16%, respectively.

~~Brain volume loss at week 108 was lower by 0.34%; the odds ratio for NEDA-3 achievement was 1.70.

~~The incidence of treatment-emergent adverse events and serious treatment-emergent adverse events was similar for both groups.

~~Treatment discontinuations because of adverse events were more common in the ponesimod group.

In this study, ponesimod was superior to teriflunomide on annualized relapse rate reduction, fatigue, magnetic resonance imaging activity, brain volume loss, and no evidence of disease activity status, but not confirmed disability accumulation. The safety profile was in line with the previous safety observations with ponesimod and the known profile of other S1P receptor modulators.

Source: https://jamanetwork.com/journals/jamaneurology/fullarticle/2777917
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