The following article is part of conference coverage from the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. .
Ponesimod may be superior to teriflunomide for magnetic resonance imaging (MRI) outcomes in relapsing multiple sclerosis (RMS), according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) MSVirtual2020 event, held September 11-13, 2020.
Ponesimod is an orally active modulator of sphingosine-1-phospate that sequesters circulating lymphocytes in lymphoid organs. The objective of this study was to assess MRI endpoints and no evidence of disease activity (NEDA) status in RMS.
In this study, participants aged 18 to 55 years with RMS were randomly assigned to receive 20 mg of ponesimod or 14 mg of teriflunomide for 108 weeks. MRI endpoints were percentage change from baseline to week 108 in brain volume, mean number of new gadolinium-enhancing T1 lesions, and the volume and count of new/enlarging T2 lesions. Additionally, researchers determined statuses of NEDA-3 (defined by absence of confirmed relapse, 12-week confirmed disability accumulation, and new T1 and T2 brain lesions on annual MRIs) and NEDA-4 (NEDA-3 and no average annual brain volume decrease ≥0.4%) between baseline and week 108.
Study researchers revealed that of the 1133 participants randomly assigned, 985 completed the study. They observed that when comparing the MRI findings of ponesimod with those of teriflunomide between baseline and 108 weeks, ponesimod produced more favorable outcomes in the least square mean percent change in brain volume (-0.91% vs -1.25%, respectively), mean number of new/enlarging T2 lesions per year (1.40 vs 3.16, respectively), and mean number of new gadolinium-enhancing T1 lesions per scan (0.18 vs 0.43). At week 108, 28.2% of the patients who received ponesimod vs 18.3% of the patients who received teriflunomide achieved NEDA-3. Up to 15% of the patients who received ponesimod vs 8.5% of the patients who received teriflunomide achieved NEDA-4. New/enlarging T2 lesions were the most common reason for failure to achieve NEDA-3 or NEDA-4.
The study researchers concluded that ponesimod showed benefit over teriflunomide for MRI outcomes in relapsing multiple sclerosis and “a significantly higher proportion of patients achieved NEDA-3 and NEDA-4 status, supporting the effects observed on clinical endpoints.
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Kappos L, Burcklen M, Freedman M, et al. Effect of oral ponesimod on clinical disease activity and MRI-based outcomes in patients with relapsing multiple sclerosis: Phase 3 OPTIMUM study. Presented at: 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event; September 11-13, 2020; P0071.