Association of brain volume loss and long-term disability outcomes in patients with multiple sclerosis treated with teriflunomide.

29 Treatment effect on BVL in the teriflunomide group in TEMSO using the initially applied magnetic resonance imaging analysis package (MRIAP) did not reach statistical significance. 16 However, due to the strong disability benefit seen with teriflunomide, the decision was made to further study potential effects of teriflunomide on BVL with SIENA, as a longitudinal and thus potentially more sensitive analysis.

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Teriflunomide 7 mg was excluded as this failed to reach significance in the TEMSO study. 8 The four Prentice criteria 14 , 15 were used to identify the proportion of treatment effect (PTE) on CDW mediated through three potential surrogates: BVL at Year 2; new or enlarging T 2w lesions over 2 years; and relapses in the first 2 years.

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