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Teriflunomide slows BVL in relapsing MS: A reanalysis of the TEMSO MRI data set using SIENA

OBJECTIVE: To assess, using structural image evaluation using normalization of atrophy (SIENA), the effect of teriflunomide, a once-daily oral immunomodulator, on brain volume loss (BVL) in patients with relapsing forms of MS enrolled in the phase 3 TEMSO study. METHODS: TEMSO MR scans were analyzed...

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Detalles Bibliográficos
Autores principales: Radue, Ernst-Wilhelm, Sprenger, Till, Gaetano, Laura, Mueller-Lenke, Nicole, Cavalier, Steve, Thangavelu, Karthinathan, Panzara, Michael A., Donaldson, Jessica E., Woodward, Fiona M., Wuerfel, Jens, Wolinsky, Jerry S., Kappos, Ludwig
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5550381/
https://www.ncbi.nlm.nih.gov/pubmed/28828394
http://dx.doi.org/10.1212/NXI.0000000000000390
Descripción
Sumario:OBJECTIVE: To assess, using structural image evaluation using normalization of atrophy (SIENA), the effect of teriflunomide, a once-daily oral immunomodulator, on brain volume loss (BVL) in patients with relapsing forms of MS enrolled in the phase 3 TEMSO study. METHODS: TEMSO MR scans were analyzed (study personnel masked to treatment allocation) using SIENA to assess brain volume changes between baseline and years 1 and 2 in patients treated with placebo or teriflunomide. Treatment group comparisons were made via rank analysis of covariance. RESULTS: Data from 969 patient MRI visits were included in this analysis: 808 patients had baseline and year 1 MRI; 709 patients had baseline and year 2 MRI. Median percentage BVL from baseline to year 1 and year 2 for placebo was 0.61% and 1.29%, respectively, and for teriflunomide 14 mg, 0.39% and 0.90%, respectively. BVL was lower for teriflunomide 14 mg vs placebo at year 1 (36.9% relative reduction, p = 0.0001) and year 2 (30.6% relative reduction, p = 0.0001). Teriflunomide 7 mg was also associated with significant reduction in BVL vs placebo over the 2-year study. The significant effects of teriflunomide 14 mg on BVL were observed in both patients with and without on-study disability worsening. CONCLUSIONS: The significant reduction of BVL vs placebo over 2 years achieved with teriflunomide is consistent with its effects on delaying disability worsening and suggests a neuroprotective potential. CLASSIFICATION OF EVIDENCE: Class II evidence shows that teriflunomide treatment significantly reduces BVL over 2 years vs placebo. CLINICALTRIALS.GOV IDENTIFIER: NCT00134563.