TEMSO Study Shows BVL Improvement with Teriflunomide
OCTOBER 31, 2017
Till Sprenger, MDData from the TEMSO study has shown that teriflunomide (Aubagio) 14 mg can significantly improve Paced Auditory Serial Addition Test (PASAT) performance in patients with multiple sclerosis (MS).
TEMSO data, presented at MS Paris 2017, the 7th joint meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis, also showed an association between brain volume loss (BVL) and long-term cognition changes. This data suggests that BVL that occurs earlier in the disease can predict longer-term cognitive function.
“This study emphasizes that early brain volume loss is a predictor not only of longer-term physical, but also cognitive disability in MS patients,” Till Sprenger, MD, principal investigator from the University Hospital Basel and the DKD HELIOS Klinik, told MD Magazine.
Teriflunomide 14 mg was associated with a +0.07 change in baseline PASAT-3 Z-score at week 96, compared to a -0.02 change in the placebo group. The least squares mean difference was 0.095 (0.003-0.187, CI 95%; P =.0435).
In the teriflunomide arm, PASAT-3 Z-scores improved 0.19 points at week 156 and 0.24 at week 252. Raw scores improved 2.36 and 2.89 points, respectively, at those same time points. Raw scores were assessed twice at the time of screening, at baseline, and at weeks 24, 48, 72, 96, and every 24 weeks in the extension period.
The investigators utilized structural image evaluation using normalization of atrophy (SIENA) reanalysis to examine magnetic resonance imaging (MRI) scans on 3 groups of patients, grouped for analysis based on percentage brain volume change (PBVC): Group 1, with ≤.52% reduction (n = 221); Group 2, >.52% to 2.18% reduction (n = 354); and Group 3, >2.18% reduction (n = 130).
Analysis showed that 34.3% of the teriflunomide-treated patients made up Group 1 (least BVL), compared with 25.3% for placebo patients. Group 2 consisted of 50.4% of teriflunomide patients and 49.8% of placebo patients. Group 3 (most BVL), was made up of 24.9% of the placebo patients, compared to 15.3% teriflunomide patients.
“In the association analysis, the groups with the least BVL from baseline to Year 2 (Group 1) and intermediate BVL (Group 2) demonstrated significant improvements in PASAT-3 Z-score with teriflunomide treatment over each of the 3 years in the TEMSO extension (up to 5 years since core study entry) vs the group with the most BVL (Group 3),” the investigators reported.
Results showed that the effect of PASAT-3 improvement was maintained over the course of the study and its extension period. Additionally, slower rates of BVL over 2 years were associated with longer-term PASAT-3 score improvement compared to the group with greater rates of BVL after 5 years, regardless of treatment group.