Teriflunomide Exerts Protective Effect on Brain Tissue in Relapsing-Remitting MS
VANCOUVER, BC—Teriflunomide treatment decreased brain volume loss in patients with relapsing-remitting multiple sclerosis (MS) independent of disability progression, a study presented at the 68th AAN Annual Meeting concluded.
"The significant, beneficial effects on brain volume loss in patients with and without confirmed disability progression suggest that teriflunomide 14mg may exert a protective effect on brain tissue," reported Till Sprenger, MD, of the DKD Helios Klinik, Wiesbaden, Germany.
To explore the relationship between brain volume loss and disability progression, Dr. Sprenger and colleagues used the SIENA (structural image evaluation using normalization of atrophy) method to analyze longitudinal changes in brain volume in a subgroup analysis of the TEMSO patient population, evaluating the effect of both 12- and 24-week on-study confirmed disability progression on brain volume loss.
In the Phase 3 TEMSO trial, teriflunomide, a once-daily oral immunomodulator, was found to significantly reduce annualized relapse rate and magnetic resonance imaging lesion activity and was also associated with significant reductions in risk of 12-week confirmed disability progression.
Results showed that brain volume loss for patients without 12-week confirmed disability progression was lower with teriflunomide. Brain volume loss was -0.40 (n=211) in Year 1 and -0.87 (n=185) in Year 2 for the teriflunomide group, compared with loss scores of -0.52 (n=211) and -1.12 (n=174) for the placebo group. The difference in median percentage change from baseline in brain volume between the teriflunomide and placebo groups was 22.2% (P=0.0128) for Year 1 and 23.0% for Year 2 (P=0.0129).
For patients with confirmed disability progression, the median percentage change from baseline in brain volume was also lower with teriflunomide. At Year 1, it was -0.25 (n=52) for the teriflunomide group, compared to -0.81 (n=65) for the placebo group; at Year 2, this loss was -0.90 (n=50) and -1.61 (n=60), respectively. The difference between teriflunomide and placebo was 68.8% (P=0.0037) for Year 1 and 43.9% (P=0.0043) for Year 2.
“Patients who experienced confirmed disability progression had a greater degree of brain volume loss, providing further support for the direct association between these outcomes," reported Dr. Sprenger, who is also with the Medical Image Analysis Center, University Hospital, Basel, Basel, Switzerland.
Study funding was provided by Sanofi Genzyme. Dr. Sprenger has received payments from Genzyme for consulting and speaking.