TY - JOUR
T1 - Magnetic resonance imaging outcomes from a phase III trial of teriflunomide
AU - Wolinsky, Jerry S.
AU - Narayana, Ponnada A.
AU - Nelson, Flavia
AU - Datta, Sushmita
AU - O'Connor, Paul
AU - Confavreux, Christian
AU - Comi, Giancarlo
AU - Kappos, Ludwig
AU - Olsson, Tomas P.
AU - Truffinet, Philippe
AU - Wang, Lin
AU - Miller, Aaron
AU - Freedman, Mark S.
PY - 2013/9
Y1 - 2013/9
N2 - Objective: The purpose of this study was to determine the effects of oral teriflunomide on multiple sclerosis (MS) pathology inferred by magnetic resonance imaging (MRI). Methods: Patients (n=1088) with relapsing MS were randomized to once-daily teriflunomide 7 mg or 14 mg, or placebo, for 108 weeks. MRI was recorded at baseline, 24, 48, 72 and 108 weeks. Annualized relapse rate and confirmed progression of disability (sustained ≤12 weeks) were the primary and key secondary outcomes. The principal MRI outcome was change in total lesion volume. Results: After 108 weeks, increase in total lesion volume was 67.4% (p=0.0003) and 39.4% (p=0.0317) lower in the 14 and 7 mg dose groups versus placebo. Other measures favoring teriflunomide were accumulated enhanced lesions, combined unique activity, T2-hyperintense and T1-hypointense component lesion volumes, white matter volume, and a composite MRI score; all were significant for teriflunomide 14 mg and most significant for 7 mg versus placebo. Conclusions: Teriflunomide provided benefits on brain MRI activity across multiple measures, with a dose effect evident on several markers. These effects were also consistent across selected subgroups of the study population. These findings complement clinical data showing significant teriflunomide- related reductions in relapse rate and disease progression, and demonstrate containment of MRI-defined disease progression.
AB - Objective: The purpose of this study was to determine the effects of oral teriflunomide on multiple sclerosis (MS) pathology inferred by magnetic resonance imaging (MRI). Methods: Patients (n=1088) with relapsing MS were randomized to once-daily teriflunomide 7 mg or 14 mg, or placebo, for 108 weeks. MRI was recorded at baseline, 24, 48, 72 and 108 weeks. Annualized relapse rate and confirmed progression of disability (sustained ≤12 weeks) were the primary and key secondary outcomes. The principal MRI outcome was change in total lesion volume. Results: After 108 weeks, increase in total lesion volume was 67.4% (p=0.0003) and 39.4% (p=0.0317) lower in the 14 and 7 mg dose groups versus placebo. Other measures favoring teriflunomide were accumulated enhanced lesions, combined unique activity, T2-hyperintense and T1-hypointense component lesion volumes, white matter volume, and a composite MRI score; all were significant for teriflunomide 14 mg and most significant for 7 mg versus placebo. Conclusions: Teriflunomide provided benefits on brain MRI activity across multiple measures, with a dose effect evident on several markers. These effects were also consistent across selected subgroups of the study population. These findings complement clinical data showing significant teriflunomide- related reductions in relapse rate and disease progression, and demonstrate containment of MRI-defined disease progression.
KW - Teriflunomide
KW - clinical trial
KW - disease-modifying therapy
KW - magnetic resonance imaging
KW - multiple sclerosis
KW - phase III
UR - http://www.scopus.com/inward/record.url?scp=84883410242&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84883410242&partnerID=8YFLogxK
U2 - 10.1177/1352458513475723
DO - 10.1177/1352458513475723
M3 - Article
C2 - 23447359
AN - SCOPUS:84883410242
SN - 1352-4585
VL - 19
SP - 1310
EP - 1319
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
IS - 10
ER -