New investigational data from a late-stage study has shown that Teriflunomide ( Aubagio ) significantly slows whole brain volume loss ( atrophy ) compared with placebo in patients with a first clinical episode suggestive of multiple sclerosis ( MS ).
Additionally, in this study, the reduction of annual whole brain volume loss was associated with a delay in conversion to clinically definite multiple sclerosis.
These results, from a post hoc analysis of the phase 3 TOPIC study, were presented during the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ( ECTRIMS ) in Berlin, Germany.
Teriflunomide 14 mg significantly reduced the median percentage of whole brain volume ( WBV ) change versus placebo at all time points evaluated ( months 6, 12, 18 and 24 ).
At month six, treatment with Teriflunomide ( n=165 ) correlated with an 87.4% median reduction in WBV loss relative to placebo ( n=154; P=0.02 ).
At month 12, treatment with Teriflunomide ( n=135 ) correlated with a 28.6% median reduction in WBV loss relative to placebo ( n=122; P=0.03 ).
At month 18, treatment with Teriflunomide ( n=109 ) correlated with a 36.1% median reduction in WBV loss relative to placebo ( n=92; P=0.0003 ).
At the last evaluation ( 24 months ), treatment with Teriflunomide ( n=89 ) correlated with a 43% median reduction in WBV loss relative to placebo ( n=69 ); P less than 0.0001 ).
Annual WBV loss observed in patients had a significant impact on conversion to clinically definite multiple sclerosis, with a 51.7% increase in risk of clinically definite multiple sclerosis conversion for every 1% decrease in WBV ( P less than 0.0001 ).
These findings have demonstrated the potential effects of Aubagio on whole brain volume loss and provide insight into how this treatment may impact the early inflammatory and neurodegenerative components of multiple sclerosis.
The TOPIC intent-to-treat ( ITT ) population of the post hoc analysis has included patients receiving placebo ( n=197 ), Teriflunomide 14 mg ( n=214 ), or Teriflunomide 7 mg ( n=203 ) for less than or equal to 108 weeks.
Post hoc, blinded analysis of changes in WBV was evaluated using longitudinal SIENA ( Structural Image Evaluation using Normalization of Atrophy ) analysis.
In the MS clinical studies of Teriflunomide, including TOPIC, the incidence of serious adverse events was similar among Teriflunomide and placebo-treated patients. ( Xagena2018 )
Source: Sanofi, 2018