Wolinsky

Question 1

Primary and secondary end points?

Answer 1

Change in Total Lesion Volume (T1 hypo & T2 hyperint)
Also: Reduction in Gd+ Enhancing Lesions
Also: Reduction in Unique Active Lesions

Question 2

Results of End points?

Answer 2

Relative risk reductions
67 %
80%
69%

Question 3

MRI Analysis method

Answer 3

99% of patients had MRI analysis

Recordings were: baseline, 24, 48 , 72, 108 Weeks

Question 4

Baseline MS patient characteristics ?

Answer 4

From first symptoms - 7.2 years
EDSS. 2.7
Total lesion volume - 18.08 
Gds 1.81 lesions
Prior Txs - 28.8%
MS Progressives -  7%

Question 5

From this study, how quickly did Aubagio work ?

Answer 5

From the first MRI after baseline - 6 months

The graph showed significant differences at the 6 month mark compared to the placebo arm.

Question 6

How does the TEMSO MS cohort compare to cohorts of other studies?
What are the primary marker baseline comparisons between Aubagio earlier agents ?

Answer 6

The TEMSO cohort had
‘more severe MRI-defined cerebral pathology at randomisation’

Mean total lesion volume/ T1-hypo intense
TOWER: 7.6/1.4 ml
CombiRx: 12.2/1.7 ml
TEMSO : 18/ 2.91

Question 7

Is there a sub-group of RRMS patients that respond better to Aubagio than other sub-groups?

Answer 7

Aubagio responds in all treatment severities and in all other patient characteristics.

The effects of the active treatment in the post-hoc analysis showed no significant differences between baseline characteristics…
Age, sex, baseline EDSS scores, relapses in past 2 years, history of DMTs, Gds, total lesion volume.