Wolinsky

Question 1

When was MRI analysis undertaken ?

Answer 1

Every 6 months.

Question 2

Baseline characteristics ?

Answer 2

Time since first symptoms - 7.2 years
Gad+ lesions-  1.81 
Totalled lesion Volume - 18.08 ml
Prior Tx - 28.4%
Non RRMS- 7.1%

Question 3

Primary Endpoint?

Answer 3

Change in total lesion volume

T2 hyper intense and T1 hypo intense

Question 4

Secondary End points?

Answer 4

> Number and Volume Enhancing Lesions

> Volume of T1s and T2s

Question 5

Explain UALs

Answer 5

Gads + Unenhanced New(T2s) + Unenhanced enlarged(T2s).

Question 6

What do T1 and T2 lesions represent?

Answer 6

T1 - severe damage, reflecting axonal loss, gliosis, and loss of intercellular matrix.

Question 7

Results?

Answer 7

Change in total LV - 67%
Gad+ Enhancing - 80%
UALs - 69%
Superior effects of -4mg over 7mg at most time points

Question 8

Indication of baseline level of severity?

Answer 8

Sicker, more severe MRI- defined cerebral pathology.

Question 9

At what time does Aubagio show significant effect from that of placebo?

Answer 9

‘Readily evident within 6 months of treatment initiation.’

Question 10

Did Aubagio show a better response in any particular sub-group of patients?

Answer 10

Post Hoc analysis of 8 different sub-groups, such as age sex, baseline EDSS scores, showed no significant differences between them.

‘Thus suggests that the effects of teriflunomide in attenuating MRI-defined pathologic brain activity are independent of disease severity when beginning treatment.’

Question 11

What percentage of patients had MRI analysis ?

Answer 11

99% of them.