BRAIN VOLUME CHANGE AND DISABILITY IN FINGOLIMOD TRIALS

Objective Investigate relationships between Brain Volume (BV) loss and clinical and MRI outcomes observed in three phase 3 fingolimod trials. Method Percentage BV change (PBVC) was measured in the core-phases and extensions of FREEDOMS, FREEDOMS II and TRANSFORMS using ‘Structural Image Evaluation Normalization, of Atrophy’. During the core-phases, correlations were assessed between PBVC and: cumulative Gd+-lesion count (LC); T2-lesion volume change (LVC);new/enlarging T2-LC; T1-hypointense LVC; number of confirmed relapses; EDSS score change; and MSFC score change. Proportions of patients with 3- or 6-month confirmed disability progression (CDP) and correlations between PBVC and EDSS were determined. Results In FREEDOMS, FREEDOMS II and TRANSFORMS, PBVC consistently correlated best with cumulative Gd+-LC(p Conclusion BV loss was greatest in patients who relapsed or who developed new Gd+ or T2-lesions. By reducing BV loss, fingolimod may slow disability progression.