PT  - JOURNAL ARTICLE
AU  - Nicholas, Richard
AU  - Barkhof, Frederik
AU  - Cohen, Jeffrey
AU  - Radue, Ernst-Willhelm
AU  - Kappos, Ludwig
AU  - Häring, Dieter
AU  - Sfikas, Nikolaos
AU  - von Rosenstiel, Philipp
AU  - Francis, Gordon
TI  - BRAIN VOLUME CHANGE AND DISABILITY IN FINGOLIMOD TRIALS
AID  - 10.1136/jnnp-2014-309236.138
DP  - 2014 Oct 01
TA  - Journal of Neurology, Neurosurgery & Psychiatry
PG  - e4--e4
VI  - 85
IP  - 10
4099  - http://jnnp.bmj.com/content/85/10/e4.44.short
4100  - http://jnnp.bmj.com/content/85/10/e4.44.full
SO  - J Neurol Neurosurg Psychiatry2014 Oct 01; 85
AB  - 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<0.0001), new/enlarging T2-LC (p<0.0001) and number of confirmed relapses (p<0.005). PBVC correlated with EDSS and MSFC in FREEDOMS (p<0.001), and with MSFC in FREEDOMS II (p=0.016). In combined study data PBVC correlation with EDSS strengthened over time (month 48, p=0.0001). Stronger correlation was seen in patients with 3- or 6-month CDP (month 48, p<0.0001).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.