RT Journal Article
SR Electronic
T1 BRAIN VOLUME CHANGE AND DISABILITY IN FINGOLIMOD TRIALS
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP e4
OP e4
DO 10.1136/jnnp-2014-309236.138
VO 85
IS 10
A1 Nicholas, Richard
A1 Barkhof, Frederik
A1 Cohen, Jeffrey
A1 Radue, Ernst-Willhelm
A1 Kappos, Ludwig
A1 Häring, Dieter
A1 Sfikas, Nikolaos
A1 von Rosenstiel, Philipp
A1 Francis, Gordon
YR 2014
UL http://jnnp.bmj.com/content/85/10/e4.44.abstract
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.