RT Journal Article
SR Electronic
T1 SUSTAINED LOW RATE BRAIN VOLUME LOSS IN LONG TERM FINGOLIMOD TREATMENT
JF Journal of Neurology, Neurosurgery & Psychiatry
JO J Neurol Neurosurg Psychiatry
FD BMJ Publishing Group Ltd
SP e4
OP e4
DO 10.1136/jnnp-2015-312379.115
VO 86
IS 11
A1 E Silber
A1 EW Radue
A1 F Barkhof
A1 R Gottschalk
A1 Y Zhang
A1 L Cappiello
A1 P von Rosenstiel
A1 L Kappos
YR 2015
UL http://jnnp.bmj.com/content/86/11/e4.19.abstract
AB Objectives To evaluate long-term Brain Volume Loss (BVL) in patients who received fingolimod 0.5 mg or placebo in the FREEDOMS or FREEDOMS-2, and LONGTERMS studies. Methods pooled-analysis of patients who completed FREEDOMS and FREEDOMS-2 core studies and received at least one fingolimod-dose in LONGTERMS. We calculated the percent brain volume change (PBVC) and the mean annualized rate of brain atrophy (ARBA) at different time points using SIENA (Structural Image Evaluation using Normalization of Atrophy). Results up-to month (M)72 are presented for continuous-fingolimod 0.5 mg patient group and for placebo-fingolimod patient groupResults 2355 patients (fingolimod 0.5 mg: 783, placebo-fingolimod: 773). Median exposure to fingolimod was 915(271–1689); 18.8% of patients had fingolimod-exposure for =2160 days (6 years). At M6,12,24,36, and 48, mean PBVC was –0.22 vs. –0.36; –0.44 vs. –0.63; –0.83 vs. –1.28; –1.22 vs. –1.73 and –1.61 vs. –2.16 for fingolimod 0.5 mg vs. placebo-fingolimod. Mean ARBA was –0.43 vs. –0.70; –0.45 vs. –0.64; –0.43 vs. –0.67; –0.41 vs. –0.59 and –0.43 vs. –0.58. Similar pattern observed at M60 and 72 (smaller patient numbers) for PBVC (–1.49 vs. – 2.41 and –1.58 vs. –2.99) and ARBA (–0.31 vs. –0.51 and –0.27 vs. –0.52). Long–term treatment with fingolimod 0.5mg is attended by sustained low rates of BVL upto–6 years. Patients switching from placebo to fingolimod did not catch-up regarding BVL.