PT  - JOURNAL ARTICLE
AU  - E Silber
AU  - EW Radue
AU  - F Barkhof
AU  - R Gottschalk
AU  - Y Zhang
AU  - L Cappiello
AU  - P von Rosenstiel
AU  - L Kappos
TI  - SUSTAINED LOW RATE BRAIN VOLUME LOSS IN LONG TERM FINGOLIMOD TREATMENT
AID  - 10.1136/jnnp-2015-312379.115
DP  - 2015 Nov 01
TA  - Journal of Neurology, Neurosurgery & Psychiatry
PG  - e4--e4
VI  - 86
IP  - 11
4099  - http://jnnp.bmj.com/content/86/11/e4.19.short
4100  - http://jnnp.bmj.com/content/86/11/e4.19.full
SO  - J Neurol Neurosurg Psychiatry2015 Nov 01; 86
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.