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 group
Results 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.