Table 2.

Percentage change in BV during three pivotal phase III trials of fingolimod in patients with RMS

Endpoint	Fingolimod 0.5 mg, oral	Placebo	IFNβ-1a IM 30 μg/week
Mean (SD) change in BV from 0 to 6 months, %
FREEDOMS [20]	−0.22 (0.81); p = 0.006	−0.34 (0.73)
FREEDOMS II [21]	−0.23 (0.87); p = 0.012	−0.38 (0.91)
Mean (SD) change in BV from 0 to 12 months, %
FREEDOMS [20]	−0.50 (1.05); p = 0.03	−0.65 (1.05)
FREEDOMS II [21]	−0.38 (0.97); p < 0.001	−0.63 (1.05)
TRANSFORMS [22]	−0.31 (0.65); p < 0.001		−0.45 (0.73)
Mean (SD) change in BV from 12 to 24 months, %
FREEDOMS [20]	−0.37 (0.81); p < 0.001	−0.67 (1.07)
FREEDOMS II [21]	−0.49 (0.90); p = 0.013	−0.68 (1.10)
Mean (SD) change in BV from 0 to 24 months, %
FREEDOMS [20]	−0.84 (1.31); p < 0.001	−1.31 (1.50)
FREEDOMS II [21]	−0.86 (1.22); p < 0.001	−1.28 (1.50)

Measured by SIENA

BV brain volume, IFNβ-1a interferon beta-1a, IM intramuscular, RMS relapsing multiple sclerosis, SD standard deviation, SIENA Structural Image Evaluation, using Normalization, of Atrophy

p Values in FREEDOMS and FREEDOMS II are versus placebo; p values in TRANSFORMS are versus IFNβ-1a IM