Table 4.

Effect of fingolimod on MRI volumes at EOS (FAS)

MRI outcomes	Mean baseline volumes		Mean percent change from baseline		Between-treatment comparison
	Fingolimod N=107	IFN β-1a N=107	Fingolimod N=107	IFN β-1a N=107	Mean difference (95% CI)	P value
T2 lesion volume* (mm3)	n=107 8902	n=106 11 455	n=107 18.4%	n=102 32.4%	–	<0.001
Gd+ T1 lesion volume† (mm3)	n=106 455	n=106 416	n=59 –72.3%	n=45 4.9%	–	0.001
T1 hypointense lesion volume‡ (mm3)	n=107 1591	n=106 2600	n=105 98.9%	n=99 81.9%	–	0.502
Annual rate of brain atrophy§ (cm3) (95% CI)	n=107 1154	n=104 1161	n=96 –0.48% (–0.65 to –0.30)	n=89 –0.80% (–0.98 to –0.61)	0.32 (0.06 to 0.57)	0.014

(–) indicates a decrease in values versus baseline. n, number of patients included in each analysis. EOS is defined as the last assessment taken on or before the final study phase visit date.

*Obtained from fitting a rank ANCOVA model adjusted for treatment, region, pubertal status (the stratification factor in IVRS) and baseline total volume of T2 lesions.

†Obtained from fitting a rank ANCOVA model adjusted for treatment, region, pubertal status (the stratification factor in IVRS) and baseline total volume of Gd+ T1 lesions.

‡Obtained from fitting a rank ANCOVA model adjusted for treatment, region, pubertal status (the stratification factor in IVRS) and baseline T1 hypointense lesion volume.

§Obtained from fitting an ANCOVA model adjusted for treatment, region, pubertal status (the stratification factor in IVRS) and baseline whole brain volume.

ANCOVA, analysis of covariance;EOS, end of the study; FAS, full analysis set; Gd+, gadolinium-enhancing; IFN, interferon; IVRS, interactive voice response system.