Table 3

Effect of fingolimod on MRI inflammatory lesion activity at EOS (FAS)

MRI outcomesAdjusted mean number (95% CI)Between-treatment comparison
Fingolimod
N=107		IFN β-1a
N=107		Rate ratio
(95% CI)		Rate reduction (%)P value
Annualised rate of new/enlargingT2 lesions (per patient per year)*n=106
4.39
(3.617 to 5.336)		n=102
9.27
(7.661 to 11.214)		0.47
(0.361 to 0.622)		52.6<0.001
No. of Gd+ T1 lesions per scan†n=106
0.44
(0.313 to 0.608)		n=101
1.28
(0.934 to 1.758)		0.34
(0.215 to 0.540)		66.0<0.001
Annualised rate of new T1 hypointense lesions (per patient per year)‡n=107
4.50
(3.468 to 5.828)		n=96
12.10
(9.242 to 15.830)		0.37
(0.255 to 0.542)		62.8<0.001
No. of CUA lesions per scan§¶n=104
2.40
(1.850 to 3.100)		n=98
6.09
(4.702 to 7.881)		0.39
(0.273 to 0.567)		60.7<0.001

  • EOS is defined as the last assessment taken on or before the final study phase visit date. n, number of patients included in each analysis.

  • *Obtained from fitting a negative binomial regression model adjusted for treatment, region, pubertal status (the stratification factor in IVRS) and baseline T2 lesion number (offset: time on study).

  • †Obtained from fitting a negative binomial regression model with the cumulative number of Gd+ T1 lesions on all scheduled post-baseline MRI scans during the study as the response variable, adjusted for treatment, region, pubertal status (the stratification factor in IVRS) and baseline number of Gd+ T1 lesions (offset: number of MRI scans).

  • ‡Obtained from fitting a negative binomial regression model with cumulative number of new T1 hypointense lesions adjusted for treatment, region and pubertal status (the stratification factor in IVRS) (offset: time on study).

  • §Obtained from fitting a negative binomial regression model adjusted for treatment, region, pubertal status (the stratification factor in IVRS), baseline number of Gd+ T1 lesions and baseline number of T2 lesions.

  • ¶CUA lesion count is defined as Gd+ lesions plus new/newly enlarging T2 lesions not associated with Gd enhancement for scans performed after Gd administration, or only new/newly enlarging T2 lesions for scans done without contrast. CUA lesions were measured from 6 months onwards.

  • CUA, combined unique active; EOS, end of the study; FAS, full analysis set; Gd+, gadolinium-enhancing; IFN, interferon; IVRS, interactive voice response system.