Table 5

Annualised rate of new/enlargingT2 lesions at EOS by subgroups (FAS)

SubgroupsAdjusted mean number (95% CI)Between-treatment comparison
Fingolimod
N=107		IFN β-1a
N=107		Rate ratio
(95% CI)		Rate reduction (%)P value
Sex
 Malen=36
3.47
(2.471 to 4.880)		n=42
7.59
(5.647 to 10.199)		0.46*
(0.292 to 0.718)		54.2<0.001
 Femalen=70
4.88
(3.850 to 6.193)		n=60
10.44
(8.175 to 13.339)		0.47*
(0.332 to 0.658)		53.2<0.001
Age
 ≤12 yearsn=13
4.3
(2.188 to 8.437)		n=8
6.28
(3.049 to 12.949)		0.68*
(0.264 to 1.772)		31.60.434
 >12 yearsn=93
4.41
(3.568 to 5.448)		n=94
9.51
(7.806 to 11.596)		0.46*
(0.348 to 0.618)		53.7<0.001
Body weight
 ≤40 kgn=9
4.74
(2.150 to 10.456)		n=1
7.05
(0.992 to 50.136)		0.67*
(0.080 to 5.624)		32.80.714
 >40 kgn=97
4.36
(3.552 to 5.359)		n=101
9.29
(7.671 to 11.251)		0.47*
(0.355 to 0.622)		53.0<0.001
DMT-experiencedn=38
5.19
(3.751 to 7.177)		n=38
10.68
(7.810 to 14.601)		0.49†
(0.308 to 0.766)		51.40.002
DMT-naïven=68
3.90
(3.062 to 4.974)		n=64
8.38
(6.589 to 10.645)		0.47†
(0.330 to 0.658)		53.4<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), subgroup, subgroup-by-treatment interaction and baseline number of T2 lesions (offset: time in study).

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

  • DMT, disease-modifying therapy; EOS, end of the study; FAS, full analysis set; IFN, interferon; IVRS, interactive voice response system.