Table 5.
Annualised rate of new/enlargingT2 lesions at EOS by subgroups (FAS)
| Subgroups | Adjusted mean number (95% CI) | Between-treatment comparison | |||
| Fingolimod N=107 |
IFN β-1a N=107 |
Rate ratio (95% CI) |
Rate reduction (%) | P value | |
| Sex | |||||
| Male | n=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 |
| Female | n=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 years | n=13 4.3 (2.188 to 8.437) |
n=8 6.28 (3.049 to 12.949) |
0.68* (0.264 to 1.772) |
31.6 | 0.434 |
| >12 years | n=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 kg | n=9 4.74 (2.150 to 10.456) |
n=1 7.05 (0.992 to 50.136) |
0.67* (0.080 to 5.624) |
32.8 | 0.714 |
| >40 kg | n=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-experienced | n=38 5.19 (3.751 to 7.177) |
n=38 10.68 (7.810 to 14.601) |
0.49† (0.308 to 0.766) |
51.4 | 0.002 |
| DMT-naïve | n=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.