Supportive and sensitivity analyses of the key secondary end point at end of study (up to month 24)
| Estimated annualised rate of n/ne T2 lesions (95% CI)* | |||||
| Fingolimod (n=107) | IFN β-1a (n=107) | Rate ratio or between-group difference (95% CI) | Rate reduction (%) | P value | |
| FAS | |||||
| Month 0–end of study | N’=106 4.39 (3.62 to 5.34) | N’=102 9.27 (7.66 to 11.21) | 0.47 (0.36 to 0.62) | 52.6 | <0.001 |
| Month 0–6 | N’=104 9.29 (7.43 to 11.62) | N’=100 17.80 (14.32 to 22.12) | 0.52 (0.38 to 0.71) | 47.8 | <0.001 |
| Month 0–12 | N’=98 5.18 (4.24 to 6.33) | N’=90 10.44 (8.57 to 12.72) | 0.50 (0.37 to 0.66) | 50.4 | <0.001 |
| Month 0–18 | N’=71 5.14 (4.10 to 6.44) | N’=53 8.48 (6.57 to 10.94) | 0.61 (0.43 to 0.85) | 39.4 | 0.004 |
| Month 0–24 | N’=35 3.48 (2.49 to 4.85) | N’=24 10.97 (7.46 to 16.13) | 0.32 (0.19 to 0.54) | 68.3 | <0.001 |
| PPS | N’=92 4.75 (3.86 to 5.85) | N’=93 9.83 (8.04 to 12.01) | 0.48 (0.36 to 0.65) | 51.6 | <0.001 |
| Excluding IFN NAbs-positive patients | N’=106 4.34 (3.58 to 5.26) | N’=93 8.29 (6.80 to 10.10) | 0.52 (0.40 to 0.69) | 47.6 | <0.001 |
| Treatment-naïve patients | N’=68 3.90 (3.06 to 4.97) | N’=64 8.38 (6.59 to 10.65) | 0.47 (0.33 to 0.66) | 53.4 | <0.001 |
End of study defined as the last assessment taken on or before the final study phase visit date.
*Between-treatment comparison obtained from fitting a negative binomial regression model adjusted as described in methodology.
FAS, full analysis set; IFN, interferon; N’, total number of subjects with available result and included in the analysis; NAbs, neutralising antibodies; PPS, per-protocol set.