Between-group comparisons of clinical and MRI outcomes
| Fingolimod 0.5 mg (N=429) | IFN-switch (N=431) | p Value | |
|---|---|---|---|
| Clinical outcomes | |||
| Annualised relapse rate (95% CI); confirmed relapses only† | |||
| M0–12 | 0.19 (0.15 to 0.24) | 0.40 (0.33 to 0.47) | <0.001* |
| M13–EOS | 0.16 (0.12 to 0.19) | 0.20 (0.16 to 0.25) | 0.101 |
| Patients with 3-month confirmed disability progression, n (%)‡ | |||
| M0–EOS | 94 (22) | 91 (21) | |
| HR (95% CI) | 0.94 (0.71 to 1.26) | 0.689 | |
| Patients with 6-month confirmed disability progression, n (%)‡ | |||
| M0–EOS | 73 (17) | 63 (15) | |
| HR (95% CI) | 1.08 (0.77 to 1.51) | 0.661 | |
| MRI outcomes | |||
| Number of new/newly enlarged T2 lesions, mean (SD) (core ITT population) | |||
| M0–12 | 1.7 (3.9) | 2.7 (5.8) | |
| M12–24 | 0.9 (1.6) | 1.0 (1.9) | |
| M24–36 | 1.0 (4.4) | 0.7 (1.7) | |
| M36–48 | 0.6 (1.4) | 0.5 (1.5) | |
| Last scheduled MRI-EOS | 0.9 (2.7) | 1.0 (4.4) | |
| Patients free of new or newly enlarged T2 lesions, n*/n (%)§ | |||
| M0–12 | 211/384 (55) | 168/375 (45) | 0.002* |
| M13–EOS | 136/324 (42) | 136/302 (45) | 0.630 |
| Number of Gd+ T1 lesions, mean (SD) (core ITT population) | |||
| Core baseline | 1 (2.8) | 1.1 (2.8) | |
| M12 | 0.2 (1.0) | 0.5 (1.9) | |
| M24 | 0.1 (0.4) | 0.2 (0.9) | |
| M36 | 0.3 (1.8) | 0.2 (0.8) | |
| M48 | 0.0 (0.2) | 0.1 (0.2) | |
| EOS | 0.3 (1.1) | 0.4 (2.7) | |
| Patients free of Gd+ T1 lesions, n*/n (%)¶ | |||
| Core baseline | 288/427 (67) | 268/354 (63) | |
| M12 | 337/374 (90) | 286/354 (81) | <0.001* |
| M13–EOS†† | 221/296 (75) | 219/283 (77) | 0.508 |
| EOS | 266/305 (87) | 253/286 (89) | |
| Per cent change in brain volume, mean/median, n‡‡ | |||
| M12 | −0.31/−0.20, 368 | −0.45/−0.40, 359 | <0.001* |
| M24 | −0.65/−0.50, 314 | −0.66/−0.60, 286 | 0.967 |
| M36 | −0.91/−0.80, 281 | −0.80/−0.70, 250 | 0.091 |
| M48 | −0.94/−0.70, 33 | −0.89/−0.80, 35 | 0.982 |
| EOS | −1.01/−0.80, 301 | −0.96/−0.80, 285 | 0.937 |
n*=number of patients free of lesion.
n=number of patients with evaluable MRI scans.
*Indicates a two-sided statistical significance at the 0.05 level.
†p Values from a negative binomial regression model, adjusted for treatment, pooled country, number of relapses in the previous 2 years before enrolment and core baseline EDSS. Log (time in the study) is the offset variable.
‡HRs and p values from the Cox proportional hazards model adjusted for treatment, pooled country, core baseline EDSS and age.
§p Value from a negative binomial regression model, adjusted for treatment, core baseline volume of T2 lesions and pooled country.
¶p Value from a logistic regression model adjusted by treatment, core baseline number of T1 lesions and pooled country.
††Includes patients not free of Gd+ T1 lesions at any particular time point of M12-EOS even if they do not have evaluable MRI at all time points.
‡‡p Value from Rank ANCOVA with covariates: treatment, pooled country and core baseline normalised brain volume.
ANOVA, analysis of variance; EDSS, Expanded Disability Status Scale; EOS, end of study; Gd+, gadolinium enhanced; IFN, interferon; ITT, intent to treat; M, month.