Effects of treatment on conversion to CDMS and McDonald MS (integrated analysis, intent-to-treat population, double-blind period)
| sc IFN β-1a tiw n=171 | sc IFN β-1a qw n=175 | Delayed treatment n=171 | |
|---|---|---|---|
| Conversion to CDMS | |||
| Month 36 | |||
| Patients converting (%) | 25.1 | 25.7 | 38.6 |
| Cumulative probability of CDMS (%) | 27.1 | 27.6 | 41.3 |
| HR (95% CI) vs DT | 0.555 (0.38; 0.82) | 0.573 (0.39; 0.84) | – |
| Relative risk reduction vs DT (%) | 44.5 | 42.7 | – |
| p Value | 0.002 | 0.006 | – |
| HR (95% CI) vs qw | 0.993 (0.65; 1.51) | – | – |
| Relative risk reduction vs qw (%) | 0.7 | – | – |
| p Value | 0.941 | – | – |
| Month 60 | |||
| Patients converting (%) | 32.2 | 36.0 | 40.4 |
| Cumulative probability of CDMS (%) | 39.2 | 40.7 | 44.6 |
| HR (95% CI) vs DT | 0.683 (0.48; 0.98) | 0.752 (0.53; 1.06) | – |
| Relative risk reduction vs DT (%) | 31.7 | 24.8 | – |
| Nominal p value | 0.032 | 0.084 | – |
| HR (95% CI) vs qw | 0.940 (0.65; 1.35) | – | – |
| Relative risk reduction vs qw (%) | 16.0 | – | – |
| Nominal p value | 0.852 | – | – |
| Conversion to McDonald MS | |||
| Month 36 | |||
| Patients converting (%) | 66.7 | 76.0 | 84.2 |
| Cumulative probability of McDonald MS (%) | 66.8 | 79.1 | 86.5 |
| HR (95% CI) vs DT | 0.508 (0.40; 0.65) | 0.698 (0.55; 0.89) | – |
| Relative risk reduction vs DT (%) | 49.2 | 30.2 | – |
| Nominal p value | <0.001 | 0.009 | – |
| HR (95% CI) vs qw | 0.722 (0.56; 0.93) | – | – |
| Relative risk reduction vs qw (%) | 27.8 | – | – |
| Nominal p value | 0.024 | – | – |
| Month 60 | |||
| Patients converting (%) | 72.5 | 82.9 | 84.2 |
| Cumulative probability of McDonald MS (%) | 79.2 | 89.5 | 86.5 |
| HR (95% CI) vs DT | 0.546 (0.43; 0.70) | 0.759 (0.60; 0.96) | – |
| Relative risk reduction vs DT (%) | 45.4 | 24.1 | – |
| Nominal p value | <0.001 | 0.040 | – |
| HR (95% CI) vs qw | 0.692 (0.54; 0.88) | – | – |
| Relative risk reduction vs qw (%) | 30.8 | – | – |
| Nominal p value | 0.005 | – | – |
Cumulative probability: Kaplan-Meier estimate of the cumulative probability of CDMS or McDonald MS; HR: multivariate Cox proportional hazards model with treatment and randomisation stratification factors as covariates; p value: two-sided log-rank test, stratified for randomisation stratification factors. Month 60 statistical analyses were exploratory; therefore, all p values for this time point were nominal (p values <0.05 are reported).
CDMS, clinically definite multiple sclerosis; DT, delayed treatment; IFN, interferon; MS, multiple sclerosis; qw, once weekly; sc, subcutaneously; tiw, three times weekly.