Effects of treatment on MRI end points (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 | |
|---|---|---|---|
| T2 lesions, mean (SE) | |||
| Month 36 | 21.16 (1.44) | 24.61 (1.62) | 25.79 (1.73) |
| Rate ratio (95% CI) vs DT | 0.82 (0.69; 0.98) | 0.95 (0.80; 1.14) | – |
| Nominal p=0.031 | Nominal p=0.606 | ||
| Month 60 | 21.46 (1.45) | 24.95 (1.62) | 26.19 (1.74) |
| Rate ratio (95% CI) vs DT | 0.82 (0.69; 0.98) | 0.95 (0.80; 1.14) | – |
| Nominal p=0.029 | Nominal p=0.591 | ||
| New T2 lesions, mean (SE) | |||
| Month 36 | 0.47 (0.06) | 0.61 (0.07) | 1.14 (0.13) |
| Rate ratio (95% CI) vs DT | 0.41 (0.30; 0.56) | 0.53 (0.39; 0.73) | – |
| Nominal p<0.001 | Nominal p<0.001 | ||
| Month 60 | 0.55 (0.07) | 0.66 (0.08) | 1.11 (0.13) |
| Rate ratio (95% CI) vs DT | 0.49 (0.36; 0.68) | 0.59 (0.43; 0.81) | – |
| Nominal p<0.001 | Nominal p<0.001 | ||
| New Gd+ lesions, mean (SE) | |||
| Month 36 | 0.14 (0.03) | 0.29 (0.05) | 0.74 (0.13) |
| Rate ratio (95% CI) vs DT | 0.18 (0.11; 0.30) | 0.39 (0.24; 0.63) | – |
| Nominal p<0.001 | Nominal p<0.001 | ||
| Month 60 | 0.16 (0.03) | 0.28 (0.05) | 0.69 (0.13) |
| Rate ratio (95% CI) vs DT | 0.23 (0.14; 0.38) | 0.41 (0.25; 0.67) | – |
| Nominal p<0.001 | Nominal p<0.001 | ||
| New T1 hypointense lesions, mean (SE) | |||
| Month 36 | 0.33 (0.05) | 0.47 (0.06) | 0.73 (0.09) |
| Rate ratio (95% CI) vs DT | 0.45 (0.32; 0.65) | 0.64 (0.45; 0.91) | – |
| Nominal p<0.001 | Nominal p=0.012 | ||
| Month 60 | 0.35 (0.05) | 0.49 (0.06) | 0.70 (0.09) |
| Rate ratio (95% CI) vs DT | 0.50 (0.35; 0.70) | 0.70 (0.50; 0.97) | – |
| Nominal p<0.001 | Nominal p=0.035 | ||
Data are per patient per scan unless stated otherwise. The negative binomial regression model is corrected for overdispersion with treatment and randomisation stratification factors as covariates and number of scans as an offset variable. Month 60 statistical analyses were exploratory; therefore, all p values for this time point were nominal (p values <0.05 are reported).
DT, delayed treatment; Gd+, gadolinium-enhancing; IFN, interferon; qw, once weekly; sc, subcutaneous; tiw, three times weekly.