Table 2

Treatment effect of subcutaneous IFN β-1a on MRI lesion counts during the double blind period (intent-to-treat population)

Lesions per patient per scan (point estimate)Subcutaneous IFN β-1a three times a week versus placebo*Subcutaneous IFN β-1a once a week versus placebo*Subcutaneous IFN β-1a three times a week versus IFN β-1a once a week*
VariableSubcutaneous IFN
β-1a three times a week
(n=171)
Subcutaneous IFN β-1a once a week (n=175)Placebo (n=171)Ratio (95% CI)p ValueRatio (95% CI)p ValueRatio (95% CI)p Value
CUA lesions per patient per scan0.500.952.580.19 (0.14 to 0.26)<0.0010.37 (0.27 to 0.50)<0.0010.52 (0.38 to 0.71)0.002
New T2 lesions per patient per scan0.170.240.550.30 (0.23 to 0.40)<0.0010.43 (0.32 to 0.57)<0.0010.71 (0.53 to 0.95)0.012
New T1 hypointense lesions per patient per scan0.180.260.410.43 (0.33 to 0.57)<0.0010.63 (0.48 to 0.81)0.0040.69 (0.53 to 0.91)0.008
New Gd+ lesions per patient per scan0.060.170.720.08 (0.05 to 0.13)<0.0010.24 (0.16 to 0.35)<0.0010.35 (0.23 to 0.54)<0.001
  • *Treatment effects were estimated using a negative binomial model, with treatment, baseline lesions and randomisation stratification variables as covariates and log number of scans as an offset variable; p values were calculated using a two-sided stratified non-parametric analysis of variance model on ranked data, with effects for treatment group, baseline lesions and randomisation stratification factors.

  • CUA, combined unique active; Gd+, gadolinium-enhancing; IFN, interferon.