Table 4

Comparisons with disability data from placebo cohorts of other published phase III trials. End points measured at 2 years unless otherwise stated

Entry EDSS range2 year EDSS difference (unadjusted)EDSS confirmed progression end points
1.0-pt 3 months1.0-pt 6 months2.0-pt 6 months
This study:
 Total cohort0 to 5.0+0.3832%21%9%
Other relapsing-remitting MS studies:
 INFβ-1b1 0 to 5.5NA28% (3 years)NANA
 INFβ-1a3 1.0 to 3.5+0.74NA35%18%
 IVIg4 1.0 to 6.0+0.12NA23% (unconfirmed)
Secondary progressive MS study:
 INFβ-1b31 3.0 to 6.5+0.60 (3 years)50% (3 years)NANA
  • The 1.0 point 6 months end point for the IVIg trial wasnot confirmed as this was not an outcome measure used in the study.