Table 2.
Siponimod (N = 413, N’ = 72) | Placebo (N = 226, N’ = 80) | Treatment difference (siponimod vs placebo) | p-value | |
---|---|---|---|---|
nMTR drop (accounting for lesion volume) | −1.35 | −1.71 | 0.36 | <0.0001 |
FAS: full analysis set; MTR: magnetization transfer ratio; N: number of patients in MTR subset; N’: number of patients with at least one MTR lesion; nMTR: normalized magnetization transfer ratio.
nMTR drop (i.e. nMTR recovery metrics) describes the total decrease in nMTR from pre- to post-nMTR lesion time points. At least three MTR scans were needed: (1) to obtain a stable pre-lesion nMTR value; (2) to detect an acute drop in nMTR indicative of a newly forming lesion; and (3) to obtain a stable post-lesion nMTR value. In this analysis, the latest available measurement before the formation of a new lesion was taken as pre-lesion time point, and the latest available measurement after the formation of a new lesion was taken as the post-lesion time point. Peri-lesion time points were not included.
FAS included all randomized patients with assigned treatments who took at least one dose of study medication.