Table 1.

Efficacy Endpoints

BIIB059
PBO50 mg150 mg450 mg
LS Mean (SE)LS Mean (SE)LSMD*
from PBO (95% CI)
P val.LS Mean(SE)LSMD*
from PBO (95% CI)
P val.LS Mean
(SE)
LSMD*
from PBO (95% CI)
P val.
Primary Endpoint
CLASI-A % change from BL-14.5 (6.4)-40.8 (7.5)-26.3 (-45.7; -7.0)0.008-47.9 (7.4)-33.5 (-52.7; -14.3)0.001-43.5 (5.5)-28.0 (-44.5; -11.5)0.001
Secondary Endpoints
n(%)n(%)LSMD*
from PBO (95% CI)
P val.n(%)LSMD*
from PBO (95% CI)
P val.n(%)LSMD*
from PBO (95% CI)
P val.
Prop. of participants achieving CLASI 507/32 (21.9%)10/26 (38.5%)15.8% (-7; 39)0.13311/25 (44.0%)21 (-2.8; 45)0.05920/43 (46.5%)23 (3; 44)0.024
Prop. of participants achieving a ≥7-point CLASI-A reduction from BL7/32 (21.9%)9/26 (34.6%)12.3 (-11.3; 35.8)0.22812/25 (48.0%)22.2 (-2.0; 46.3)0.05518/43 (41.8%)16.8 (-6.7; 40.4)0.048
  • *LSMD=LS Mean Difference