Table 4

Endpoints with at least a trend for the 0.5 mg dose as compared with placebo (intention to treat (ITT) or <20 mg steroid dose cohort)

End pointPredefined/post hocLevel of significance
Disease activity cluster
 BILAG responders (SR, PR,NR)Predefined-statistical analysis plan (SAP)p<0.05 (ITT, <20)
 Total BILAG score (medians)Predefined-SAPp<0.05 (<20), trend (ITT)
 BILAG responders (3 points)Post hocp<0.05 (<20), trend (ITT)
 BILAG responders (5 points)Post hocp<0.05 (ITT)
 BILAG MC systemPost hocp<0.05 (<20), trend (ITT)
 SLEDAI decreased to ≤2Post hocTrend (ITT, <20)
Flare cluster
 Medicinal flare (5 mg from baseline)Predefined-SAPTrend (ITT, <20)
 Medicinal flare (5 mg from lowest point from previous dose)Post hocp<0.05 (ITT)
 Medicinal flare (10 mg from lowest point from previous dose)Post hocTrend (ITT)
  • BILAG, British Isles Lupus Assessment Group; NR, no response; PR, partial response; SR, substantial response.