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 point | Predefined/post hoc | Level 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-SAP | p<0.05 (<20), trend (ITT) |
| BILAG responders (3 points) | Post hoc | p<0.05 (<20), trend (ITT) |
| BILAG responders (5 points) | Post hoc | p<0.05 (ITT) |
| BILAG MC system | Post hoc | p<0.05 (<20), trend (ITT) |
| SLEDAI decreased to ≤2 | Post hoc | Trend (ITT, <20) |
| Flare cluster | ||
| Medicinal flare (5 mg from baseline) | Predefined-SAP | Trend (ITT, <20) |
| Medicinal flare (5 mg from lowest point from previous dose) | Post hoc | p<0.05 (ITT) |
| Medicinal flare (10 mg from lowest point from previous dose) | Post hoc | Trend (ITT) |
BILAG, British Isles Lupus Assessment Group; NR, no response; PR, partial response; SR, substantial response.