From: Increasing power in the analysis of responder endpoints in rheumatology: a software tutorial
Components | Response criteria | Treatment arm | |
---|---|---|---|
Anifrolumab 300Â mg | Placebo | ||
SLEDAI | Improvement of at least 4 points (change from baseline ≤− 4) | 58/89 | 41/76 |
PGA | No flare/worsening of disease as measured by PGA (change from baseline <0.3) | 87/89 | 75/76 |
BILAG | No flare/worsening of disease as measured by BILAG (no new Grade A or more than one Grade B compared to baseline) | 86/89 | 72/76 |
OCS | Sustained reduction in oral corticosteroids | 53/95 | 37/87 |
Overall SRI + OCS response | Must responds in all four components | 34/95 | 18/87 |