Endpoint | Robustness (discriminatory capacity) | Suitability for primary endpoint | Data management challenges | Validation/ community acceptance |
SRI or BICLA2–4 9–11 17–27 75 76 89 | Moderate | Strong | High | High |
Enhanced SRI/BICLA2 3 11 | Strong | Strong | High | Medium |
Four-point SLEDAI decrease2 3 9 10 12 | Moderate | Strong | Low | Medium |
Severe flare2 3 | Moderate | Moderate | Moderate | Medium |
Mild/moderate flare2 3 | Modest | Weak | Moderate | Low |
CLASI12 110–114 | Strong | Strong | Moderate | High |
Low disease activity12 | Strong | Strong | Moderate | Early |
Sustained improvement12 | Strong | Strong | Moderate | Early |
PROs116 117 | Unknown | Unknown | Moderate | Increasing |
BICLA, BILAG-based Combined Lupus Assessment; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; PRO, patient-reported endpoint; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; SRI, Systemic Lupus Erythematosus Responder Index.