Table 3

Performance of outcome measures for lupus studies

EndpointRobustness
(discriminatory capacity)
Suitability for primary endpointData management
challenges
Validation/
community acceptance
SRI or BICLA2–4 9–11 17–27 75 76 89 ModerateStrongHighHigh
Enhanced SRI/BICLA2 3 11 StrongStrongHighMedium
Four-point SLEDAI decrease2 3 9 10 12 ModerateStrongLowMedium
Severe flare2 3 ModerateModerateModerateMedium
Mild/moderate flare2 3 ModestWeakModerateLow
CLASI12 110–114 StrongStrongModerateHigh
Low disease activity12 StrongStrongModerateEarly
Sustained improvement12 StrongStrongModerateEarly
PROs116 117 UnknownUnknownModerateIncreasing
  • 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.