Table 1 End-points to be considered in clinical trials in systemic lupus erythematosus
No.*Type of end-pointExamplesMean level of agreement (scale 1–10)
1.1Disease activityValidated disease activity index with global score8.5
Validated disease activity index with system scores8.9
Specific organ manifestations9.4
Biomarkers8.0
1.2Disease severityDamage score9.1
Organ-specific manifestation or measure9.3
1.3Health status and/or quality of lifeGeneric measure, eg, SF (Short-Form)-367.6
Lupus specific measures7.1
1.4Adverse events (Harms)Standardised reporting methods for assessing toxicity, safety and tolerability, eg, National Cancer Institute common terminology criteria for adverse events or OMERACT 7 drug safety module criteria8.7
Mortality9.8
1.5Cost-effectivenessDirect and indirect costs6.5
1.6Changes in drug therapyeg, Steroid dosing during study and reduction achieved8.3
1.7MortalityUsually part of adverse events as rarely primary outcome in SLE trials9.1

  • *Numbers correspond to subheadings in text.