Outcome measures to be used in clinical trials in systemic lupus erythematosus

The optimal outcome measures to be employed in clinical trials of systemic lupus erythematosus (SLE) have yet to be determined. Useful instruments sho uld assess disease outcome in terms of all organ system involvement, as wel l as measures important to the patient, This cuticle reviews those outcome measures that have been utilized in cohort studies in SLE, as well as their limited use in randomized clinical trials (RCT), Six disease activity meas ures have been developed: British Isles Lupus Assessment Group Scale (BILAG ), European Consensus Lupus Activity Measure (ECLAM), Lupus Activity Index (LAI), National Institutes of Health SLE Index Score (SIS), Systemic Lupus Activity Measure (SLAM), and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). They have been validated in cohort studies as reflecting ch ange in disease activity, and against each other. RCT utilizing SLAM, SLEDA I, BILAG, ECLAM, SIS, SLAM, SLEDAI are ongoing, It is recommended that the disease activity index of choice be selected: but simultaneous computer gen eration of multiple indices will facilitate comparisons across therapeutic interventions, A damage index has been developed and validated as the Syste mic Lupus International Cooperating Clinics (SLICC)/American College of Rhe umatology (ACR) Damage Index or SDI, In several cohort studies it has been shown sensitive to change over time, and to reflect cumulative disease acti vity. There is no health status or disability instrument specific to SLE, T he Medical Outcomes Survey (SF-20) captures health status/health related qu ality of life (HRQOL) better than the Health Assessment Questionnaire (HAQ) in patients with SLE. but does not adequately reflect fatigue. The SF-36 d oes assess fatigue, and correlates closely with the SF-20. These data indic ate that any individual measure of clinical response to a therapeutic inter vention in SLE may reflect only a portion of what might be: termed the "tru e outcome." Based on this work, the way is now paved to attempt to develop consensus on the important domains to be measured in clinical trials in SLE , the most appropriate instruments to use and the minimal clinically import ant differences in their results.