Systemic lupus erythematosus assessment and endpoints review

Systemic lupus erythematosus (SLE) clinical trials are complex, and, to date, only three compounds have been approved for this condition. There remains some controversy around which outcome measures and endpoints are best for SLE trial design. Unmet needs include residual disease activity, frequent flares, glucocorticoid toxicity, comorbidities and organ damage with low daily quality of life. In this white paper, we provide an overview of the current assessments and endpoints frequently used in SLE clinical trials to obtain an optimal evaluation of outcomes, monitor patients and assess responses to new drugs being developed.