SLE is a chronic autoimmune disease that affects multiple organ systems and significantly impacts patient-reported health-related quality of life (HRQoL). The clinical manifestations of SLE are heterogeneous, vary over time, and may include fatigue, pain, depression, sleep disturbance and cognitive dysfunction. The multisystemic nature of SLE poses a challenge for evaluating treatment benefit and underscores the importance of using a multidimensional approach when assessing HRQoL. In 1998, the Outcome Measures in Rheumatology (OMERACT) international consensus effort recommended five domains for assessment in all randomised controlled trials (RCTs) and longitudinal observational studies (LOS) in SLE, including disease activity, damage, HRQoL, adverse events and economic costs.

This working group will be working on an update to the existing Core Set.