Measures both cutaneous lupus activity and damage8 9; response correlates with changes in QoL and biomarkers, and meaningful response from patient perspective determined10 11

Validation studies show excellent inter-rater and intra-rater reliability, responsiveness8 12 13

Used in prospective international phase II and III trials, showing differences in response in treatment relative to placebo arms14 15

Widely used as both primary outcome in phase I and II CLE trials and secondary outcome in SLE phase I–III trials14 15

Includes a SLE disease activity index without points for anti-DNA or low complement (cSLEDAI) and a PhGA (Physician Global Assessment) <0.5 (0–3), irrespective of serology5 6

Two-part system with patient-reported outcome and clinician-reported outcome measures that allow for integration of both for targeted treatment decision-making

Use does not require specialised training or fluency in English

Has been used as an exploratory endpoint in several clinical trials and has proven effective16 17

Concept definition is ‘A state, which if sustained is associated with a low likelihood of adverse outcome, considering disease activity and medication safety’. Incorporates thresholds for disease activity and treatment burden especially glucocorticoid dose

Formally validated in prospective multinational studies as protective against flare, damage, loss of quality of life and mortality.18 19 Also validated in many retrospective cohort studies

Extensive evaluation in post hoc analysis of clinical trials data, where it has good to excellent performance discriminating active treatment from placebo20–22

Widely adopted prospectively as a key secondary outcome measure in SLE trials23 24

A SLE continuous measure with high sensitivity for changes in disease activity

Includes 17 weighted clinical and laboratory parameters attributed to SLE disease activity including continuous measures, important manifestations absent from SLEDAI and an improved weighting system

Validated in peer reviewed publications25–28

Identifying key domains such as disease activity, health-related quality of life and functional ability

Goal is to update original core domain set from 1998

Will continue to be updated following the results of additional studies aiming to generate a preliminary list of domains relevant for patients with SLE, physicians and other stakeholders and further analyses and vote on the final OMERACT SLE core domain set

Developed to capture change with the least number of features in trials; aggregates changes in SLEDAI score, selected BILAG items, prednisone dose and selected biomarkers29

Validated using the Bliss-76 study7

Study findings suggest that LuMOS 2.0 formula may be a potential primary endpoint in future SLE trials

Multi-domain ClinRO being developed for use in randomised clinical trials. Will measure domains that impact how the patient feels, functions and survives in accordance with FDA guidance30