Background Existing methods for grading lupus flares or improvement in disease activity require definition-based thresholds as increments of change. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. We analyzed the performance of two scales, the SELENA SLEDAI Physician’s Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REALTM) as measures of progress in SLE.
Methods Prospectively, we evaluated the agreement between collected disease activity (SLEDAI, BILAG-2004, CLASI, SSPGA and LFA-REALTM) and response (SRI-4 and BICLA) measures in an ongoing clinical trial.
Results 50 patients (47 females, mean age 45±11.6 years) were assessed at 528 consecutive visits (average 10.6±4.1 visits per patient). Changes in disease activity compared to baseline were examined in 478 visit pairs. SSPGA and LFA-REALTM correlated with each other (r=0.936), and with SLEDAI and BILAG [SSPGA: r=0.742 (SLEDAI), r=0.776 (BILAG); LFA-REALTM: r=0.778 (SLEDAI), r=0.813 (BILAG); all p<0.0001]. Changes (Δ) in SSPGA and LFA-REALTMcompared to screening correlated with each other (r=0.857) and with changes in SLEDAI and BILAG [ΔSSPGA: r=0.678 (ΔSLEDAI), r=0.624 (ΔBILAG); ΔLFA-REALTM: r=0.686 (ΔSLEDAI), and 0.700 (ΔBILAG); all p<0.0001]. Changes in SSPGA and LFA-REALTM strongly correlated with SRI-4 and BICLA by ROC analysis (p<0.0001 for both, see figure 1 below). Additionally, LFA-REALTM correlated to individual BILAG organ scores [musculoskeletal: r=0.842, mucocutaneous: r=0.826 (p<0.0001 for both)].
Conclusions SSPGA and LFA-REALTM are reliable surrogates of common SLE trial endpoints and could be used as continuous or dichotomous response measures. Additionally, LFA-REALTM can provide individualized scoring at the symptom or organ level.
Acknowledgements We thank the patients for their participation in the study. Clarification of Abatacept Effects in SLE with Integrated Biologic and Clinical Approaches (The ABC Study) is an ongoing, investigator-initiated, clinical trial, conducted at the Oklahoma Medical Research Foundation (OMRF), with funding from Bristol Myers Squibb (NCT02270957).
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