THU0342 The lupus foundation of america rapid evaluation of activity in lupus (LFA-REAL) provides a simple but reliable measurement of sle disease activity
Authors: A. Thanou, C. Arriens, T. Aberle, J.A. James, J.T. Merrill, A.D. Askanase
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Clinical trial evaluations in SLE are problematic, in part due to glossary-based outcome measures with imperfect granular relevance. Visual analogue scales (VAS) allow real world scaling of disease severity, but may be inconsistent when used over time or by different raters. The SELENA SLEDAI Physician's Global Assessment (SSPGA) is a VAS with severity anchors and instructions to promote consistent, transitional scoring. The Rapid Evaluation of Activity in Lupus (LFA-REAL<sup>TM</sup>) extends the SSPGA by scoring each active feature separately, allowing additive impact of each manifestation within organs, and a global score with meaningful weighting of multiple symptoms. It differs from previous constructions that combine PGA with component scoring<sup>1</sup> by incorporating all manifestations of lupus and refining scaling of the SSPGA<sup>2</sup>. <h3>Objectives</h3> To compare performance of SSPGA and LFA-REAL<sup>TM</sup> to accepted SLE trial outcome measures during an ongoing trial in SLE, using a strict protocol for transitional scoring. <h3>Methods</h3> Disease activity, SLEDAI, BILAG 2004 CLASI, SSPGA and LFA-REAL<sup>TM</sup>) was evaluated at monthly visits in an investigator-initiated, double-blind, placebo controlled study of abatacept (trial results pending). Validation of total scores and change in SSPGA and REAL vs SLEDAI and BILAG were examined by Spearman Correlation. ROC curve analysis compared changes in SSPGA and LFA-REAL<sup>TM</sup> to the dichotomous SLE trial endpoints, SRI-4 and BICLA. <h3>Results</h3> 50 adult SLE patients, 47 female, were assessed at 528 visits. Changes in disease activity compared to screening were examined in 478 visit pairs. Total SSPGA and REAL scores strongly correlated to each other (r=0.932), as well as to total SLEDAI and BILAG [SSPGA: r=0.742 (SLEDAI), r=0.776 (BILAG); REAL: r=0.776 (SLEDAI), r=0.813 (BILAG); all p&lt;0.0001]. Changes in SSPGA and LFA-REAL<sup>TM</sup> at each visit compared to screening correlated to each other (r=0.857) as well as to changes in SLEDAI and BILAG (all p&lt;0.0001) (table 1). Changes in SSPGA and LFA-REAL<sup>TM</sup> were very strongly related to the dichotomous SRI-4 and BICLA endpoints by ROC analysis (all p&lt;0.0001) (table 2). LFA-REAL<sup>TM</sup> musculoskeletal correlated to BILAG musculoskeletal, SLEDAI arthritis, and tender and swollen joint counts (r=0.842, 0.817, 0.634 and 0.784 respectively, all p&lt;0.0001). LFA-REAL<sup>TM</sup> mucocutaneous also correlated to BILAG mucocutaneous, the sum of SLEDAI mucocutaneous features as well as CLASI activity (r=0.826, 0.798 and 0.789 respectively, all p&lt;0.0001). <h3>Conclusions</h3> Both the SSPGA and LFA-REAL<sup>TM</sup> are reliable surrogates of commonly used endpoints in SLE trials. Both instruments are easy to score and understand, and could be employed as continuous or dichotomous endpoints. The LFA-REAL<sup>TM</sup> allows individualised scoring at the symptom or organ level, and each symptom contributes its exact severity to a global score. The simplicity of PGA scoring is accompanied by gains in versatility. <h3>References</h3> [1] Askanase AD, et al. Arthritis Care Res2017Oct 9. doi:10.1002/acr.23445 [2] Petri M, et al. J Rheumatol1992;19:53–9. <h3>Disclosure of Interest</h3> None declared