POS0119 SLE-DAS REMISSION AND LOW DISEASE ACTIVITY STATES ARE ASSOCIATED WITH IMPROVED HEALTH-RELATED QUALITY OF LIFE AND FATIGUE: POST-HOC ANALYSIS OF THE BLISS-52 AND BLISS-76 PHASE III TRIALS.

Background Accurate and practical outcome measures for clinical trials in systemic lupus erythematosus (SLE) are lacking. The SLE Disease Activity Score (SLE-DAS) is a recently validated 17-item instrument, with high accuracy sensitivity to changes disease activity. SLE-DAS definitions of remission low activity (LDA) were newly against physician-applied the setting [1, 2]. Criterion validity Patient Reported Outcomes, namely health-related quality life (HR-QoL) fatigue needs be assessed. Objectives To evaluate if attainment LDA states associated improvements HR-QoL fatigue. Methods Post-hoc analysis merged study population BLISS-52 -76 ( NCT00424476 ; NCT00410384 ) intravenous belimumab versus placebo moderate severe We analysed Functional Assessment Chronic Illness Therapy (FACIT) 36-Item Short Form Survey (SF-36) trial data. Fulfillment (defined as absence all items prednisone ≤5mg/day) SLE-DAS≤2.48 ≤7.5mg/day) retrospectively assessed from individual participants’ Mean baseline week 52 FACIT SF-36 physical component summary (PCS) mental (MCS) domain scores compared between patients attaining at vs non-remission non-LDA using multivariate regression adjusted scores. Results A total 1684 included. Few (0.5%) (0.8%) entry. At 52, 12.5% attained 17.5% LDA. PCS MCS greater that (5.4 3.4, 4.6 2.7, respectively; p<0.005 both) (5.0 3.4 2.6, both), (Figure 1). Similarly, (all p<0.005) Importantly, largely exceeded minimum clinically important differences (MCIDs) 2.5 5 points, respectively, those or Figure 1. domains 52. #p<0.005; *p<0.001; MICD, Minimum Clinically Important Difference; MCS, Mental Component Summary; PCS, Physical SF-36, Medical Outcomes Form; SLE-DAS, Systemic Lupus Erythematosus Score. Additionally, mean higher than (6.3 3.6, p<0.001) (5.9 p<0.001), MCID 4 points. Conclusion Attainment meaningful improvement References [1]Jesus D, et al. enables accurate user-friendly categories Ann Rheum Dis 2021;80:1568-74. [2]Assunção H, Definition Low State based on SLE-DAS: Derivation validation multicentre real-life cohort. Rheumatology (Oxford 2021;3;keab895. Acknowledgements authors would like thank GlaxoSmithKline (Uxbridge, UK) granting access data 76 through Clinical Study Data Request consortium. Disclosure Interests None declared