Ab1038 Erythrocyte Sedimentation Rate as a Biomarker in Sle

Background: There has been a long-standing interest in the use of biomarkers in SLE, both to measure current disease activity and to predict disease outcomes. Erythrocyte sedimentation rate (ESR), a non-specific biomarker of inflammation, has been shown to correlate with SLE disease activity as well as predict SLE flares and organ damage in some studies, yet it is not used in clinical trial endpoints. Objectives: We sought to evaluate the associations of ESR with disease activity flares, organ damage and mortality in a large, multi-national cohort of SLE patients. Methods: Data were prospectively collected between 2013 and 2020, including both clinical and laboratory data recorded at each clinic visit, in a multinational cohort of patients who meet ACR/SLICC Criteria. Patients with at least one ESR result were included in this study. Patients were categorised according to whether the ESR had, or had not, ever been above the relevant upper limit of normal 1. Outcomes included disease activity (SLEDAI-2K), Lupus Low Disease Activity State (LLDAS), DORIS remission and steroid-free remission (DORIS-0); flares (SELENA-SLEDAI flare index); organ damage (SLICC Damage Index (SDI)); and mortality. Distributions of these outcomes between ESR categories were analysed using Pearson's Chi-squared test (categorical variables) or Wilcoxon rank-sum test (continuous variables). Results: 3,457 patients were studied over 39,228 visits. 2,272 (66.7%) patients had an elevated ESR at least once (high ESR-ever). High ESR-ever patients had a significantly higher proportion of females (p=0.005) and had a younger median age at diagnosis (28.0 vs 31.0 years, pvs 44.0 years, pvs 3.4, pvs 15.1%, pvs 29.5%, pvs 13.1%, pConclusion: SLE patients with elevated ESR at least once had higher disease activity, flares, organ damage and mortality. Re-evaluation of the use of ESR as a clinical trial outcome measure is justified. REFERENCES: 1 Tishkowski K, Gupta V. Erythrocyte sedimentation rate. StatPearls Internet: StatPearls Publishing; 2023. Table 1. Associations between elevated ESR and clinical outcomes of interest DORIS remission: prednisolone dose Acknowledgements: We acknowledge the Asia Pacific Lupus Collaboration (APLC) patient cohort participants and the data collectors at all APLC sites. Disclosure of Interests: Laura Eades: None declared, Vera Golder: None declared, Alberta Hoi Advisory board for Abbvie and GSK, AstraZeneca, GSK, BMS, Janssen, Merck Serono, Worawit Louthrenoo: None declared, Yi-Hsing Chen: None declared, Laniyati Hamijoyo: None declared, Jiacai Cho: None declared, Aisha Lateef: None declared, Chak Sing Lau: None declared, Shue Fen Luo: None declared, Yeong-Jian Jan Wu: None declared, Zhanguo Li: None declared, Sargunan Sockalingam: None declared, Yasuhiro Katsumata Asahi Kasei Pharma, Astellas Pharma Inc., AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation, Pfizer Japan Inc., Sanofi K.K., Masayoshi Harigai AbbVie Japan GK, Ayumi Pharmaceutical Co., Boehringer Ingelheim Japan, Inc., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Kissei Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd., AbbVie, Boehringer-ingelheim, Bristol Myers Squibb Co., Kissei Pharmaceutical Co.,Ltd. and Teijin Pharma., AbbVie Japan GK, Asahi Kasei Corp., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co., Daiichi-Sankyo, Inc., Eisai Co., Ltd., Kissei Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Nippon Kayaku Co., Ltd., Sekiui Medical, Shionogi & Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Teijin Pharma Ltd., Yanjie Hao: None declared, Zhuoli Zhang: None declared, Sandra Navarra AstraZeneca, Boehringer Ingelheim, GSK, Pfizer, AstraZeneca, Biogen, Boehringer Ingelheim, Aurinia, Biogen, Idorsia, Novartis, Leonid Zamora: None declared, Madelynn Chan: None declared, Shereen Oon: None declared, Sang-Cheol Bae: None declared, Jun Kikuchi: None declared, Tsutomu Takeuchi Bristol-Myers Squibb, Eli Lilly Japan, Mitsubishi-Tanabe Pharma Corp., Sanofi K.K., Eli Lilly Japan, Astellas Pharma Inc., Mitsubishi-Tanabe Pharma Corp., Shionogi & Co., Ltd., Sean O'Neill: None declared, Annie Law Hui Nee: None declared, Fiona Goldblatt: None declared, Naoaki Ohkubo: None declared, Sunil Kumar: None declared, Cherica Tee: None declared, Michael Tee: None declared, Duminda Basnayake: None declared, Kristine Pek Ling Ng: None declared, Yoshiya Tanaka Eli Lilly, AstraZeneca, Abbvie, Gilead, Chugai, Behringer-Ingelheim, GlaxoSmithKline, Eisai, Taisho, Bristol-Myers, Pfizer, Taiho, Mitsubishi-Tanabe, Eisai, Chugai, Taisho, Mandana Nikpour AstraZeneca, Boehringer Ingelheim, GSK, Janssen, AstraZeneca, Boehringer Ingelheim, GSK, Janssen,, Boehringer Ingelheim, Janssen, Eric Morand Honoraria from AstraZeneca, Biogen, Bristol Myers Squibb, EMD Serono, Gilead, EMD Serono, AstraZeneca, Biogen, Bristol Myers Squibb, Eli Lilly, Genentech, GlaxoSmithKline, Janssen, Novartis, AbbVie, Galapagos, IgM, AbbVie, Amgen, Biogen, AstraZeneca, Bristol Myers Squibb, Janssen, Eli Lilly, EMD Serono, Genentech, GSK, Union Chimique Belge, Fabien Vincent Janssen-Cilag, CSL Limited, Rangi Kandane-Rathnayake GSK, Novartis (all institutional research grants).