OP0125 REAL WORLD LONGITUDINAL DATA USING EULAR OUTCOME ASSESSMENT TOOLS FOR PRIMARY SJÖGREN’S SYNDROME (PSS) PATIENTS IN A UK CLINIC

Abstract

Background The EULAR Sjogren’s Syndrome Study Group has developed standardised outcome assessment tools for pSS, which are used in clinical trials and routine clinical assessment. While there has been a growing body of data on the use of these outcome assessment tools, data on their application in routine clinical practice, particularly over time, remains scarce. Objectives This paper aims to investigate how EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI) and EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) scores change at multiple timepoints in a large cohort of pSS patients. Methods ESSDAI and ESSPRI scores were collected from patients with a confirmed diagnosis of pSS attending a pSS clinic at a single UK centre over a ten-year time-period. Anonymised data from 2009 to 2019 were analysed for patterns of change in the (overall and domain-specific) ESSDAI and ESSPRI scores over time. Time between clinic visits was also plotted against each patient’s ESSDAI and ESSPRI score at each clinic visit to give an idea of real-world fluctuations in these assessment outcomes over a period time in this large group of patients. Baseline characteristics were also analysed to determine predictors in ESSPRI and ESSDAI changes. Results 634 patients used the clinic with 467 of them had more than one visit and 297 of them having three or more clinic visits. 32% had an ESSPRI at least 1 point higher at the last compared to the first visit (ESSPRI-worse group). 16% had an ESSPRI at least 1 point lower (ESSPRI-improved group) and 48% had a change of less than 1 in ESSPRI between the first and last visits (ESSPRI-unchanged group). The ESSPRI-worse group had a lower mean initial ESSPRI (4.59), compared to the ESSPRI-unchanged and ESSPRI-Improved group (6.27 and 6.29 respectively). There were no significant differences in age, sex and anti-Ro positivity between the three groups; age, percentage female and percentage anti-Ro+ were 60 years, 89%, 66% (ESSPRI-worse); 60 years; 86%, 60% (ESSPRI-unchanged); 62 years, 91%, 73% (ESSPRI-improved). 16% had an ESSDAI at least 3 points higher at the last visit (ESSDAI-worse group); 19% patients had an ESSDAI at least 3 points lower (ESSDAI-improved); and 62% of patients had a difference of less than 3 in ESSDAI between the first and last visits (ESSDAI-unchanged). The mean ESSDAI at first visit was significantly higher in the ESSDAI-improved group (9.2) compared to the ESSDAI-unchanged and ESSDAI-worse groups (3.1 and 2.4 respectively). There was no difference in age between the 3 ESSDAI groups. The ESSDAI-worse group had more female subjects and less anti-Ro positivity (93% & 54% respectively) compared to the ESSDAI-improved (84% & 59%) and ESSDAI-unchanged 86% & 65%) groups. Conclusion ESSPRI and ESSDAI scores did not change significantly over time when looking at an overall cohort level. However, there were significant changes in these outcomes on an individual level. Worsening ESSPRI was associated with lower baseline score whereas improvement in ESSDAI was associated with higher baseline score. Given the lack of proven treatment available for pSS, our data may reflect natural history of the disease course rather than treatment effects.