BACKGROUND:Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease characterized by fluctuating activity affecting multiple organ systems. Timely and accurate assessment of disease activity is critical for guiding clinical decisions and implementing treat-to-target strategies. The Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) is a recently developed, continuous, and weighted index for disease activity, though it has not yet been validated in Russian patients. OBJECTIVE:To validate SLE-DAS in a Russian cohort of patients with SLE. METHODS:We prospectively enrolled 200 SLE patients followed for ≥12 months at the V.A. Nasonova Research Institute of Rheumatology. The median age was 35.0 [26.0-43.0] years; 84.5% were female. Median disease duration was 63.0 [22.0-158.0] months. Clinical and laboratory data were analyzed to asses SLE-DAS performance. Internal consistency of SLE-DAS was assessed using Cronbach's alpha. Convergent validity was evaluated via correlation with the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and Physician Global Assessment (PGA). To compare the ability of SLE-DAS and SLEDAI-2K to identify active SLE, we performed a receiver operating characteristic (ROC) analysis with determination of the area under the curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's kappa. Responsiveness was analyzed using the Wilcoxon test, SRM, and Cohen's d. RESULTS:At baseline, the median SLEDAI-2K was 8.0, PGA 0.99, and SLE-DAS 8.38. SLE-DAS showed excellent convergent validity (ρ = 0.878 with both SLEDAI-2K and PGA). Internal consistency was moderate for binary components (α = 0.663), while quantitative variables showed low agreement. According to DORIS remission framework, 90.5% of patients had active SLE. ROC analysis showed high diagnostic accuracy: AUC = 0.899 for SLE-DAS and 0.870 for SLEDAI-2K. After reclassifying 23 patients on glucocorticoids >5 mg/day without clinical activity as inactive, SLE-DAS showed superior performance: AUC = 0.973, sensitivity 96.2%, specificity 97.6%, PPV 99.3%, NPV 82.4%, κ = 0.86. Responsiveness at 6 and 12 months was also confirmed (SRM = -0.78 and -0.66, both p < 0.0001). CONCLUSION:SLE-DAS is a valid, responsive, and accurate tool for assessing SLE activity in Russian patients and may improve clinical monitoring in routine practice.

OBJECTIVES:To enhance clinical and multicentre research outcomes in systemic lupus erythematosus (SLE), standardised documentation of patient- and disease-related features is important. The aim of this European Alliance of Associations for Rheumatology (EULAR) taskforce was to define a core set of essential items for the comprehensive care of SLE patients in clinical practice, with an extension for vital elements required for translational and observational research. METHODS:A multidisciplinary EULAR task force group engaged in a multistep approach including a 4-round Delphi survey and a face-to-face meeting. RESULTS:Twenty-five stakeholders from 14 different countries participated. During the process, the initial list of 99 items was reduced to 73 items for inclusion in the clinical core dataset and 8 additional items for research extension. The items were grouped in the domains 'general', 'disease activity', 'disease history', 'disease damage', 'comorbidities', 'patient reported outcomes', 'laboratory markers', 'outcomes', and 'treatment', with suggested frequencies of assessment. CONCLUSIONS:The presented clinical core dataset and its research extension are designed to improve SLE patient care and facilitate collaborative research by ensuring the comparability of datasets and cohort descriptions. This initiative lays the foundation for the establishment of a global SLE data space and has the potential to expedite the implementation of personalised medicine in SLE care.

OBJECTIVES:To assess adverse events (AE) associated with first-line therapies for rheumatoid arthritis (RA) in a real-world setting. MATERIAL AND METHODS:Retrospective multicenter cohort study of patients fulfilling classification criteria for RA and followed up in 66 rheumatology centers from the Rheumatic Diseases Portuguese Registry (Reuma.pt). All AE reports associated with first-line disease-modifying antirheumatic drugs (DMARDs) up to November 2024 were included. Demographic and clinical data were analyzed, and AE characteristics were investigated. Categorical and continuous variables were compared using chi-square tests and Mann-Whitney U tests, respectively. Statistical significance was defined as p < .05. RESULTS:Among 1 880 AE entries, 377 (20.1%) were attributed to first-line DMARDs, most commonly methotrexate (62.9%) although no information on drug dosage was available. The median age at AE occurrence was 58.6 years (IQR: 19.32), and 82% were female. A causality assessment was available in 317 reports, with 40.3% deemed "probable," 28.1% "possible," and 10.6% "definitive." Severe AE were reported in 13.2% of cases, with pulmonary involvement being the most common (20.8%).Overall, 46.7% of patients discontinued treatment for any reason. Male sex was significantly associated with severe AE (OR = 2.31; 95% CI: 1.17-4.55; p = .014), and older patients were more likely to experience severe AE (median age 65.7 vs. 57.9 years; p < .001). The most affected body organ systems were gastrointestinal (9.3%), skin (8.2%), and hematological (8.2%). The median time to AE onset from treatment initiation was 1.27 years (IQR: 2.63), and from disease onset was 8.56 years (IQR: 11.76). CONCLUSIONS:AE related to first-line RA therapies can lead to significant clinical consequences, including treatment discontinuation. Male sex and advanced age were associated with increased AE severity. The most affected systems appear consistent with known drug safety profiles, particularly that of methotrexate; however, the absence of information regarding drug dosage precludes more detailed conclusions. These findings emphasize the need for individualized monitoring strategies and improved pharmacovigilance to optimize long-term treatment safety and adherence in RA management.

PV214 / #533 Poster Topic:AS23 - SLE-Diagnosis, Manifestations, & Outcomes Recently, a EULAR/ACR 2019 systemic lupus erythematosus (SLE) classification criteria (EULAR/ACR 2019) score≥20 was identified in a SLE inception cohort with less than 2 years from diagnosis as a marker for more severe disease, including higher disease activity, more frequent flares, higher use of immunosuppressants, lower probability of achieving remission, and more damage accrual. However, this analysis has not been performed in SLE patients with longer disease duration.[1] The aim of our study was to assess a EULAR/ACR 2019 score ≥20 as a marker for severe disease in a prevalent SLE cohort. We performed a cross-sectional multicenter study of patients fulfilling the EULAR/ACR 2019 classification criteria for SLE in the Portuguese registry of rheumatic diseases (Reuma.pt). Disease activity (SLE-DAS) and the EULAR/ACR score were assessed at the last visit, between June 2023 and March 2024. Groups of patients with EULAR/ACR 2019 score ≥20 or <20 were compared for demographic, clinical and treatment features, with parametric and non-parametric tests, as appropriate. Separate models were tested using different definitions of severe SLE (dependent variable), as present/absent: (1) cumulative SLE major organ involvement; (2) moderate/severe disease activity, defined as SLE-DAS>7.64; (3) ongoing immunosuppressants; (4) ongoing systemic prednisolone>7.5 mg/day; (5) organ damage, defined as SLICC/ACR Damage Index (SDI) ≥ 1. Predictors for each of these definitions were assessed in a 2-step approach with logistic regression (LR) univariate analysis, followed by multivariate LR models including variables with p<0.10 in the first step, while excluding variables with multicollinearity. Multivariate analysis was used to identify independent predictors and estimate the respective adjusted odds ratios (OR) with 95% confidence intervals. There were 2459 patients registered in Reuma.pt, from 37 participating centers. A total of 709 patients, from 18 centers, who had data on and fulfilled the EULAR/ACR 2019 classification criteria and had a SLE-DAS scoring were included, 65.6% having an EULAR/ACR 2019 score≥20. These patients were younger at diagnosis (p<0.001), had longer disease duration (p<0.001), higher SLE-DAS score (p=0.001), received less frequently antimalarials (p=0.004), and were more frequently treated with synthetic and/or biologic immunosuppressants (p<0.001) and glucocorticoids (p<0.001). On univariate LR analysis, a EULAR/ACR 2019 score≥20 was associated with all definitions of severe disease (Table 1). On multivariate LR analysis, a EULAR/ACR 2019 score≥20 was an independent predictor of cumulative major organ involvement (OR 7.30, 95% CI 4.86-10.95, p<0.001), moderate/severe disease activity (OR 7.36, 95% CI 2.18-24.82, p=0.001), ongoing immunosuppressants (OR 2.73, 95% CI 1.82-4.09, p<0.001), and ongoing systemic prednisolone>7.5 mg/day (OR 2.71, 95% CI 1.29-5.69, p=0.009), adjusted for significant covariates. In the multivariate LR, a EULAR/ACR score≥20 was not associated with organ damage, defined as SDI≥1. Table 1 Univariate and multivariate logistic regression analysis for severe SLE A EULAR/ACR 2019 score ≥20 is associated with severe disease in a prevalent SLE cohort. Although this is not surprising, given the similarity and close relationship between items included in all instruments, this score may, in association with measures of disease activity, contribute to management in clinical practice, stratification of cases in observational studies and selection of patients for clinical trials.References:[1.] Whittall-Garcia LP. Ann Rheum Dis. 2021;80(6):767-74. * Carolina Mazeda and Beatriz Mendes contributed equally and share first authorship.

PV173 / #295 Poster Topic:AS19 - Patient-Reported Outcome Measures SLE is a chronic inflammatory systemic disease characterized by a complex clinical picture. It has been demonstrated that achieving remission or low disease activity is crucial to improve long-term outcomes. However, in daily clinical practice, it is not rare to observe a relevant discordance between patient and physician global assessment, because of different illness perceptions. Recently, it has been proposed a different way to categorize SLE manifestations: classic inflammatory signs and symptoms has been labeled as type 1, whereas other frequent symptoms as fatigue, widespread pain, sleep disorder, brain fog with an unclear relationship to inflammation as type 2.[1] The presence and severity of type 2 manifestations can be assessed with the use of Polysymptomatic distress (PSD) scale, derived from 2016 ACR Fibromyalgia Criteria.[2] The aim of the present collaborative study was to assess the prevalence of type 2 in a multicenter cohort of SLE patients, to evaluate correlations with other PROs and to evaluate differences in clinical manifestations, disease activity, treatment and PROs performance in patients with or without high level type 2 SLE Adult SLE patients consecutively followed in 2 Lupus Clinic from March to July 2024 were included. PSD score is obtained by summing the Widespread Pain Index and Symptom Severity Scale (range score 0-31), and high level type 2 is defined as ≥ 12 (2). Fatigue was assessed through FACIT-Fatigue, quality of life with EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) and Short-Form-36 Health Survey (SF-36). Medical records including demographic data, clinical characteristics and outcomes measures were collected The study included 238 patients (92% women), Caucasian in 95%, with a median age of 47 years and a mean disease duration of 199 months. Concerning level of education 28.1% had a primary/middle school education, high school in 38.6% and 33.3% postsecondary education. The majority of patients were employed (68.7%), followed by retired in 17.8%, unemployed 10% and 3.5% were students. 30 (12.7%) patients had a diagnosis of fibromyalgia. At the last evaluation mean SLEDAI was 1.48 (±1.77), mean SLE-DAS 1.34 (±1.94); 193 (81.4%) and 184 (80.3%) met the criteria for SLE-DAS or DORIS remission. We reported a mean PSD of 7.99 (±6.08) and, as shown in Table 1, PSD score strongly correlated negatively with SF-36 domains, FACIT and EQ-5D-3L and patient global assessment, whereas it does not correlate with physician global assessment, disease activity or damage scores. Moreover, a significant positive correlation was found with BMI and disease duration. A high-level type 2 (PSD≥12) was found in 58 patients (24.3%), and comparison between patients with and without high level type 2 is reported in Table 2. No differences were found in cumulative clinical manifestations, disease activity or damage and ongoing SLE treatment, whereas patients with higher PSD were older, with a higher BMI and more frequently had a primary/secondary education. Moreover, they had a worse performance in all the PROs. Table 1. Table 2. High level type 2 SLE symptoms occurred in nearly 25% and its occurrence was not related to classic disease manifestation or objective disease activity, but with other features as weight, age, concomitant depression/anxiety. Moreover, PSD performance strongly correlates with other PROs and has the advantage of being completed in a short time and therefore its use in daily practice could be more feasible.References:[1.] Pisetsky DS. Arthritis Care Res (Hoboken) 2019;71(6):735-41. [2.] Wolfe F. Semin Arthritis Rheum 2016;46:319-29.

PV175 / #503 Poster Topic:AS19 - Patient-Reported Outcome Measures Fatigue is a major symptom in patients with systemic lupus erythematosus (SLE) significantly impacting health-related quality of life (HR-QoL). Causes of fatigue in SLE are multifactorial and not well understood. A novel framework categorizes SLE manifestations into type 1 and type 2. Type 1 manifestations can be ascribed to inflammation and captured in activity indexes, whereas type 2 symptoms (such as fatigue, pain, sleep, and mood disturbances) have no clear relation to disease activity. Type-2 SLE is defined using the polysymptomatic distress scale (PDSS). Objective: To identify predictors of fatigue in SLE patients. Cross-sectional study of SLE patients fulfilling ACR/EULAR 2019 and/or SLICC 2012 classification criteria followed in a Rheumatology outpatient clinic. Inclusion was from December 2023 to May 2024. The study included 200 patients with SLE (female: 92.0%; mean age: 46.4±14.3 years; median age at diagnosis: 28.5 [16.0] years). Severe fatigue was present in 28.6%. In the study population, 87.5% fulfilled the LDA treatment target, 30.5% had type 2 SLE, 38.5% had organ damage, and 17.0% were diagnosed with fibromyalgia. Patients with severe fatigue had worse scores in both PDSS and aPDSS (p<0.0001). The aPDSS cut-off that better predicted SLE type 2 was ≥9.50 (sensitivity 96.9%, specificity 99.9%). Univariate analysis showed significant variables for severe fatigue: female sex (p=0.04), age (p=0.02), disease duration (p=0.02), SLE-DAS (p=0.03), type 2 SLE (PDSS and aPDSS definitions) (p<0.001), and fibromyalgia (p<0.001), while LDA was protective (p<0.01). SLEDAI and SDI were not significant. Multivariate analysis revealed type 2 SLE [OR 25.33; 95% CI(10.63-60.31); p<0.001) and diagnosis of fibromyalgia [OR 3.51; 95% CI(1.16-10.69); p<0.05] as independent predictors of severe fatigue. Similar findings were found when using aPDSS, [OR 16.16; 95% CI(7.22-36.13); p<0.001)] for type 2 SLE and [OR 4.44; 95% CI(1.51-12.26); p<0.05] for fibromyalgia. In this cohort of SLE patients, type 2 lupus was the major predictor of severe fatigue. Physicians and patients should be careful not to attribute fatigue to inflammatory type 1 disease activity when the LDA treatment target is achieved. This should be taken into consideration for establishing the management strategy. * First and second authors listed share first authorship.

PV215 / #526 Poster Topic:AS23 - SLE-Diagnosis, Manifestations, & Outcomes Treat-to-target (T2T) aiming for remission, or at least low disease activity (LDA), while tapering prednisone to ≤5 mg/day is established as a pillar for management of systemic lupus erythematosus (SLE) in the 2023 updated EULAR recommendations for clinical practice. The aim of our study was to investigate the attainment of the T2T goal in the SLE population from the Rheumatic Diseases Portuguese Registry (Reuma.pt) and identify unmet treatment needs. We performed a cross-sectional multicenter study of patients fulfilling the EULAR/ACR 2019 classification criteria for SLE in the Reuma.pt. The assessment was performed at the last visit occurring between June 2023 and March 2024. Disease activity and attainment of T2T were assessed with the SLE Disease Activity Score (SLE-DAS).[1] Patients with no SLE-DAS scoring were excluded. Patients were classified as in remission (clinical items of SLE-DAS =0 and prednisone ≤5 mg/day), low disease activity (LDA) (SLE-DAS ≤2.48 and prednisone ≤5 mg/day) and, for those not attaining T2T, in categories of disease activity (mild: 2.089.90). Descriptive analysis was performed, and a comparison between the remission vs. non-remission and LDA vs. non-LDA groups was performed using Student’s t-test, Fisher’s exact test, Chi-square or Mann-Whitney U tests, as appropriate. IBM SPSS Statistics software version 27 was used. p≤0.05 was considered statistically significant. There were 2459 patients with SLE from 37 centers registered in Reuma.pt. Of these, 1664 (67.7%) were excluded due to: missing data on fulfillment (n=1257, 51.1%) or no fulfillment (n=83, 3.4%) of EULAR/ACR classification criteria; missing data for SLE-DAS (n=324, 13.2%). A total of 795 patients from 18 participating centers were included [89.6% female; mean age 49.9 (SD 14.2) years] (Table 1). Main cumulative SLE clinical features included: mucocutaneous (72.5%), hematological (66.7%), arthritis (63.6%), nephritis (38.9%), serositis (19.4%) and neuropsychiatric lupus (6.8%). Remission was attained by 71.3% and an additional 3.0% were in LDA, meaning that the EULAR treatment target was achieved by 74.3%. The remaining patients presented active disease (mild 20%, moderate 2.6%, severe 3%). Hydroxychloroquine (HCQ) was prescribed to 88.3% of all patients. Patients not in LDA were more frequently treated with synthetic (69.1% vs 39.6%, p<0.001) and biologic (19.1% vs 8.5%, p<0.001) immunosuppressants. Of the patients with active SLE, 40.2% were receiving >7.5 mg/day of prednisolone-equivalent dose and 72.7% were treated with synthetic and/or biologic immunosuppressants. Table 1. Characteristics of the patients included (n=795). This subgroup of patients with SLE registered in Reuma.pt present a high rate of attainment of the T2T, and most are treated with HCQ, in line with the EULAR recommendations. The high number of patients excluded preclude the generalization of these conclusions. This provides benchmarking indicators demonstrating high quality of care. Furthermore, unmet needs for new and improved therapies are demonstrated, with over a quarter of patients presenting active disease despite more intensive standard-of-care. Longitudinal studies are needed to assess if T2T goals are sustained over time. Optimized treatment regimens are needed to attain recommended T2T goals in many SLE patients. Improvement of registry in Reuma.pt is indispensable for a representative national appraisal.References:[1.] Jesus D. Ann Rheum Dis 2021;80(12):1568-74. * Carolina Mazeda and Beatriz Mendes contributed equally and share first authorship.

O016 / #589 Topic:AS23 - SLE-Diagnosis, Manifestations, & Outcomes ABSTRACT CONCURRENT SESSION 02: SLE METRICS – IMPROVING OUTCOMES & MEASURES 22-05-2025 1:40 PM - 2:40 PM Reliability measures the consistency of an instrument’s assessments. Instruments intended for clinical and research use must exhibit high reliability. There is a need for studies that evaluate and compare the reliability of different instruments used to measure SLE disease activity. This study aims to estimate the intrarater and interrater reliability of 3 SLE disease activity measurement tools as assessed by lupus experts: the SLE Disease Activity Score (SLE-DAS), the SLE Disease Activity Index 2000 (SLEDAI-2K), and the Physician Global Assessment (PGA).[1,2] A group of 19 lupus experts from 12 countries (Europe, North America, South America, and Asia) evaluated 24 clinical case vignettes of SLE covering a wide spectrum of organ manifestations and disease severity. All raters completed a training on scoring rules for SLE-DAS, SLEDAI-2K and PGA before assessing the clinical vignettes. Raters scored each clinical vignette with SLE-DAS, SLEDAI-2K, and PGA twice, with at least a 10-day interval between rounds. The clinical vignettes were randomly ordered and assessed through an online survey. Intrarater and interrater reliability were assessed using the Intraclass Correlation Coefficient (ICC) and reported with 95% CI. For this analysis, ICC estimates were derived from a two-way random effects model (single rater). All calculations were performed using the Stata Statistical Software (Release 17) with the kappaetc module. The Coefficient of Variation (CV) was also used as a measure of reliability.[3] The CV was calculated for each vignette, based on the 19 measurements from each rater, for SLE-DAS, SLEDAI-2K, and PGA. Then, for each disease activity measure, the mean of the CV values across the 24 vignettes was used as a summary measure of within-subject variability and is expressed as a percentage. The 24 clinical vignettes represented a wide variety of active SLE manifestations, including skin rash (20.8%), arthritis (12.5%), renal involvement (12.5%), thrombocytopenia (12.5%), cardiac/pulmonary involvement (12.5%), mucocutaneous vasculitis (8.3%), serositis (8.3%), and neuropsychiatric SLE (8.3%). Systemic vasculitis, myositis, alopecia, hemolytic anemia, and leukopenia were each present in 4.2% of the vignettes. Hypocomplementemia and/or positive anti-dsDNA were present in 75.0%. All the 19 lupus experts completed 2 rounds of assessment of the 24 clinical vignettes, totaling 912 case assessments. Scores ranged from 0.37 to 27.37 in SLE-DAS, 0 to 21 in SLEDAI-2K, and 0.0 to 3.0 in PGA. The interrater ICCs were 0.93, 0.91, and 0.74, and the intrarater ICCs were 0.94, 0.93, and 0.88 for SLE-DAS, SLEDAI-2K, and PGA, respectively. The CVs (first rating round) were 8.2%, 19.7%, and 41.1% for SLE-DAS, SLEDAI-2K, and PGA, respectively. The ICCs (95% CI) and CVs for SLE-DAS, SLEDAI-2K, and PGA are detailed in Table 1 and Table 2. Table 1. Inter-rater and intra-rater Intraclass Correlation Coefficient (ICC) of SLE-DAS, SLEDAI-2K and PGA. Table 2. Coefficient of Variation (CV) of SLE-DAS, SLEDAI-2K and PGA. This study demonstrates that both SLE-DAS and SLEDAI-2K presented good to excellent interrater reliability, indicating strong consistency in scoring across different experts. Notably, SLE-DAS achieved excellent intrarater reliability, reflecting a high degree of stability in individual assessments between assessments at different times. Both SLEDAI-2K and PGA exhibited good to excellent intrarater reliability, while PGA showed moderate to good interrater reliability. Furthermore, SLE-DAS exhibited the lowest within-subject variability, as evidenced by its lower CV values compared to SLEDAI-2K and PGA.References:[1.] Jesus D. Ann Rheum Dis 2019;78:365-71. [2.] Piga M. Lancet Rheumatol 2022;4:e441-9. [3.] Shechtman O. In: S.A.R. Doi, G.M. Williams (Eds.). Methods Clin Epidemiol 2013:39-49.

OBJECTIVES:To compare proliferative (PLN) and membranous (MLN) lupus nephritis (LN) regarding clinical and laboratory presentation and long-term outcomes, and to investigate predictors of progression to chronic kidney disease (CKD). METHODS:Multicentre observational study, with retrospective analysis of a prospective cohort, using data from the Rheumatic Diseases Portuguese Registry - Reuma.pt. Patients with biopsy-proven PLN, MLN and mixed LN were included. Cox regression survival analysis was used to investigate predictors of CKD. RESULTS:A total of 260 patients were included. Median follow-up was 8 years (IQR 11; minimum 1, maximum 35 years). MLN patients presented with significantly lower serum creatinine [0.70 (IQR 0.20; minimum 0.50, maximum 1.30) mg/dl vs 0.80 (IQR 0.31; minimum 0.26, maximum 2.60) in PLN, P = 0.003]. Proteinuria levels did not differ between groups (P = 0.641). Levels of complement were reduced in PLN but nearly normal in MLN patients, and there were fewer patients with positive anti-dsDNA antibodies in the MLN group (P < 0.001). One year after the beginning of treatment, 62% of the patients achieved EULAR/ERA-EDTA complete response, with a further 5% achieving partial response. Patients with lower proteinuria at diagnosis were more likely to achieve a complete renal response at one year; however, proteinuria at diagnosis or at one year did not predict long-term CKD. Estimated glomerular filtration rate (eGFR) ≤75 mL/min/1.73 m2 at one year was the strongest predictor of progression to CKD (HR 23 [95% CI 8-62], P < 0.001). Other possible predictors included the use of azathioprine for induction of remission, older age at diagnosis and male sex. CONCLUSION:Proteinuria levels did not predict LN histologic class in our cohort. eGFR cutoff of 75 mL/min/1.73 m2 after one year of treatment was strongly predictive of progression to CKD.

Objectives To assess agreement between the 2021 Definition Of Remission In SLE (DORIS) and physician-judged lupus activity. Methods A cross-sectional analysis was conducted of data from a Spanish prospective multicentre study of SLE patients. We applied the 2021 DORIS criteria and assessed whether remission status based on this definition agreed with remission as per physician clinical judgement and reasons for disagreement between them. Results Out of 508 patients [92% women; mean age (s.d.): 50.4 years (13.7)] studied, 267 (54.4%) met the criteria for 2021 DORIS remission. Based on physicians' judgement, 277 (55.9%) patients were classified as in remission or serologically active clinically quiescent (SACQ). The overall rate of agreement between these assessments was 81.2% (95% CI: 79.9, 82.9%) with a Cohen's kappa of 0.62 (0.55-0.69). Overall, 46 (9.1%) patients were classified as in remission/SACQ by rheumatologists but did not meet the 2021 DORIS criteria for remission. The main reasons for discrepancies were a clinical SLE Disease Activity Index (cSLEDAI) score >0 in 39 patients, a Physician Global Assessment score >0.5 in five patients, and prednisone >5 mg/day in another five patients. Conclusions The 2021 DORIS remission is an achievable target in clinical practice. There is substantial agreement between the DORIS definition and physician-judged remission. The discordance was mainly due to physicians classifying some patients with ongoing mild disease activity as in remission. Thus, the standardized DORIS definition should be used to define the target in a treat-to-target strategy for the management of SLE.

Background No data on agreement between patient perception, DORIS 2021 remission, LLDAS, or physician assessment is currently available. The aim is to compare the SLE activity perceived by the patient using the Patient Acceptable Symptom State (PASS) question with the global assessment of activity by the physician, and the definitions of LLDAS/DORIS2021. Methods A cross-sectional multicenter study involving SLE patients from seven Spanish Rheumatology Departments was conducted. The study applied DORIS 2021 remission criteria and LLDAS. Rheumatologists classified disease activity into five categories: remission, SACQ, low, moderate, or high. The patients were asked about their clinical SLE condition through the PASS question: 'Considering all the different ways your disease is affecting you, if you were to stay in this state for the next few months, do you consider your current state satisfactory?': PASS yes/PASS no. Statistical analysis included descriptive cross-sectional analysis and Cohen's kappa for agreement analysis. Results Among the 503 patients in the study (table 1), 386 (77.4%) reported an acceptable symptom state according to the PASS question. Mean patient global assessment (PtGA) was 29.62 (±24.38) on a scale of 0–100, while mean physician global assessment (PGA) was 0.46 (±0.59) on a scale of 0–3. A total of 236 (47.6%) patients met DORIS 2021 remission criteria, and 289 (59%) met LLDAS. According to the rheumatologists' categorical classification, 435 (86.8%) patients were in remission or low disease activity (table 2). Among PASS-affirmative patients, 65.5% met LLDAS and 57.9% met DORIS 2021 remission criteria, with lower PtGA (19.7) and PGA (0.29) scores. In the non-PASS group, 62.8% were not in LLDAS, and 87.6% did not meet DORIS 2021 remission criteria, with higher PtGA (58) and PGA (1) scores (table 3). The overall agreement between PASS and categorical classification was 82% with a Cohen's kappa of 0.43. Conclusions The majority of SLE patients reported an acceptable symptom state according to the PASS question, which aligns with the PtGA scale. Physicians' assessments also showed similarities with patient perspectives. However, notable differences were observed regarding remission/LLDAS criteria, indicating that while patient and physician perspectives align on subjective classification, variations exist concerning LLDAS and DORIS.

BACKGROUND:Since the development of the OMERACT Systemic Lupus Erythematosus (SLE) Core Outcome Set (COS) in 1998, many new SLE domains have been identified and measures developed, creating a need to update the SLE COS. To revisit the 1998 SLE COS and research agenda domains, and generate new candidate domains, we conducted this study of patients with SLE and collaborators. OBJECTIVE:(1) To evaluate existing candidate SLE domains for inclusion in the SLE COS. (2) To generate additional candidate SLE domains for COS consideration. (3) To engage SLE collaborators, including patients, in developing the updated SLE COS. METHODS:The OMERACT SLE Working Group's steering committee developed a survey to assess the importance of candidate SLE domains and generate additional domains for consideration towards the SLE COS. Patients with SLE followed at the University of Toronto Lupus Clinic (patient group) and members of the OMERACT SLE Working Group (collaborator group) were invited to complete the survey between August 2022 and February 2023. RESULTS:A total of 175 patients were invited and 100 completed the survey. Of 178 collaborators invited, 145 completed the survey. Patients tended to prioritize life-impact domains while collaborators prioritized clinical domains. Both patients and collaborators recommended additional domains to those included in the 1998 SLE COS and research agenda. CONCLUSION:The domain inclusion and importance results demonstrate that patients and collaborators prioritize different domains, so capturing the perspectives of both groups is essential to ensure a holistic assessment of SLE. The results of the study identify domains that already have a high level of agreement for potential inclusion in the SLE COS, domains that require further explanation, and novel domains that warrant consideration.

Background A gold-standard definition of severe SLE disease activity is lacking for use both in clinical trials and daily clinical setting. The SLE-DAS is an easy to use, validated instrument, with high accuracy and sensitivity to change in SLE disease activity. The SLE-DAS definition for severe disease activity (SDA) was recently derived and validated. Objectives To compare the disease features and health-related quality of life (HR-QoL) of patients fulfilling the SDA definition both by SLE-DAS and BILAG-2004 with those in SDA: (a) only by SLE-DAS (but not BILAG-2004); (b) only by BILAG-2004 (but not SLE-DAS). Methods Post-hoc analysis of the aggregated intention-to-treat, placebo arm participants, in the anifrolumab versus placebo for moderate-to-severe SLE phase 2 and 3 RCTs [MUSE (NCT01438489), TULIP-1 (NCT02446912), TULIP-2 (NCT02446899)]. At the RCTs week 12, we analyzed the physicians' assessments (including clinical and analytical data, BILAG-2004, CLASI-A, SLEDAI-2K), and patient reported outcomes (PROs) [LupusQoL, EQ-5D, FACIT-F, Patient Global Assessment (PtGA) scores]. The SLE-DAS was retrospectively scored. Active lupus features and PROs at week 12 were compared between the group of patients classified in SDA by both the SLE-DAS (>9.90) and BILAG-2004 (>11) vs patients classified in SDA only according to SLE-DAS or BILAG-2004. Chi-squared, Fishers' or Mann-Whitney tests were applied. Results From 438 SLE patients, at week 12 were classified in SDA: 34% by both instruments (SLE-DAS+BILAG-2004), 12.6% by SLE-DAS only, and 10.05% by BILAG-2004 only. The groups in SDA according to SLE-DAS+BILAG-2004 and to SLE-DAS-only did not present any significant differences in active disease features and the HR-QoL PROs (table 1). In contrast, patients classified in SDA only by BILAG-2004 presented significantly lower SLEDAI-2K, less serositis, nephritis and arthritis. Notably, patients in SDA by BILAG-2004 alone presented significantly less severe impact in the HR-QoL PROs (table 1). Conclusion Patients in SDA defined either by SLE-DAS+BILAG-2004 or by SLE-DAS only present similarly severe disease, both according to active lupus features and the HR-QoL PROs. Contrarily, those classified in SDA only by BILAG-2004 may present less severe disease, according both to the physician and patient assessments. Acknowledgement This publication is based on research using data from data contributors AstraZeneca that has been made available through Vivli, Inc. Vivli has not contributed to or approved, and is not in any way responsible for, the contents of this publication.

Objective Our objective was to evaluate the ability of Systemic Lupus Erythematosus Disease Activity Score (SLE‐DAS) remission and low disease activity (LDA) to discriminate active drug from placebo and to discriminate outcomes in the patients’ perspective (health‐related quality of life [HR‐QoL]) in SLE trials. Methods This was a post hoc analysis of the pooled Belimumab in Subjects With SLE (BLISS)‐52 (NCT00424476) and BLISS‐76 (NCT00410384) trials data. SLE‐DAS remission and LDA attainment and discrimination between belimumab and placebo at 52 weeks were compared using chi‐square tests. At week 52, 36‐item Short Form Health Survey (SF‐36) and Functional Assessment of Chronic Illness Therapy Fatigue (FACIT‐F) scores were compared between patients attaining SLE‐DAS remission versus nonremission and SLE‐DAS LDA versus non‐LDA using the t ‐test and Mann‐Whitney test. Mean changes from week 0 to 52 in SF‐36 and FACIT‐F scores were compared between groups using multivariate regression analysis adjusted for baseline scores. Results At week 52, significantly more patients attained SLE‐DAS LDA taking belimumab 1 mg/kg (17.9% vs 13.0%; P = 0.023; odds ratio [OR] 1.459; relative risk [RR] 1.377; number needed to treat [NNT] 20.4) and 10 mg/kg (21.7% vs 13.0%; P < 0.001; OR 1.853; RR 1.668; NNT 11.5) compared with placebo. Likewise, more patients attained SLE‐DAS remission taking belimumab 10 mg/kg compared to placebo (14.7% vs 10.1%; P = 0.019; OR 1.532; RR 1.454; NNT 21.7). At week 52, patients attaining SLE‐DAS remission and LDA presented higher SF‐36 domain and summary scores (all P < 0.001) and FACIT‐F scores (both P < 0.001). Mean improvements from baseline in SF‐36 and FACIT‐F scores were significantly higher in patients achieving SLE‐DAS remission and LDA. Conclusion SLE‐DAS remission and LDA showed discriminant ability for identifying patients receiving active drug in SLE clinical trials. Attainment of these SLE‐DAS targets are associated with better HR‐QoL.

Background: Accurate and practical outcome measures for clinical trials in Systemic lupus erythematosus (SLE) are lacking. Currently used primary endpoint measures (i.e. the SRI and BICLA) include over 120 items, are cumbersome to score and not feasible in the clinical setting. The SLE Disease Activity Score (SLE-DAS) is a recently validated 17-item instrument, with high accuracy and sensitivity to changes in SLE disease activity [1,2]. The new SLE-DAS Responder Index (SLE-DAS RI) may provide an outcome measure with high performance and feasibility. The SLE-DAS RI has 17 items and defines a responder as: decrease in SLE-DAS ≥1.72 and no moderate/severe disease activity (SLE-DAS score ≤7.64). Objectives: To evaluate the performance of the SLE-DAS RI to identify improvement in clinical and laboratory aspects of SLE, and in health-related quality of life (HR-QoL) patient reported outcomes (PROs). Methods: Post-hoc analysis of the aggregated intention-to-treat, placebo arm participants, in the anifrolumab versus placebo for moderate-to-severe SLE phase 2 and 3 RCTs [MUSE (NCT01438489), TULIP-1 (NCT02446912), TULIP-2 (NCT02446899)]. We analyzed the physicians' assessments [including clinical and analytical data, BILAG-2004, CLASI-A, SLEDAI-2K and Physician Global Assessment (PhGA)], the patient reported outcomes (PROs) [LupusQoL, SF-36, EQ-5D, FACIT-F and Patient Global Assessment (PtGA) scores] and the cumulative glucocorticoid intake. The SLE-DAS score was retrospectively assessed from the individual participants' data. Disease activity was categorized as severe (SLE-DAS >9.90), moderate (SLE-DAS >7.64 to ≤9.90) or mild/remission (SLE-DAS ≤7.64) and the fulfillment of SLE-DAS response was assessed (defined as a decrease in SLE-DAS ≥1.72 + SLE-DAS score ≤7.64). Changes from study baseline to week 52 in clinical, laboratory and HR-QoL PROs were compared among SLE-DAS responders versus non-responders using logistic regression and linear regression models adjusted for baseline scores. Results: We assessed 438 SLE patients. At week 52, 34% (n=149) of the patients achieved a SLE-DAS response, presenting significantly lower disease activity measured by SLE-DAS, SLEDAI-2K and PhGA (Table 1 and Figure 1). None of the SLE-DAS responders presented activity in major organ systems, including the central nervous system, cardiopulmonary, renal, vasculitis, gastrointestinal or hemolytic anaemia). Only 2% (n=3) and 0.6% (n=1) presented ≥1 new BILAG A/B domain and an increase in PhGA ≥0.3 points, respectively. Importantly, the SLE-DAS responders had significantly lower glucocorticoid use during the study follow-up. Additionally, SLE-DAS responder presented significantly higher improvements in all aspects of HR-QoL PROs, namely the LupusQoL, SF-36, EQ-5D, FACIT-F and PtGA. Conclusion: Achievement of SLE-DAS response is associated with significant improvements both in the physician measures of disease activity and the HR-QoL PROs as compared to non-responders. The SLE-DAS RI provides an accurate and feasible endpoint for SLE clinical trials. REFERENCES: [1] Jesus D, Matos A, Henriques C, et al. Derivation and validation of the SLE Disease Activity Score (SLE-DAS): a new SLE continuous measure with high sensitivity for changes in disease activity. Ann Rheum Dis 2019;78:365-71. [2] Jesus D, Larosa M, Henriques C, et al. Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) enables accurate and user-friendly definitions of clinical remission and categories of disease activity. Ann Rheum Dis 2021;80:1568-74. Acknowledgements: This publication is based on research using data from data contributors AstraZeneca that has been made available through Vivli, Inc. Vivli has not contributed to or approved, and is not in any way responsible for, the contents of this publication. Disclosure of Interests: None declared.