OP0204 LUPUS DAMAGE INDEX REVISION – ITEM GENERATION AND REDUCTION PHASE

Background: The Systemic Lupus International Collaborating Clinics ( SLICC)/ American College of Rheumatology (ACR) Damage Index for Systemic Lupus Erythematosus (SLE) (SDI) [1] is a robust instrument, but has limitations in terms of missing items, limited usefulness in paediatric patients, and outdated item definitions[2]. SLICC, ACR and the Lupus Foundation of America (LFA) collaboratively embarked on a project to develop a revised SLE Damage Index using data-driven and expert/patient consensus-based approaches. The methodological approach includes 5 phases: updating the construct of damage, item generation, item reduction, item definition and weighting/threshold determination, and the assessment of validation and reliability. In phase I, qualitative methods were used to define the modern construct of damage in SLE [3]. Objectives: To report the item generation and reduction phases for developing a revised SDI. Methods: Item generation began with a comprehensive literature review and an initial Delphi exercise of international SLE experts. Item reduction involved conducting two additional Delphi rounds, where items with a median score of ≤4 out of 9 were excluded (1 = not at all appropriate and 9=completely appropriate). Items that were redundant, did not reflect the damage construct, were excessively rare, or were not feasible to assess were also removed. The expert organ domain groups defined the remaining items and suggested severity gradations for relevant items. Results: A panel of 146 individuals from 35 countries, broadly reflecting the lupus research and patient community, was established. The literature review generated 4 (1.8%) unique items, while 103 (46.8%) unique items were generated in the Delphi process, and 113 (51.4%) items overlapped in both processes. After the second Delphi round, Delphi participants suggested an additional 6 unique items, giving a total of 226 items. Thirty-six items scoring ≤4 out of 9 were removed. A further 126 items were removed due to redundancy, inadequate reflection of damage construct, association with lupus disease activity, rarity, or limited feasibility for assessment. This process excluded all items in two newly proposed organ domains including haematology and reproduction/pregnancy, reducing the number of organ domains to 12. The expert organ domain groups reviewed the candidate items, leading to a final total of 38 items. Figure 1 shows the number of candidate items identified at different stages of Phase II/III during revised SDI development. Figure 1Number of candidate items identified at different stages of Phase II/III during revised SDI development Eleven items from the previous SDI, including chronic peritonitis, muscle atrophy, and osteomyelitis, were removed. Several new items were proposed, such as growth failure/reduced final height and adrenal insufficiency. Moreover, 13 items had proposed gradings of severity (Table 1). For example, ischaemic heart disease is proposed to be graded as follows: Grade 1: asymptomatic ischaemia on testing, Grade 2: symptomatic angina with confirmatory tests Grade 3: myocardial infarction (clinical presentation and confirmatory tests) and Grade 4: multiple myocardial infarctions and/or coronary artery bypass grafting. Similarly, kidney function impairment is proposed to be graded according to Kidney Disease Improving Global Outcomes (KDIGO) categories of glomerular filtration rate (GFR). Grade 0 -GFR ≥60 mL/min/1.73 m², Grade 1 -GFR 30-59 mL/min/1.73 m², Grade 2 - GFR 15-29 mL/min/1.73 m², and Grade 3 GFR <15 mL/min/1.73 m². Conclusion: The item generation and reduction phases resulted in 38 candidate items to be taken forward to the next stages. Grading damage items is possible for 34.2% of proposed items in a new revised damage index. This offers a more detailed and clinically relevant assessment of organ damage in SLE patients. It reflects current evidence based medical practice and is likely to improve sensitivity of the index in SLE populations. Further validation in cohorts and consideration of weighting of grades across clinical organ systems is now underway. REFERENCES: [1] Gladman, Dafna, et al. "The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus." Arthritis & Rheumatism: Official Journal of the American College of Rheumatology 39.3 (1996): 363-369. [2] Barber, Megan RW, et al. "Evolving concepts in systemic lupus erythematosus damage assessment." Nature Reviews Rheumatology 17.6 (2021): 307-308. [3] Johnson, Sindhu R., et al. "Evaluating the construct of damage in systemic lupus erythematosus." Arthritis Care & Research 75.5 (2023): 998-1006. Table 1Items suggested for gradation in the revised damage index..ItemsGradesStroke1,2,3Cognitive impairment1,2Ocular damage1,2,3,4,5Kidney function impairment1,2,3Renal biopsy findings1,2Pulmonary fibrosis1,2Cardiomyopathy1,2,3,4Ischaemic heart disease1,2,3,4Valve vegetations/thickening1,2,3Pulmonary hypertension1,2Scarring chronic alopecia1,2,3Cutaneous scarring or atrophy1,2Dyspigmentation1,2 Acknowledgements: We thank the revised SDI collaborators for their valuable input. The project is supported by LFA, SLICC and ACR. Disclosure of Interests: Burak Kundakci: None declared, Megan Barber AbbVie, AstraZeneca, GSK, Janssen, Sanofi-Genzyme, Ann E. Clarke AstraZeneca, GSK, BMS, Novartis, Roche, GSK, Sindhu R. Johnson: None declared, Ian Bruce Astra Zeneca, Janssen, GSK, Novartis, Astra Zeneca, Janssen, GSK, Novartis, Takeda, BMS, Grants to Institution from Astra Zeneca, Janssen, GSK, Otsuka, on behalf of the Revised Systemic Lupus Erythematosus (SLE) Organ Damage Index (SDI) Collaborators: None declared. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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