Pos1236 Sjögren’s Disease Activity and Clinical Characteristics of Patients With Seropositive and Seronegative Anti-Ssa/Ro and Anti-SSB/La Antibody Test Results

Background: Sjögren's disease (SjD) is a chronic autoimmune condition that can affect the musculoskeletal system, nervous system, and/or vascular system. Autoantibodies anti–Sjögren's-syndrome-related antigen A (anti-SSA/Ro) and B (anti-SSB/La) are hallmark autoantibodies in SjD 1, associated with earlier disease onset, extra-glandular manifestations, and more significant glandular dysfunction. Anti-SSA/Ro antibodies are associated with hematologic abnormalities, and extra-glandular disease such as lymphadenopathy 2. Objectives: The aim of this study is to describe the systemic disease activity of SjD patients with and without the presence of these autoantibodies. Methods: Data were drawn from the Adelphi Real World SjD Disease Specific Programme™, a cross-sectional survey of rheumatologists and their next six consecutively consulting patients with SjD conducted in France, Germany, Italy, Spain, and the United States in June – October 2018. Rheumatologists provided retrospective information regarding patient testing at diagnosis, including the serum anti-SSA/Ro and serum anti-SSB/La antibody tests, as well as patients' current clinical characteristics and systemic involvement. These data were used for the calculation of a proxy clinical EULAR Sjögren's syndrome disease activity index (clinESSDAI) score, calculated using physician-perceived severity scores of the individual organ domains. These same patients were asked to complete patient self-completion questionnaires which included the EQ-5D-3L, EuroQoL Visual Analogue Scale (EQ-VAS), Functional Assessment of Chronic Illness Therapy – Fatigue Scale (FACIT-Fatigue), and work productivity and activity impairment questionnaire (WPAI). All data are reported descriptively. Results: Rheumatologists (n=319) reported data on 1,879 patients; mean (SD) patient age was 53.2 (12.2) years, 89% of patients were female and 89% were white. Table 1 shows the clinical and patient-reported outcomes for both seropositive and seronegative anti-SSA/Ro and anti-SSB/La SjD patients, with a combined group of patients seropositive (49%) or seronegative (4%) for both antibody tests. Of patients with reported antibody test results for anti-SSA/Ro (n=1404), 92% were seropositive. For anti-SSB/La (n=1341) 73% were seropositive. Haematological involvement was reported for 22% of double seropositive patients but only 9% of double seronegative patients. Mean clinESSDAI scores for seropositive patients were 3.1 (anti-SSA/Ro) and 1.8 (anti-SSB/La) points higher than in seronegative patients (Table 1). Patient-reported EQ-5D-3L and WPAI scores are reported in Table 1. Mean (SD) EQ-VAS score for double seropositive patients was 61.5 (18.6), on a scale 0-100 where 100 is equal to the best imaginable health state. Mean (SD) EQ-VAS score for double seronegative patients was 73.4 (26.2). Mean (SD) FACIT-Fatigue scores for double seropositive and seronegative patients were 30.6 (10.46) and 36.3 (13.3) respectively, on a scale of 0-52 with higher scores indicating less fatigue. Conclusion: Patients who were seronegative had a similar level of organ involvement as seropositive patients, but seropositive patients had directionally higher clinESSDAI scores. Therefore, patients who had serum anti-SSA/Ro and/or serum anti-SSB/LA autoantibodies at diagnosis could represent a group of SjD patients likely to experience more clinical activity. Patient-reported outcome measures also suggest seropositive SjD patients may experience a lower health state and greater fatigue than in seronegative SjD patients. Further research is needed to better explore this potential indicator of clinical activity among SjD patients. REFERENCES: 1 Hernández-Molina G, et al. Autoimmun Rev. 2011;10(3):123-125. 2 Alexander EL, et al. Ann Int Med. 1983;98(2):155–159. Acknowledgements: Medical writing support was provided by Panita Maturavongsadit, PhD, of Lumanity Communications Inc., and was funded by Janssen Global Services, LLC. Disclosure of Interests: Jacques-Eric Gottenberg AbbVie, Janssen, BMS, UCB, MSD, Novartis, Pfizer, Gilead, Galapagos, Lilly, Sanofi, Nicola Massey Adelphi Real World, Megan Hughes Adelphi Real World, Victoria Barton Adelphi Real World, Sarah Weatherby Adelphi Real World, Federico Zazzetti May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Andras Borsi May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Wim Noel May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Evo Alemao May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Harman Dhatt May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Angelina Villasis-Keever May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Anna Sheahan May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine, Urbano Sbarigia May own shares/stock options of Johnson & Johnson, Johson & Johnson Innovative Medicine.