Pos0754 patient Acceptable Symptom State (Pass) in Patients With Primary Sjögren’s Syndrome in Daily Clinical Practice

Abstract

BackgroundPrimary Sjögren’s syndrome (pSS) has great impact on all aspects of patients’ lives, not only physically, but also mentally, socially and financially.1 Sicca symptoms are mainly treated with local treatment, but no systemic immunosuppressive treatment is registered yet for pSS, which may have significant consequences on whether patients find their symptom state acceptable (PASS). In a previous study, a cut-off for acceptable symptom state based on the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI, score <5) was developed for inclusion of patients with an unacceptable symptom state in clinical trials.2ObjectivesTo explore the presence of PASS in a standard of care cohort of pSS patients and to compare patient characteristics and disease activity including ESSPRI between patients with and without PASS.MethodsConsecutive outpatients with pSS from the REgistry of Sjögren Syndrome LongiTudinal (RESULT) cohort, who fulfilled the ACR/EULAR classification criteria and had available PASS data at baseline were included. Patient-reported outcomes were reported through questionnaires, which included the PASS (“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?”; yes/no) and ESSPRI (“How severe has your dryness, fatigue and pain been during the last two weeks?”; scale 0-10). An acceptable ESSPRI symptom state has been defined as <5.2 Systemic disease activity was assessed with EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). Independent samples t-test, Mann-Whitney U test or Chi Square test were used to analyse differences between patients with or without PASS.ResultsOf 277 included pSS patients, 248 (90%) were female, median age was 54 years (IQR 43-64) and disease duration 5 years (2-11). 198 (71%) patients scored their symptom state as acceptable according to PASS. Patients with PASS were significantly older and had a longer disease duration compared to patients without PASS. Furthermore, patients with PASS had more often a low disease activity according to ESSDAI, and less often moderate disease activity (Table 1). The difference in ESSDAI activity was mainly observed in the articular and constitutional domains. ESSPRI was significantly lower in patients with PASS (median 5 vs. 7). No differences were seen in functional or laboratory parameters (Table 1). Of all included patients, only 86 (31%) patients had an acceptable symptom state according to the pre-defined cut-off point for ESSPRI (score <5). Sensitivity and specificity of this ESSPRI cut-off point for reaching PASS was 40% and 92%, respectively.Table 1.Baseline characteristics of pSS patients with and without PASSPASS (n=198)Without PASS (n=79)Gender (female)177 (89)71 (90)Age (years)57 (44-65)*49 (41-60)*Disease duration (years)6 (2-12)*5 (2-8)*ESSDAI (total)4 (2-6) (n=191)4 (2-9) (n=75)<5127 (66)*38 (51)*5-1452 (27)*32 (43)*≥1412 (6)5 (7)ESSPRI (total)5 (4-7)**7 (6-8)**<580 (40)**6 (8)**Schirmer’s test (mm)4 (1-10) (n=179)4 (1-10) (n=72)Ocular staining score2 (1-4) (n=190)2 (0-4) (n=77)Unstimulated whole salivary flow (ml/min)0.05 (0.01-0.14) (n=187)0.08 (0.01-0.19) (n=76)Stimulated whole salivary flow (ml/min)0.54 (0.15-0.99) (n=189)0.58 (0.21-0.97) (n=76)SSA positive172/197 (87)66/79 (84)IgG (g/L)14 (11-19) (n=196)14 (10-19) (n=79)Rheumatoid factor (IU/ml)12 (3-39) (n=196)16 (2-47) (n=78)Data presented as median (IQR) or n (%)*Significant difference p<0.05***Significant difference p<0.001ConclusionThe majority (71%) of pSS patients reported being in an acceptable symptom state according to the PASS question in our standard of care cohort in daily clinical practice, despite high ESSPRI scores (60% with score ≥5). Further analyses of influences of treatment in these patients will be conducted.References[1]Vieira et al. Clin Exp Rheum 2021;39(Suppl. 133):S14-S16.[2]Seror et al. Ann Rheum Dis 2016;75:382-389.AcknowledgementsUnrestricted grants from the Dutch Arthritis Patients Association (ReumaNL), Bristol-Myers Squibb and NovartisDisclosure of InterestsLiseth de Wolff: None declared, Suzanne Arends: None declared, Esther Mossel: None declared, Greetje S. van Zuiden: None declared, Jolien F. van Nimwegen Speakers bureau: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Lisette Olie: None declared, Alja J. Stel: None declared, Konstantina Delli: None declared, Gwenny M. Verstappen: None declared, Frans G.M. Kroese: None declared, Arjan Vissink: None declared, Hendrika Bootsma Speakers bureau: Bristol Myers Squibb and Novartis, Consultant of: Bristol Myers Squibb, Roche, Novartis, Medimmune, Union Chimique Belge, Grant/research support from: Unrestricted grants from Bristol Myers Squibb and Roche