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Background: The definition of Patient Acceptable Symptom State (PASS) has been recently derived from the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) to include patients with Sjögren’s disease (SD) in clinical trials. However, little is known regarding the prevalence and factors associated with PASS in daily practice.
To explore the percentage of patients with PASS in consecutive SD subjects in clinical practice.
To investigate clinical and serological factors associated with the presence of PASS.
Methods: In this cross-sectional study consecutive SD patients (2016 ACR/EULAR Criteria) were included. Demographic, clinical and serological data were collected including information about other common comorbidities (i.e. fibromyalgia, osteoporosis, thyroid disorders, blood hypertension, anxiety and depression). Disease activity was defined according to the ESSDAI, ongoing treatments were recorded and the following PROMs were assessed: ESSPRI, VAS dry mouth, VAS dry eyes, FACIT-Fatigue, Hospital Anxiety and Depression Scale (HADS). PASS was defined as an ESSPRI score < 5. Mann-Whitney U test or Chi Square were used to analyze differences between patients with and without PASS. Logistic regression analysis was used to assess independent factors associated with PASS.
Results: Of 253 included SD patients, 242 (95.7%) were female, the median age was 62 yrs (95% CI 52.5-71) and disease duration was 7 yrs (95% CI 4-13). Patients with PASS were 86/253 (34%). No differences in demographics, disease duration and clinESSDAI were observed comparing patients with and without PASS. However, patients with PASS had a significantly more frequent higher biological disease activity according to ESSDAI and higher combined positivity for anti-Ro/SSA and anti-La/SSB autoantibodies (54.7% vs 38.3%, p= 0.02). Moreover, patients with PASS presented a significantly lower prevalence of fibromyalgia (14% vs 46.1%, p< 0.001), anxiety (3.7% vs 24.7%, p< 0.001), depression (3.7% vs 27.2%, p< 0.001) and osteoporotic fragility fractures (1.4% vs 11.3%, p= 0.02). At inclusion, 13/86 (15.1%) of patients with PASS were assuming low doses of glucocorticoids compared to 46/167 (27.5%) of patients without PASS (p value= 0.03). FACIT-Fatigue questionnaire was significantly higher in patients with PASS, whereas all the other PROMS were significantly lower than in those without PASS. At multivariate analysis, independent factors associated with PASS were fibromyalgia, combined positivity for anti-Ro/SSA and anti-La/SSB autoantibodies, depression and anxiety (p< 0.05).
Conclusion: Patients with PASS represented only one third of our cohort. Despite a higher biological disease activity, they had a similar clinESSDAI to patients without PASS with a lower frequency of anxiety, depression and fibromyalgia. Complementary PROMs may help in identifying the impact of comorbidities on patient perceptions of symptom burden.
REFERENCES: NIL.
Acknowledgements: NIL.
Disclosure of Interests: None declared.