ASSESSMENT OF SYSTEMIC DISEASE ACTIVITY IS COMPLEMENTARY TO ASSESSMENT OF PATIENT'S SYMPTOMS IN PRIMARY SJOGREN'S SYNDROME

Background: We recently developed 2 scores for assessment of primary Sjogren's syndrome (SS) patients: the EULAR SS Disease Activity Index (ESSDAI) and the EULAR SS Patient reported Index (ESSPRI). We strongly believe that these 2 components were different and must be evaluated separately. Objectives: To assess whether common patient's symptoms were correlated to the level of systemic activity in primary SS. Methods: 15 French Rheumatology and internal medicine units included primary SS patients, fulfilling AECG criteria, in the prospective ASSESS cohort between May 2006 and July 2009. At baseline, physicians completed the ESSDAI and assessed systemic disease activity on 0-10 physician global assessment (Physician GA) scale, and evaluated separately importance of patients' symptoms on 0-10 scale. Patients completed the ESSPRI, Sicca Symptoms Inventory (SSI), Profile of Fatigue and Discomfort (PROFAD) questionnaires and 0-10 scale for patient global assessment of symptoms (Patient GA). Correlations between scores of systemic activity and patients' symptoms were obtained. Results: Of the 376 patients analyzed from the ASSESS cohort, 352 (93.6%) were females: mean age =58.1±12.5 yrs, mean disease duration =6.6±5.8 yrs, 59.4.7% anti-SSA and/or SSB positive. Mean ESSPRI, SSI and PROFAD scores (0-10) were 5.4±2.1, 4.9±2.3 and 4.7±2.2, respectively. The mean ESSDAI was 5.7±5.9, ESSDAI range from 0 to 29 and 73 (19.7%) patients had a score of 0. ESSPRI was significantly correlated with SSI (rho=0.54, p<0.0001), PROFAD (rho=0.69, p<0.0001). Correlations between ESSPRI and dryness (rho=0.76) were stronger between SSI and dryness (rho=0.62). Also fatigue and pain had higher correlation with ESSPRI (rho=0.83 and 0.84) than PROFAD (rho=0.59 and 0.62). ESSDAI was not correlated with ESSPRI (rho=0.097), SSI (rho=0.092) or PROFAD (rho=0.102). Physician GA was significantly correlated with ESSDAI (rho=0.52, p<0.0001), but not with ESSPRI (rho=0.078). In addition, patient GA was significantly correlated with ESSPRI (rho=0.75, p<0.0001) but not with ESSDAI (rho=0.073). As expected, physician evaluation of patients' symptoms was less correlated with ESSPRI (rho=0.40; p<0.0001) than patient GA. Conclusions: Our results confirmed that patient's symptoms and systemic complications are 2 different pictures of primary SS. We found that ESSDAI was not correlated with ESSPRI and patient's symptoms. Therefore, the use of both ESSDAI and ESSPRI are necessary to completely assess patients, theses 2 scores are complementary and did not overlap. As a consequence, when designing clinical trials in primary SS, one should define which component of the disease is the target of the treatment to test. Disclosure of Interest: None DeclaredCitation: Annals of the Rheumatic Diseases, volume 70, supplement 3, year 2011, page 505Session: SLE, Sjögren's and APS – clinical aspects (other than treatment) (Poster Presentations )