BIG DATA SJOGREN PROJECT (EULAR-SS TASK FORCE INTERNATIONAL NETWORK): SYSTEMIC INVOLVEMENT AT DIAGNOSIS EVALUATED BY THE ESSDAI IN 3314 PATIENTS WITH PRIMARY SJÖGREN SYNDROME

P. Brito Zeron, B.A. Kostov, R. Seror, C. Baldini, L. Quartuccio, M. Kvarnstrom, A. Kruize, G. Hernández Molina, S. Praprotnik, E. Bartoloni, R. Solans, E. Theander, V. Valim, R. Priori, M. Zeher, D. Isenberg, A. Rasmussen, R. Giacomelli, S. Carsons, D. Hammenfors, C. Vollenweider, F. Atzeni, T. Mandl, S. De Vita, M. Wahren-Herlenius, J. Sanchez-Guerrero, R. Gerli, K. Sivils, S. Mowa, J.G. Brun, X. Mariette, M. Ramos-Casals, on behalf of EULAR-SS Task Force International NetworkHosp. Clinic, IDIBAPS CAPSBE, IDIBAPS, Barcelona, Spain Hosp. Hotel Dieu, Paris, France Rheumatol Clinic, Pisa Univ. Hosp. Santa Maria Misericordia, Udine, Italy Karolinska Inst, Stockholm, Sweden UMCU, Utrecht, Netherlands INCMyN Salvador Zubirán, Mexico, Mexico Univ. Clin Center, Ljubljana, Slovenia Univ. Perugia, Perugia, Italy Hosp Vall Hebron, Barcelona, Spain Lund Univ., Malmo, Sweden Univ Fed Espírito Santo, Vitoria, Brazil Sapienza Universita, Roma, Italy Univ. Debrecen, Debrecen, Hungary UCL, London, United Kingdom OMRF, Oklahoma, United States Univ of, L'Aquila, Italy Stony Brook Univ. School, Mineola N.Y., United States Haukeland Univ Hosp, Bergen, Norway German Hosp, Buenos Aires, Argentina Sacco Univ Hosp, Milan, Italy Mount Sinai Hosp, Toronto, Canada Université Paris-Sud, Paris, FranceObjectives: To characterize and quantify systemic involvement at diagnosisinalarge international cohort of patients diagnosed with primary Sjogren syndrome (SS). Methods: The Big Data Sjögren Project is an international, multicenter registry formed in 2014 with the aim of taking a “high-definition” picture of the main features of primary SS at diagnosis by merging international SS databases. By January 2015, the database included 5027 consecutive patients fulfilling the 2002 classification criteria for primary SS from 13 countries (9 European, 4 American). Systemic involvement was defined according to the ESSDAI and retrospectively calculated. Results: Baseline ESSDAI data was collected in3314 patients (94% female, mean age at diagnosis 54.25 years). The main features of systemic involvement at diagnosis included biological activity in 43%of patients, articular involvement in 35%, hematological activity in 25%and glandular involvementin 19%. The mean ESSDAI score at diagnosis of the entire cohort was 5.63 (range, 0-62). Low DAS was reported in 1267 (38%) patients, moderate DASin 943 (28%) and high DAS in 378 (11%) patients; in the remaining 726 patients (22%), the ESSDAI score at diagnosis was 0. The mean baseline ESSDAI was higher in males (7.33 vs 5.52, p<0.001), patients diagnosed ≤35 years (6.71 vs 5.63, p=0.001), those with positive ocular tests (5.75 vs 4.98, p=0.023) and those with positive immunological markers including ANA (6.71 vs 4.63, p<0.001), RF (7.46 vs 5.49, p<0.001), anti-Ro/SSA (6.77 vs 5.48, p<0.001) and anti-La/SSB (6.91 vs 6.0, p<0.001). According to the number of criteria fulfilled at diagnosis, a higher mean baseline ESSDAI was found in patients fulfilling the six criteria (7.67 vs 5.65 in those fulfilling 5 criteria and 5.23 in those fulfilling 3-4 criteria, p<0.001). Conclusions: Epidemiological features (male sex, younger age at diagnosis) and positive autoantibodies at diagnosis were closely-related to greater systemic activity. Using the ESSDAI in real-life situations may help identify epidemiological and immunological subsets with high systemic activity at diagnosis and, therefore, at high risk of suffering a complicated clinical course. Disclosure of Interest: None declared DOI: 10.1136/annrheumdis-2015-eular.4752Citation: Annals of the Rheumatic Diseases, volume 74, supplement 2, year 2015, page 578Session: SLE, Sjögren's and APS - clinical aspects (other than treatment) (Poster Presentations )