Objectives To analyse the diagnostic approach used in the largest international cohort of patients with primary Sjögren syndrome (pSS)

Methods The Big Data Sjögren Project is a multicentre registry formed in 2014 by experts participating in the EULAR-SS Task Force. By January 2016, the database included 8315 consecutive patients fulfilling the 2002 criteria. The main features at diagnosis/recruitment (time of criteria fulfilment) were collected and analysed

Results The cohort included 7753 (93%) women (mean age at diagnosis 53 years). Sicca symptoms were reported in more than 90% of patients at diagnosis (92% for dry eye and 92.5% for dry mouth). The diagnostic tests used included the determination of anti-Ro/La antibodies in 8250 (99%) patients, Schirmer test in 6205 (75%), salivary gland biopsy in 5988 (72%), salivary flows in 4941 (59%), corneal stainings in 3304 (40%), scintigraphy in 2578 (31%) and sialography in 873 (10%) patients. The mean number of diagnostic tests included in the 2002 AE criteria was 4.85 ± 1.44 (of a maximum of 8 different tests), and was higher in patients with negative ANA (5.18 vs 4.80 in ANA+, p<0.001) or negative RF (5.06 vs 4.81 in RF+, p<0.001), and was also higher in American patients vs European or Asian patients (5.28 vs 4.83 and 4.63, respectively). A correlation was found between the number of tests carried out and the number of 2002 criteria finally fulfilled (R=0.48)

Conclusions We found a heterogeneous diagnostic approach of pSS with respect to the number of 2002AE diagnostic tests carried out; the approach varied significantly according to geographic origin and baseline immunological profile

Disclosure of Interest None declared