Abstract

Background Primary Sjogren’s Syndrome (pSS) is associated with a biological panel of B-cell activity markers such as hypergammaglobulinemia, rheumatoid factor (RF), decreased C3/C4 complement, cryoglobulinemia, and an increase in β2-microglobulin, used to calculate the biological domain of The EULAR Sjogren’s Syndrome Disease Activity Index (ESSDAI). In 80% of patients, anti-nuclear autoantibodies, especially anti-Ro/SSA and anti-La/SSB, are also observed. The change in these biological tests during follow-up of pSS patients has been poorly investigated. Objectives The objectives of our study were to assess the change in immunological parameters during the follow-up of pSS and to analyse the association with the clinical evolution. Methods We analysed data from the French prospective multicenter ASSESS cohort, including 395 patients with pSS. Clinical and biological data were collected at the baseline, then annually. Patients were included if at least two biological assessments and concomitant ClinESSDAI activity scores were available, based on standardized clinical evaluations of the patients. Anova, Wilcoxon and Chi-square tests were used to analyse the relationship between the clinical evolution and immunological profile. A p-value≤0.05 was considered as statistically significant. Results 362 of 395 patients had required data to allow their inclusion. The mean number of visits was 5.5. In 81.7% of patients, the biological status did not change throughout the 5-year follow-up (Table 1). The clinical evolution was not related to the immunological changes observed between the previous two visits (p=0.30). There was no significant difference between the number of abnormal immunological markers and the ClinESSDAI activity score (p=0.437) at the same visit. Disease activity according to the ClinESSDAI score remained stable in 257 patients (out of 351 with available data) during follow-up. 175 patients (49.8%) were in remission and 82 (23.3%) had an active disease. The number of abnormal biological markers at baseline was associated with subsequent clinical evolution: detection of ≥5 B-cell activity markers at baseline was a bad prognostic marker, (present in 12.4% of patients having persistent disease activity, versus 3.6% among patients with clinical favourable outcome) (p=0.04). Conclusion The biological profile of pSS patients is usually stable over time, especially if the initial assessment is negative, but a higher immunological activity profile might be a bad prognostic factor. Changes in biological parameters do not predict the subsequent clinical course. In conclusion, it is not relevant to systematically repeat the complete immunological screening in pSS patients. Disclosure of Interests Paulina Szafors: None declared, Cedric Lukas: None declared, Jacques-Eric Gottenberg Grant/research support from: Bristol-Myers Squibb, Grant/research support from: Bristol-Myers Squibb, Consultant for: Bristol-Myers Squibb, Lilly, Pfizer, Sanofi-Genzyme, UCB Pharma, Consultant for: Bristol-Myers Squibb, Eli Lilly, UCB, Sanofi-Genzyme, Pfizer, Xavier Mariette Grant/research support from: Servier, Consultant for: AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, Pfizer, UCB Pharma, Bernard Combe Consultant for: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche-Chugai, Sanofi, UCB, Jacques Morel: None declared

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