This study aims to evaluate the prognostic value of quantitative anti-Ro52 antibody levels in patients with primary Sjögren's Syndrome. Anti-Ro52 antibodies are frequently detected in this autoimmune disease, but their specific role in disease stratification, systemic involvement, and long-term outcomes remains unclear. Through a prospective cohort analysis, the investigators will investigate the association between anti-Ro52 titers and clinical phenotypes, including extraglandular manifestations, immunological profiles, and disease progression. The objective is to determine whether quantitative assessment of anti-Ro52 antibodies can serve as a biomarker to refine risk stratification and guide personalized management in primary Sjögren's Syndrome.
Age ≥ 18 years at the time of inclusion,
Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria,
Quantitative measurement of anti-Ro52 antibodies performed as part of routine care, starting from 2020 (date of routine implementation in the laboratory),
Documented medical follow-up in the internal medicine department (or other participating department),
Presence of another systemic autoimmune connective tissue disease, including systemic lupus erythematosus, systemic sclerosis, autoimmune myositis, rheumatoid arthritis (except nonspecific arthralgia without classification criteria),
History of solid organ or bone marrow transplantation,
Severe immunosuppression unrelated to Sjögren's syndrome (e.g., HIV infection, ongoing chemotherapy for active hematologic malignancy),
Incomplete or non-exploitable clinical or biological data preventing analysis of primary or secondary endpoints,
This study will include adult patients (≥18 years old) diagnosed with primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria. Participants must have had a quantitative measurement of anti-Ro52 antibodies performed as part of routine clinical care since 2020. Eligible patients will be followed in the internal medicine department or other participating units and must provide informed consent or non-opposition to participate. Patients with other systemic autoimmune diseases, prior organ or bone marrow transplantation, severe immunosuppression unrelated to Sjögren's syndrome, incomplete clinical or laboratory data, or under legal protection will be excluded.
Cohort
Retrospective
Not listed
Occurrence of a severe clinical event during follow-up
Occurrence of a severe clinical event during follow-up, defined as the first occurrence of any of the following: Death (any cause), Histologically confirmed lymphoma, Severe organ involvement (e.g., glomerulonephritis, interstitial lung disease requiring immunosuppression, autoimmune CNS/PNS involvement, systemic vasculitis), Persistently high disease activity, defined as an ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index) score ≥ 5 for ≥12 consecutive months. ESSDAI ranges from 0 to 123; higher scores indicate worse disease activity.
Frequency of anti-Ro52 positiviy
Frequency of anti-Ro52 antibodies (presence vs absence) and quantitative distribution within the study cohort.
Association between anti-Ro52 antibody levels and disease activity
Association between anti-Ro52 antibody levels and disease activity, using the ESSDAI score and, where applicable, biomarkers such as gammaglobulins and complement levels (C3/C4).
Correlation between quantitative anti-Ro52 antibody levels and clinical/immunological features at baseline.
Correlation between anti-Ro52 levels (IU/mL, ELISA) and baseline clinico-biological features: Glandular vs extraglandular involvement (binary phenotype from clinical chart), Presence of cryoglobulinemia (% of patients, assessed by immunofixation), Autoimmune cytopenias (% of patients with diagnosis from CRF), Hypergammaglobulinemia (serum IgG, g/L, measured by nephelometry), Immunoglobulin deficiency (IgG/A/M, g/L). Statistical correlations will be assessed using Spearman or logistic regression as appropriate.
Classification of patients into subgroups (clusters) based on anti-Ro52 levels.
Cluster-based classification of patients using anti-Ro52 levels (IU/mL, ELISA) and associated variables (clinical phenotype, immunological markers, disease course). A data-driven clustering approach (e.g., hierarchical or k-means) will be applied to group patients. For each cluster, the following aggregated characteristics will be described: type of organ involvement (% of patients), presence of immunological markers (e.g., cryoglobulinemia, cytopenias), and indicators of disease progression (e.g., number of flares, treatment escalation).
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