Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro/SSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro/SSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro/SSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro/SSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index/Eular Sjogren's Syndrome Patient Reported Index).
Primary Sjögren's syndrome according to the American-European Consensus Criteria)
Informed and having signed the study consent form
Secondary Sjögren's syndrome
Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)
Incapacity or refusal to sign the informed consent form
Incapacity or refusal to perform the follow-up examinations required by the study
Patients with primary Sjögren's syndrome
Cohort
Prospective
Blood samples
Other interventionBlood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).
Proportion of anti-Ro/SSA IgE positive patients
Comparison of proportion of anti-Ro/SSA IgE positive patients between patients with active pSS and patient without active pSS anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Active pSS is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI) ≥ 5
Correlation between anti-Ro/SSA IgE titers and pSS's activity.
pSS's activity is defined by Eular Sjögren Syndrome Disease Activity Index (ESSDAI). Anti-Ro/SSA IgE titers is measured by serial dilutions of the serum. Anti-Ro/SSA IgE titers is the last dilution whose absorbance (in optical density) is higher than positivity threshold.
Correlation between anti-Ro/SSA IgE positive patients and the symptomatology level
Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). The symptomatology level is measured by the Score Eular Sjogren's Syndrome Patient Reported Index (ESSPRI). If ESSPRI≥5: symptomatology whose intensity felt by the patient is not acceptable. If ESSPRI\<5: symptomatology whose intensity felt by the patient is acceptable.
Correlation between anti-Ro/SSA IgE positive patients and onset of lymphoma
Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). There is a medical monitoring every years by medical record and/or by phone know that a development of lymphoma.
Correlation between anti-Ro/SSA IgE positive patients and interferon alpha signature
Anti-Ro/SSA IgE is measured by an indirect quantitative Enzyme Linked ImmunoSorbent Assay (ELISA). Interferon alpha signature level is measured by real-time Polymerase Chain Reaction (PCR). They calculate the average of delta cycle threshold in messenger ribonucleic acid (mRNA) of regulate gene by interferon alpha.
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Centre Hospitalier Universitaire de Saint Etienne
Lead sponsor
Ministry of Health, France
Collaborator
