Primary Sjögren's Syndrome: Impact of Quantitative Anti-Ro52 Antibody Analysis on Patient Prognosis and Stratification
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Occurrence of a severe clinical event during follow-up
研究概览
简要总结
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.
详细描述
Primary Sjögren's Syndrome (pSS) is a systemic autoimmune disorder characterized by lymphocytic infiltration of exocrine glands, leading to dryness symptoms, and by a wide spectrum of systemic manifestations. Autoantibodies, particularly anti-Ro/SSA antibodies, are hallmark features of the disease and play a central role in diagnosis and classification. Among these, anti-Ro52 antibodies have been increasingly recognized as a distinct immunological marker, often co-occurring with or without anti-Ro60 and anti-La antibodies.
While qualitative detection of anti-Ro52 is widely used in routine clinical practice, the clinical significance of their quantitative levels remains underexplored. Recent studies suggest that high titers of anti-Ro52 may be associated with more severe systemic disease, including pulmonary, muscular, and neurological involvement, as well as with increased interferon signature activity. However, no consensus currently exists regarding their utility as a prognostic or stratification biomarker in pSS.
This retrospective cohort study aims to assess whether quantitative anti-Ro52 antibody levels correlate with specific clinical phenotypes, immunological patterns, and long-term outcomes in patients with primary Sjögren's Syndrome. Clinical data, including organ involvement, biological markers, disease activity scores (e.g., ESSDAI), and treatment response, will be collected and analyzed in relation to anti-Ro52 titers measured by standardized quantitative assays.
The objectives are:
- To determine whether high anti-Ro52 titers are predictive of systemic involvement at baseline or during follow-up;
- To identify clusters of patients based on anti-Ro52 levels and associated clinical/immunological profiles;
- To evaluate the potential of quantitative anti-Ro52 testing as a tool for risk stratification and personalized therapeutic strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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),
- •No objection to participation in research after being informed according to current regulations (record of non-opposition if applicable).
排除标准
- •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,
- •Individuals under legal protection measures (e.g., guardianship).
结局指标
主要结局
Occurrence of a severe clinical event during follow-up
时间窗: 2 years
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.
次要结局
- Frequency of anti-Ro52 positiviy(2 years)
- Association between anti-Ro52 antibody levels and disease activity(2 years)
- Correlation between quantitative anti-Ro52 antibody levels and clinical/immunological features at baseline.(2 years)
- Classification of patients into subgroups (clusters) based on anti-Ro52 levels.(2 years)
研究者
JACQUEL Léa
Docteur
Central Hospital, Nancy, France