Association Between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 主要终点
- Anti-ficolin-3 antibodies presence in SLE patients
研究概览
简要总结
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. Antibodies against Ficolin-3 were previously identified in the sera of some SLE patients, but their prevalence and significance have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-3 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE.
In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-3, anti-dsDNA and anti-C1q antibodies levels were measured in sera by ELISA. First, a highly significant difference was found in the anti-ficolin-3 levels between SLE patients and healthy subjects. Anti-ficolin-3 antibodies were detected as positive in 58 of 165 (35%) SLE patients. The titer of anti-ficolin-3 antibodies was correlated with the SLEDAI score (p<0.0001). The presence of anti-ficolin-3 antibodies was associated with anti-C1q and anti-dsDNA antibodies. Regarding associations with clinical manifestations, only the presence of active lupus nephritis was significantly associated with the presence of anti-ficolin-3 antibodies (p=0.0001). This association with renal involvement was higher with anti-ficolin-3 antibodies than with other auto-antibodies. Interestingly, the combination of anti-ficolin-3 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker.
These results suggest that anti-ficolin-3 could be useful for the diagnosis of active nephritis in SLE patients.
详细描述
For this retrospective study, a brief summary should be enough.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: ≥ 18 years old
- •Patients with lupus diagnostic criteria (ACR1997)
排除标准
- •Pregnant women
- •Patient with known evolutive cancer
- •48 healthy patients matched in age and sex with one or several SLE patients
结局指标
主要结局
Anti-ficolin-3 antibodies presence in SLE patients
时间窗: measured at day of inclusion = T0.
Anti-ficolin-3 antibodies in SLE patients, considered positive if superior than 70 arbitrary units. This study have a single visit approach with serum collection so every outcome is measured at T0, which is the only visit for the patient.
次要结局
- Correlation of anti-ficolin-3 antibodies with anti-DNA antibodies in SLE patients(measured at day of inclusion = T0.)
- Correlation of anti-ficolin-3 antibodies with anti-C1q antibodies in SLE patients(measured at day of inclusion = T0.)
- Correlation of anti-ficolin-3 antibodies with lupus activity (SLEDAI score) in SLE patients(measured at day of inclusion = T0.)
- Anti-ficolin-3 antibodies presence in SLE patients with active nephritis(measured at day of inclusion = T0.)