Anti-ficolin-3 Autoantibodies in Lupus Nephritis
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Other: Biological analysis
- Registration Number
- NCT02625831
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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.
- Detailed Description
For this retrospective study, a brief summary should be enough.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- Age: ≥ 18 years old
- Patients with lupus diagnostic criteria (ACR1997)
-
Pregnant women
-
Patient with known evolutive cancer
48 healthy patients matched in age and sex with one or several SLE patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description healthy patients Biological analysis 48 healthy patients. Biological analysis were performed. SLE patients Biological analysis 165 SLE patients. Subgroup : 77 with active lupus and 88 in disease remission. in the active subgroup : 36 with lupus nephritis and 41 without. Biological analysis were performed.
- Primary Outcome Measures
Name Time Method Anti-ficolin-3 antibodies presence in SLE patients 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.
- Secondary Outcome Measures
Name Time Method Correlation of anti-ficolin-3 antibodies with anti-DNA antibodies in SLE patients measured at day of inclusion = T0. 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.
Correlation of anti-ficolin-3 antibodies with anti-C1q antibodies in SLE patients measured at day of inclusion = T0. 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.
Correlation of anti-ficolin-3 antibodies with lupus activity (SLEDAI score) in SLE patients measured at day of inclusion = T0. 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.
Anti-ficolin-3 antibodies presence in SLE patients with active nephritis measured at day of inclusion = T0. 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.