Lupus Erythematosus, Systemic
Conditions
Keywords
ficolin-2, anti-ficolin-2 antibodies, lupus nephritis, Lupus Erythematosus, Systemic, biomarker, ficolin-3, anti-ficolin-3 antibodies
Brief summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE. This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0). 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-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels. The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p\<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies. Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker. These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.
Detailed description
For this retrospective study, the well written brief summary should be sufficient.
Interventions
OTHERBIological analysis
Biological analysis : ficolin-2 et anti-ficolin-2 antibodies
Sponsors
University Hospital, Marseille
University Hospital, Grenoble
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
165 SLE patients Inclusion Criteria: * Age: ≥ 18 years old * Patients with lupus diagnostic criteria (ACR1997)
Exclusion criteria
* Pregnant women * Patient with known evolutive cancer 48 healthy patients matched in age and sex with one or several SLE patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-ficolin-2 antibodies presence in SLE patients | measured at day of inclusion = T0 | Anti-ficolin-2 antibodies in SLE patients, considered positive if superior than 95 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
| Measure | Time frame | Description |
|---|---|---|
| Correlation of anti-ficolin-2 antibodies with anti-DNA antibodies in SLE patients | measured at day of inclusion = T0 | Correlation between Anti-ficolin-2 antibodies presence and anti-DNA antibodies presence. 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-2 antibodies with anti-C1q antibodies in SLE patients | measured at day of inclusion = T0 | Correlation between Anti-ficolin-2 antibodies presence and anti-C1q antibodies presence. 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-2 antibodies with lupus activity (SLEDAI score) in SLE | measured at day of inclusion = T0 | Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of SLE activity according to SLEDAI score (2012). 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-2 antibodies presence with active nephritis in SLE patients | measured at day of inclusion = T0 | Correlation between Anti-ficolin-2 antibodies presence and clinical and/or biological evidence of active nephritis 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. |
Outcome results
None listed