Anti-ficolin-2 Autoantibodies in Lupus Nephritis (Ficolupus2)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Lupus Erythematosus, Systemic

Treatments: Other: BIological analysis

Study type: Observational

Funder types: Other

Identifiers

NCT03063281

2030950v0

Details and patient eligibility

About

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.

Full description

For this retrospective study, the well written brief summary should be sufficient.

Enrollment: 213 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

213 participants in 2 patient groups

SLE patient

Description:

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.

Treatment:

Other: BIological analysis

healthy patients

Description:

48 healthy patients. Biological analysis were performed.

Treatment:

Other: BIological analysis