Clinical trial NCT02625831: Anti-ficolin-3 Autoantibodies in Lupus Nephritis
Official title: Association Between the Presence of Autoantibodies Targeting Ficolin-3 and Active Nephritis in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus Erythematosus, Systemic
Keywords: ficolin-3
anti-ficolin-3 antibodies
lupus nephritis
Lupus Erythematosus, Systemic
biomarker
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Hospital, Marseille
First posted: 2015-12-09
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SLE patients were studied from medical data files of the Departments of Internal Medicine (Grenoble University Hospital, France) and Nephrology (Conception University Hospital, Marseille, France). For SLE patients, clinical and biological manifestations as well as treatments received and disease activity evaluated using the SLE Disease Activity Index (SLEDAI) at the time of sampling were recorded. SLE patients were divided into subgroups as described in group section.

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.

Eligibility 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

Primary outcomes:
measure: Anti-ficolin-3 antibodies presence in SLE patients
timeFrame: measured at day of inclusion = T0.
Secondary outcomes:
measure: Correlation of anti-ficolin-3 antibodies with anti-DNA antibodies in SLE patients
timeFrame: measured at day of inclusion = T0.
measure: Correlation of anti-ficolin-3 antibodies with anti-C1q antibodies in SLE patients
timeFrame: measured at day of inclusion = T0.
measure: Correlation of anti-ficolin-3 antibodies with lupus activity (SLEDAI score) in SLE patients
timeFrame: measured at day of inclusion = T0.
measure: Anti-ficolin-3 antibodies presence in SLE patients with active nephritis
timeFrame: measured at day of inclusion = T0.
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Grenoble, FRANCE
name: Chantal DUMESTRE-PERARD, PhD
role: PRINCIPAL_INVESTIGATOR
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