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Biomarkers for Systemic Lupus Erythematosus Disease Activity, and Intensity and Flare

a biomarker and lupus erythematosus technology, applied in immunology, rheumatology and molecular biology, can solve the problems of insufficient onset inability to recognize and treat tissue and organ damage early, and inability to adequately detect the earliest or sufficient biologic signals of worsening diseas

Inactive Publication Date: 2015-04-09
OKLAHOMA MEDICAL RES FOUND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for diagnosing a systemic lupus erythematosus (SLE) patient as being in a pre-flare event by measuring the levels of various cytokines, chemokines / adhesion molecules, TNFR superfamily members, and other mediators previously shown to play a role in SLE pathogenesis. The method can also involve assessing the levels of regulatory mediators and performing a SLEDA Index analysis or anti-dsDNA antibody testing. This can help in diagnosing and treating SLE patients more effectively.

Problems solved by technology

Given the heterogeneous nature of SLE, recognition and early treatment to prevent tissue and organ damage is clinically challenging.
However, the traditional biomarkers incorporated in the SELENA-SLEDAI are not necessarily the earliest or sufficient biologic signals of worsening disease.
However, their roles in ensuing disease flares are presently unknown.

Method used

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  • Biomarkers for Systemic Lupus Erythematosus Disease Activity, and Intensity and Flare
  • Biomarkers for Systemic Lupus Erythematosus Disease Activity, and Intensity and Flare
  • Biomarkers for Systemic Lupus Erythematosus Disease Activity, and Intensity and Flare

Examples

Experimental program
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example 1

Materials and Methods

[0211]Study Population.

[0212]Experiments were performed in accordance with the Helsinki Declaration and approved by the Institutional Review Boards of the Oklahoma Medical Research Foundation and the University of Oklahoma Health Sciences Center. Study participants were enrolled in the SLE Influenza Vaccination Cohort (Crowe et al., 2011) after written informed consent. Female EA SLE patients (meeting ≧4 ACR classification criteria; Hochberg, 1997) with disease flare 6-12 weeks post-vaccination (age 47.0±13.5 years, n=28) were matched by age (±5 years), race, gender, and time of disease assessment to patients with stable disease (age 46.8±11.9 years, n=28), as well as unrelated healthy controls (age 46.8±13.5 years, n=28). Samples from 13 SLE patients pre-flare were compared to samples drawn from the same individuals in a different year with no flare.

[0213]Clinical Data and Sample Collection.

[0214]Demographic and clinical information were collected as previously...

example 2

Results

[0221]Inflammatory Mediators and Regulatory Cytokines are Altered Prior to SLE Disease Flare.

[0222]SLE patients within this cohort were followed longitudinally and evaluated for evidence for SELENA-SLEDAI disease flare. The inventors hypothesized that clinical changes in disease activity are the result of a perturbation in the already dysregulated immune system of SLE patients. To test whether markers of immune dysregulation might precede clinical disease flares, 52 soluble analytes were compared in 28 EA SLE patients in whom flare was detected after influenza vaccination, matched SLE patients who did not experience flare for at least 12 weeks post-vaccination, and matched healthy individuals. All SLE patients, with or without subsequent flare, had similar SELENA-SLEDAI scores at baseline (3.8±3.7 flare vs. 2.6±3.2 non-flare [NF], p=0.2451 by Wilcoxon matched-pairs test).

[0223]At baseline and follow-up, non-flare SLE patients had levels of T cell mediators that were similar t...

example 3

Discussion

[0237]Delays in treating SLE flares may potentiate chronic inflammation, leading to recurrent illness and end-organ damage. Immune dysregulation in SLE likely precedes clinical disease, and in some cases, low grade, smoldering inflammation could persist over time, contributing to progressive organ damage in the absence of overt clinical flare. The data point to the “yin-yang” nature of the immune response that either leads to impending disease flare (inflammation) or allows for periods of non-flare (regulation). In this study elevated levels of shed TNF receptors and / or pro-inflammatory Th adaptive pathway cytokines were found in nearly all SLE patients prior to impending flare (FIG. 5). While a predominant inflammatory pathway is evident for a subset of patients, most had elevated inflammatory mediators from multiple pathways, which may help explain variability among previous reports of inflammatory mediators in SLE patients with active disease (Gomez et al., 2004; Tokano...

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Abstract

The present invention involves the identification of biomarkers that are predictive of impeding systemic lupus erythematosus (SLE) disease flare. Methods for treating patients so identified are also provided.

Description

[0001]This application claims benefit of priority to U.S. Provisional Application Ser. No. 61 / 886,189, filed Oct. 3, 2013, the entire contents of which are hereby incorporated by reference.GOVERNMENT SUPPORT CLAUSE[0002]This invention was made with government support under grant no. P30AR053483, U19A1082714, U01AI101934, P30GM103510, 510RR026735, and HHSN266200500026C awarded by the National Institutes Health. The government has certain rights in the invention.BACKGROUND OF THE INVENTION[0003]1. Field of the Invention[0004]The present invention relates generally to the fields of autoimmune disease, immunology, rheumatology and molecular biology. More particularly, it concerns soluble inflammatory mediators that are predictive of and involved in systemic lupus erythematosus flares.[0005]2. Description of Related Art[0006]Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disease characterized by variable immune dysregulation, disabling symptoms and progressive organ dama...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G01N33/564G01N33/68
CPCG01N33/564G01N2800/52G01N2800/104G01N33/6863C12Q1/6883C12Q2600/158A61P37/00C12Q2600/118
Inventor JAMES, JUDITH A.MUNROE, MELISSA E.
Owner OKLAHOMA MEDICAL RES FOUND
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