detecting or altering (e.g., altering expression or methylation status of) autoimmune or chronic inflammatory disease proteins (e.g., CD70 and CD40L); rheumatoid arthritis; systemic lupus erythematosus; polymerase chain reaction
Inventors
Richardson, Bruce • Lu, Qianjin
Assignees
USA DEPARTMENT OF VETERANS AFFAIRS • US Department of Veterans Affairs
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Publication Number
US-7439024-B2
Publication Date
2008-10-21
Expiration Date
2026-06-01
Abstract
The present invention relates to compositions and methods for diagnosing, monitoring and/or treating an autoimmune or chronic inflammatory disease. In particular, the present invention provides methods for diagnosing, monitoring and treating an autoimmune disease (e.g., rheumatoid arthritis) or chronic inflammatory disease (e.g., systemic lupus erythematosus) based on detecting or altering (e.g., altering expression or methylation status of) autoimmune or chronic inflammatory disease proteins (e.g., CD70 and CD40L). The present invention also provides kits for detecting methylation status of autoimmune or chronic inflammatory disease proteins (e.g., CD70 and CD40L) and for diagnosing, monitoring and/or treating autoimmune or chronic inflammatory diseases.
Core Innovation
The present invention relates to compositions and methods for diagnosing, monitoring and/or treating an autoimmune or chronic inflammatory disease. In particular, the invention provides methods for diagnosing, monitoring and treating conditions such as rheumatoid arthritis or systemic lupus erythematosus based on the detection or alteration, including expression or methylation status, of autoimmune or chronic inflammatory disease markers, specifically CD70 and CD40L. Additionally, kits are provided for detecting methylation status of these markers and for diagnosing, monitoring, and/or treating these diseases.
Autoimmune diseases like rheumatoid arthritis and systemic lupus erythematosus are characterized by immune responses directed to self antigens, often involving T cell immunity, leading to chronic inflammation and organ damage. Disease severity is variable and difficult to diagnose and monitor due to clinical heterogeneity. There is a need for reliable diagnostic and prognostic indicators that can accurately reflect disease severity, predict future severity, and monitor response to therapy.
The invention addresses this need by identifying methylation patterns and altered expression of specific markers such as CD70 and CD40L that correlate with autoimmune and chronic inflammatory diseases. Methods involve detecting methylation status in biological samples using various techniques including polymerase chain reaction and antibody binding assays. Altering methylation status or expression of these markers provides therapeutic approaches. Kits for detection and monitoring enable diagnosis and management of autoimmune or chronic inflammatory diseases.
Claims Coverage
The patent discloses one independent claim related to a method for diagnosing or monitoring autoimmune or chronic inflammatory diseases, focusing on detecting methylation status of specific genetic markers.
Method for diagnosing or monitoring autoimmune or chronic inflammatory disease based on methylation status of CD40L
A method that comprises providing nucleic acid from a subject and detecting the methylation status of CD40L to diagnose or monitor an autoimmune or chronic inflammatory disease such as systemic lupus erythematosus or rheumatoid arthritis.
Detection of methylation status of specific CD40L regions
The method includes detecting methylation status specifically in the 5′ untranslated region, particularly in the −350 to −400 region or 125 to −400 region of CD40L.
Combined methylation status detection of multiple markers
The method optionally includes detecting methylation status of one or more additional markers including CD70, perforin, CD11a, CD11c, IgE FCRγ1, and CD30 in combination with CD40L.
Use of kits comprising reagents for methylation detection
Utilizing kits that contain reagents sufficient for detecting methylation status of CD40L in a subject, including positive controls indicating CD40L methylation status.
Use of methylation sensitive polymerase chain reaction
The detection may employ polymerase chain reaction, specifically methylation sensitive PCR, as well as other techniques such as differential antibody binding, oligonucleotide binding assays, microarrays, and restriction enzyme digestion.
Overall, the claims cover methods and kits for diagnosing or monitoring autoimmune and chronic inflammatory diseases by detecting methylation status of CD40L alone or in combination with other markers, using various molecular biology techniques.
Stated Advantages
Provides reliable diagnostic and prognostic methods to monitor disease activity and response to therapy in autoimmune and chronic inflammatory diseases.
Identifies methylation-sensitive gene markers (e.g., CD70 and CD40L) that correlate with disease presence and severity.
Enables detection and monitoring via minimally invasive biological samples using various detection methods including PCR and antibody assays.
Allows for therapeutic targeting by altering expression or methylation status of key markers.
Documented Applications
Diagnosing and monitoring autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus by detecting methylation status of CD70, CD40L, and other markers.
Using kits for detecting methylation status of these markers to diagnose, monitor, and potentially guide treatment of autoimmune or chronic inflammatory diseases.
Screening candidate therapeutic compounds by assessing their capacity to modulate expression of autoimmune or chronic inflammatory disease marker genes.
Therapeutic applications including antisense therapy, genetic therapies, and antibody-based treatments targeting markers like CD70 and CD40L.
In vivo imaging of autoimmune or chronic inflammatory disease marker expression to visualize sites of inflammation or disease activity.
Use of transgenic animals expressing autoimmune or chronic inflammatory disease marker genes to study disease and evaluate therapies.
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