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Assays for detecting autoantibodies to anti-TNF alpha drugs

An autoantibody and drug technology, applied in the fields of RA, Crohn's, autoimmune diseases, and anti-inflammatory drugs, which can solve problems such as hindering drug treatment.

Inactive Publication Date: 2014-01-08
SOC DES PROD NESTLE SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such HACA, HAHA, or HAMA immune responses are associated with hypersensitivity and dramatic alterations in the pharmacokinetics and in vivo breakdown of immunotherapeutic TNFα inhibitors, which hinder further treatment with this drug

Method used

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  • Assays for detecting autoantibodies to anti-TNF alpha drugs
  • Assays for detecting autoantibodies to anti-TNF alpha drugs
  • Assays for detecting autoantibodies to anti-TNF alpha drugs

Examples

Experimental program
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Effect test

preparation example Construction

[0279] Preparations of yeast cell wall mannan, eg, PPM, can be used to determine the level of ASCA-IgA and / or ASCA-IgG in a sample. Such water-soluble surface antigens may be prepared by any suitable extraction technique known in the art, including, for example, by high pressure treatment, or may be obtained commercially (see, for example, Lindberg et al., Gut, 33:909-913( 1992)). The acid stability portion of PPM can also be used in the statistical algorithm of the present invention (Sendid et al., Clin. Diag. Lab. Immunol., 3:219-226 (1996)). An exemplary PPM for determining ASCA levels in a sample is derived from Saccharomyces cerevisiae strain ATCC #38926.

[0280] Purified oligosaccharide antigens such as mannooligosaccharides can be used to determine the level of ASCA-IgA and / or ASCA-IgG in a sample. Purified mannooligosaccharide antigens are preferably converted to neoglycolipids as described in, eg, Faille et al., Eur. J. Microbiol. Infect. Dis., 11:438-446 (1992). ...

Embodiment 1

[0336] Example 1. Novel mobility shift assay for measuring levels of anti-TNFα biologics

[0337] This example illustrates a new homogeneous assay for measuring anti-TNFα drug concentrations in patient samples (eg, serum) using size exclusion chromatography to detect binding of anti-TNFα drugs to fluorescently labeled TNFα. This assay is advantageous as it avoids the need for washing steps, the use of fluorophores allows for detection visually and / or on an IR spectrometer (IR spectrum), which reduces background and serum interference issues due to the high detection of fluorescent labels Sensitivity, increases the ability to detect anti-TNFα drugs in patients with low titers, and occurs as a liquid phase reaction, thereby reducing the chance of any changes in the epitope due to attachment to a solid surface such as an ELISA plate.

[0338] In an exemplary embodiment, a fluorophore (e.g., Alexa 647 ) label TNFα, where the fluorophore can be detected visually and / or on an IR sp...

Embodiment 2

[0342] Example 2. New Mobility Shift Assay for Measuring HACA and HAHA Levels

[0343] This example shows a new homogeneous assay for measuring the concentration of autoantibodies (e.g., HACA and / or HAHA) in patient samples (e.g., serum) using size exclusion chromatography to detect the association of these autoantibodies with fluorescently labeled Combination of Anti-TNFα Drugs. This assay is advantageous because it avoids the need for washing steps to remove low-affinity HACA and HAHA, the use of fluorophores allows for detection visually and / or on an IR spectrometer, which reduces background and serum interference issues due to fluorescent labeling The high sensitivity of the assay increases the ability to detect HACA and HAHA in low titer patients, and the reaction occurs in a liquid phase, thereby reducing the chance of any changes in the epitope due to attachment to a solid surface such as an ELISA plate.

[0344] Measuring self-produced TNFα inhibitors is illustrated b...

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Abstract

The present invention provides assays for detecting and measuring the presence or level of autoantibodies to anti-TNFa drug therapeutics in a sample. The present invention is useful for optimizing therapy and monitoring patients receiving anti-TNFa drug therapeutics to detect the presence or level of autoantibodies against the drug. The present invention also provides methods for selecting therapy, optimizing therapy, and / or reducing toxicity in subjects receiving anti-TNFa drugs for the treatment of TNFa-mediated disease or disorders.

Description

[0001] Cross-references to related applications [0002] This application claims U.S. Provisional Application No. 61 / 444,097, filed February 17, 2011, U.S. Provisional Application No. 61 / 484,594, filed May 10, 2011, and U.S. Provisional Application No. 61 / 496,501, filed June 13, 2011 priority of said application, the disclosure of which is hereby incorporated by reference in its entirety for all purposes. Background of the invention [0003] Autoimmune diseases are important and widespread medical problems. For example, rheumatoid arthritis (RA) is an autoimmune disease that affects more than two million people in the United States. RA causes chronic inflammation of the joints and is often a progressive disease that can lead to joint destruction and functional disability. The cause of rheumatoid arthritis remains unknown, although genetic predisposition, infectious agents, and environmental factors have all been implicated in the etiology of the disease. In active RA, sympt...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/564G01N33/94
CPCG01N33/94G01N33/564G01N2800/52
Inventor S·辛格S·L·王L·奥尔穆德S·豪恩施泰因
Owner SOC DES PROD NESTLE SA
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