Assay and method for predicting therapeutic efficacy of immunoglobulin therapy in individual patients with relapsing remitting multiple sclerosis (RR-MS)
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An immunoglobulin and individual technology, applied in the direction of biochemical equipment and methods, microbial determination/testing, etc., can solve problems such as unclear underlying mechanisms
Inactive Publication Date: 2015-12-02
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Problems solved by technology
Mechanisms underlying regulation of natural killer (NK) cell function by intravenous immunoglobulin (IVIg) are poorly understood
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Embodiment 1
[0175] Example 1: Calculation of LDA scores involving 9 individuals:
[0176] ●Determination of SNP results
[0177] The homozygous SNP combination of interest associated with the KLHDC8A gene is represented by dbSNPRSID rs7549293-rs10751436-rs913723-rs913722 with the SNP combination (in the same order as the given dbSNPRSID) CC-TT-AA-TT, which indicates non-responders and Contribute "1" to individual LDA score calculation;
[0178] The homozygous SNP combination of interest associated with the PRDM9 and OR9Q1 genes is represented by dbSNPRSIDrs13182871-rs7701403-rs12576939-rs1376486 with the SNP combination GG-AA-TT-GG (in the same order as the given dbSNPRSID), which indicates a non-response and contribute "1" to the individual LDA score calculation;
[0179] The homozygous SNP combination of interest associated with the ADAMTS9 gene consists of dbSNPRSID rs9820942-rs6780659-rs6445415-rs11721258 with the SNP combination GG-CC-AA-TT-AA-GG-TT-AA (in the same order as the g...
Embodiment 2
[0202] Calculations involving 2-8 LDA scores were performed in the same manner as in Example 1.
[0203] This method makes it possible to identify the responsiveness / non-responsiveness of a person to any immunoglobulin product suitable for in vivo use in diseases that can in principle be treated by immunoglobulins, such as intravenous, Those immunoglobulin products for subcutaneous, intramuscular, intraocular, intrathecal, buccal, topical or inhalation administration of diseases such as immune-mediated inflammatory diseases, autoimmune diseases, allergies, graft-versus-host reactions and prophylaxis Transplant rejection, multiple sclerosis of any kind or any other demyelinating neurological disease, or relapsing-remitting multiple sclerosis.
[0204] The method also allows the prediction of the MS patient's likelihood of relapse and / or the rate of progression of the disease in the patient's disability and / or function (measured by a clinical scale such as, but not limited to, t...
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Abstract
A method for generating a reference for determining the likelihood of response of a patient, suffering from a disease, towards immunoglobulin therapy comprising the steps of a) providing samples of a sufficient number of individuals, in particular at least 10 individuals, the samples containing B- and T-lymphocytes, natural killer cells, invariant T-cells and monocytes of the individuals; b) determination of values of immune parameters which are either static, such as leukocyte subpopulations and cytokine-level in the plasma or functional, like gene expression and cytokine release after lipopolysaccharide (LPS) and / or IVIG stimulation ex vivo; c) the determined values derived from immune parameters of the samples of the individuals are ordered in quartiles and the values belonging to the 1. quartile, values distributed at the low end of the corresponding parameter, are set to “−1”, whereas values distributed in the 4. quartile are set to “+1” for an individual LDA-score calculation and values in between are set to “0”; d) genotyping of at least two of the polynucleotides selected from the group consisting of MTM1, EIF3E, COPS8, ADAMTSL1, CXXC4, RSPO2, OR9Q1, ADAMTS9, KLHDC8A and PRDM9, in the samples of the individuals and awarding the value of 0 for specific homozygous SNP combinations (SNP—Single Nucleotide Polymorphism), which indicates that the blood sample stems from a person which will respond to immunoglobulin (IG) treatment, while awarding the value of 1 for SNP combinations not meeting that criteria, which indicates that the blood sample stems from a person which will not respond to immunoglobulin treatment; e) combining the results of genotyping with results of immuno parameter determination in the calculation of an individual LDA-score (LDA—Linar Discriminant Analysis); f) combining a multiplicity of individual LDA-scores to create a reference Responder Score, which allows discrimination between responders and non-responders. The method can be employed for determining the likelihood of response of a patient, suffering from a disease, towards immunoglobulin therapy.
Description
technical field [0001] The present invention relates to methods of determining the responsiveness of an individual to immunoglobulin therapy. Background technique [0002] B cells recognize pathogens when antibodies (B cell receptors) on their surface bind to specific foreign antigens. In response, B cells divide and differentiate into plasma cells, which secrete thousands of copies of antibodies that recognize the activating antigen. Antibodies (also known as immunoglobulins) recognize a variety of targets, including many different compounds, structures, and substances that are also part of the cellular structure; and often neutralize their biological effects. Immune complexes are rapidly cleared, leading to the elimination of the "target" molecule, so the functions of recognition, binding and removal are undoubtedly of integral importance, which is predisposed to disease by patients with deficient or reduced levels of immunoglobulins confirmed by the fact of severe and r...
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