专利名称：ASSAY AND METHOD FOR PREDICTING
THERAPEUTIC EFFICACY OFIMMUNOGLOBULIN THERAPY ININDIVIDUAL PATIENTS WITH RELAPSINGREMITTING MULTIPLE SCLEROSIS (RR-MS)
发明人：MEUER, Stefan,GIESE, Thomas,WIETEK,
Stefan
申请号：EP13730848.2申请日：20130614公开号：EP2861755A1公开日：20150422
摘要：A method for generating a reference for determining the likelihood ofresponse of a patient, suffering from a disease, towards immunoglobulin therpycomprising the steps of a) providing samples of a sufficient number of individuals, inparticular at least 10 individuals, the samples containing B- and T-lymphocytes, naturalkiller cells, invariant T-cells and monocytes of the individuals; b) determination of valuesof immune parameters which are either static, such as leukocyte subpopulations andcytokine-level in the plasma or functional, like gene expression and cytokine release afterlipopolysaccharid (LPS) and/or IVIG stimulation ex vivo; c) the determined values derivedfrom immune parameters of the samples of the individuals are ordered in quartiles andthe values belonging to the 1. quartile, values distributed at the low end of thecorresponding parameter, are set to ''-1'' whereas values distributed in the 4. quartileare 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 groupconsisting of MTM1, EIF3E, COPS8, ADAMTSL1, CXXC4, RSP02, OR9Q1, ADAMTS9,KLHDC8A and PRDM9, in the samples of the individuals and awarding the value of 0 forspecific homozygous SNP combinations (SNP - Single Nucleotide Polymorphism), whichindicates that the blood sample stems from a person which will respond to
immunoglobulin (IG) treatment, while awarding the value of 1 for SNP combinations notmeeting that criteria, which indicates that the blood sample stems from a person whichwill not respond to immunoglobulin treatment; e) combining the results of genotypingwith 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 betweenresponders and non- responders. The method can be employed for determining thelikelihood of response of a patient, suffering from a disease, towards immunoglobulintherapy.
申请人：Octapharma AG,Ruprecht-Karls-Universität Heidelberg
地址：Seidenstrasse 2 8853 Lachen CH,Grabengasse 1 69117 Heidelberg DE
国籍：CH,DE
代理机构：Von Kreisler Selting Werner - Partnerschaft von Patentanwälten undRechtsanwälten mbB
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