Max-planck-gesellschaft Zur F&#xf6;rderung Der Wissenschaften E. V.

Charité – Universitätsmedizin Berlin

Zoltán Konthur

Hans Lehrach

Karl Skriner

The invention refers to a method for diagnosing an individual who is to be subjected to or is being subjected to an anti-tumor necrosis factor alpha (TNF&#x3b1; or TNF) treatment to assess the responsiveness to an anti-TNF treatment which comprises the detection of immunoglobulin(s) against one or more biomarker proteins in a bodily fluid or an excrement of said patient, and sorting the individual into one of two categories based on detection of said immunoglobulin(s), wherein individuals are classified as NON-responder or responder. The invention refers to diagnostic kits comprising said one or more biomarker proteins and the use of these kits for assessing the responsiveness to an anti-TNF treatment of an individual who is to be subjected to or is being subjected to an anti-TNF&#x3b1; treatment.

Biomarker for the prediction of responsiveness to an anti-tumour necrosis factor alpha (TNF) treatment

The invention refers to a method for diagnosing an individual who is to be subjected to or is being subjected to an anti-tumor necrosis factor alpha (TNF&#x3b1; or TNF) treatment to asses the responsiveness to an anti-TNF treatment which comprises the detection of immunoglobulin(s) against one or more biomarker proteins in a bodily fluid or an excrement of said patient, and sorting the individual into one of two categories based on detection of said immunoglobulin(s), wherein individuals are classified as NON-responder or responder. The invention refers to diagnostic kits comprising said one or more biomarker proteins and the use of these kits for assessing the responsiveness to an anti-TNF treatment of an individual who is to be subjected to or is being subjected to an anti-TNF&#x3b1; treatment.

The present invention pertains to a diagnostic assay for the diagnosis of an autoimmune disease. The present invention provides an improved diagnostic assay for the diagnosis of an autoimmune disease, particularly rheumatoid arthritis (RA) and Systemic Lupus Erythematosus (SLE). In particular the invention pertains to a method of determining in a sample of a subject the presence of two or more antibodies comprising the step of determining whether an antibody is present in a sample that specifically recognizes a hnRNP-DL polypeptide or a fragment thereof or a splice variant thereof and the further step of determining whether at least one further antibody is present in the sample that specifically recognizes a at least one other hnRNP polypeptide which is not sequence homologue to said hnRNP-DL polypeptide or fragments thereof or splice variants thereof, and/or said CCP peptide and/or a polypeptide comprising at least the Fc-part of IgG, respectively. The invention also relates to polypeptides, protein sets and antibodies that may be used in such methods and assays and for therapeutic use in RA and SLE patients.

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Berlin, Germany

Zoltán Konthur