Biological Markers and Methods for Predicting Response to B-Cell Antagonists
AssigneeGenentech, Inc.
InventorsTimothy W. Behrens, Kasia Owczarczyk, Michael J. Townsend
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Abstract
Biological markers that predict patient responsiveness to B-cell antagonists are provided. Also provided are methods of using such biological markers. In addition, methods for identifying patients suffering from an autoimmune disease, e.g., rheumatoid arthritis, who are not likely to respond to B-cell antagonists are provided, as are methods of treating such patients. Methods for selecting therapeutic agents to treat such patients are also provided.
Claims101
A biomarker for predicting the response of a patient to a therapeutic agent comprising a B-cell antagonist, wherein the biomarker comprises elevated total plasma/plasmablast cell mRNA in a biological sample obtained from the patient compared to the level of total plasma/plasmablast cell mRNA in a biological sample obtained from a control subject or compared to a threshold value for total plasma/plasmablast cell mRNA.
A biomarker for predicting the response of a patient to a therapeutic agent comprising a B-cell antagonist, wherein the biomarker comprises an elevated expression level of a plasma/plasmablast cell-enriched gene in a biological sample obtained from the patient compared to the expression level of the plasma/plasmablast cell-enriched gene in a biological sample obtained from a control subject or compared to a threshold value for the plasma/plasmablast cell-enriched gene.
A method of predicting the response of a patient to a therapy comprising a B-cell antagonist, the method comprising:
- measuring in a biological sample obtained from the patient the expression of at least one gene enriched in plasma/plasmablast cells and
- comparing the expression of the at least one gene in the patient's biological sample to the expression of the same at least one gene in a biological sample obtained from a control subject or to a threshold value for the at least one plasma/plasmablast cell-enriched gene,
- wherein elevated expression of the at least one gene in the patient's biological sample compared to the expression in the control subject's biological sample or to the threshold value is predictive of response of the patient to the therapy comprising the B-cell antagonist.
A method of treating rheumatoid arthritis in a patient comprising administering a therapeutically effective amount of a therapeutic agent other than a B-cell antagonist to the patient to treat the rheumatoid arthritis, provided that a biological sample obtained from the patient has been shown to possess elevated expression of at least one gene enriched in plasma/plasmablast cells compared to the expression level of the same at least one gene in a biological sample obtained from a control subject or to a threshold value for the plasma/plasmablast cell-enriched gene.
A method of treating multiple sclerosis in a patient comprising administering a therapeutically effective amount of a therapeutic agent other than a B-cell antagonist to the patient to treat the multiple sclerosis, provided that a biological sample obtained from the patient has been shown to possess elevated expression of at least one gene enriched in plasma/plasmablast cells compared to the expression level of the same at least one gene in a biological sample obtained from a control subject or to a threshold value for the plasma/plasmablast cell-enriched gene.
A method of treating ANCA-vasculitis in a patient comprising administering a therapeutically effective amount of a therapeutic agent other than a B-cell antagonist to the patient to treat the ANCA-vasculitis, provided that a biological sample obtained from the patient has been shown to possess elevated expression of at least one gene enriched in plasma/plasmablast cells compared to the expression level of the same at least one gene in a biological sample obtained from a control subject or to a threshold value for the plasma/plasmablast cell-enriched gene.
A method of treating lupus in a patient comprising administering a therapeutically effective amount of a therapeutic agent other than a B-cell antagonist to the patient to treat the lupus, provided that a biological sample obtained from the patient has been shown to possess elevated expression of at least one gene enriched in plasma/plasmablast cells compared to the expression level of the same at least one gene in a biological sample obtained from a control subject or to a threshold value for the plasma/plasmablast cell-enriched gene.
A method of selecting a therapeutic agent for treatment of a patient suffering from an autoimmune disease comprising:
- obtaining a biological sample from the patient;
- measuring in the biological sample obtained from the patient the expression of at least one gene enriched in plasma/plasmablast cells;
- comparing the expression of the at least one gene in the patient's biological sample to the expression of the same at least one gene in a biological sample obtained from a control subject or to a threshold value for the at least one plasma/plasmablast cell-enriched gene;
- determining whether the expression of the at least one gene in the patient's biological sample is elevated compared to the expression in the control subject's biological sample or to the threshold value;
- and
- selecting a therapeutic agent other than a B-cell antagonist provided the expression of the at least one gene in the patient's biological sample is elevated.
Dependencies are inferred from the claim text.