Assay for detecting TH1 and TH2 cell populations
AssigneeAmgen Inc.
InventorsKevin Gorski, Jane R. Parnes, Jeannette Bigler, Michael J. Boedigheimer, Andrew A. Welcher
Life of this patent
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Abstract
The present disclosure relates to a method for detecting T helper cell or CTL subpopulations in a subject affected by disease or disorder having an immune component. The methods are also useful for determining efficacy of a treatment of the disease or disorder by detecting skewing of the T helper cells and CTLs in a therapeutic or adverse direction.
Claims21
A method for detecting a ratio of T helper 2 (Th2) and T helper 1 (Th1) cells in a sample from a patient suffering from asthma comprising measuring levels of Th2-specific and Th1-specific cytokines, the method comprising:
- a) contacting the sample with
- i) two or more specific binding agents that bind two or more Th2 cytokines, wherein the two or more specific binding agents for the Th2-specific cytokines are labeled with a first fluorophore;
- and
- ii) at least one specific binding agent that binds a Th1 cytokine, wherein the specific binding agent for the Th1 cytokine is labeled with a second fluorophore that is different from the first fluorophore;
- b) measuring levels of the first and second fluorophores in the sample and designating the cell as a Th1 or Th2 cell based on the level of Th1-specific and Th2-specific fluorophore detected;
- and
- c) determining the ratio of Th2 to Th1 cells in a sample.
A method for detecting a ratio of T helper 1 (Th1) and T helper 17 (Th17) cells in a sample from a patient suffering from asthma comprising measuring levels of Th1-specific and Th17-specific cytokines, the method comprising:
- a) contacting the sample with
- i) two or more specific binding agents that bind two or more Th17 cytokines, wherein the two or more specific binding agents for the Th17-specific cytokines are labeled with a first fluorophore;
- and
- ii) at least one specific binding agent that binds a Th1 cytokine, wherein the specific binding agent for the Th1 cytokine is labeled with a second fluorophore that is different from the first fluorophore;
- b) measuring levels of the first and second fluorophores in the sample and designating the cell as a Th1 or Th17 cell based on the level of Th1-specific and Th17-specific fluorophore detected;
- and
- c) determining the ratio of Th1 to Th17 cells in a sample.
A method for detecting a ratio of T helper 2 (Th2) and T helper 17 (Th17) cells in a sample from a patient suffering from asthma comprising measuring levels of Th2-specific and Th17-specific cytokines, the method comprising:
- a) contacting the sample with
- i) two or more specific binding agents that bind two or more Th2 cytokines, wherein the two or more specific binding agents for the Th2-specific cytokines are labeled with a first fluorophore;
- and
- ii) at least one specific binding agent that binds a Th17 cytokine, wherein the specific binding agent for the Th17 cytokine is labeled with a second fluorophore that is different from the first fluorophore;
- b) measuring levels of the first and second fluorophores in the sample and designating the cell as a Th2 or Th17 cell based on the level of Th2-specific and Th17-specific fluorophore detected;
- and
- c) determining the ratio of Th2 to Th17 cells in a sample.
A method for identifying a sub-population of asthma patients suffering from mild, moderate, or severe asthma that are responsive to treatment with a an anti-TSLP antibody, comprising measuring the baseline ratio of T helper 2 (Th2) and T helper 1 (Th1) cells in a patient sample and measuring changes in the ratio in a sample taken one week, two weeks, three weeks, four weeks, six weeks, two months, three months or more after administration of the anti-TSLP antibody, the method comprising:
- a) contacting the sample with
- i) two or more specific binding agents that bind two or more Th2-specific cytokines, wherein the two or more specific, binding agents for the Th2-specific cytokines are labeled with a first fluorophore;
- and
- ii) gat least one specific binding agent that binds a Th1-specific cytokine, wherein the specific binding agent for the Th1 -specific cytokine is labeled with a second fluorophore that is different from the first fluorophore;
- b) pleasuring levels of the first and second fluorophores in the sample and designating the cell as a Th1 or Th2 cell based on the level of Th2-specific and Th1-specific fluorophore detected;
- and
- c) determining, the ratio of Th2 to Th1 cells in a sample based on the level of Th2-specific cytokine and Th1-specific cytokine detected, wherein the patient is identified as responsive to the anti-TSLP antibody if the ratio of Th2 cells/Th1 cells decreases;
- and
- d) altering treatment with the anti-TSLP antibody if the patient is determined to be non-responsive to the anti-TSLP antibody or maintaining the dose of anti-TSLP antibody if the patient is determined to be responsive to treatment with the anti-TSLP antibody.
Dependencies are inferred from the claim text.