Method for evaluating immunosuppressive regimens

• US 6,329,153 B1
• Filed: 06/22/1999
• Issued: 12/11/2001
• Est. Priority Date: 06/22/1998
• Status: Expired due to Fees

• Current Assignee: Vanderbilt University
• Original Assignee: Vanderbilt University
• Inventors: Murray, John J., Wood, Alastair J. J., Stein, Charles M.
• Primary Examiner(s): Saoud, Christine J.
• Assistant Examiner(s): HAMUD, FOZIA M
• Application Number:
  US09/337,967
• Time in Patent Office: 903 Days
• Field of Search: 435/7.1, 435/7.2, 435/7.92, 435/355, 435/372, 435/366, 436/512, 530/351
• US Class Current: 435/7.1
• CPC Class Codes: G01N 2333/55 IL-2
• CPC Class Codes: G01N 33/505 involving T-cells
• CPC Class Codes: G01N 33/5091 for testing the pathological state of an organism
• CPC Class Codes: G01N 33/9493 Immunosupressants

Abstract

The present invention describes a simple technique that provides a biologically relevant measure of the inhibitory effect of cyclosporine in vivo. This ability to measure response to cyclosporine may improve prediction of the efficacy of immunosuppressive treatment in patients and may allow optimal immunosuppression in individual patients.

Claims

1. A method of measuring the biological effect of treatment with an immunosuppressive or immunomodulatory agent in an individual, comprising the steps of:

extracting a sample of whole blood from said individual;

treating the blood sample with a mitogenic agent for about 1 hour to about 6 hours, measuring the concentration of interleukin-2 (IL-2) in said blood sample; and

comparing said concentration of IL-2 prior to and after said treatment with said immunosuppressive or immunomodulatory agent, wherein said treatment with said immunosuppressive agent resulting in an inhibition of IL-2 reflects a biological effect.

2. The method of claim 1, wherein said immunosuppressive or immunomodulatory agent is selected from the group consisting of cyclosporin, and immunomodulatory agents with similar mechanism of action as cyclosporin.

3. The method of claim 1, wherein said mitogenic agent is selected from the group consisting of phytohemmagluttinin, phorbol esters, lipopolysaccharides and calcium ionophores.

4. The method of claim 1, wherein said individual has received a medical procedure selected from the group consisting of an organ transplant, a cell transplant and a tissue graft.

5. The method of claim 1, wherein said individual has a disease selected from the group consisting of an auto-immune disease and inflammatory disease.

6. The method of claim 1, wherein the purpose of said treatment is to prevent or treat transplant or graft rejection.

7. The method of claim 1, wherein the purpose of measuring said biological effect is to prevent or treat toxicity to said immunosuppressive agent.

8. The method of claim 1, wherein the purpose of measuring said biological effect is to maintain the therapeutic effect of said immunosuppressive agent within a target range.

9. The method of claim 8, wherein said target range is approximately midway between a peak and a trough biological effect of said agent.