FSTL-1 AS A BIOMAKER OF INFLAMMATION

• US 20110045507A1
• Filed: 01/29/2009
• Published: 02/24/2011
• Est. Priority Date: 01/29/2008
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Hirsch, Raphael
• Granted Patent: US 8,211,652 B2
• Time in Patent Office: Days
• US Class Current: 435/7.92
• CPC Class Codes: G01N 2800/102 Arthritis; Rheumatoid arthritis, i.e. inflammation of peripheral joints
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

The invention provides methods and kits for diagnosing severity of particular types of inflammatory diseases, such as rheumatic diseases, by assessing protein levels of follistatin-like protein 1 (FSTL-1). The level of FSTL-1 protein present in the serum or synovial fluid of individuals suspected of having certain inflammatory disease (e.g, rheumatoid arthritis) is positively correlated with the severity of the disease.

Claims

1. A method for assessing the severity of an inflammatory disease in an individual comprising:

(a) assessing the level of protein expression of FSTL-1 in a biological sample from the individual; and

(b) correlating the level of protein expression of FSTL-1 with the severity of the disease wherein a higher level of FSTL-1 expression relative to a normal individual is associated with greater severity of the disease.

2. The method according to claim 1 wherein the inflammatory disease is selected from the group consisting of juvenile rheumatoid arthritis, Kawasaki'"'"'s disease, rheumatoid arthritis, gouty arthritis, psoriatic arthritis, septic arthritis, osteoarthritis, or reactive arthritis.

3. The method according to claim 1 wherein the biological sample is plasma, serum, synovial fluid, broncheoalveolar lavage fluid, cerebrospinal fluid, pleural fluid or pericardial fluid.

4. The method according to claim 2 wherein the most severe form of juvenile rheumatoid arthritis is systemic juvenile rheumatoid arthritis.

5. The method according to claim 2 wherein the less severe form of juvenile rheumatoid arthritis is polyarticular juvenile rheumatoid arthritis.

6. The method according to claim 2 wherein the least severe form of juvenile rheumatoid arthritis is pauciarticular juvenile rheumatoid arthritis.

7. The method according to claim 1 wherein the level of FSTL-1 is assessed prior to the start of a treatment plan and monitored during the course of treatment to determine the efficacy of the treatment plan.

8. A method for assessing the degree of erosiveness of arthritis in an individual comprising:

(a) assessing the level of protein expression of FSTL-1 in a biological sample from the individual; and

(b) correlating the level of protein expression of FSTL-1 with the severity of the disease wherein a higher level of FSTL-1 expression relative to a normal individual is associated with erosive arthritis.

9. The method according to claim 8 wherein the biological sample is serum or synovial fluid.

10. The method according to claim 8 wherein the highest level of FSTL-1 is predictive of erosive disease.

11. The method according to claim 8 wherein a moderate level of FSTL-1 is predictive of moderately erosive disease.

12. The method according to claim 8 wherein a low level of FSTL-1 is predictive of non-erosive disease.

13. The method according to claim 8 wherein the level of FSTL-1 is assessed prior to the start of a treatment plan and monitored during the course of treatment to determine the efficacy of the treatment plan.

14. A method for assessing infectious disease in an individual comprising assessing the level of protein expression of FSTL-1 in a biological sample from an individual wherein a higher level of FSTL-1 relative to a normal individual is associated with infectious disease.

15. The method according to claim 14 wherein the infectious disease is bacterial infection, viral infection or septic shock.

16. The method according to claim 14 wherein the biological sample is plasma, serum, synovial fluid, broncheoalveolar lavage fluid, cerebrospinal fluid, pleural fluid or pericardial fluid.

17. The method of according to claim 14 wherein the level of FSTL-1 is assessed prior to the start of a treatment plan and monitored during the course of treatment to determine the efficacy of the treatment plan.