Methods of monitoring inflammatory bowel diseases
AssigneeIcahn School of Medicine at Mount Sinai
InventorsJean-Frederic Colombel, James Ferrara, John E. Levine, Umut Ozbek, Ryan Ungaro
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Abstract
The present application discloses diagnostic methods and kits for detecting disease activity in a subject having an inflammatory bowel disease, such as Crohn's disease. Methods of treating endoscopically active gastrointestinal disease, as well as methods of determining effectiveness of a treatment for endoscopically active gastrointestinal disease in a subject, are also disclosed.
Claims17
A method for detecting Crohn's disease in a human subject, said method comprising:
- (a) detecting, in a biological sample from the human subject, an expression level of regenerating islet-derived protein 3 alpha (REG3α) and an expression level of C-reactive protein (CRP), the biological sample comprising at least one of a serum sample or a whole blood sample;
- (b) applying a statistical algorithm to said expression levels of REGα and CRP to generate a combined REG3α/CRP index score;
- (c) determining that the human subject has or is likely to have Crohn's disease based on the combined REG3α/CRP index score being higher than an optimal classification threshold detecting the Crohn's disease in the subject;
- and
- (d) administering to the human subject a therapeutic agent under conditions effective to treat Crohn's disease in the human subject.
A method of determining effectiveness of a treatment of Crohn's disease in a human subject, said method comprising:
- detecting expression levels of regenerating islet-derived protein 3 alpha or (REG3α) and C-reactive protein (CRP) in a first biological sample from the human subject before the human subject receives the treatment for the Crohn's disease;
- applying a statistical algorithm to said expression levels of REGα and CRP in the first biological sample to generate a first combined REG3α/CRP index score;
- detecting expression levels of REG3α and CRP in a second biological sample from the human subject after the subject has received the treatment for the Crohn's disease;
- applying a statistical algorithm to said expression levels of REGα and CRP in the second biological sample to generate a second combined REG3α/CRP index score;
- and
- comparing the second combined REG3α/CRP index score to the first combined REG3α/CRP index score to determine effectiveness of the treatment in the human subject.
Dependencies are inferred from the claim text.