Patent ID: 11946927
Assignee: nan
Field: Pharmaceuticals (Chemistry)
Classification: CPC G  A  Y | IPC A  G

Claim 4:
5. A process of predicting and individual's risk of developing inflammatory bowel disease (IBD), the process comprises the steps of:
selecting an individual to be tested prior to the individual showing symptoms of IBD such that the individual is diagnosed with having IBD, wherein the individual is further selected based on Disease Factors of the selected individual;
obtaining a first blood sample of the selected individual;
examining the blood sample to obtain a level of each predictive target biomarker listed in a prediction panel of predictive target biomarkers for IBD;
determining the total level of protein in the blood sample;
using a prediction logistic regression model that uses the predictive target biomarkers listed in the prediction panel of predictive target biomarkers for determining a risk value of an individual developing IBD and using the prediction logistic regression model for predicting the risk of an individual developing IBD and the levels of each predictive target biomarker listed in the prediction panel of predictive target biomarkers for IBD and the total level of protein in the blood sample to calculate a risk value for the selected individual developing IBD;
determining if the risk value for the selected individual developing IBD is above or below a cut-off value for the prediction logistic regression model for predicting the risk of an individual developing IBD;
wherein the prediction panel of predictive target biomarkers for use in determining the risk value of an individual developing IBD comprises the predictive target biomarkers of Haptoglobin (HP), Granulocyte Colony Stimulating Factor (GCSF), Resistin (RETN), C-Reactive Protein (CRP), Soluble Interacellular Adhesion Molecule 1 (sICAM1) and Antibody TT and identifies the relationships of sICAM1×HP, GCSF×CRP and GCSF×RETN;
wherein the prediction logistic regression model for determining the risk value for an individual developing IBD is: Log (P/1ip)=−641.8833706+71.65755693×HP−41.87442414×GCSF−45.27490174×RETN−16.22723673×CRP−1.029456032×Antibody TT+14.476981343×sICAM1+5.667294456×(sICAM1×HP)−0.80715758×(GCSF×CRP)−2.288843531×(GCSF×RETN), wherein the cut-off value is 0.68;
using a second prediction panel of predictive target biomarkers and a second prediction logistic regression model for determining the risk of an individual developing IBD, wherein the predictive target biomarkers listed in the second prediction panel of predictive target biomarkers are sICAM1, GCSF, HP, CRP, RETN and Antibody TT and the second prediction logistic regression model is: Log (p/1ip)=1101.571616−0.813305575×deployment−104.1257102×sICAM1−62.63858365×GCSF−5.604142451×sICAM1×GCSF+65.611507602×HP+5.107130532×sICAM1×HP−36.81637743×Antibody TT−1.711888269×GCSF×Antibody TT+0.767135503×CRP+1.770741857×RETN having a cut-off value of 0.56;
wherein if the risk value determined using the first prediction logistic regression model or the risk value determined using the second prediction logistic regression model is greater than the cut-off values for the first prediction logistic regression model or the second prediction logistic regression model, respectively, the process includes using a prediction panel of predictive target biomarkers for use in determining the risk of an individual developing Crohn's disease having a list of predictive target biomarkers for use in determining the risk value of an individual developing Crohn's disease;
examining the blood sample to obtain a total level of protein in the blood sample and a level of each predictive target biomarker listed in the prediction panel of predictive target biomarkers for use in determining a risk value of an individual developing Crohn's disease;
using a prediction logistic regression model for determining the risk of an individual developing Crohn's disease that uses the total level of protein in the blood sample and the level of each predictive target biomarker listed in the prediction panel of target biomarkers for determining the risk of an individual developing Crohn's disease to determine a risk value of the selected individual developing Crohn's disease;
determining if the risk value for the selected individual developing Crohn's disease is above or below a cut-off value for the prediction logistic regression model for use in determining the risk of an individual developing Crohn's disease;
wherein the prediction panel of predictive target biomarkers for use in determining the risk of an individual developing Crohn's disease comprises AutoAb to topisomerase type 1 (SLC70), Angiotensin 1 converting enzyme (AcE), RETN, CRP, GCSF and Antibody TT and identifies the relationships of sICAM1×RETN, GCSF×Antibody TT;
wherein the prediction logistic regression model for determining the risk value for an individual developing Crohn's disease is Log (p/1ip)=−174.4+171.2×SLC70−4.0×AcE−32.2×RETN+1.1×CRP+15.9×GCSF−57.4×Antibody TT+11.6×(sICAM1×RETN)−2.7×(GCSF×Antibody TT and wherein the cut-off value is 0.5;
wherein if the risk value for the selected individual developing Crohn's disease is below the cut-off value for the prediction logistic regression model for use in determining the risk of an individual developing Crohn's disease, the process includes the steps of using a prediction panel of predictive target biomarkers for use in determining the risk of an individual developing ulcerative colitis (UC) to determine a risk value of the selected individual developing UC, wherein the prediction panel of predictive target biomarkers for use in determining the risk of an individual developing UC comprises the predictive target biomarkers of HP, SICAM1 and RETN, and identifies the relationship of sICAM1×HP;
examining the blood sample to obtain a total level of protein in the blood sample and a level of each predictive target biomarker listed in the prediction panel of predictive target biomarkers for use in determining the risk of the individual developing UC;
using a prediction logistic regression model for use in determining a risk value of an individual developing UC and using the logistic regression model and the total level of protein in the blood sample and the levels of each predictive target biomarker listed in the prediction panel of predictive target biomarkers for use in determining the risk value of an individual developing UC to calculate a risk value for selected individual developing UC;
determining if the risk value for the selected individual developing UC is above or below a cut-off value for the prediction logistic regression model for use in determining the risk of an individual developing UC;
wherein the prediction logistic regression model for determining the risk value for an individual developing UC is Log (p/1−p)=221.7+2.2×RETN+15.1×sICAM1+61.5×HP+4.9×(sICAM1×HP) and the cut-off value is 0.52;
wherein if the risk value for the selected individual developing IBD or Crohn's disease or UC is greater than the cut-off value for the prediction logistic regression model for determining the risk of an individual developing IBD, Crohn's disease or UC, respectively, the process includes the step of administering a therapy known to treat IBD or Crohn's disease or UC and repeating the process to determine if the risk value of developing IBD or Crohn's disease or UC is decreasing, remaining the same or increasing and if the risk value is remaining the same or increasing, modifying the therapy until the risk value of developing IBD or Crohn's disease or UC is below the cut-off value for developing IBD, Crohn's disease or UC, respectively; and
wherein if the risk values for the selected individual developing IBD and Crohn's disease and UC are below the cut-off values for the prediction logistic regression model used for determining the risk value of an individual developing IBD, Crohn's disease and UC, respectively, the process includes using Disease Factors of the selected individual to determine if the process is to be performed again at a future date or administer a therapy to the selected individual when the selected individual is diagnosed with IBD, Crohn's disease or UC for treating IBD, Crohn's disease or UC.