Biomarker panel for assessment of mucosal healing
AssigneeNestec S.A.
InventorsSharat Singh, Severine Vermeire
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Abstract
The present invention provides methods for predicting the likelihood of mucosal healing in an individual with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis (UC). In addition, the present invention provides methods for monitoring the progression of mucosal healing in an individual with a disease such as IBD. Information on mucosal healing status derived from the use of the present invention can also aid in optimizing therapy and/or monitoring the therapeutic efficiency of an anti-TNFα inhibitor drug.
Claims23
A method for predicting the likelihood or extent of intestinal mucosal healing in a subject using an endoscopic surrogate measurement score, the method comprising:
- (a) measuring the concentration or level of each of a plurality of biomarkers in a sample obtained from the subject, wherein the plurality of biomarkers consists of a combination of hepatocyte growth factor (HGF), betacellulin (BTC), an anti TNFα drug trough level and vascular cell adhesion molecule 1 (VCAM-1);
- (b) comparing the concentration or level of the plurality of biomarkers to a cut-off value for each biomarker to assign an index value to the concentration or level of each biomarker;
- (c) determining a cumulative biomarker score by applying an algorithm to the index values to determine said endoscopic surrogate measurement score;
- and
- (d) predicting an increased likelihood or the extent of intestinal mucosal healing in the subject based on the endoscopic surrogate measurement score.
A method for predicting the likelihood of intestinal mucosal healing in a subject, the method comprising:
- (a) measuring the concentration or level of each of a plurality of biomarkers in a sample obtained from the subject, wherein the plurality of biomarkers consists of a combination of hepatocyte growth factor (HGF), betacellulin (BTC), the anti-TNFα trough level, and vascular cell adhesion molecule 1 (VCAM-1);
- (b) comparing the concentration or level of the plurality of biomarkers to a cut-off value for each biomarker to assign an index value to the concentration or level of each biomarker;
- (c) determining a cumulative biomarker score by applying an algorithm to the index values to determine said endoscopic surrogate measurement score;
- and
- (d) predicting an increased likelihood or the extent of intestinal mucosal healing in the subject based on the endoscopic surrogate measurement score.
A method for determining an endoscopic endoscopic surrogate measurement score in a subject, the method comprising:
- (a) measuring the concentration or level of each of a plurality of biomarkers in a sample obtained from the subject, wherein the plurality of biomarkers consists of a combination of the following biomarkers, which include hepatocyte growth factor (HGF), betacellulin (BTC), an anti TNFα drug trough level and vascular cell adhesion molecule 1 (VCAM-1);
- (b) comparing the concentration or level of the plurality of biomarkers to a cut-off value for each biomarker to assign an index value to the concentration or level of each biomarker;
- (c) determining a cumulative biomarker score by applying an algorithm to the index values;
- and
- (d) determining the endoscopic surrogate measurement score in the subject based on if the cumulative biomarker score.
A method for determining an endoscopic surrogate measurement score in a subject, the method comprising:
- (a) measuring the concentration or level of each of a plurality of biomarkers in a sample obtained from the subject, wherein the plurality of biomarkers consists of a combination of hepatocyte growth factor (HGF), betacellulin (BTC), tumor-necrosis factor-related weak inducer of apoptosis (TWEAK) and vascular cell adhesion molecule 1 (VCAM-1);
- (b) comparing the concentration or level of the plurality of biomarkers to a cut-off value for each biomarker to assign an index value to the concentration or level of each biomarker;
- (c) determining a cumulative biomarker score by applying an algorithm to the index values;
- and
- (d) determining the endoscopic surrogate measurement score in the subject based on the cumulative biomarker score.
Dependencies are inferred from the claim text.