Methods for predicting post-operative recurrence of Crohn's disease
Inventors
Lockton, Steven • FERRANTE, MARC • VERMIERE, SEVERINE • Singh, Sharat
Assignees
Katholieke Universiteit Leuven • Prometheus Laboratories Inc
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Publication Number
US-10697961-B2
Publication Date
2020-06-30
Expiration Date
Abstract
The present invention provides methods for predicting post-operative recurrence of Crohn's disease (CD) in a subject. With the present invention it is possible to predict whether a patient undergoing surgical treatment of CD is at risk of developing histological, radiographic, endoscopic, and/or clinical recurrence of the disease.
Core Innovation
The invention relates to methods for predicting post-operative recurrence of Crohn's disease in a subject with Crohn's disease that is undergoing or planning on undergoing surgical treatment. The prediction is based on determining pre-operative risk factors from a pre-operative sample and links recurrence after surgery to immune marker detection and active smoking.
The method determines a first risk factor by detecting an elevated level of an anti-flagellin antibody in the pre-operative sample relative to an average subject with Crohn's disease, and determines a second risk factor by detecting the presence of pANCA in the sample. A third risk factor is determined by whether the subject is an active smoker, and recurrence is characterized as endoscopic recurrence, histological recurrence, or clinical recurrence.
The presence count of the three risk factors stratifies post-operative recurrence risk: one risk factor is predictive of an increased risk relative to an average subject, two risk factors are predictive of a greater risk relative to the presence of one risk factor, and three risk factors are predictive of a greater risk relative to the presence of two risk factors. The method also provides post-operative Crohn's disease therapy based on the presence of one, two, or three of the risk factors.
Claims Coverage
The provided material includes two independent claims. Both claims cover a three-factor, pre-operative prediction framework for post-operative Crohn's disease recurrence risk based on elevated anti-flagellin antibody, presence of pANCA, and active smoking, with recurrence classified into endoscopic, histological, or clinical recurrence, and with a risk gradient based on whether one, two, or three risk factors are present.
Three pre-operative risk factors predict post-operative recurrence
Predicting a risk of post-operative recurrence of Crohn's disease based on the presence of a first risk factor (elevated anti-flagellin antibody level relative to an average subject), a second risk factor (presence of pANCA), and a third risk factor (whether the subject is an active smoker), wherein recurrence comprises endoscopic recurrence, histological recurrence, or clinical recurrence.
Presence count stratifies recurrence risk
Wherein the presence of one risk factor is predictive of an increased risk of post-operative recurrence relative to an average subject, wherein the presence of two of the risk factors is predictive of a greater risk relative to the presence of one of the risk factors, and wherein the presence of three of the risk factors is predictive of greater risk relative to the presence of two of the risk factors.
Post-operative therapy based on risk-factor presence
Providing a post-operative Crohn's disease therapy to the subject based on the presence of one, two, or three of the risk factors.
Immunoassay detection of anti-flagellin threshold
Detecting, by an immunoassay, a level of an anti-flagellin antibody greater than 66 EU/ml in a pre-operative sample.
Across the independent claims, the coverage centers on a pre-operative, three-risk-factor recurrence prediction model using anti-flagellin antibody detection, pANCA detection, and active smoking status, with risk increasing with the number of risk factors present and recurrence classified into endoscopic, histological, or clinical categories; one independent claim additionally requires providing post-operative Crohn's disease therapy based on the detected risk-factor count.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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