Anti-GM-CSF Antibody Measurement for IBD Relapse Prediction

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Solution Overview

Problem

Current diagnostic tools lack sufficient accuracy to predict relapse or sustained remission in inflammatory bowel diseases (IBD), making it challenging to select appropriate therapies effectively.

Innovation Solution

Measuring the level of anti-GM-CSF antibodies in a subject's sample to determine IBD relapse risk, allowing for the selection of appropriate treatments based on the predicted risk, including comparing antibody levels over time and using additional biomarkers like fecal S100A8/A9.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If standardized care is provided to IBD patients, then treatment coverage is ensured, but relapse prediction accuracy remains insufficient

Engineering Contradiction:
Improverelapse prediction accuracyVSAvoiddiagnostic tool complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent changes the parameter being measured from general inflammatory markers to specific anti-GM-CSF antibody levels. This parameter change enables more accurate relapse prediction by focusing on the specific immune mechanism underlying IBD relapse, thereby resolving the contradiction between prediction accuracy and diagnostic complexity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent replaces complex clinical assessment mechanisms with a simplified immunological assay. Instead of relying on multiple clinical parameters and subjective assessments, the invention uses a direct measurement of anti-GM-CSF antibodies, substituting a complex diagnostic system with a more precise and manageable biochemical test.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If anti-TNF therapy is introduced early, then sustained remission rates improve, but treatment selection accuracy lacks guidance

Engineering Contradiction:
Improvesustained remission rateVSAvoidpatient subset differentiation
Core Design Contradiction:
ReliabilityVSLoss of information

Solution Approach 1:

The patent segments the IBD patient population into distinct subsets based on their anti-GM-CSF antibody profiles. This segmentation allows for differentiated treatment selection, where patients with high antibody levels can be identified as likely responders to anti-TNF therapy, thereby preventing loss of information about patient heterogeneity and enabling more reliable treatment outcomes.

Inventive Principle:
Principle #1Segmentation

3Loss of time

If monitoring frequency is increased to detect relapse early, then intervention timing improves, but resource utilization increases

Engineering Contradiction:
Improverelapse detection timeVSAvoidresource utilization efficiency
Core Design Contradiction:
Loss of timeVSProductivity

Solution Approach 1:

The patent implements preliminary action by measuring anti-GM-CSF antibody levels before clinical relapse symptoms appear. This early detection capability allows for timely intervention without requiring frequent monitoring, as the biomarker provides advance warning of impending relapse. This resolves the contradiction by enabling effective early detection while maintaining resource efficiency through targeted rather than routine monitoring.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP2997369B1Methods and compositions for determining relapse in inflammatory bowel disease
Publication Date: 2019.12.25 CHILDRENS HOSPITAL MEDICAL CENT CINCINNATI
  • EP2997369B1 patent drawingFigure 1A~1B
  • EP2997369B1 patent drawingFigure 1C~1D
  • EP2997369B1 patent drawingFigure 2A~2B

AI summary

Described are methods and compositions for evaluating the relapse risk in subjects having an inflammatory bowel disease (IBD) by measuring the level of an anti-GM-CSF antibody in a sample from said subject, thereby determining the IBD relapse risk for said subject. Some embodiments include selecting a treatment for an evaluated IBD relapse risk in a subject. Some such methods include providing the result of said measuring to a party in order for said party to evaluate IBD relapse risk for said subject; or providing the IBD relapse risk to a party in order for said party to select a treatment for said subject.