Anti-TNF Response Prediction Using Biomarker Classifiers in RA

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Solution Overview

Problem

Current anti-TNF therapies exhibit inconsistent response rates, leading to delayed treatment and increased risks of side effects due to the inability to accurately predict which patients will benefit from the therapy, resulting in prolonged symptom progression and potential harm.

Innovation Solution

A method utilizing a classifier that assesses gene expression levels, single nucleotide polymorphisms (SNPs), and clinical characteristics to distinguish between responsive and non-responsive patients, enabling personalized treatment decisions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anti-TNF therapy is administered to all RA patients, then some patients achieve disease remission, but response rates are inconsistent and many patients do not benefit while experiencing side effects

Engineering Contradiction:
Improvetreatment response rateVSAvoidside effects and infection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by developing and applying a machine learning classifier before anti-TNF therapy administration to predict patient response. The classifier analyzes multiple biomarkers and clinical characteristics to identify likely responders in advance, enabling selective treatment only for patients predicted to benefit, thereby avoiding side effects in non-responders while maintaining high response rates among treated patients

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If patients are switched to alternative therapies after failing anti-TNF treatment, then treatment options are explored, but the process takes over a year and disease progresses during this delay

Engineering Contradiction:
Improvetreatment option availabilityVSAvoidtime to reach effective treatment
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The patent implements preliminary action by performing response prediction using the machine learning classifier before initiating anti-TNF therapy. This upfront assessment identifies likely non-responders who can be directed to alternative therapies immediately, avoiding the traditional sequential approach where patients cycle through multiple anti-TNF agents over a year before switching. The classifier enables immediate treatment optimization, preventing disease progression during the selection period

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If machine learning classifiers are continuously updated with new data, then prediction accuracy improves, but implementation in clinical labs is difficult due to validation requirements

Engineering Contradiction:
Improveprediction accuracyVSAvoidsoftware update and validation process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies dynamics by creating a flexible machine learning classifier system that can be retrained and updated with new data while maintaining clinical utility. The system architecture allows for periodic retraining with accumulating clinical data to improve prediction accuracy over time, while the validation framework enables controlled updates without requiring complete system re-validation, thus balancing adaptability with regulatory compliance

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS12525318B2Method of monitoring anti-TNF therapy in a subject suffering from rheumatoid arthritis based in part on a trained machine learning classifier
Publication Date: 2026.01.13 SCIPHER MEDICINE CORP
  • US12525318B2 patent drawing
  • US12525318B2 patent drawing
  • US12525318B2 patent drawing

AI summary

Presented herein are systems and methods for developing classifiers useful for predicting response to particular treatments. For example, in some embodiments, the present disclosure provides a method of treating subjects suffering from an autoimmune disorder, the method comprising administering an alternative to anti-TNF therapy to subjects who have been determined to be non-responsive via a classifier established to distinguish between responsive and non-responsive prior subjects in a cohort who have received the anti-TNF therapy.