Anti-TNF Response Classifier for Autoimmune Treatment Selection

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Solution Overview

Problem

Current anti-TNF therapies for autoimmune diseases like rheumatoid arthritis exhibit inconsistent response rates, leading to delayed treatment and increased risks of side effects due to the inability to accurately predict responder and non-responder patients.

Innovation Solution

A classifier is developed to distinguish between responsive and non-responsive patients using gene expression differences, single nucleotide polymorphisms, and clinical characteristics, allowing for personalized treatment decisions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If anti-TNF therapy is administered to all RA patients, then treatment coverage is maximized, but treatment effectiveness decreases due to inclusion of non-responders

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidnumber of patients treated
Core Design Contradiction:
ProductivityVSQuantity of substance

Solution Approach 1:

The patient population is segmented into responder and non-responder groups using a classifier based on gene expression profiles. This allows selective administration of anti-TNF therapy only to patients predicted to respond, improving treatment effectiveness while maintaining broad coverage through stratified patient identification.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent changes the parameter of patient selection from clinical criteria alone to multi-parameter assessment including gene expression signatures, SNPs, and clinical characteristics. This enhanced parameter set enables more accurate prediction of treatment response, allowing differentiation between responders and non-responders.

Inventive Principle:
Principle #35Parameter changes

2Loss of time

If anti-TNF therapy is administered without response prediction, then treatment initiation is simplified, but treatment delay increases for non-responders

Engineering Contradiction:
Improvetreatment delayVSAvoidclassification system complexity
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The classifier is applied before treatment initiation to predict response in advance. By performing this classification preliminary action, the system identifies non-responders before they undergo unnecessary treatment delays, allowing alternative therapies to be initiated sooner for patients unlikely to benefit from anti-TNF therapy.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The response prediction classifier acts as an intermediary between patient assessment and treatment decision-making. It processes multiple input parameters (gene expression, SNPs, clinical data) and outputs treatment recommendations, mediating the complexity of treatment selection while reducing overall treatment delay.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If anti-TNF therapy is administered to all patients, then treatment accessibility is maximized, but harmful side effects increase due to unnecessary treatment

Engineering Contradiction:
Improveside effectsVSAvoidtreatment accessibility
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

Patients are segmented into those likely to respond and those unlikely to respond based on their molecular and clinical profile. This segmentation enables selective treatment administration, reducing harmful side effects in non-responders while maintaining accessibility for the responder population through targeted identification.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent converts the previously harmful effect of treating all patients (including non-responders) into a benefit by using the same comprehensive data collection to identify and exclude non-responders. The comprehensive data gathering that initially seemed to increase complexity actually enables more precise, harm-reducing treatment selection.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Data Source

PatentUS20250270307A1Methods of classifying and treating patients
Publication Date: 2025.08.28 SCIPHER MEDICINE CORP
  • US20250270307A1 patent drawing
  • US20250270307A1 patent drawing
  • US20250270307A1 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 methods of treating subjects suffering from an autoimmune disorder, the method comprising: administering an anti-TNF therapy to subjects who have been determined to be responsive via a classifier established to distinguish between responsive and non-responsive prior subjects in a cohort who have received the anti-TNF therapy. For example, in some embodiments, the present disclosure provides methods of treating subjects suffering from an autoimmune disorder during therapeutic treatment, the method comprising: identifying responsive and non-responsive prior subjects over a time period beginning from the administering of the anti-TNF therapy.