Oral Immunotherapy Peanut Desensitization Protocol

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Solution Overview

Problem

Current treatments for peanut allergy, including oral immunotherapy, face challenges such as poor tolerability and efficacy, particularly in gradually escalating doses, and lack of knowledge on avoiding and managing food allergy emergencies, leading to increased risk of accidental reactions.

Innovation Solution

A method of oral immunotherapy involving gradual dose escalation of peanut protein from 2mg to 800mg over several weeks, with a maintenance phase of daily or weekly administration for at least two years, using peanut flour or whole peanuts, often masked in food products to reduce gastrointestinal reactions, and monitored for adverse symptoms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If oral immunotherapy with gradual dose escalation is used to treat peanut allergy, then the tolerated dose of peanut protein increases, but the treatment duration is extended to at least two years

Engineering Contradiction:
Improvetolerated dose of peanut proteinVSAvoidtreatment duration
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The patent implements a preliminary action by establishing a structured gradual dose escalation protocol with predetermined increments (2mg, 5mg, 12.5mg, 25mg, 50mg, 100mg, 200mg, 400mg, 800mg) administered at specific intervals (at least 2 weeks between increments). This preliminary structuring of the immunotherapy process enables systematic desensitization over time, ultimately achieving a thousand-fold increase in tolerated peanut protein dosage while maintaining safety through pre-planned progression steps.

Inventive Principle:
Principle #10Preliminary action

2Object-affected harmful factors

If peanut protein is administered orally to desensitize patients, then allergic reactions are reduced, but gastrointestinal adverse reactions occur

Engineering Contradiction:
Improveallergic reactionsVSAvoidgastrointestinal adverse reactions
Core Design Contradiction:
Object-affected harmful factorsVSObject-generated harmful factors

Solution Approach 1:

The patent applies parameter changes by systematically modifying the dosage parameters of peanut protein administration. The protocol employs gradual dose escalation with specific increments (2mg starting dose, increasing through 5mg, 12.5mg, 25mg, 50mg, 100mg, 200mg, 400mg to 800mg maximum) administered at controlled intervals (at least 2 weeks between increments). This parameter modification approach transforms the harmful allergic reaction profile by progressively adapting the patient's immune system to tolerate higher doses, reducing IgE-mediated allergic responses while monitoring and managing gastrointestinal adverse reactions throughout the two-year treatment period.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If subcutaneous immunotherapy is used for peanut allergy, then efficacy is achieved, but severe adverse reactions occur

Engineering Contradiction:
Improveefficacy of treatmentVSAvoidsevere adverse reactions
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs an intermediary approach by transitioning from subcutaneous immunotherapy (which directly injects allergen into the bloodstream, causing severe adverse reactions) to oral immunotherapy (which administers peanut protein through the gastrointestinal tract). This intermediary route of administration allows for gradual desensitization through the digestive system, providing a safer alternative that achieves comparable efficacy without the severe adverse reactions associated with subcutaneous injection, while still producing reliable desensitization outcomes.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Loss of time

If rush protocol is used for peanut oral immunotherapy, then treatment time is reduced, but tolerability during rush period is poor

Engineering Contradiction:
Improvetreatment timeVSAvoid tolerability during rush period
Core Design Contradiction:
Loss of timeVSEase of operation

Solution Approach 1:

The patent implements periodic action by establishing a structured immunotherapy protocol with regular dosing intervals (at least 2 weeks between dose increments) and a sustained maintenance phase (at least 2 years of daily or weekly administration at maximum dose). This periodic approach, contrasting with continuous rush protocols, allows the patient's immune system to adapt systematically to increasing peanut protein doses, achieving both tolerability during the escalation phase and sustained desensitization efficacy throughout the long-term maintenance period.

Inventive Principle:
Principle #19Periodic action

Data Source

PatentEP2686013B1Treatment for peanut allergy
Publication Date: 2017.05.03 CAMBRIDGE UNIV HOSPITALS NHS FOUND TRUS
  • EP2686013B1 patent drawingFigure 1
  • EP2686013B1 patent drawingFigure 2
  • EP2686013B1 patent drawingFigure 3A~3B

AI summary

The present invention relates to oral immunotherapy for the desensitisation of patients who are hypersensitive to peanut allergen. The immunotherapy comprises increasing the oral dose daily dose of peanut protein administered to the patient at intervals of at least 2 weeks in a series of increments from an initial dose to a maximum dose, the series of dose increments including 2mg, 5mg, 12.5mg, 25mg, 50mg, 0mg, 200mg, 400mg and 800mg; administering a daily oral dose of the maximum dose of peanut protein for at least 2 years and then administering a weekly oral dose of the maximum dose of peanut protein for at least 2 years.