Allergen desensitization method
Inventors
Dupont, Christophe • Benhamou, Pierre-Henri • Dupont, Bertrand
Assignees
Assistance Publique Hopitaux de Paris APHP • DBV Technologies SA • Universite Paris Cite
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Publication Number
US-10758610-B2
Publication Date
2020-09-01
Expiration Date
Abstract
The present application relates to a method for desensitization of allergic patients. More specifically it relates to an epicutaneous desensitization method, applicable to any type of allergens and of patients. The method of the invention is essentially non-invasive and does not require the use of adjuvants. Further, it may be easily applied and monitored by the actual patient.
Core Innovation
The invention relates to epicutaneous desensitization of a subject allergic to milk by epicutaneously exposing the subject to a milk allergen and generating an immune reaction through application of a dose of the milk allergen, without an adjuvant, onto an intact region of skin. The method repeatedly applies the milk allergen, without an adjuvant, to an intact region of the skin using a dose, frequency, or application time adapted to sustain the immune reaction, and the exposure and sustained immune reaction lead to desensitization of the subject.
A cutaneous occlusive device configured to ensure contact between the allergen and the region of skin is used to apply the milk allergen. The dose of milk allergen is comprised between 0.1 and 1,000 μg/cm2 of a surface area of the device, and the approach sustains a controlled allergen-specific inflammatory reaction in the skin without adjuvants while orienting the immune response toward tolerance.
The method includes monitoring the cutaneous inflammation or immune reaction and adapting the dose, frequency, or application time based on the level of immune reaction. The document describes evaluation of immune reaction by visual evaluation, including immune reaction observable by the naked eye, and eligibility is described based on initial skin reactivity.
Claims Coverage
The independent claim covers epicutaneous desensitization of a subject allergic to milk using an adjuvant-free milk allergen applied to intact skin with a cutaneous occlusive device, where the regimen is adapted to sustain an immune reaction that leads to desensitization. The claim includes one quantitative limitation on the allergen dose based on device surface area, and dependent features refine the allergen composition or form and the evaluation and adjustment of the immune reaction over repeated applications.
Adjuvant-free epicutaneous allergen exposure on intact skin
Epicutaneously exposing the subject to a milk allergen and generating an immune reaction in the subject by applying a dose of the milk allergen, without an adjuvant, onto an intact region of skin of the subject, and repeatedly applying the milk allergen, without an adjuvant, to an intact region of the skin at a dose, frequency, or for an application time adapted to sustain the immune reaction, the exposure and sustained reaction leading to desensitization.
Occlusive cutaneous device ensuring contact
Applying the milk allergen by a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin.
Device-surface dose between 0.1 and 1,000 μg/cm2
The dose of milk allergen is comprised between 0.1 and 1,000 μg/cm2 of a surface area of the device.
Milk allergen comprises milk proteins
The milk allergen comprises milk proteins.
Milk allergen provided in powder form
The milk allergen is provided in powder form.
Visual evaluation of immune reaction
Including the visual evaluation of an immune reaction.
Immune reaction visible by naked eye
The immune reaction produced during the generating step can be seen by the naked eye.
Adaptation of dose, frequency, or application time based on immune reaction
Increasing or decreasing the dose, frequency, or application time of a milk allergen during repeated applications as the immune reaction decreases.
Overall, the claim set centers on adjuvant-free epicutaneous application of a milk allergen to intact skin using an occlusive contact device and a defined device-surface dose, while repeatedly adapting dose, frequency, or application time to sustain an immune reaction that leads to desensitization; dependent features further specify milk proteins and powder form and include visual or naked-eye assessment with adaptation based on immune reaction level.
Stated Advantages
Desensitization of the subject allergic to milk is achieved by sustaining a controlled allergen-specific inflammatory reaction without adjuvants.
Reduced cutaneous reactivity and increased tolerance threshold are described.
Reduced bronchial hyperreactivity and altered antibody profiles are described.
Reduced histamine release is described.
Improved cow-milk tolerance threshold in a pediatric case is described.
Documented Applications
Epicutaneous desensitization of subjects allergic to milk, with described monitoring and adaptation of cutaneous immune reaction and reported clinical or experimental outcomes including reduced bronchial hyperreactivity and improved cow-milk tolerance threshold.
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