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-11202826-B2
Publication Date
2021-12-21
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 peanut by epicutaneously exposing the subject to a peanut allergen and generating an immune reaction in the subject by applying a dose of the peanut allergen, without an adjuvant, onto an intact region of skin of the subject. The immune reaction is sustained by repeated epicutaneous exposure so that the exposure and the sustained reaction lead to desensitization of the subject.
A central aspect is repeatedly applying the peanut 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 adaptation supports control of the resulting allergen-specific cutaneous inflammatory reaction, including adapting dose and frequency and/or application time.
The epicutaneous application is carried out using a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin. The document emphasizes monitoring and evaluating cutaneous inflammation, including visible inflammation grades, with reported embodiments using occlusive or passive-diffusion devices such as a transparent backing configured to allow the immune reaction to be viewed, including the Viaskin® type approach and an assessment grid.
The document reports that sustaining and controlling the resulting allergen-specific cutaneous inflammatory reaction guides the immune response toward tolerance, including immunological and clinical readouts. Reported outcomes include reduction of bronchial hyperreactivity and allergen-specific responses, including reduced IgE and histamine responses, and an immune deviation described as a shift from TH2 toward TH1 with longer applications, and increased oral tolerance threshold in a human example.
Claims Coverage
The partial content provides one independent claim. This independent claim defines epicutaneous peanut desensitization without adjuvant, with repeated administration at a dose, frequency or application time adapted to sustain an immune reaction, using a cutaneous occlusive device with defined dose-per-device-surface-area constraints.
Adjuvant-free epicutaneous peanut allergen on intact skin
Epicutaneously exposing a subject allergic to peanut to a peanut allergen by applying a dose of the peanut allergen, without an adjuvant, onto an intact region of skin of the subject to generate an immune reaction.
Repeated allergen application adapted to sustain the immune reaction
Repeatedly applying the peanut 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, wherein the exposure and sustained reaction lead to desensitization of the subject.
Cutaneous occlusive device ensuring allergen-skin contact
Applying the peanut allergen by a cutaneous occlusive device configured to ensure contact between the allergen and the region of skin.
Dose-per-device-surface-area constraint for the peanut allergen
Defining said dose of peanut allergen as comprised between 0.1 and 1,000 μg/cm2 of a surface area of the device.
Across the independent claim, desensitization is achieved by adjuvant-free epicutaneous administration of a peanut allergen onto intact skin, with repeated dosing parameters adapted to sustain the immune reaction, delivered via a cutaneous occlusive device ensuring contact, and with a defined dose-per-device-surface-area range.
Stated Advantages
Desensitization of the subject allergic to peanut.
Control of the resulting allergen-specific cutaneous inflammatory reaction by adapting dose, frequency or application time.
Induction of an immune response oriented toward tolerance.
Reported reduction of bronchial hyperreactivity.
Reported reduction of IgE and histamine responses.
Reported shift from TH2 toward TH1 with longer applications.
Reported increase in oral tolerance threshold in a human example.
Documented Applications
Mouse desensitization with reduced bronchial hyperreactivity and reduced allergen-specific responses, including reduced IgE and histamine responses, with an immune shift described as from TH2 toward TH1 with longer applications.
A human example with an increased oral tolerance threshold.
Use or assessment during atopy patch testing context, including atopy patch test using the DIALLERTEST® approach, with visible inflammation grading.
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