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Innovative delivery systems for epicutaneous immunotherapy.

ABSTRACT: Allergen-specific immunotherapy (AIT) describes the establishment of peripheral tolerance through repeated allergen exposure, which qualifies as the only curative treatment for allergic diseases. Although conventional subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) have been approved to treat respiratory allergies clinically, the progress made is far from satisfactory. Epicutaneous immunotherapy (EPIT) exploits the skin's immune properties to modulate immunological response, which is emerging as a promising alternative and has shown effectiveness in many preclinical and clinical studies for both respiratory and food allergies. It is worth noting that the stratum corneum (SC) barrier impedes the effective delivery of allergens, while disrupting the SC layer excessively often triggers unexpected Th2 immune responses. This work aims to comprehend the immunological mechanisms of EPIT, and summarize the innovative system for sufficient delivery of allergens as well as tolerogenic adjuvants. Finally, the safety, acceptability, and cost-effectiveness of these innovative delivery systems are discussed, which directs the development of future immunotherapies with all desirable characteristics.

SUBMITTER: Wang Z

PROVIDER: S-EPMC10479942 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Innovative delivery systems for epicutaneous immunotherapy.

Wang Zhen Z Wu Lingzhi L Wang Wei W

Frontiers in immunology 20230822

Allergen-specific immunotherapy (AIT) describes the establishment of peripheral tolerance through repeated allergen exposure, which qualifies as the only curative treatment for allergic diseases. Although conventional subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) have been approved to treat respiratory allergies clinically, the progress made is far from satisfactory. Epicutaneous immunotherapy (EPIT) exploits the skin's immune properties to modulate immunological response ...[more]

PMID: 37675117

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Project description:BackgroundThere is ongoing debate about the safety and efficacy of epicutaneous immunotherapy (EPIT) in treating food allergies. The systematic review and meta-analysis aimed to evaluate the safety and efficacy of EPIT.MethodsWe systematically searched international trial registers (ClinicalTrials.gov), PubMed, Embase, the Cochrane Central of Controlled Trials (CENTRAL), and Web of Science from the inception of the database until June 25, 2023. Two authors independently screened potential studies based on the following criteria: food allergy, epidermal immunotherapy, and randomized controlled trials(RCTs). The risk-of-bias assessment was performed using the Cochrane risk-of-bias 2 (ROB 2) tool. The primary outcomes included desensitization, local adverse events, systemic adverse events, and quality of life. Secondary outcomes included epinephrine utilization, topical medication utilization, and severe adverse events. We assessed certainty of evidence by the GRADE approach.ResultsTen studies involving 1970 participants were included. Ten high-quality RCTs focusing on peanut allergy and cow's milk allergy were included in the analysis. The meta-analysis revealed that EPIT promoted desensitization in patients with food allergy (RR 2.11, 95% CI 1.72-2.58; I 2 = 0%, high certainty), particularly in aged ≤ 11 years (RR 3.84, 95% CI 2.39-6.26; I 2 = 34%). Additionally, treatment duration ≥ 52 weeks was found to increase immune tolerance (RR 3.37, 95% CI 2.39-4.75; I 2 = 13%). Patients who undergo EPIT treatment not only raised the local adverse reactions (RR 1.63, 95% CI 1.10-2.41; I 2 = 82%, low certainty) but also raised systemic adverse reactions (RR 1.52, 95% CI 1.01-2.28; I 2 = 0%, high certainty).ConclusionAfter EPIT treatment, patients with food allergy can effectively increase their immune tolerance to food. However, it also significantly increases mild-to-moderate anaphylaxis. There is limited data on the impact of EPIT on quality of life and other food allergic diseases, indicating a need for further research.

Project description:Given the potent immunological properties of the skin, epicutaneous immunotherapy (EPIT) emerges as a promising treatment approach for inducing immune tolerance, particularly for food allergies. Targeting the highly immunocompetent, non-vascularized epidermis allows for the application of microgram amounts of allergen while significantly reducing the risk of allergen passage into the bloodstream, thus limiting systemic allergen exposure and distribution. This makes EPIT highly suitable for the treatment of potentially life-threatening allergies such as food allergies. Multiple approaches to EPIT are currently under investigation for the treatment of food allergy, and these include the use of allergen-coated microneedles, application of allergen on the skin pretreated by tape stripping, abrasion or laser-mediated microperforation, or the application of allergen on the intact skin using an occlusive epicutaneous system. To date, the most clinically advanced approach to EPIT is the Viaskin technology platform. Viaskin is an occlusive epicutaneous system (patch) containing dried native allergen extracts, without adjuvants, which relies on frequent application for the progressive passage of small amounts of allergen to the epidermis through occlusion of the intact skin. Numerous preclinical studies of Viaskin have demonstrated that this particular approach to EPIT can induce potent and long-lasting T-regulatory cells with broad homing capabilities, which can exert their suppressive effects in multiple organs and ameliorate immune responses from different routes of allergen exposure. Clinical trials of the Viaskin patch have studied the efficacy and safety for the treatment of life-threatening allergies in younger patients, at an age when allergic diseases start to occur. Moreover, this treatment approach is designed to provide a non-invasive therapy with no restrictions on daily activities. Taken together, the preclinical and clinical data on the use of EPIT support the continued investigation of this therapeutic approach to provide improved treatment options for patients with allergic disorders in the near future.

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Innovative delivery systems for epicutaneous immunotherapy.

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Innovative delivery systems for epicutaneous immunotherapy.

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