Epicutaneous Immunotherapy Research Articles

Novel Approaches to Allergen Immunotherapy for Respiratory Allergies

Allergen immunotherapy (AIT) remains the cornerstone for managing respiratory allergies, offering long-term symptom relief, disease modification, and prevention of disease progression. While novel approaches like intralymphatic and epicutaneous immunotherapy and the combination of allergens with adjuvants show promise, traditional methods remain effective and safe. Hypoallergenic T-cell peptide vaccines and recombinant allergens require further research to confirm their clinical benefits. Passive immunotherapy, while demonstrating effectiveness in specific cases, needs exploration of its long-term efficacy and broader applicability. Combining AIT with biologics may enhance safety and treatment outcomes. Despite emerging innovations, allergen-specific immunotherapy with natural allergen extracts remains the primary disease-modifying treatment, offering long-term symptom relief and prevention of disease progression. Continued research is essential to refine and optimize allergen immunotherapy strategies, providing patients with more effective and personalized treatment options.

The use of biologics in food allergy management.

Patients and families living with food allergy may experience significant burdens, including social isolation, impaired quality of life, and anxiety. Allergists/immunologists play a critical role in educating families living with food allergies about risk, particularly with regard to the rarity of fatal food allergy. Appropriate risk framing can greatly decrease the fear-based burden of disease. In 2024, an increasing complex fabric of food allergy treatments has emerged that includes oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and omalizumab, with the promise of additional treatments, including epicutaneous immunotherapy and oral mucosal immunotherapy in the near future. Younger children may be most likely to benefit from OIT and SLIT, with some evidence that suggests the possibility of an immunomodulatory effect. Omalizumab, approved in 2024 for use in conjunction with strict avoidance, increases the threshold of reactivity before a moderate-to-severe reaction for many, but not all, patients. There is no evidence to date that omalizumab has an immunomodulatory effect, and young children treated with omalizumab monotherapy may bear a lost opportunity cost from possible immunomodulation would they have been treated with OIT or SLIT instead; however, within a shared decision-making paradigm, beyond label use of omalizumab may include treatment with OIT or SLIT. Fortunately, the co-evolution of shared decision-making with modern food allergy treatments will facilitate the critical preference-sensitive care that must be characteristic of all decisions surrounding active food allergy management.

EAACI guidelines on the management of IgE-mediated food allergy.

This European Academy of Allergy and Clinical Immunology (EAACI) guideline provides recommendations for the management of IgE-mediated food allergy and was developed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Following the confirmation of IgE-mediated food allergy diagnosis, allergen avoidance and dietary advice (with support of a specialised dietitian, if possible) together with the provision of a written treatment plan, education on the recognition of allergic symptoms and prescription of medication including adrenaline using an auto-injector are essential. Patients with significant anxiety and requirement for coping strategies may benefit from support from a clinical psychologist. As immunomodulatory interventions, omalizumab is suggested for treatment of IgE-mediated food allergy in children from the age of 1 and adults; and oral allergen-specific immunotherapy is recommended for children and adolescents with peanut allergy and suggested for milk and egg allergies (generally after 4 years of age for milk and egg). Sublingual and epicutaneous immunotherapy are suggested for peanut allergy but are not yet available at the point of care. Future research into disease modifying treatments for IgE-mediated food allergy are highly needed, with standardised and patient-focused protocols and outcomes.

Probiotics as adjuvants to mitigate adverse reactions and enhance effectiveness in Food Allergy Immunotherapy.

In the past decades, food allergies became increasingly dominant since early childhood, leading to a lower quality of life and to increasing costs addressed by the health care system. Beside standard avoidance of specific allergens and drug treatments following allergen exposure, a great deal of research has lately focused on Food Allergy Allergen Immunotherapy (FA-AIT). SCIT and EPIT (Subcutaneous and Epicutaneous Immunotherapy), OIT (Oral Immunotherapy), and SLIT (Sublingual Immunotherapy) consist in gradual exposure to allergens to desensitize and achieve tolerance once therapy has ended. Although promising, FA-AIT may bring acute local and systemic adverse reactions. To enhance efficacy, safety and convenience of AIT, the quest of potential adjuvants to mitigate the adverse reactions becomes crucial. Immunomodulatory activities, such as that of increasing the regulatory T cells and decreasing the IgE, have been observed in specific probiotics' strains and multiple studies elucidated the role of gut microbiota as a major interplayer among the host and its immune system. In this review, the microbiome modulation is shown as potential AIT adjuvant, nevertheless the need of more clinical studies in the near future is pivotal to assess the efficacy of targeted bacterial therapies and faecal microbiota transplantation.

Food allergy in children: treatment challenges and outcome standardization

Relevance. Food allergy (FA) is an important public health concern, particularly among children, with an increasing prevalence. It is associated with a significant decrease in the quality of life for patients and their families due to the need to avoid allergens and the risk of severe allergic reactions, such as anaphylaxis. Despite active research, the primary treatment remains elimination diets, which limit patients’ options and highlight the need for new therapeutic solutions.Aim of the review. This review aims to summarize the current treatment methods for food allergy, discuss the challenges in evaluating the effectiveness of interventions, and highlight the importance of standardizing outcomes in clinical trials to improve comparability and practical relevance.Content. The review discusses modern therapeutic approaches for food allergy, such as oral, epicutaneous, and sublingual immunotherapies, which have shown positive results in achieving tolerance to allergens. Special attention is given to safety concerns, particularly for children, emphasizing the need for further research. The potential use of biological agents, such as omalizumab, in food allergy treatment is also explored. The review addresses challenges in choosing and standardizing endpoints in clinical trials, where most focus on desensitization and immunological markers, while patient-centered outcomes, such as quality of life, remain under-researched. The implementation of “core outcome sets” is highlighted as an important step toward improving data comparability and forming a more objective basis for clinical recommendations.Conclusions. The review emphasizes significant progress in food allergy treatment but notes the need for further research to ensure the safety of new therapies, particularly for children. Standardizing outcomes in clinical trials plays a key role in improving the quality and comparability of research, which will, in turn, help develop more effective clinical guidelines and improve patients’ quality of life.

Epicutaneous immunotherapy for the treatment of peanut allergy.

Peanut allergy treatment options remain limited, but novel approaches are being studied, including epicutaneous immunotherapy (EPIT). EPIT uses the cutaneous immune system to promote tolerance to food allergens. Viaskin™ Peanut, an approach to EPIT in late-stage clinical development uses an occlusive patch with a condensation chamber that enables natural epidermal water loss to solubilize dry antigen on the patch, which is then absorbed and captured by skin Langerhans cells. This form of EPIT does not require disruption of the skin barrier, thus avoiding a proinflammatory cytokine response by targeting the nonvascularized epidermis and limiting systemic allergen exposure. Extensive preclinical research suggests that Viaskin Peanut has a distinct mechanism of desensitization, including the potential for disease modification, driven by a unique population of regulatory T cells. Numerous clinical studies of Viaskin Peanut have demonstrated desensitization and reductions in reaction severity, particularly in children aged 1 through 11 years, as well as a favorable safety profile with mostly mild-to-moderate skin reactions that were observed to decrease over time. EPIT with Viaskin Peanut may be a potential therapeutic option for peanut allergy that is clinically practical with long-term efficacy and tolerability.

Allergen immunotherapy and eosinophilic esophagitis: friends or foes?

The connection between eosinophilic esophagitis (EoE) and food and airborne allergens is complex. Exposure to allergens (mainly food) is often the trigger for EoE flares. The development of EoE has been described as a side effect of allergen immunotherapy, especially oral immunotherapy (OIT, with food allergens), while isolated cases of EoE have been reported during sublingual immunotherapy (SLIT, with extracts of aeroallergens). EoE is currently recognized as a common side effect of OIT, while a solid correlation between SLIT and EoE is missing. Animal models have been developed to study the pathophysiological link between sensitization to aeroallergens and the induction of EoE and will probably provide an interpretation of why there are cases of EoE developed during SLIT. Recent findings in animal models suggest a genetic connection to EoE development after sensitization and re-exposure to airborne allergens. Subcutaneous allergen immunotherapy does not have a causative effect on EoE; on the contrary, a beneficial effect on EoE has been reported. Moreover, epicutaneous immunotherapy with a vector containing milk has also been used to treat children with milk-induced EoE. Discovering the immune links between allergens and EoE will further guide the proper use of allergen immunotherapy and help define future strategies for the management of EoE.

A Streamlined Strategy for Basophil Activation Testing in a Multicenter Phase III Clinical Trial

BackgroundThe basophil activation test (BAT) has been limited to research settings due to technical issues. Novel approaches using dry, ready-to-use reagents and streamlined protocols offer greater flexibility and may open opportunities for easier implementation in clinical research. ObjectiveUsing a streamlined BAT (sBAT) strategy and the settings of the baseline study of the EPITOPE trial of EPicutaneous ImmunoTherapy (EPIT™) for peanut allergy, we aimed to assess the feasibility of implementing BAT in a multicenter trial and to evaluate its utility in predicting the outcomes of peanut double-blind placebo-controlled food challenge (DBPCFC). MethodsWhole blood samples were collected from subjects aged 1-3 years (n=241) undergoing baseline eligibility DBPCFC in the EPITOPE study across 15 clinical sites in North America. After preparation with sBAT reagents, processed samples were analyzed in a single central laboratory within 5 days of collection and preparation. The eliciting dose (ED) at DBPCFC was determined using PRACTALL criteria. Using a machine learning (ML) approach which incorporated BAT-derived features, clinical characteristics, and peanut-specific IgE, the ability to predict outcomes of interest (ED [<300 mg or >300 mg] and use of epinephrine) was assessed using data randomly split into training (n=182) and validation (n=59) subsets. ResultsThe expression of basophil activation markers CD203c and CD63 correlated with ED and severity outcomes of DBPCFC. Most informative concentrations of peanut extract in the sBAT assay for these associations were 1 and 10 ng/ml. Using ML to assess the ability to predict the outcomes of DBPCFC, the best models using only the BAT-derived features provided relatively high sensitivities of 0.86 and 0.85 for predicting eliciting dose and epinephrine use, respectively, while specificities were lower, ranging from 0.60 to 0.80. While including specific IgE and SPT data in addition to those from sBAT did not improve the ability to identify individuals most at risk for severe reactions, it did improve the ability to identify patients with an eliciting dose above 300 mg. ConclusionIn addition to facilitating implementation in multicenter trials, sBAT retains the potential of BAT to characterize allergic patients and confirms its potential to contribute to predicting the outcome of oral food challenges.

Current state and advances in desensitization for peanut allergy in pediatric age.

Peanut allergy affects about 1%-3% of the pediatric population in the world, with an important increase in the last decades. Nowadays, international guidelines recommend the early introduction of peanuts in the infant diet, with poor information about the quantity and the frequency of the intake. Allergen immunotherapy may represent the only therapeutic strategy able to modify the natural history of peanut allergy. In particular, oral immunotherapy showed the most promising results in terms of efficacy, but with significant rates of adverse reactions, mostly gastrointestinal. In 2020, the Food and Drug Administration and the European Medicines Agency approved Palforzia®, an oral drug for patients aged 4-17 years. Several studies are ongoing to improve the tolerability of oral immunotherapy and standardize the desensitization protocols. Sublingual immunotherapy permits to offer much lower doses than oral immunotherapy, but fewer adverse events are shown. Subcutaneous immunotherapy is associated with the greatest systemic adverse effects. Epicutaneous immunotherapy, for which Viaskin® patch was approved, has the highest safety profile. Innovative studies are evaluating the use of biological drugs, such as omalizumab or dupilumab, and probiotics, such as Lactobacillus rhamnosus, in monotherapy or associated with oral immunotherapy. Therapy for peanut allergy is constantly evolving, and new perspectives are ongoing to develop.

From Skin to Solution: Exploring Epicutaneous Immunotherapy for Peanut Allergy-A Systematic Review and Meta-Analysis.

Peanut allergy is a leading cause of severe food reactions. This meta-analysis evaluates the efficacy and safety of epicutaneous immunotherapy (EPIT) compared to placebo for peanut-allergic individuals. After prospectively registering on PROSPERO, we searched three databases (PubMed, Google Scholar, and Cochrane CENTRAL) and 2 trial registries till September 2023. Analysis was conducted via RevMan where data was computed using risk ratios (RR). The Cochrane Risk of Bias tool and GRADE criteria were used to appraise and evaluate the evidence. From 4927 records, six multicenter randomized placebo-controlled trials comprising 1453 participants were included. The 250µg EPIT group had a significant increase in successful desensitization compared to placebo (RR: 2.13 (95% C.I: 1.72, 2.64), P < 0.01, I2 = 0%), while the 100µg EPIT group did not (RR: 1.54 (95% C.I: 0.92, 2.58), P = 0.10, I2 = 0%) (moderate certainty evidence). Moreover, there was a significant increase in local (RR: 1.69 (95% C.I: 1.06, 2.68), P = 0.03, I2 = 89%) and systemic adverse events (RR: 1.75 (95% C.I: 1.14, 2.69), P = 0.01, I2 = 0%) with EPIT. Additionally, individuals administered EPIT have an increased probability of requiring rescue medications like epinephrine (RR: 1.91 (95% C.I: 1.12, 3.28), P = 0.02, I2 = 0%) and topical corticosteroids (RR: 1.49 (95% C.I: 1.29, 1.73), P < 0.01, I2 = 0%) to treat adverse events. The association of adverse events post-treatment including anaphylaxis (RR: 2.31 (95% C.I: 1.00, 5.33), P = 0.05, I2 = 36%), skin/subcutaneous disorders like erythema or vesicles (RR: 0.93 (95% C.I: 0.79, 1.08), P = 0.33, I2 = 0%), and respiratory disorders like dyspnea or wheezing (RR: 0.94 (95% C.I: 0.77, 1.15), P = 0.55, I2 = 0%) with EPIT is inconclusive. EPIT, although effective in desensitization, is linked to an increased risk of adverse events. PROSPERO registration: CRD42023466600.

The future of cow's milk allergy - milk ladders in IgE-mediated food allergy.

Cow's milk allergy (CMA) is one of the most common and complex presentations of allergy in early childhood. CMA can present as IgE and non-IgE mediated forms of food allergy. Non-IgE mediated CMA includes food protein-induced enterocolitis syndrome (FPIES), eosinophilic gastrointestinal disorders (EGIDs), and food protein-induced proctocolitis (FPIAP). There are recent guidelines addressing CMA diagnosis, management, and treatment. Each of these guidelines have their own strengths and limitations. To best manage CMA, individualized avoidance advice should be given. Cow's milk (CM) can be replaced in the diet by using hypoallergenic formulas or plant-based milk, depending on factors such as the child's age and their current food intake. Oral and epicutaneous immunotherapy is used to increase tolerance in children with CMA but is not without risk, and the long-term outcome of sustained unresponsiveness is still unclear. The allergenicity of CM proteins are affected differently by different forms of heating, leading to the use of baked milk or milk ladders in the management of CMA, most likely the most promising option for future management and treatment of CMA. Future management of children with CMA will also include discussion around the immunomodulatory potential of the child's dietary intake.

Varying Doses of Epicutaneous Immunotherapy With Viaskin Milk vs Placebo in Children With Cow’s Milk Allergy

No approved treatment exists for allergen-specific immunoglobulin E (IgE)-mediated cow's milk allergy (CMA), a common childhood food allergy. To assess dose, efficacy, and safety of epicutaneous immunotherapy with Viaskin milk in children with IgE-mediated CMA. A phase 1/2, 2-part, randomized, double-blind, placebo-controlled dose-ranging clinical trial in children aged 2 to 17 years with IgE-mediated CMA was conducted between November 2014 through December 2017. It took place at 17 trial sites in the US and Canada. Current CMA was confirmed by double-blind, placebo-controlled food challenge at study entry. Part A assessed the short-term safety of 150 μg, 300 μg, or 500 μg of Viaskin milk; part B evaluated the efficacy and safety of the 3 doses vs placebo over 12 months of treatment. Of the 308 screened participants with physician-diagnosed CMA, 198 met eligibility criteria (including an eliciting dose 300 mg or less) and were randomized. Safety of Viaskin milk (150-μg, 300-μg, or 500-μg doses) was evaluated over a 3-week period (part A). In part B, 180 additional participants were randomized to receive Viaskin milk at doses of 150 μg, 300 μg, or 500 μg or placebo (1:1:1:1) for 12 months. The primary outcome was the proportion of treatment responders, defined as a 10-fold or more increase in the cumulative reactive dose of cow's milk protein (reaching at least 144 mg) or a cumulative reactive dose of cow's milk protein at 1444 mg or more at the month 12 double-blind, placebo-controlled food challenge. A total of 95.5% of the randomized participants (mean [SD] age, 8 [4.17] years; 124 of 198 were male [62.6%]) completed treatment. The highest response rate was observed in participants who received Viaskin milk at the 300-μg dose with 24 of 49 responders (49.0%) overall vs 16 of 53 responders (30.2%) in the placebo group (odds ratio, 2.19; 95% CI, 0.91-5.41; P = .09), highest in the 2 to 11 years age group (22 of 38 [57.9%] vs 13 of 40 [32.5%]; P = .04). Most treatment-emergent adverse events were mild or moderate application-site reactions. One participant in the 500-μg Viaskin milk dose group experienced treatment-related anaphylaxis. In this randomized clinical trial, 12 months of daily epicutaneous immunotherapy with a dose of Viaskin milk at 300 μg was associated with a statistically significant treatment response in 2- to 11-year-old children with IgE-mediated CMA. Treatment-related anaphylaxis and treatment-related discontinuation rates were low. Further research is needed to explore Viaskin milk as a viable treatment option for children with IgE-mediated CMA. ClinicalTrials.gov Identifier: NCT02223182.

Food Allergen Immunotherapy in the Treatment of Patients with IgE-Mediated Food Allergy.

The prevalence of allergic diseases, including food allergy, is increasing, especially in developed countries. Implementation of an elimination diet is not a sufficient therapeutic strategy in patients with food allergy, whose quality of life is significantly impaired. In recent years, new effective therapeutic strategies have been developed, such as the application of oral, sublingual, and epicutaneous immunotherapy. Oral immunotherapy is the most often applied strategy because of its effectiveness and ease of application, with an acceptable safety profile. The effectiveness of oral immunotherapy in patients with egg, cow's milk, and peanut allergy has been proven both in terms of raising of the threshold and the development of tolerance, and in some patients, the development of sustainable unresponsiveness. Although oral immunotherapy is an effective treatment for food allergy, several limitations, including a long duration and a significant rate of reported adverse events, reduces its success. Therefore, new therapeutic options, such as treatment with biologicals, either as combinations with food allergen immunotherapy or as monotherapy with the aim of improving the efficacy and safety of treatment, are being investigated.

Immunotherapy for food allergy: current proposals to improve safety and efficacy

Abstract This review mainly focuses on the novel approaches that improve the safety and efficacy of immunotherapies, namely SLIT [alone or as pre-treatment of oral immunotherapy (OIT)], epicutaneous immunotherapy (EPIT), combination of anti-IgE into OIT or sublingual immunotherapy (SLIT) and introduction of hypoallergenic allergens by modifying native food products (boiling, baking, etc.) or manufacturing recombinant proteins. Among these proposals, some are clinically proven safe such as the use of anti-IgE while some are still under preclinical trials such as the use of some newly developed recombinant food protein allergens. What is certain is that more preclinical and clinical reviews and trials would be required on all these proposals before they could be maturely, safely, and effectively promoted in the clinical settings for patients’ use.

Probiotics and other adjuvants in allergen-specific immunotherapy for food allergy: a comprehensive review.

This review delves into the potential of manipulating the microbiome to enhance oral tolerance in food allergy, focusing on food allergen-specific immunotherapy (FA-AIT) and the use of adjuvants, with a significant emphasis on probiotics. FA-AIT, including oral (OIT), sublingual (SLIT), and epicutaneous (EPIT) immunotherapy, has shown efficacy in desensitizing patients and achieving sustained unresponsiveness (SU). However, the long-term effectiveness and safety of FA-AIT are still under investigation. Probiotics, particularly strains of Lactobacillus, play a crucial role in enhancing immune tolerance by promoting regulatory T cells (Tregs) and modulating cytokine profiles. These probiotics can induce semi-mature dendritic cells, enhance CD40 expression, inhibit IL-4 and IL-5, and promote IL-10 and TGF-β, thus contributing to mucosal defense and immunological tolerance. Clinical trials combining probiotics with FA-AIT have demonstrated improved desensitization rates and immune tolerance in food-allergic patients. For example, the combination of Lactobacillus rhamnosus with peanut OIT resulted in a significantly higher rate of SU compared to the placebo group, along with notable immune changes such as reduced peanut-specific IgE and increased IgG4 levels. The review also explores other adjuvants in FA-AIT, such as biologic drugs, which target specific immune pathways to improve treatment outcomes. Additionally, nanoparticles and herbal therapies like food allergy herbal formula 2 (FAHF-2) are discussed for their potential to enhance allergen delivery and immunogenicity, reduce adverse events, and improve desensitization. In conclusion, integrating probiotics and other adjuvants into FA-AIT protocols could significantly enhance the safety and efficacy of FA-AIT, leading to better patient outcomes and quality of life.

Epicutaneous immunotherapy desensitizes toddlers with peanut allergy

Epicutaneous immunotherapy desensitizes toddlers with peanut allergy

The Hydrogel Based Allergen-Coated Gold Nanoparticles for Topical Administration: A Possible Epicutaneous Immunotherapy in Pollen-Sensitized Mice?

ABSTRACT Background The rapid uptake of antigens by antigen-presenting cells (APCs) and their migration to draining lymph nodes in the initial hours after antigen administration in epicutaneous allergen specific immunotherapy (EPIT) prompted us to investigate whether the topical administration of allergens without patch application could alleviate allergy in pollen-sensitized mice. We evaluated the immunotherapeutic effect of topically administering hydrogel-based Gold nanoparticles (AuNPs) loaded with a total extract of Platanus orientalis pollen (Pla. ext (50 μg)-AuNPs) on intact skin. Methods Mice sensitized to P. orientalis pollen were divided into three groups and treated with Pla. ext (50 μg)-AuNPs: 1) patch with Pla. ext (50 μg)-AuNPs, 2) patch with Pla. ext (50 μg)-AuNPs in combination with hydrogel, and 3) topical application of Pla. ext (50 μg)-AuNPs in combination with hydrogel. The immunotherapeutic effects were evaluated by measuring serum specific and total IgE antibodies, total cell and eosinophil count in nasopharyngeal lavage fluid, cytokines in the supernatants of re-stimulated splenocytes by the total extract, and histological examination of lung and nasal mucosa. Results Topical administration of Pla. ext (50 μg)-AuNPs, like patch-based administration, significantly downregulated specific and total IgE and IL-4 production, promoted secretion of IFN-γ and IL-10, markedly reduced the number of inflammatory cells, particularly eosinophils, in nasopharyngeal lavage fluid (p < .05), and inhibited inflammation and pathological damage in lung and nasal mucosa. Conclusion Our results suggest that topical administration of AuNPs loaded with P. orientalis total pollen extract on intact skin could be a potential application for EPIT in the P. orientalis pollen -sensitized mice.

Food desensitization

In recent times, the primary approach to treating food allergies involved strict avoidance of the triggering allergen. Many considered this approach as lacking true treatment, leaving patients vulnerable to even small amounts or hidden sources of the allergenic food. Desensitization or Oral Tolerance Induction (OTI) is a studied method aiming for a lasting tolerance to the allergen. The ultimate goal is permanent tolerance, where allergic reactions won't reoccur after new exposure to the triggering allergen, following a period of abstinence. The research mainly focuses on allergen-specific immunotherapy, covering three routes: oral, sublingual, and epicutaneous immunotherapy. Milk, egg, and peanuts are the extensively studied foods due to their prevalence in allergies. The oral route is favored for inducing tolerance because ingestion of a food antigen by a non-allergic individual triggers an active immune response without causing an allergic reaction. The paradigm has shifted from recommending avoidance to early consumption strategies to prevent allergies. The period from 4 to 6 months of age is considered immunologically sensitive, where children with risk factors show increased allergic sensitization risk. Implementing these recommendations, considering family and community preferences, may reduce the burden of food allergies and healthcare costs.

Epicutaneous immunotherapy with Viaskin™ Peanut in toddlers: a plain language summary.

This is a summary of an article published in The New England Journal of Medicine about the EPITOPE clinical study, which tested a skin patch called ViaskinTM Peanut 250μg (micrograms) as a treatment option for peanut allergy in children aged 1 through 3years. The patch is a form of epicutaneous immunotherapy (EPIT), which is a new approach to allergen immunotherapy that delivers a small amount of peanut protein to the immune system through the skin. Viaskin Peanut is an investigational therapy, meaning it has not yet been approved by the United States Food and Drug Administration (FDA), that has been studied before in young children aged 4 through 11years. In those studies, the children who received the patch were desensitized and were less likely to experience anaphylaxis when they ate peanut at the end of the study. The EPITOPE study included children aged 1 through 3years with peanut allergy and looked at how well the peanut patch worked and how safe it was compared to a patch with no medicine (placebo, no medicine) after 12months. The study showed that the peanut patch was better in desensitizing children to peanuts than the placebo patch. Most of the children in the study who received the peanut patch for 12months (the treatment group) were able to eat and tolerate more peanut at the end of the study than those who received only the placebo patch (the control group). This demonstrates that the children in the treatment group were less likely to have an allergic reaction if they ate peanut by accident at the end of the study. The children in the treatment group also had less severe symptoms when they were given peanut during the oral food challenges at the end of the study. Most children in both groups experienced side effects. Mild to moderate local skin reactions where the patch was applied were most common. These side effects happened less often and were less serious over the 12-month treatment period. Overall, these results show the peanut patch may be a possible treatment option to help desensitize young children with peanut allergy to peanut.

Severity of eczema at patch site during epicutaneous immunotherapy may predict subsequent response to oral immunotherapy

Severity of eczema at patch application site during epicutaneous immunotherapy could be an independent predictor of subsequent response to oral immunotherapy. The delay between epicutaneous immunotherapy discontinuation and initiation of oral immunotherapy does not appear to affect response to the latter.