Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch

Jones, Stacie M.; Agbotounou, Wence; Fleischer, David M.; Burks, A. Wesley; Pesek, Robert D.; Harris, Michael W.; Martin, Laurent; Thébault, Claude; Ruban, Charles; Benhamou, Pierre-Henri

doi:10.1016/j.jaci.2016.01.008

Cited by 93 publications

(58 citation statements)

References 8 publications

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“…This cutaneous reaction was mild enough to allow application of another Viaskin peanut 24 hours later. It has been shown in clinical trials that during EPIT, skin reactivity, here mainly due to eosinophilic infiltration, progressively decreases, further underscoring the systemic desensitization effect of EPIT. Epicutaneous application of allergens through intact skin of sensitized animals leads to its transport via Langerhans cells to the draining lymph nodes and is likely to promote a specific T regulatory cell response not only at the draining lymph node, but also at the systemic level, thus reaching the skin, the gut immune system and other organs .…”

Section: Discussionmentioning

confidence: 96%

Treatment of gastric eosinophilia by epicutaneous immunotherapy in piglets sensitized to peanuts

Mondoulet

Kalach

Dhelft

et al. 2017

Clin Experimental Allergy

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Summary Background Eosinophilic gastrointestinal disorders (EGIDs) are hypersensitivity disorders frequently triggered by food allergy and manifested by mucosal eosinophilic infiltration at any level of the gastrointestinal tract. This study established a model of gastric eosinophilia in peanut‐sensitized piglets to evaluate the efficacy of epicutaneous immunotherapy (EPIT) for its treatment. Methods Experiments were carried out in piglets first sensitized by three intra‐peritoneal injections of peanut protein extract (PPE) with adjuvant, and then given PPE orally for 10 days, a sequence leading to gastric eosinophilia assessed by endoscopy. For 3 months, eight piglets received active EPIT, using Viaskin® loaded with PPE, applied daily on the ear, while eight received placebo EPIT (Placebo). Piglets were exposed to a second 10‐day period of PPE orally. Lesions were scored by endoscopy on the last day of PPE exposure. After killing, all parts of the digestive tract were analysed by a pathologist unaware of the piglets’ status. IgE response was measured, and mechanistic parameters were analysed in the spleen. Results After sensitization, a significant increase of total IgE was observed in sensitized compared to naive animals (61.1 ± 13.3 vs 27.8 ± 6 ng/mL, P < .01). Following oral intake of PPE, sensitized piglets developed moderate gastritis compared to naive piglets (1.5 vs 1.0, median score). After 3 months of immunotherapy, median IgE was significantly reduced in EPIT vs placebo piglets (61.4 ± 16.3 vs 105.9 ± 25.6 ng/mL, P < .01). Active EPIT significantly reduced gastric mucosal lesions induced by PPE oral intake (macroscopic score 0 [0‐2] vs 2 [1‐3], P < .01, respectively, active vs placebo) and gastric mucosa eosinophils counts (239 eosinophils/mm2 [59‐645] vs 2554 eosinophils/mm2 [462‐8057], P < .01, respectively active vs placebo). GATA‐3, IL‐5 and eotaxin mRNA expression decreased significantly after EPIT (P < .05). Conclusions This study describes a large animal model of gastric eosinophil in peanut‐sensitized piglets. Utilizing this model, we demonstrated the efficacy of EPIT in treating peanut‐induced EGIDs.

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Section: Discussionmentioning

confidence: 96%

Treatment of gastric eosinophilia by epicutaneous immunotherapy in piglets sensitized to peanuts

Mondoulet

Kalach

Dhelft

et al. 2017

Clin Experimental Allergy

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“…In particular, smaller SPT results and lower allergen‐specific IgE levels were predictive of successful outcome. Moreover, a sustained unresponsiveness after egg OIT was enhanced with longer duration of therapy and increased the likelihood of tolerating unbaked egg in the diet . On the contrary, peanut OIT and SLIT induced rapid suppression of basophil effector functions, dendritic cells activation, and Th2 cytokine responses during the initial phases of immunotherapy in an antigen‐non‐specific manner .…”

Section: Therapeutic Approachesmentioning

confidence: 99%

Food allergy and atopic dermatitis: Prediction, progression, and prevention

Mastrorilli

Caffarelli

Hoffmann‐Sommergruber

2017

Pediatric Allergy Immunology

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The rising burden of allergic diseases in childhood requires a compelling need to identify individuals at risk for atopy very early in life or even predict the onset of food allergy and atopic dermatitis since pregnancy. The development and clinical phenotypes of atopic diseases in childhood depend on a complex interaction between genetic and environmental factors, such as allergen exposure, air pollution, and infections. Preventive strategies may include avoidance measures, diet supplements, and early complementary food introduction. Overall, the management of allergic diseases has been improving to date toward a patient's tailored approach. This review will cover the current understanding of risk factors, prediction, and management of food allergy and atopic dermatitis in childhood and discuss how these may contribute to the modification of the natural history of food allergy and atopic dermatitis.

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“…via tape stripping) 23 or by using microneedles 24 . Also, application of allergen as a powder to intact skin, followed by covering the area with an occlusive chamber, which leads to maceration of the skin and uptake of the allergen, has been shown to be a useful approach for skin-based AIT 25 . However, localized and even systemic side effects have been reported as a consequence of cutaneous AIT 26 .…”

Section: Novel Routesmentioning

confidence: 99%

Potential of nanoparticles for allergen-specific immunotherapy – use of silica nanoparticles as vaccination platform

Scheiblhofer

Machado

Feinle

et al. 2016

Expert Opinion on Drug Delivery

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Allergen-specific immunotherapy is the only curative approach for the treatment of allergies. There is an urgent need for improved therapies, which increase both, efficacy and patient compliance. Novel routes of immunization and the use of more advanced vaccine platforms have gained heightened interest in this field. Areas covered: The current status of allergen-specific immunotherapy is summarized and novel routes of immunization and their challenges in the clinics are critically discussed. The use of nanoparticles as novel delivery system for allergy vaccines is comprehensively reviewed. Specifically, the advantages of silica nanoparticles as vaccine carriers and adjuvants are summarized. Expert opinion: Future allergen-specific immunotherapy will combine engineered hypoallergenic vaccines with novel routes of administration, such as the skin. Due to their biodegradability, and the easiness to introduce surface modifications, silica nanoparticles are promising candidates for tailor-made vaccines. By covalently linking allergens and polysaccharides to silica nanoparticles, a versatile vaccination platform can be designed to specifically target antigen-presenting cells, render the formulation hypoallergenic, and introduce immunomodulatory functions. Combining potent skin vaccination methods, such as fractional laser ablation, with nanoparticle-based vaccines addresses all the requirements for safe and efficient therapy of allergic diseases.

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Safety of epicutaneous immunotherapy for the treatment of peanut allergy: A phase 1 study using the Viaskin patch

Cited by 93 publications

References 8 publications

Treatment of gastric eosinophilia by epicutaneous immunotherapy in piglets sensitized to peanuts

Treatment of gastric eosinophilia by epicutaneous immunotherapy in piglets sensitized to peanuts

Food allergy and atopic dermatitis: Prediction, progression, and prevention

Potential of nanoparticles for allergen-specific immunotherapy – use of silica nanoparticles as vaccination platform

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