Oral and Sublingual Immunotherapy: Potential Causes for Eosinophilic Gastrointestinal Disorders?

Babaie, Delara; Mesdaghi, Mehrnaz; Nishino, Makoto; Mansouri, Mahboubeh; Ebisawa, Motohiro

doi:10.1159/000457796

Cited by 23 publications

(21 citation statements)

References 97 publications

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“…Digestive symptoms have been commonly reported, in particular abdominal pain, nausea and oropharyngeal symptoms. In addition to these symptoms, the prevalence of eosinophilic esophagitis has been estimated at 2.7% and more with other foodstuffs . In the many studies published, peanut is usually administered in a vehicle food.…”

Section: Introductionmentioning

confidence: 99%

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Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build‐up phase of a randomized, double‐blind, placebo‐controlled trial (PITA study)

Fauquert

Michaud

Pereira³

et al. 2018

Clin Experimental Allergy

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Summary Background Oral immunotherapy to peanut is effective in desensitizing patients but has significant side effects including anaphylaxis and gastrointestinal symptoms. In most protocols, peanut is administered in a vehicle food. Objective In an exclusively adolescent population, we tested a new approach using sealed capsules of peanut (gastrointestinal delivery oral immunotherapy or GIDOIT) to bypass the upper gastrointestinal tract. The primary aim was to assess the efficacy of the oral build‐up phase of GIDOIT and the secondary aim to analyse its safety. Methods Adolescents with a history of a clinical allergic reaction after peanut ingestion were included in a 2‐armed, parallel‐design, individually randomized, double‐blind, placebo‐controlled, multicentre trial after a positive double‐blind placebo‐controlled oral food challenge (DBPCFC1). A central randomization centre used computer‐generated tables to allocate treatments. Peanut (or placebo) capsules were ingested daily over a period of 24 weeks with increments every 2 weeks from 2 to 400 mg of peanut protein (pp). Primary outcome was tolerance of 400 mg of pp at DBPCFC2. Results Thirty patients were included between September 2013 and May 2014. At DBPCFC2, unresponsiveness to 400 mg of pp was achieved in 17/21 peanut group patients (2 withdrawn patients) and 1/9 in the placebo group (Intention‐to‐treat analysis, P < .001, absolute difference = 0.7, 95%IC 0.43 0.96). Oropharyngeal symptoms were equally frequent in both groups. No dysphagia or other signs of eosinophilic oesophagitis occurred. Digestive adverse events (AE) were more frequent in the treated group (P = .02), but mild and without compliance issues. Only one severe advent event led to withdrawal in a patient who ingested twice the investigated treatment. Peanut‐specific humoral immune responses were modulated. Conclusion The GIDOIT protocol demonstrated clinical and immunological efficacy and had an acceptable level of safety with weak oropharyngeal symptoms, no dysphagia, mild digestive events and few severe systemic AE.

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Section: Introductionmentioning

confidence: 99%

“…In addition to these symptoms, the prevalence of eosinophilic esophagitis has been estimated at 2.7% and more with other foodstuffs. [18][19][20] In the many studies published, peanut is usually administered in a vehicle food. We decided to deliver peanut in sealed capsules, incrementally increasing over time the amount of peanut ingested.…”

Section: Introductionmentioning

confidence: 99%

Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build‐up phase of a randomized, double‐blind, placebo‐controlled trial (PITA study)

Fauquert

Michaud

Pereira³

et al. 2018

Clin Experimental Allergy

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“…Topical treatment with corticosteroids and/or oral antihistamines was sufficient to relieve symptoms. Unlike OIT and SLIT, no persistent GI symptoms or eosinophilic esophagitis has been reported with EPIT treatment [12]. Concerning efficacy, OIT is superior compared to SLIT and EPIT.…”

Section: Safety Efficacy and Adherencementioning

confidence: 92%

Epicutaneous immunotherapy: the next step for food allergy desensitization

Jong

2018

Expert Review of Clinical Immunology

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“…This has been coupled with a high rate of adherence across the published trials. Unlike OIT and SLIT, no persistent GI symptoms or eosinophilic esophagitis has been reported with EPIT treatment …”

Section: Epicutaneous Viaskin® Patch In Clinical Trialsmentioning

confidence: 96%

Safety and efficacy of epicutaneous immunotherapy for food allergy

Wang

Sampson

2018

Pediatric Allergy Immunology

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Food allergy is increasingly common in children, affecting about 4%-8%. The mainstays of management remain allergen avoidance and emergency preparedness to treat allergic reactions with emergency medications. Unfortunately, these approaches are unsatisfactory for many patients and their families as the restrictions, constant vigilance, and unpredictable severity of allergic reactions negatively impact quality of life. In recent decades, there has been significant interest in developing treatments for food allergy that lead to desensitization to increase thresholds for triggering allergic reactions and decrease the risk of reacting to allergen-contaminated food products. Epicutaneous immunotherapy (EPIT) is a novel therapy that is currently under investigation, delivering allergen via repeated applications to the skin and targeting antigen-presenting cells in the superficial skin layers. Murine models have demonstrated that allergen uptake is an active process by skin dendritic cells with subsequent migration to draining lymph nodes. Allergen exposure to the non-vascularized epidermis limits systemic absorption, contributing to the high-safety profile. Results from murine experiments showed that EPIT has comparable efficacy as subcutaneous immunotherapy in terms of challenge outcomes, airway hyper-responsiveness, and immunologic parameters. Several clinical trials of EPIT have recently been completed or are ongoing. Results support the high safety and tolerability of this approach. Efficacy data suggest that the change in threshold eliciting dose following 1 year of therapy is less than that seen compared to high-dose (2-4 g peanut protein) oral immunotherapy, but more prolonged treatment with EPIT appears to lead to increasing desensitization. Additional data from larger-scale studies should provide a more robust assessment of safety and efficacy of EPIT.

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Oral and Sublingual Immunotherapy: Potential Causes for Eosinophilic Gastrointestinal Disorders?

Cited by 23 publications

References 97 publications

Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build‐up phase of a randomized, double‐blind, placebo‐controlled trial (PITA study)

Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build‐up phase of a randomized, double‐blind, placebo‐controlled trial (PITA study)

Epicutaneous immunotherapy: the next step for food allergy desensitization

Safety and efficacy of epicutaneous immunotherapy for food allergy

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