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The Heterogeneity of Oral Immunotherapy Clinical Trials: Implications and Future Directions

  • Immunotherapy and Immunomodulators (B Vickery, Section Editor)
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Abstract

Food allergy is a potentially life-threatening disease which affects up to 8 % of children and 2–3 % of adults. Increasing food allergy prevalence poses a major public health concern. Induction of desensitization to food allergens through oral immunotherapy (OIT) is an expanding area of study encompassing peanut, egg, milk, and other food allergens. OIT consists of administering incremental doses of food allergen to food-allergic patients, to induce a state of desensitization. Safety, tolerability, and efficacy all remain ongoing concerns. Clinical trials for oral immunotherapy have encompassed many variations, including differences in dosage sizes and frequency, duration of build-up, type of allergen used, patient characteristics, and adjuvant therapies. Consequently, studies have also shown variation in rates of adverse effects, and successful desensitization. Here, we provide an overview of the key studies and discuss the implications of this heterogeneity. While desensitization is successful in the majority of patients, only a minority appear to develop sustained unresponsiveness even after years of therapy. Much larger and longitudinal studies using more homogenous protocols are needed in order to evaluate the clinical applicability of OIT, its long-term effectiveness, and effect on quality of life. The role of adjunctive therapies, including omalizumab and probiotics, requires further evaluation.

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Abbreviations

BAT:

Basophil activation test

CM:

Cow’s milk

DB:

Double blind

DBPCFC:

Double-blind placebo-controlled food challenge

FC:

Food challenge

N/A:

Not available

OFC:

Oral food challenge

OIT:

Oral immunotherapy

PC:

Placebo controlled

QoL:

Quality of life

RCT:

Randomized controlled trial

Specific-IgE:

s-IgE

SU:

Sustained unresponsiveness

Treg:

Regulatory T cell

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Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Correspondence to Rima Rachid.

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Dr. Rachid declares grants from Aimmune, from Food Allergy Research and Education and from CSL-Behring.

Dr. Yee declares no conflict of interest.

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This article does not contain any studies with human or animal subjects performed by any of the authors.

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This article is part of the Topical Collection on Immunotherapy and Immunomodulators

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Yee, C.S.K., Rachid, R. The Heterogeneity of Oral Immunotherapy Clinical Trials: Implications and Future Directions. Curr Allergy Asthma Rep 16, 25 (2016). https://doi.org/10.1007/s11882-016-0602-0

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