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Regulatory Requirements for the Quality of Allergen Products for Allergen Immunotherapy of Food Allergy.
Englert, L, Mahler, V, Bonertz, A
Current allergy and asthma reports. 2021;(5):32
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Abstract
PURPOSE OF REVIEW Medicinal products for allergen immunotherapy (AIT) of food allergies have gained enormous momentum in recent years. With this new class of products entering marketing authorization procedures, compliance to regulatory requirements becomes a critical element. Here, an overview is provided on specific requirements and aspects concerning the quality control and manufacturing of these products. RECENT FINDINGS Recent developments in the field of AIT for food allergies are divers, including products for oral, epicutaneous, and subcutaneous application, most notably targeting egg, milk, and peanut allergy. As the source materials for food AIT product are typically produced for food consumption and not for medicinal purposes, unique challenges arise in the manufacturing processes and controls of these medicinal products. Individual approaches are needed to assure acceptable quality, including control of relevant quantitative and qualitative characteristics. Major characteristics for quality verification include determination of protein content, total allergenic activity, and major allergen content. The applied manufacturing processes need to be established such that relevant process parameters are kept within justified limits and consistency of produced batches is assured. Allergen products for food AIT present specific challenges with respect to quality aspects that differentiate them from other commonly available AIT products. While established regulation is available and provides clear guidance for most aspects, other issues require consideration of new and individual settings relevant here. Consequently, as experience grows, respective amendments to currently available guidance may be needed.
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Monoclonal Antibodies in Treating Food Allergy: A New Therapeutic Horizon.
Manti, S, Pecora, G, Patanè, F, Giallongo, A, Parisi, GF, Papale, M, Licari, A, Marseglia, GL, Leonardi, S
Nutrients. 2021;(7)
Abstract
Food allergy (FA) is a pathological immune response, potentially deadly, induced by exposure to an innocuous and specific food allergen. To date, there is no specific treatment for FAs; thus, dietary avoidance and symptomatic medications represent the standard treatment for managing them. Recently, several therapeutic strategies for FAs, such as sublingual and epicutaneous immunotherapy and monoclonal antibodies, have shown long-term safety and benefits in clinical practice. This review summarizes the current evidence on changes in treating FA, focusing on monoclonal antibodies, which have recently provided encouraging data as therapeutic weapons modifying the disease course.
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Mechanisms Underlying the Skin-Gut Cross Talk in the Development of IgE-Mediated Food Allergy.
van Splunter, M, Liu, L, van Neerven, RJJ, Wichers, HJ, Hettinga, KA, de Jong, NW
Nutrients. 2020;(12)
Abstract
Immune-globulin E (IgE)-mediated food allergy is characterized by a variety of clinical entities within the gastrointestinal tract, skin and lungs, and systemically as anaphylaxis. The default response to food antigens, which is antigen specific immune tolerance, requires exposure to the antigen and is already initiated during pregnancy. After birth, tolerance is mostly acquired in the gut after oral ingestion of dietary proteins, whilst exposure to these same proteins via the skin, especially when it is inflamed and has a disrupted barrier, can lead to allergic sensitization. The crosstalk between the skin and the gut, which is involved in the induction of food allergy, is still incompletely understood. In this review, we will focus on mechanisms underlying allergic sensitization (to food antigens) via the skin, leading to gastrointestinal inflammation, and the development of IgE-mediated food allergy. Better understanding of these processes will eventually help to develop new preventive and therapeutic strategies in children.
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New Perspectives in Food Allergy.
De Martinis, M, Sirufo, MM, Suppa, M, Ginaldi, L
International journal of molecular sciences. 2020;(4)
Abstract
The improvement of the knowledge of the pathophysiological mechanisms underlying the tolerance and sensitization to food antigens has recently led to a radical change in the clinical approach to food allergies. Epidemiological studies show a global increase in the prevalence of food allergy all over the world and manifestations of food allergy appear increasingly frequent also in elderly subjects. Environmental and nutritional changes have partly changed the epidemiology of allergic reactions to foods and new food allergic syndromes have emerged in recent years. The deepening of the study of the intestinal microbiota has highlighted important mechanisms of immunological adaptation of the mucosal immune system to food antigens, leading to a revolution in the concept of immunological tolerance. As a consequence, new prevention models and innovative therapeutic strategies aimed at a personalized approach to the patient affected by food allergy are emerging. This review focuses on these new perspectives and their practical implications in the management of food allergy, providing an updated view of this complex pathology.
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Prevention of baker's asthma.
Jeebhay, MF, Baatjies, R
Current opinion in allergy and clinical immunology. 2020;(2):96-102
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Abstract
PURPOSE OF REVIEW Baker's allergy and asthma continue to represent an important contributor of occupational asthma globally. This review identified recent studies related to the prevention of baker's allergy and asthma. RECENT FINDINGS Studies with respect to regulatory exposure standards, workplace control measures aimed at reduction of flour dust exposures, surveillance programmes (exposure monitoring, medical surveillance) and workplace information, education and training programmes were identified. SUMMARY Detailed knowledge on risk factors and detection methods to assess exposure and early identification of high-risk workers exist, but workplace control measures remain sub-optimal because they are rarely multifaceted. This is compounded by the lack of health-based exposure standards globally. Exposure level monitoring and medical surveillance are integral to assessing effectiveness of preventive strategies. Triage systems for optimizing the efficiency of medical surveillance programmes show promise, but need replication in different contexts. Future studies need to focus on evaluating the relevance and quantification of peak exposures in increasing risk; developing standardized respiratory questionnaires for medical surveillance; and further exploration of serial fractional exhaled nitric oxide (FeNO) measurements as an adjunct to allergic sensitization for the early identification of baker's asthma and assessing the long-term impact of interventions.
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Approaches and Challenges to Management of Pediatric and Adult Patients With Eosinophilic Esophagitis.
Hirano, I, Furuta, GT
Gastroenterology. 2020;(4):840-851
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Abstract
Treatment of eosinophilic esophagitis has progressed from elemental formula for children and esophageal dilation for adults to selective exclusion of food triggers and swallowed topical corticosteroids. Management guidelines are available from the American Gastroenterological Association and the Joint Task Force on Allergy Immunology Practice Parameters. We cannot, however, evaluate the efficacy of treatments without a definition of response. We propose a treat-to-target approach, based on symptoms and findings from endoscopy and histology. This approach addresses dissociations between outcomes, such as symptom persistence despite normalization of histologic features and symptom resolution after esophageal dilation despite histologic features of active disease. Eosinophilic esophagitis can now be treated with biologic agents that target specific immune pathways, and findings from prospective trials have indicated that less-restrictive, empiric, elimination diets can be effective and reduce the need for repeated endoscopic assessment of disease activity during food reintroduction. We also discuss eosinophilic esophagitis subtypes, factors associated with disease, and advances in management.
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Ligand Binding of PR-10 Proteins with a Particular Focus on the Bet v 1 Allergen Family.
Aglas, L, Soh, WT, Kraiem, A, Wenger, M, Brandstetter, H, Ferreira, F
Current allergy and asthma reports. 2020;(7):25
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Abstract
PURPOSE OF REVIEW Pathogenesis-related class 10 (PR-10) proteins are highly conserved plant proteins, which are induced in response to abiotic and biotic stress factors. To date, no unique biological function could be assigned to them. Rather a more general role of PR-10 in plant development and defense mechanisms has been proposed. In addition, some PR-10 proteins act as allergens by triggering allergic symptoms in sensitized individuals. Regardless of the diversity of reported activities, all PR-10 proteins share a common fold characterized by a solvent-accessible hydrophobic cavity, which serves as a binding site for a myriad of small-molecule ligands, mostly phytohormones and flavonoids. RECENT FINDINGS Most of available data relate to the ligand binding activity of allergenic PR-10, particularly for those belonging to Bet v 1 family of allergens. Bet v 1 and its homologues were shown to bind flavonoids with high affinity, but the specificity appears to differ between homologues from different species. The flavonoid Q3O-(Glc)-Gal was shown to specifically bind to hazelnut Cor a 1 but not to Bet v 1. Similarly, Q3OS bound only to the major isoform Bet v 1.0101 and not to other closely related isoforms. In contrast, Bet v 1 and hazelnut Cor a 1 showed very similar binding behavior towards other flavonoids such as quercetin, genistein, apigenin, daidzein, and resveratrol. Recent research findings highlighted the importance of more precise knowledge of ligand binding for understanding the functional diversification of PR-10 proteins.
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Controversies in Allergy: Food Testing and Dietary Avoidance in Atopic Dermatitis.
Robison, RG, Singh, AM
The journal of allergy and clinical immunology. In practice. 2019;(1):35-39
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Epithelial-stromal crosstalk and fibrosis in eosinophilic esophagitis.
Muir, AB, Wang, JX, Nakagawa, H
Journal of gastroenterology. 2019;(1):10-18
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Abstract
Eosinophilic esophagitis (EoE) is a food allergen-induced inflammatory disorder. EoE is increasingly recognized as a cause of swallowing dysfunction, food impaction and esophageal stricture. Inflammation of the esophageal mucosa involves immune cell infiltrate, reactive epithelial changes and fibroblast activation, culminating in robust tissue remodeling toward esophageal fibrosis characterized by excess collagen deposition in the subepithelial lamina propria. Fibrosis contributes to a unique mechanical property of the EoE-affected esophagus that is substantially stiffer than the normal esophagus. There is a great need to better understand the processes behind esophageal fibrosis in order to foster improved diagnostic tools and novel therapeutics for EoE-related esophageal fibrosis. In this review, we discuss the role of esophageal inflammatory microenvironment that promotes esophageal fibrosis, with specific emphasis upon cytokines-mediated functional epithelial-stromal interplays, recruitment and activation of a variety of effector cells, and tissue stiffness. We then explore the current state of clinical methodologies to detect and treat the EoE-related esophageal stricture.
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The Effects of Air Pollution on the Development of Atopic Disease.
Hassoun, Y, James, C, Bernstein, DI
Clinical reviews in allergy & immunology. 2019;(3):403-414
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Abstract
Air pollution is defined as the presence of noxious substances in the air at levels that impose a health hazard. Thus, there has been long-standing interest in the possible role of indoor and outdoor air pollutants on the development of respiratory disease. In this regard, asthma has been of particular interest but many studies have also been conducted to explore the relationship between air pollution, allergic rhinitis, and atopic dermatitis. Traffic-related air pollutants or TRAP refers to a broad group of pollutants including elemental carbon, black soot, nitrogen dioxide (NO2), nitric oxide (NO), sulfur dioxide (SO2), particulate matter (PM2.5 and PM10), carbon monoxide (CO), and carbon dioxide (CO2). In this review, we aim to examine the current literature regarding the impact of early childhood exposure to TRAP on the development of asthma, allergic rhinitis, and atopic dermatitis. Although there is growing evidence suggesting significant associations, definitive conclusions cannot be made with regard to the effect of TRAP on these diseases. This conundrum may be due to a variety of factors, including different definitions used to define TRAP, case definitions under consideration, a limited number of studies, variation in study designs, and disparities between studies in consideration of confounding factors. Regardless, this review highlights the need for future studies to be conducted, particularly with birth cohorts that explore this relationship further. Such studies may assist in understanding more clearly the pathogenesis of these diseases, as well as other methods by which these diseases could be treated.