Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients

Summary Purpose The long-term effects of targeted micronutrition with the holoBLG lozenge in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients were evaluated at a follow-up visit in an allergen exposure chamber (AEC). Methods Patients who were supplemented for 3‑months with the holoBLG lozenge in a previous study with two controlled HDM-AEC challenges [visits: V1, V3] were recruited for a third AEC challenge (V5) 7–8 months after cessation of supplementation. Symptoms (nose, conjunctival, bronchial, others), well-being, and lung function parameters were recorded exactly as in the previous study. Primary endpoint was change in median Total Nasal Symptom Score (TNSS) at V5 compared to V1. Secondary endpoints included e.g. change in median Total Symptom Score (TSS) and the exploratory analysis of temporal evolution of symptom scores using linear mixed effects models. Results Of the 32 patients included in the original study, 27 could be recruited for the follow-up visit with a third AEC challenge. An improvement of 20% (p = 0.15) in the primary endpoint TNSS [V1: 2.5 (interquartile range [IQR]: 1–4), V5: 2.0 (IQR: 1–3)] was observed; 40% (p = 0.04) improvement was seen for the TSS [V1: 5.0 (IQR: 3–9), V5: 3.0 (IQR: 2–5.5)]. Analysis of temporal evolution of all symptom scores, and the personal well-being revealed sustained, clinically meaningful improvement at V5 compared to V1. No relevant lung function parameter differences were observed. Conclusions Sustained long-term reduction of TNSS (primary endpoint) and sustained long-term improvement of secondary endpoints (temporal evolution of all symptom scores and well-being) were demonstrated 7–8 months after cessation of holoBLG supplementation, indicative of a long-lasting nature of immune resilience induced by holoBLG. Trial registration The study was registered at clinicaltrials.gov (NCT04872868).

White paper peanut allergy—part 2: Diagnosis of peanut allergy with special emphasis on molecular component diagnostics

Summary Background Peanut allergy is an immunoglobulin E (IgE)-mediated immune response that usually manifests in childhood and can range from mild skin reactions to anaphylaxis. Since quality of life maybe greatly reduced by the diagnosis of peanut allergy, an accurate diagnosis should always be made. Methods A selective literature search was performed in PubMed and consensus diagnostic algorithms are presented. Results Important diagnostic elements include a detailed clinical history, detection of peanut-specific sensitization by skin prick testing and/or in vitro measurement of peanut (extract)-specific IgE and/or molecular components, and double-blind, placebo-controlled food challenge as the gold standard. Using these tools, including published cut-off values, diagnostic algorithms were established for the following constellations: 1) Suspicion of primary peanut allergy with a history of immediate systemic reaction, 2) Suspicion of primary peanut allergy with questionable symptoms, 3) Incidental findings on sensitization testing and peanut ingestion so far or 4) Suspicion of pollen-associated peanut allergy with solely oropharyngeal symptoms. Conclusion The most important diagnostic measures in determining the diagnosis of peanut allergy are clinical history and detection of sensitizations, also via component-based diagnostics. However, in case of unclear results, the gold standard—an oral food challenge—should always be used.

White paper on peanut allergy: treatment pathway

Summary Background Peanuts are a member of the legume family (botanical family Leguminosae) and peanut allergies are the most common cause of food anaphylaxis in many countries. The prevalence of peanut allergy is increasing. Methods Experts from Germany and Austria performed a standardized literature search and published their consensus recommendations in a White Paper on Peanut Allergy, which this care pathway is based upon, thus, providing a comprehensive diagnosis and treatment algorithm. Results The most important diagnostic key elements include a detailed clinical medical history, evidence of peanut-specific sensitization by means of skin prick testing and/or in vitro determination of the peanut (extract)-specific IgE and/or the molecular component diagnostics (most important Ara h 2-specific IgE, sometimes also Ara h1-, 3-, 6-, 8- and 9-specific IgE) as well as the gold standard, the double-blind, placebo-controlled food challenge. The diagnostic algorithms were created for the following constellations: Suspected primary peanut allergy with a clear history of systemic immediate-type reaction, suspected primary peanut allergy with questionable symptoms, suspected secondary (possibly pollen-associated) peanut allergy with a history of solely oropharyngeal symptoms and incidental finding of sensitization and no peanut ingestion so far. Conclusions After established diagnosis the standard of care is counseling to avoid peanut contact and prescription of emergency medications (oral antihistamines, oral steroids, inhaled β2-agonists, injectable intramuscular epinephrine) as needed. Instruction on the use of these emergency medications should be provided. A preparation for oral immunotherapy (OIT) for 4 to 17 years old peanut allergic children/ adolescents has been recently approved by the regulatory authorities. OIT for peanut allergy shows high efficacy and an acceptable safety profile, improves quality of life, and health economic aspects. Thus it offers a therapeutic option for peanut allergic children and adolescents.

Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?

Background All currently available products for diagnosis and therapy of type I allergies are protein extracts from allergenic source material. The extracted proteins have different properties and their structure is differently labile to temperature variations. Despite various pharmaceutical formulations to increase product stability, with few exceptions, allergen products must be refrigerated to ensure that their quality and native protein structure do not change during storage and transport. Maintaining quality is a challenge in complex distribution chains. Methods Regulatory requirements and guidelines that apply to cold storage and transport of allergen products are summarized and the responsibilities of the stakeholders are explained. Results The storage conditions determined in stability studies correspond to the transport conditions. These stability data can also be used to assess tolerable conditions during transport. According to a good distribution practice (GDP) contracts must be concluded between the responsible pharmaceutical entrepreneur and the qualified distribution service provider that regulate storage and transport in accordance with the product requirements. Conclusion Monitoring of storage and transport conditions is achieved by transport in qualified means of transport (e.g. truck). Alternatively, qualified transport packaging with active or passive cooling (e.g. cold packs) and qualified “data loggers” that record the transport temperatures can be used. Regardless of the system used, it must be demonstrated—by validating the transport conditions, routes and packaging at different times of the year and over the entire duration of transport—that regulatory requirements are met and that the quality of the products is maintained during shipment.

How do food businesses provide information on allergens in non-prepacked foods? A cross-sectional survey in Switzerland

Summary Purpose This project aimed to investigate allergen information practices of food businesses selling non-prepacked foods after the implementation of the new Swiss food law in May 2017. Methods A cross-sectional telephone survey was conducted with food businesses selling non-prepacked foods in Switzerland. A short, standardised questionnaire was developed in German, based on previous research and literature. It was subsequently translated into French and Italian. Altogether, 882 businesses (restaurants, dairies, butcher shops and bakeries) were contacted, of which 387 were willing to participate. SPSS® (IBM, Armonk, NY, USA) was used for statistical analyses. Results The vast majority (86.0%) of food businesses provides oral allergen information. Only 14.0% currently provide written allergen information to the customer, either upfront or on request. The most frequently used labelling system in written allergen declaration was naming all ingredients (35.2%). A significant number (39.8%) do not place a notice on how to obtain allergen information, although this is a legal requirement in Switzerland when not providing written information upfront. Conclusion So far, not all food businesses have been complying with the new Swiss food law on allergen information of non-prepacked food. Therefore, awareness of the legal obligations around communicating allergen information as well as the verification of its implementation should be enhanced. To meet the needs of consumers and avoid reactions, some form of written allergen information should be promoted. Giving this information on request might encourage communication between customer and staff, thus providing an extra measure of verification.

Tolerability, course and follow-up of specific immunotherapy using a modified ultra-rush procedure in children and adolescents with insect venom allergy

Summary Background Specific immunotherapy with insect venom (hymenoptera venom (HG)-AIT) is an effective and the only causal treatment for patients with systemic reactions due to IgE-mediated insect venom allergy. The present study investigated the quality of care after bee and wasp venom allergy, the tolerability of modified ultra-rush immunotherapy and the course after the conclusion of maintenance therapy in children and adolescents. Studies on the quality of life of children with insect venom allergy are scarce. Methods The efficacy, safety and tolerability of an ultra-rush protocol was analysed in 114 patients aged 4–17 years with insect venom allergy. After the end of HG-AIT, patients were contacted by questionnaire and asked to report on the quality of care as well as the course of insect venom allergy, including accidental stinging events. Quality of life was validated using the established questionnaire VQLQ‑d (Vespid Quality of Life Questionnaire), which is also used for bee venom allergy patients. Results Discontinuation of the initial therapy was not necessary in any patient. Side effects were mostly mild and did not require treatment. In 16 patients, a new sting reaction occurred during maintenance therapy, in another 15 patients a sting event was documented after cessation of HG-AIT. The intensity of the reaction to the accidental insect bite according to the severity classification after Ring and Messmer decreased from an average of 2.3 to 0.9 in these patients. This corresponds to a decrease of 61%. An emergency kit was carried by 70% of the patients, the expiry date of which, however, had already passed in almost 40% of the respondents. After the end of the therapy, most patients were not under any medical care or had never been to a check-up (92%). The evaluation of the VQLQ‑d showed a medium to low level of stress during or after therapy. Discussion Ultra-rush AIT in childhood and adolescence is safe, tolerable and effective. HG-AIT has a lasting positive effect on the health-related quality of life of patients. However, after the end of HG-AIT, there are deficits in the follow-up and care of the patients.

White paper on peanut allergy – part 1: Epidemiology, burden of disease, health economic aspects

Peanuts are Leguminosae, commonly known as the legume or pea family, and peanut allergy is among the most common food allergies and the most common cause of fatal food reactions and anaphylaxis.The prevalence of peanut allergy increased 3.5-fold over the past two decades reaching 1.4–2% in Europe and the United States. The reasons for this increase in prevalence are likely multifaceted. Sensitization via the skin appears to be associated with the development of peanut allergy and atopic eczema in infancy is associated with a high risk of developing peanut allergy.Until recently, the only possible management strategy for peanut allergy was strict allergen avoidance and emergency treatment including adrenaline auto-injector in cases of accidental exposure and reaction.This paper discusses the various factors that impact the risks of peanut allergy and the burden of self-management on peanut-allergic children and their caregivers.