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Background No approved treatment for peanut allergy exists for children younger than 4 years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown. Methods We conducted this phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo. Results Of the 362 patients who underwent randomization, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P

BackgroundEffectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.MethodsCOMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult and paediatric clinicians, pharmaceutical representatives, and health regulators from across Europe. Evidence included a systematic review of development, validity and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients’ and carers’ views about outcome measures. It was discussed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.ResultsBoth adult and paediatric COM sets include forced expiratory volume in 1 s (FEV1) as z-scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire and Asthma Control Test or Childhood Asthma Control Test, while the adult COM set includes the Severe Asthma Questionnaire and Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately).ConclusionsThis patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.

Introduction: adolescence is a critical stage of rapid biological, emotional and social change and development. Adolescents and young adults (AYA) with asthma and allergies need to develop the knowledge and skills to self-manage their health independently. Healthcare professionals (HCP), parents and their wider network play an essential role in supporting AYA in this process. Previous work showed significant limitations in transition care across Europe. In 2020, the first evidence-based guideline on effective transition for AYA with asthma and allergies was published by EAACI.Aim: we herein summarize practical resources to support this guideline's implementation in clinical practice.Methods: for this purpose, multi-stakeholder Task Force members searched for resources in peer review journals and grey literature. These resources were included if relevant and of good quality and were pragmatically rated for their evidence-basis and user friendliness.Results: resources identified covered a range of topics and targeted healthcare professionals, AYA, parents/carers, schools, workplace and wider community. Most resources were in English, web-based and had limited evidence-basis.Conclusions: this position paper provides a valuable selection of practical resources for all stakeholders to support effective transitional care for AYA with asthma and allergies. Future research should focus on developing validated, patient-centred tools to further assist evidence-based transition care.

Background: The benefit of daily administration of Peanut (Arachis hypogaea) Allergen Powder-dnfp (PTAH)-formerly AR101-has been established in clinical trials, but limited data past the first year of treatment are available. This longitudinal analysis aimed to explore the impact of continued PTAH therapeutic maintenance dosing (300 mg/day) on efficacy, safety/tolerability, and food allergy-related quality of life.Methods: We present a subset analysis of PALISADE-ARC004 participants (aged 4-17 years) who received 300 mg PTAH daily for a total of similar to 1.5 (Group A, n = 110) or similar to 2 years (Group B, n = 32). Safety assessments included monitoring the incidence of adverse events (AEs), accidental exposures to food allergens, and adrenaline use. Efficacy was assessed by double-blind, placebo-controlled food challenge (DBPCFC); skin prick testing; peanut-specific antibody assays; and Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) scores.Results: Continued maintenance with PTAH increased participants' ability to tolerate peanut protein: 48.1% of completers in Group A (n = 50/104) and 80.8% in Group B (n = 21/26) tolerated 2000 mg peanut protein at exit DBPCFC without dose-limiting symptoms. Immune biomarkers showed a pattern consistent with treatment-induced desensitization. Among PTAH-continuing participants, the overall and treatment-related exposure-adjusted AE rate decreased throughout the intervention period in both groups. Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitization as determined by the DBPCFC and improved quality of life.Conclusions: These results demonstrate that daily PTAH treatment for peanut allergy beyond 1 year leads to an improved safety/tolerability profile and continued clinical and immunological response.

Background Food allergen immunotherapy (FA-AIT) practice is known to vary globally. This project aims to identify and characterize European centres performing FA-AIT. Methods An EAACI task force conducted an online survey to gather relevant information regarding FA-AIT practice and setting-specific resources after reviewing the published literature and congress abstracts throughout Europe. Results We identified 102 FA-AIT centres in 18 countries; only Spain (n = 39) and France (n = 16) had ≥10 such centres. Overall, most facilities were hospital-based (77.5%), publicly funded (80.4%) and delivered FA-AIT as routine clinical care (80.4%). On average, departments had 3 allergists/paediatric allergists and 2 nurses. Surveyed centres had provided FA-AIT for a median of 9 years [1-24] to a median of 105 [5-2415] patients. The estimated total number of treated patients was 24875, of whom 41.3% received AIT for milk, 34.2% egg, 12.8% peanut and 11.7% other foods. Anaphylaxis to AIT doses requiring over 4-6 h of observation was reported by 70.6% of centres, ICU admissions by 10.8% and eosinophilic esophagitis by 45.1%. Quality of life and sustained unresponsiveness were evaluated in 20.6% and 54.9% of centres, respectively. The main contraindications for food AIT were severe asthma (57%-63%), eosinophilic esophagitis (56%-48%) and age below 5 years (47%-41%). Conclusions In Europe, FA-AIT is provided mostly in clinical practice. Significant variation is seen in the number of centres per country, facility characteristics and inclusion/exclusion criteria, and in certain aspects of protocols. Potential inequality in access to AIT has been identified as well as the need for education and guidance for treatment standardization.

SummaryBackgroundPeanuts 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.MethodsExperts 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.ResultsThe 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.ConclusionsAfter 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.

An expert workshop in collaboration of the German Society of Allergy and Clinical Immunology (DGAKI) and the Japanese Society of Allergy (JSA) provided a platform for key opinion leaders of both countries aimed to join expertise and to highlight current developments and achievements in allergy research. Key domains of the meeting included the following seven main sections and related subchapters: 1) basic immunology, 2) bronchial asthma, 3) prevention of allergic diseases, 4) food allergy and anaphylaxis, 5) atopic dermatitis, 6) venom allergy, and 7) upper airway diseases. This report provides a summary of panel discussions of all seven domains and highlights unmet needs and project possibilities of enhanced collaborations of scientific projects. © Dustri-Verlag Dr. K. Feistle.

Zusammenfassung Hintergrund In Industrieländern sind bis zu 3 % aller Kinder von einer Erdnussallergie betroffen. Allergy to Peanuts imPacting Emotions And Life (APPEAL) ist die erste große Studie, die die Auswirkungen und Belastungen durch eine Erdnussallergie auf Betroffene und Angehörige untersucht. Material und Methoden Betroffene mit Erdnussallergie und deren Eltern/Betreuer nahmen entweder an einer Online-Umfrage teil (APPEAL‑1, n = 273) oder gaben detaillierte Interviews (APPEAL‑2, n = 32). Ergebnisse Von den Befragten der APPEAL-1-Studie (56 erwachsene Patienten mit Erdnussallergie und 217 Eltern/Betreuer von Personen mit Erdnussallergie) gaben 85 % an, dass die Erdnussallergie ihre täglichen Aktivitäten beeinflusst, 65 % fühlten sich deshalb isoliert. 91 % sorgten sich besonders bei gesellschaftlichen Anlässen vor einer potenziellen Erdnussexposition; 85 % verspürten Hindernisse beim Pflegen sozialer Kontakte. Die häufigsten psychologischen Auswirkungen der Erdnussallergie waren Frustration (89 %), Unsicherheit (86 %) und Stress (88 %). Ein Großteil der Befragten (84 %) beschrieb ein Gefühl der Andersartigkeit. Durch die Erdnussallergie kommt es häufig zu Beeinträchtigungen bei sozialen Aktivitäten, im schulischen Umfeld, im Beruf (bei Eltern und erwachsenen Betroffenen) sowie in Bezug auf emotionales Befinden und Beziehungen. Als wichtigste Bewältigungsstrategien nannten die Teilnehmer eine gute Überwachung von Nahrung und Hygiene, den Austausch mit anderen und eine akribische Planung von Aktivitäten. Schlussfolgerungen Dies ist die erste alltagsbezogene Umfrage in Deutschland, die die Auswirkungen und Belastungen einer Erdnussallergie bei betroffenen Kindern, Jugendlichen und deren Eltern/Betreuern sowie bei selbst betroffenen Erwachsenen aufzeigt.

Background Allergy to Peanuts ImPacting Emotions And Life (APPEAL‐1) was a recent European multi‐country questionnaire survey that highlighted the negative impacts of peanut allergy (PA) on quality of life. A follow‐on qualitative study, APPEAL‐2, further assessed the burden of PA and associated coping strategies through semi‐structured interviews. Objective To gain qualitative insight on the strategies used to cope with and manage PA and the impact of these strategies on the quality of life of children, teenagers and caregivers. Methods This cross‐sectional qualitative study was conducted in eight European countries: the United Kingdom, France, Germany, Ireland, Spain, Italy, Denmark and the Netherlands. Semi‐structured interviews were conducted with children (aged 8‐12 years) and teenagers (aged 13‐17 years) with self‐/proxy‐reported moderate or severe PA and with parents/caregivers of children or teenagers (aged 4‐17 years) with moderate or severe PA. Data were analysed using thematic analysis; data saturation was assessed. Two conceptual models were developed to illustrate the impacts of PA and coping strategies used to manage them for (a) individuals with PA and (b) parents/caregivers of children with PA. Results 107 participants were interviewed: 24 children, 39 teenagers and 44 caregivers. The conceptual models illustrated themes related to coping and control, driven by the fear of PA reactions, and the associated emotional, social, relationship and work impacts. Factors moderating these impacts included social attitudes and support, child‐caregiver relationship and coping strategies used. Conclusions and Clinical Relevance The APPEAL‐2 results substantiate the findings of APPEAL‐1; the results also suggest that the severity of experience with PA may not correlate with perception of its overall burden and show variable impacts by country.

Hintergrund: Eltern von schulpflichtigen Kindern mit Nahrungsmittelallergien und dem Risiko anaphylaktischer Reaktionen wunschen sich einen

Summary Background Acetylsalicylic acid (ASA) may cause difficult-to-treat symptoms of the airways, skin, or gastrointestinal tract in hypersensitive patients. Due to the chemical relationship between salicylic acid and ASA, a role of a low-salicylate diet has been discussed. Methods This review evaluates whether low salicylate diets are meaningful from an allergological or nutritional–physiological perspective. Results The body’s arachidonic acid metabolism plays a crucial role in the pathogenesis of ASA intolerance. Despite their chemical affinity, ASA and salicylic acid affect the arachidonic pathway differently. The intake of salicylic acid with food is low compared to therapeutic doses of ASA. There is increasing evidence that protective effects of a high fruit and vegetables diet is related in part to the intake of salicylates. In salicylate-low diets, fruit and vegetables are reduced, harboring the risk of an insufficient diet and malnutrition. Conclusion Dietary therapy in ASA-intolerant patients is not recommended.

Introduction In ARTEMIS, 58% of AR101-treated subjects vs. 2% of placebo-treated subjects tolerated 1000 mg peanut protein as a single dose at exit double-blind, placebo-controlled food challenge (DBPCFC; P Methods All enrolled subjects had a clinical history of peanut allergy, demonstrated sensitization to peanut (skin prick test [SPT] mean wheal diameter ≥ 3 mm and/or peanut-specific immunoglobulin E [psIgE] ≥ 0.35 kUA/L), and reacted to ≤ 300 mg peanut protein at screening DBPCFC. SPT wheal diameter (mm), psIgE (kUA/L) and psIgG4 (mgA/L) assessments were performed at screening, end of dose escalation and study completion (following 3 months at 300 mg/day). Differences between treatment groups from screening to exit were analyzed using an ANCOVA model with terms fitted for group, country and screening value. Results A total of 175 ARTEMIS subjects (AR101 n = 132, placebo n = 43) were treated. SPT wheal diameter, psIgE levels, psIgG4 levels and psIgE/IgG4 ratio are summarized in Table 1 . From baseline to exit (AR101 vs. placebo), psIgG4 levels increased (P Conclusion Exposure to AR101 was associated with immunologic changes consistent with immunomodulation: increased psIgG4, decreased peanut SPT wheal size and transient changes in psIgE levels, as reported in previous peanut oral immunotherapy trials.

Stefan Zielen,1 Gianna Reichert,1 Helena Donath,1 Jordis Trischler,1 Johannes Schulze,1 Olaf Eickmeier,1 Martin Eckrich,2 Katharina Blumchen1 1Department for Children and Adolescents, Division of Allergology, Pulmonology and Cystic Fibrosis, University Hospital Frankfurt, Frankfurt, Germany; 2Group Practice Dres. Med. Martin Eckrich and Matthias Gründler, Offenbach am Main, GermanyCorrespondence: Stefan ZielenDepartment for Children and Adolescents, Division of Allergology, Pulmonology and Cystic Fibrosis, University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt 60590, GermanyTel +49 (69) 6301-83063Email Stefan.Zielen@kgu.deBackground: Toddlers with asthma suffer disproportionally more than school-aged children from exacerbations with emergency visits and hospital admissions despite inhaled corticosteroid (ICS) treatment. A recent trial for children ≤ 5 years showed tolerability of tiotropium and potential to reduce asthma-related events.Methods: We conducted a retrospective analysis of electronic outpatient records (2017‒2019) of children < 6 years treated with ICS plus long-acting β2-agonists (LABAs) plus tiotropium as an add-on for uncontrolled severe asthma. The primary endpoint was a comparison of systemic corticosteroid (SCS) prescriptions 6 months before and after ICS/LABA/tiotropium start. Secondary endpoints included physician visits, hospitalisations and antibiotic prescriptions. We compared outcomes with children without asthma matched for age, sex, season and screening date.Results: Compared with a mean 2.42 (95% CI: 1.75, 3.36) SCS courses per patient within 6 months prior to ICS/LABA/tiotropium, 0.74 (95% CI: 0.25, 1.08) SCS courses per patient were prescribed within 6 months after starting ICS/LABA/tiotropium (P< 0.001). Physician visits dropped from 9.23 (95% CI: 7.15, 12.72) to 5.76 (95% CI: 3.10, 7.70) per patient (P< 0.01). Nineteen hospitalisations were recorded 6 months before ICS/LABA/tiotropium compared with one hospitalisation after (P< 0.01). A mean 1.79 antibiotic courses (95% CI: 1.22, 2.23) per patient were prescribed before ICS/LABA/tiotropium compared with 0.74 (95% CI: 0.22, 1.00) after ICS/LABA/tiotropium (P< 0.001). Hospitalisation rates for patients at observation end were not statistically different from healthy controls before/after matching.Interpretation: Our retrospective study showed that adding tiotropium to ICS/LABA is a new treatment option for patients with severe preschool asthma; however, larger confirmatory studies are needed.Keywords: preschool asthma, severe uncontrolled asthma, tiotropium, inhaled steroids, long-acting β2-agonists, LABAs

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.

Background The European Academy of Allergy and Clinical Immunology has developed a guideline to provide evidence-based recommendations for healthcare professionals to support the transitional care of adolescents and young adults (AYA) with allergy and/or asthma. The goal of this work was to ensure that the draft recommendations are also important for patients. Methods We surveyed patients aged 11-25 years with allergy and/or asthma and their parents across Europe between 17th February and 16th March 2020. The multilingual survey was distributed through national allergy and asthma patient organisations in Europe as well as through social media. Results A total of 1210 responses from 24 European countries were collected. There were 415 (34.3%) AYA and 795 (65.7%) parents. The majority of AYA (72.3%) and parents (81.9%) were female. Patients had a history of asthma (61.1%), allergic rhinoconjunctivitis (54.1%), food allergy (53.8%), atopic eczema (42.6%), and anaphylaxis (28.8%). All recommendations achieved the median score of either 'important' or 'very important'. The least supported recommendations were the use of joint clinics with both paediatric and adult physicians attending and the use of web-based or mobile technologies for communication with the AYA. The most supported recommendation was checking that the AYA is knowledgeable and compliant with their prescribed medication. Qualitative analysis revealed conditional approval for some recommendations. Conclusions There was agreement from patients and parents on the importance of the draft recommendations on transitional care for adolescents and young adults with allergy and/or asthma and their parents. The recommendations now need to be implemented into clinical practice across Europe.

Concerns for anaphylaxis may hamper severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunization efforts. We convened a multidisciplinary group of international experts in anaphylaxis composed of allergy, infectious disease, emergency medicine, and front-line clinicians to systematically develop recommendations regarding SARS-CoV-2 vaccine immediate allergic reactions. Medline, EMBASE, Web of Science, the World Health Organizstion (WHO) global coronavirus database, and the gray literature (inception, March 19, 2021) were systematically searched. Paired reviewers independently selected studies addressing anaphylaxis after SARS-CoV-2 vaccination, polyethylene glycol (PEG) and polysorbate allergy, and accuracy of allergy testing for SARS-CoV-2 vaccine allergy. Random effects models synthesized the data to inform recommendations based on the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach, agreed upon using a modified Delphi panel. The incidence of SARS-CoV-2 vaccine anaphylaxis is 7.91 cases per million (n = 41,000,000 vaccinations; 95% confidence interval [95% CI] 4.02-15.59; 26 studies, moderate certainty), the incidence of 0.15 cases per million patient-years (95% CI 0.11-0.2), and the sensitivity for PEG skin testing is poor, although specificity is high (15 studies, very low certainty). We recommend vaccination over either no vaccination or performing SARS-CoV-2 vaccine/excipient screening allergy testing for individuals without history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient, and a shared decision-making paradigm in consultation with an allergy specialist for individuals with a history of a severe allergic reaction to the SARS-CoV-2 vaccine/excipient. We recommend further research to clarify SARS-CoV-2 vaccine/vaccine excipient testing utility in individuals potentially allergic to SARS-CoV2 vaccines or their excipients.

Background: Adolescence represents a vulnerable time for individuals with asthma and allergic conditions. They suffer an unexpected degree of morbidity. This systematic review aimed to understand the challenges faced by adolescents and young adults with these conditions. Methods: A systematic literature search was undertaken across eight databases. References were checked by two reviewers for inclusion. Study data were extracted, and their quality was assessed in duplicate. A narrative meta-synthesis was undertaken. Results: A total of 108 papers describing 106 studies were retrieved, most focused on asthma. Five themes were identified across studies: (a) Health-related quality of life—impairment was associated with poor disease control, psychosocial issues, adolescent-onset allergic disease and female sex; (b) Psychological factors—asthma and food allergy were associated with anxiety and depression, atopic dermatitis was associated with suicidal ideation, and that parental emotional support may be protective; (c) Adherence—suboptimal adherence was associated with older age, barriers to medication usage, poor symptom perception and failure to take responsibility, and positive factors were routines, simpler treatment regimes, better knowledge and perceptions about medications; (d) Self-management—facilitated by education, knowledge and a positive attitude; and (e) Supportive relationships—families could modify barriers to adherence and foster positive views about self-management, adolescents suggested that their peers should be more involved in supporting them, and adolescents also wished to have support from nonjudgemental healthcare professionals. Conclusions: We have some understanding of the challenges faced by adolescents with asthma, less so for other allergic conditions. This knowledge will be used to support guidelines for managing adolescents.

Background Peanut allergy is the leading cause of food-related anaphylaxis. Current management options can negatively affect food allergy-related quality of life. We aimed to investigate the efficacy of an investigational oral biologic drug (AR101). Methods The AR101 Trial in Europe Measuring Oral Immunotherapy Success in peanut-allergic children (ARTEMIS) trial was a multicentre, double-blind, randomised, placebo-controlled phase 3 trial done at 18 hospitals in Ireland, France, Germany, Italy, Spain, Sweden, and the UK. Children and adolescents with peanut allergy, aged 4–17 years, who developed dose-limiting symptoms to 300 mg or less peanut protein (equivalent to approximately one peanut kernel) during a double-blind placebo-controlled food challenge test at study entry were enrolled. Participants were randomly assigned (3:1) to receive daily doses of either AR101 oral immunotherapy (AR101 group) or a taste-masked placebo (placebo group). All participants, investigators, and care providers were masked to treatment allocation until the study was completed. Doses were increased every 2 weeks over 6 months until a dose of 300 mg was reached and maintained for 3 months. The primary endpoint was the proportion of participants in the intention-to-treat or safety population (defined as those participants who had been randomly assigned and had received at least one dose of the assigned drug) who could consume a single dose of 1000 mg (cumulative dose 2043 mg) peanut protein without developing dose-limiting allergic symptoms at an exit double-blind placebo-controlled food challenge after 9 months of treatment. Additional endpoints included safety (ie, the frequency and severity of adverse events) and changes in food allergy-related quality of life, assessed by use of age-appropriate Food Allergy Quality of Life Questionnaires (FAQLQs) and the Food Allergy Independent Measure (FAIM). The study is registered with ClinicalTrials.gov, NCT03201003, and is completed. Findings Between June 12, 2017, and Feb 15, 2018, 227 patients were screened, of whom 175 were randomly assigned to the AR101 group (n=132) and the placebo group (n=43). All primary and secondary endpoints were met. 77 (58%) of 132 participants in the AR101 group tolerated 1000 mg peanut protein at the exit food challenge versus one (2%) of 43 participants in the placebo group (AR101–placebo treatment difference 56·0% [95% CI 44·1–65·2], p

Adolescent and young adult (AYA) patients need additional support, while they experience the challenges associated with their age. They need specific training to learn the knowledge and skills required to confidently self-manage their allergies and/or asthma. Transitional care is a complex process, which should address the psychological, medical, educational and vocational needs of AYA in the developmentally appropriate way. The European Academy of Allergy and Clinical Immunology has developed a clinical practice guideline to provide evidence-based recommendations for healthcare professionals to support the transitional care of AYA with allergy and/or asthma. This guideline was developed by a multidisciplinary working panel of experts and patient representatives based on two recent systematic reviews. It sets out a series of general recommendations on operating a clinical service for AYA, which include the following: (a) starting transition early (11-13 years), (b) using a structured, multidisciplinary approach, (c) ensuring AYA fully understand their condition and have resources they can access, (d) active monitoring of adherence and (e) discussing any implications for further education and work. Specific allergy and asthma transition recommendations include (a) simplifying medication regimes and using reminders; (b) focusing on areas where AYA are not confident and involving peers in training AYA patients; (c) identifying and managing psychological and socio-economic issues impacting disease control and quality of life; (d) enrolling the family in assisting AYA to undertake self-management; and (e) encouraging AYA to let their friends know about their allergies and asthma. These recommendations may need to be adapted to fit into national healthcare systems.

Background Peanut allergy (PA) is a common, potentially life‐threatening and typically lifelong condition with a significant burden of illness. However, information is lacking on how persons with PA (PwPA) and their caregivers perceive the psychosocial impact of living with PA. The Allergy to Peanuts imPacting Emotions And Life 1 (APPEAL‐1) survey, conducted across Europe, investigated the experience and impact of living with PA. Here, we report data evaluating the psychosocial impact of PA on PwPA and their caregivers. Methods Allergy to Peanuts imPacting Emotions And Life study 1 was an online survey conducted in eight European countries. Representatives of eight patient advocacy groups and five healthcare‐research specialists developed the survey. Eligible respondent groups included the following: adults diagnosed with PA (self‐report); parent/nonparent caregivers (proxy‐report for a child with PA); and parent/nonparent caregivers (self‐report of PA impact on themselves). Results Of 1846 total study respondents, 419 were adults with PA (self‐report); 546 were parents/caregivers (proxy‐report); and 881 were parents/caregivers (self‐report). Most respondents reported lifestyle restrictions regarding food (84%‐93%) and additional domains including parties and socializing, holiday activities and destinations, and taking public transport (53%‐89%). Approximately 40% rated themselves as “very” frustrated and “very” stressed. Two‐thirds (65%) felt socially isolated; 43% were bullied. Less than half felt confident in knowing when to use an adrenaline autoinjector. Several intercountry differences were observed such as high levels of uncertainty and stress in respondents from Ireland, highest rates of anxiety in respondents from Germany, and social exclusion and isolation most common in respondents from France. Conclusions Peanut allergy imposes an adverse psychosocial impact on patients and caregivers, leading to frustration, stress and isolation. Attention to the impact of PA is needed in research and clinical practice to improve PA healthcare and public education programmes., The APPEAL‐1 study—multidimensional, pan‐European investigation of the impact of living with PA—revealed that PA imposes an adverse psychosocial impact on patients and caregivers. Study findings deepen our knowledge and understanding of the impact of PA on everyday lives. The study also underscores unmet needs and provides signposts for clinicians and policymakers on how these may be addressed. Abbreviation: PA, peanut allergy.

Background: Peanut allergy (PA) is associated with marked quality‐of‐life (QoL) impairment. However, data are lacking on the experience and impact of living with PA from the perspectives of persons with PA (PwPA) and their caregivers. A llergy to P eanuts imP acting E motions A nd L ife study 1 (APPEAL‐1) was a pan‐European survey investigating these perspectives. This first of two articles reports clinical characteristics of PwPA and PA management practices. Methods: APPEAL‐1 was a quantitative, online survey conducted in eight European countries, developed by eight representatives of patient advocacy groups and five healthcare professionals and researchers. Eligible participants included adults with PA and parents/caregivers of PwPA who responded by self‐report and provided proxy‐report for the PwPA under their care. Data were summarised using nonweighted descriptive statistics. Results: Of 1846 completed/analysed questionnaires, 528 were from adults with PA (self‐report); 437 by proxy for children with PA (34 aged 0‐3 years, 287 aged 4‐12 years, 116 aged 13‐17 years); 881 from parents/caregivers (self‐report). Of PwPA (N=965), 95% reported diagnosis by healthcare professionals, mostly by clinical history and peanut‐specific allergy testing. Rates of allergic rhinitis, asthma, and other food allergies in PwPA were 50%, 42%, and 79%, respectively. Only 31% of PwPA received HCP advice/support following their worst allergic reaction, and 28% had not been prescribed an adrenaline auto‐injector. Results were similar by country but varied by age group. Conclusions: The APPEAL‐1 findings contribute to greater understanding of PA impact on PwPA, caregivers, and family members and the need for improved PA management across Europe.

Summary Background Parents of school-age children with food allergies and potential anaphylactic reactions want their children to have an unburdened and risk-free everyday school life. Thus, particularly in the case of peanut allergy, demands for peanut-free schools are put forward. Results and discussion The position paper of the food allergy working group of the German Society for Allergology and Clinical Immunology (Deutsche Gesellschaft für Allergologie und klinische Immunologie) highlights why the concept of peanut-free schools does not protect peanut allergic children, but rather bears potential disadvantages and risks for all those involved. The focus on peanut as a potential trigger of anaphylactic reactions ignores other relevant triggers. Conclusion In order to address the fears and concerns of patients, parents, and school staff, it is mandatory to develop various coping strategies. These should enable and ensure the safety and participation of food-allergic pupils in classes and other school activities. Therefore, it is important to implement adequate measures for allergen avoidance and emergency treatment for students with confirmed food allergies.

BACKGROUND: Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions.METHODS: In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms.RESULTS: Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; PCONCLUSIONS: In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo. (Funded by Aimmune Therapeutics; PALISADE ClinicalTrials.gov number, NCT02635776 .).

ZusammenfassungIn den letzten Jahren häuft sich die Nennung der Nicht-Zöliakie-Gluten-/Weizen-Sensitivität (NCGS, „non celiac gluten sensitivity“) sowohl in den Medien, aber auch in Fachkreisen. Die Existenz und die möglichen verantwortlichen Trigger werden kontrovers diskutiert. Drei internationale Expertentreffen mit Empfehlungen zur NCGS waren nicht unabhängig organisiert und wenig transparent bezüglich potenzieller Interessenkonflikte der Teilnehmer.Die vorliegende Stellungnahme enthält wichtige Überlegungen aus allergologischer und ernährungsphysiologischer Sicht: (1) Aufgrund häufiger Selbstdiagnosen, unklarer Prävalenz und unbestätigter Ätiologie der NCGS sind validierte Diagnosekriterien und/oder verlässliche Biomarker notwendig. (2) Infolge hoher Nocebo- und häufiger Placebo-Effekte konnte Gluten bislang nicht sicher als Auslöser einer NCGS identifiziert werden. Doppelblinde, placebokontrollierte Provokationen (DBPCFC: double-blind, placebo-controlled food challenge) sind bei Verdacht auf NCGS nur in modifizierter Form (verändertes Verhältnis von Placebo zu Verum) geeignet. (3) Zahlreiche Störgrößen (Confounder) erschweren die Bewertung subjektiver Symptome unter glutenarmer/-freier Kost. Letztere kann je nach Lebensmittelauswahl (z. B. vermehrt Gemüse mit löslichen Ballaststoffen) physiologische Verdauungseffekte bewirken und gastrointestinale Transitzeiten unabhängig vom Glutenverzicht verändern. (4) Streng glutenfreie Kost ist bei einer gesicherten Zöliakie wissenschaftlich begründet und unerlässlich. Bei einem medizinisch unbegründeten Glutenverzicht überwiegen jedoch potenzielle Nachteile und Risiken. (5) Aktuell kann wegen fehlender überzeugender Diagnosekriterien bei Verdacht einer NCGS ausschließlich eine sorgfältige Differenzialdiagnostik empfohlen werden. Hierzu gehören eine sorgfältige Anamnese, einschließlich eines Ernährungs- und Symptomtagebuchs, eine allergologische Diagnostik und ein sicherer Ausschluss einer Zöliakie.Wir befürworten ein derartiges strukturiertes Vorgehen, da ohne eine medizinisch gesicherte Diagnose die Durchführung einer längeren Glutenkarenz nicht zu empfehlen ist. Englische Fassung http://link.springer.com/journal/40629

Within the last decade, non-celiac gluten/wheat sensitivity (NCGS) has been increasingly discussed not only in the media but also among medical specialties. The existence and the possible triggers of NCGS are controversial. Three international expert meetings which proposed recommendations for NCGS were not independently organized and only partially transparent regarding potential conflicts of interest of the participants. The present position statement reflects the following aspects about NCGS from an allergist’s and nutritionist’s point of view: (A) Validated diagnostic criteria and/or reliable biomarkers are still required. Currently, this condition is frequently self-diagnosed, of unknown prevalence and non-validated etiology. (B) Gluten has not been reliably identified as an elicitor of NCGS because of high nocebo and placebo effects. Double-blind, placebo-controlled provocation tests are of limited value for the diagnosis of NCGS and should be performed in a modified manner (changed relation of placebo and active substance). (C) Several confounders hamper the assessment of subjective symptoms during gluten-reduced or gluten-free diets. Depending on the selection of food items, e.g., an increased vegetable intake with soluble fibers, diets may induce physiological digestive effects and can modify gastrointestinal transit times independent from the avoidance of gluten. (D) A gluten-free diet is mandatory in celiac disease based on scientific evidence. However, a medically unjustified avoidance of gluten may bear potential disadvantages and risks. (E) Due to a lack of diagnostic criteria, a thorough differential diagnostic work-up is recommended when NCGS is suspected. This includes a careful patient history together with a food-intake and symptom diary, if necessary an allergy diagnostic workup and a reliable exclusion of celiac disease. We recommend such a structured procedure since a medically proven diagnosis is required before considering the avoidance of gluten.

Genetic factors and mechanisms underlying food allergy are largely unknown. Due to heterogeneity of symptoms a reliable diagnosis is often difficult to make. Here, we report a genome-wide association study on food allergy diagnosed by oral food challenge in 497 cases and 2387 controls. We identify five loci at genome-wide significance, the clade B serpin (SERPINB) gene cluster at 18q21.3, the cytokine gene cluster at 5q31.1, the filaggrin gene, the C11orf30/LRRC32 locus, and the human leukocyte antigen (HLA) region. Stratifying the results for the causative food demonstrates that association of the HLA locus is peanut allergy-specific whereas the other four loci increase the risk for any food allergy. Variants in the SERPINB gene cluster are associated with SERPINB10 expression in leukocytes. Moreover, SERPINB genes are highly expressed in the esophagus. All identified loci are involved in immunological regulation or epithelial barrier function, emphasizing the role of both mechanisms in food allergy., Food allergy is an increasing public health problem. In a genome-wide scan of children diagnosed by oral food challenge, Marenholz et al. find new genetic associations underlying food allergy, implicating the immune system and the epithelial barrier.

Die wichtigste Sofortmasnahme im Rahmen anaphylaktischer Reaktionen ist die Verabreichung von Adrenalin – vorzugsweise i.m. Derzeit gibt es 3 Adrenalinautoinjektormodelle auf dem deutschen Markt, die eine ausreichende Breite an Charakteristika aufweisen, um den meisten Patienten gerecht zu werden. Im vorliegenden Beitrag werden Indikationskriterien fur die Verschreibung vorgestellt, die Zahl der zu verschreibenden Autoinjektoren diskutiert, die richtige Injektionstechnik erlautert, Indikation zum Einsatz genannt und praktische Details erortert.

Seit mehreren Jahren wird zunehmend an kausalen Therapiemoglichkeiten fur Nahrungsmittelallergien geforscht, besonderer Fokus lag dabei auf der oralen Immuntherapie (OIT) bei Huhnerei-, Kuhmilch- und Erdnussallergie im Kindesalter. Die Moglichkeit einer Desensibilisierung oder Steigerung der Reaktionsschwelle unter OIT konnte bislang in mehreren Studien gezeigt werden. Jedoch waren auch schwere Nebenwirkungen unter dieser Behandlungsmethode keine Seltenheit. Ob die OIT zu einer andauernden, „robusten“ Toleranzentwicklung bei den Patienten fuhren kann, ist noch nicht ausreichend untersucht. Neben der OIT wurden auch vereinzelt Studien zur sublingualen (SLIT) und epikutanen Immuntherapie (EPIT) durchgefuhrt, mit dem Ziel, ein verbessertes Nebenwirkungsprofil zu erreichen. Auch eine Kombination aus SLIT und OIT oder eine parallele Behandlung mit Anti-IgE oder Probiotika wurden in ersten Pilotstudien untersucht. Weitere placebokontrollierte Studien mit groserem Patientenkollektiv sind allerdings notig, um standardisierte Protokolle entwickeln zu konnen, bevor die Immuntherapie in Zukunft als Behandlungskonzept bei Nahrungsmittelallergien im Kindesalter auch auserhalb der klinischen Forschung zum Einsatz kommen kann.

A recent genome-wide association study suggested novel candidate loci for food allergy. Apart from the established locus at 11q13, these revealed no association with food allergy in the Genetics Of Food Allergy Study.