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Abstract Background High-fidelity simulations based on real-life clinical scenarios have frequently been used to improve patient care, knowledge and teamwork in the acute care setting. Still, they are seldom included in the allergy-immunology curriculum or continuous medical education. Our main goal was to assess if critical care simulations in allergy improved performance in the clinical setting. Methods Advanced anaphylaxis scenarios were designed by a panel of emergency, intensive care unit, anesthesiology and allergy-immunology specialists and then adapted for the adult allergy clinic setting. This simulation activity included a first part in the high-fidelity simulation-training laboratory and a second at the adult allergy clinic involving actors and a high-fidelity mannequin. Participants filled out a questionnaire, and qualitative interviews were performed with staff after they had managed cases of refractory anaphylaxis. Results Four nurses, seven allergy-immunology fellows and six allergy/immunologists underwent the simulation. Questionnaires showed a perceived improvement in aspects of crisis and anaphylaxis management. The in-situ simulation revealed gaps in the process, which were subsequently resolved. Qualitative interviews with participants revealed a more rapid and orderly response and improved confidence in their abilities and that of their colleagues to manage anaphylaxis. Conclusion High-fidelity simulations can improve the management of anaphylaxis in the allergy clinic and team confidence. This activity was instrumental in reducing staff reluctance to perform high-risk challenges in the ambulatory setting, thus lifting a critical barrier for implementing oral immunotherapy at our adult center.

Abstract Background Reports of allergic reactions to the COVID-19 vaccines have been documented, which may also contribute to hesitancy. Despite the low likelihood that the COVID-19 vaccine will trigger an allergic reaction, we and others have reported that families with allergy remain vaccine hesitant due to concerns of COVID-19-vaccine-triggered anaphylaxis. Objective To present our scoping review protocol, that will inform a forthcoming living scoping review in which we will investigate the peer-reviewed and grey literature on COVID-19 vaccine hesitancy and allergic disease and/or allergic reactions following a COVID-19 vaccine. Methods Informed by Arksey and O’Malley framework for methodological review, we have developed a search strategy with content and methodological experts, and which has undergone Peer Review of Electronic Search Strategies review. A search of four scientific databases, as well as gray literature, will be performed without restriction to articles by type of COVID-19 vaccine, or country of study, and will include publications in the ten languages our team can handle. Bi-monthly search alerts based on the search strategy will be generated. Results The first search will result in a stand alone peer reviewed scoping review. Bi-monthly updates will be posted on a pre-print server. Depending on the volume of literature, these updates will be synthesized and submitted for peer-review at 6 and/or 12 months. Conclusion COVID-19 vaccine hesitancy amongst individuals with allergy persists, despite very low risk of serious adverse reactions. Our living scoping review, which includes multiple forms of knowledge translation, will be a rigorous way to address hesitancy.

Background: Reports of allergic reactions to coronavirus disease 2019 (COVID-19) vaccines, coupled with an “infodemic” of misinformation, carry the potential to undermine confidence in the COVID-19 vaccines. However, no attempts have been made to comprehensively synthesize the literature on how allergic disease and fear of allergic reactions to the vaccines contribute to hesitancy. Objectives: Our aim was to review the academic and gray literature on COVID-19 vaccine hesitancy and allergic reactions. Methods: We searched 4 databases (CINAHL, PsycINFO, MEDLINE, and Embase) using a search strategy developed by content and methodologic experts. No restrictions were applied regarding COVID-19 vaccine type, country of study, or patient age. Eligible articles were restricted to 10 languages. Results: Of the 1385 unique records retrieved from our search, 60 articles (4.3%) were included. Allergic reactions to the COVID-19 vaccine were rare but slightly more common in individuals with a history of allergic disease. A fifth of the studies (13 of 60 [22%]) discussed vaccine hesitancy due to possibility of an allergic reaction. Additionally, the present review identified research on details of vaccine-related anaphylaxis (eg, a mean and median [excluding clinical trial data] of 12.4 and 5 cases per million doses, respectively) and allergic reactions (eg, a mean and median [excluding clinical trial data] of 489 and 528 cases per million doses, respectively). Conclusion: COVID-19 vaccine acceptance among individuals living with allergy and among those with no history of allergic disease may be affected by fear of an allergic reaction. Despite the low incidence of allergic reactions to the COVID-19 vaccine, fear of such reactions is one of the most commonly cited concerns reported in the literature.

BackgroundThe COVID-19 pandemic has affected the supply, cost, and demand for certain foods, but it is not clear how these changes have affected food-allergic households.ObjectiveTo describe the changes in food-related costs that have followed COVID-19, as reported by higher- and lower-income households with a food-allergic member.MethodsBetween May 1-June 30, 2020, Canadian households, with at least one food-allergic member, completed an online survey on food shopping and preparation habits before and during the COVID-19 pandemic. The sample was divided into binary groups, either higher or lower than the sample median income. Data were analyzed using descriptive statistics and multiple regression.ResultsThe sample was comprised of 102 participants (i.e., 51/ income group). The three most common food allergies amongst both groups were peanuts, tree nuts and milk. Since the start of the pandemic, both groups reported greater monthly direct grocery costs, although costs amongst the higher-income group were twice as high as the lower-income group ($212.86 vs. $98.89, respectively). Indirect food preparation costs were similarly elevated. Higher-income households with food procurement difficulties reported increased indirect shopping costs following the outbreak of COVID-19, whereas those without such difficulties reported decreased costs. Lower-income households with allergies to milk, wheat, or eggs (i.e., staple allergy) experienced a larger change in indirect food preparation costs following the outbreak of COVID-19 relative to those with other food allergies ($244.58 vs. –$20.28, respectively; p = 0.03).ConclusionBoth higher and lower income households with food allergy reported greater direct food costs and indirect food preparation costs following the COVID-19. Households with staple allergy and those with difficulties finding their typical food items were particularly affected.

Abstract Oral immunotherapy (OIT) is now widely recognized as a valid option for the management of IgE-mediated food allergies. However, in real-life practice, OIT can lead to a variety of unique situations where the best course of action is undetermined. In patient-centered care, individual patient preferences, needs and values, should guide all clinical decisions. This can be achieved by using shared-decision making and treatment customization to navigate areas of uncertainty in a way that is responsive to patient’s needs and preferences. However, in the context of OIT, lack of awareness of potential protocol adaptability or alternatives can become a barrier to treatment personalization. The purpose of this article is to review the theoretical bases of patient-centered care and shared decision-making and their practical implication for the patient-centered delivery of OIT. Clinical cases highlighting common challenges in real-life OIT practice are presented along with a discussion of potential personalized management options to be considered. While the practice of OIT is bound to evolve as additional scientific and experiential knowledge is gained, it should always remain rooted in the general principles of patient-centered care.

Abstract Background Previous proof-of-concept studies have shown that a short course of omalizumab can safely accelerate the oral immunotherapy schedule for multiple allergens simultaneously. Considering the high cost of medication, the dose-related efficacy of omalizumab at decreasing the duration of oral immunotherapy up-dosing phase must be objectively quantified before cost–benefit analyses can be performed. The primary objective of this trial will be to compare the efficacy of 2 omalizumab dosages to placebo at decreasing time-to-maintenance dose during a symptom-driven multi-food OIT protocol. Methods A total of 90 participants aged 6 to 25 with multiple food allergies (3 or more) will be enrolled at four sites in Canada. Participants will be randomized to: (A) Omalizumab 8 mg/kg per month (n = 36); (B) Omalizumab 16 mg/kg per month (n = 36); or (C) Placebo (n = 18). Study drug will be administered at full dosage for 12 weeks, then progressively tapered at 50% dosage (8 mg/kg vs 4 mg/kg vs placebo) for 4 weeks and at 25% dosage (4 mg/kg vs 2 mg/kg vs placebo) for another 4 weeks. After a pre-treatment period of 8 weeks, participants will undergo an initial food escalation (IFE) to an OIT mix containing 3 allergens and start daily home dosing with biweekly increases until a target daily maintenance of 1500 mg protein is achieved. The amount escalated at each visit will vary based on treatment tolerance according to a standardized up-dosing algorithm. Participants will be followed for at least 12 months following the initial food escalation. The primary endpoint will be time from IFE to the target maintenance dose of 1500 mg protein. Time-to-event analytic methods, including the log-rank test, will be used to compare the 3 arms. Discussion This trial uses a novel pragmatic approach to compare OIT with omalizumab to OIT without omalizumab in a blinded manner, which allows to single out the effect of this anti-IgE medication on treatment effectiveness speed without the recourse to predetermined schedules. The innovative patient-centered up-dosing algorithm allows to maximise treatment effectiveness speed without compromising patient safety, regardless of whether the patient is on omalizumab or not. This study will also provide novel prospective data to inform on the optimal and most cost-effective dosage for this indication. Trial registration ClinicalTrials.gov, NCT04045301, Registered 5 August 2019, https://clinicaltrials.gov/ct2/show/NCT04045301

Oral immunotherapy (OIT) is an emerging treatment of IgE-mediated egg allergy. In the past decade, a multitude of studies have assessed the potential for egg OIT to induce clinical desensitization. The following review will evaluate the efficacy and safety of this therapy as determined by randomized controlled, non-randomized controlled and uncontrolled trials. Recent studies using reduced allergenic egg products and anti-IgE assisted therapy to improve egg OIT safety will also be discussed. Recent advances in the mechanisms underlying food OIT suggest that certain immune parameters may be helpful in monitoring response to therapy, including egg OIT. Although, egg OIT is consistently shown to be effective with regards to clinical desensitization, fewer studies have looked at persistent tolerance or sustained unresponsiveness. Limited results of long-term follow-up trials suggest that this therapy may have disease-modifying effects. In general, the comparison of studies is complicated by major differences in study designs, OIT protocols and endpoints.

Theresa W Guilbert,1 Alberto Tolcachier,2 Alessandro G Fiocchi,3 Constance H Katelaris,4,5 Wanda Phipatanakul,6,7 Philippe Begin,8 Inés de Mir,9 Arman Altincatal,10 Rebecca Gall,11 Olivier Ledanois,12 Amr Radwan,11 Juby A Jacob-Nara,13 Yamo Deniz,11 Paul J Rowe13 1Department of Pediatrics, Cincinnati Children’s Hospital and University of Cincinnati, Cincinnati, OH, USA; 2Center for Allergy and Respiratory Diseases, Buenos Aires, Argentina; 3Bambino Gesù Children’s Hospital IRCCS, Rome, Italy; 4Department of Medicine, Campbelltown Hospital, Campbelltown, NSW, Australia; 5Immunology & Allergy Unit, Western Sydney University, Sydney, NSW, Australia; 6Department of Allergy and Immunology, Boston Children’s Hospital, Boston, MA, USA; 7Department of Pediatrics, Harvard Medical School, Boston, MA, USA; 8Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal, QC, Canada; 9Pediatric Pulmonary Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain; 10Sanofi, Cambridge, MA, USA; 11Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA; 12Sanofi, Paris, France; 13Sanofi, Bridgewater, NJ, USACorrespondence: Theresa W Guilbert, Cincinnati Children’s Hospital and University of Cincinnati, 3333 Burnet Ave, Cincinnati, OH, 45229, USA, Tel +1 513-636-6771, Email theresa.guilbert@cchmc.orgPurpose: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukins-4/-13, key and central drivers of type 2 inflammation in multiple diseases. This post hoc analysis of the Phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959) evaluated the efficacy of dupilumab in children aged 6 to 11 years with moderate-to-severe asthma with a type 2 inflammatory phenotype (blood eosinophil count ≥ 150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥ 20 ppb) and a history of 1, 2, or ≥ 3 prior exacerbations. The impact of baseline type 2 biomarker levels on the efficacy of dupilumab in this population was also investigated.Patients and Methods: Patients were stratified by the number of exacerbations in the prior year (1, 2, or ≥ 3) and level of FeNO or blood eosinophil count at baseline. Endpoints included rate of severe exacerbations, percentage of non-exacerbators, and change from baseline in both lung function parameters (pre- and post-bronchodilator [BD] percent predicted forced expiratory volume in 1 s (ppFEV1) and ppFEV1/forced vital capacity [FVC] ratio) and Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) score.Results: A total of 350 patients were included in this analysis. Across patients with 1, 2, or ≥ 3 prior exacerbations and different levels of type 2 biomarkers, dupilumab reduced the risk of severe asthma exacerbations vs placebo by 53.0– 96.0% and improved both pre-BD ppFEV1 and pre-BD FEV1/FVC ratio at Week 52. Dupilumab led to significant reductions in ACQ-7-IA scores in all groups of patients by Week 52.Conclusion: In children with uncontrolled, moderate-to-severe asthma with a type 2 phenotype, dupilumab consistently reduced the risk of asthma exacerbations, improved lung function, and reduced ACQ-7-IA scores, regardless of exacerbation history. Keywords: pediatric asthma, type 2 asthma, lung function, asthma control, biologics, anti-interleukin-4 and -13

Abstract Background and methods The Zéro allergie research clinic (Saguenay, Canada) is a clinical and research initiative in oral immunotherapy (OIT) for managing IgE-mediated food allergy (FA). A total of 183 children with FA and 27 non-allergic siblings were recruited to date in the Zéro allergie cohort (ZAC) to better understand biological mechanisms underlying FA and OIT prognosis. The primary aims are to (a) better understand the genetic, epigenetic, transcriptomic, metabolomic, and microbial diversity associated with FA; (b) establish the multi-omics and microbial diversity profiles of children following OIT to identify predictive prognosis biomarkers, (c) make OIT more accessible to the population of the Saguenay–Lac-Saint-Jean region, and (d) build a biobank of data and biological material. Results The ZAC constitutes a unique and rich biobank of biological samples (blood, buccal swabs, microbiota samples [intestinal, buccal, nasal, and cutaneous]) combined with clinical data and more than 75 phenotypic characteristics. Conclusions This represents an innovative interdisciplinary initiative by researchers, allergists, and paediatricians to make FA care accessible to a greater number of children with IgE-mediated FA. Ultimately, it will contribute to provide more accessible treatment options with greater chances of success through a better understanding of the biological nature of FA and OIT.

Abstract Current recommendations for the management of penicillin allergy are to perform penicillin skin testing (PST) with penicilloyl-polylysine (PPL) and benzylpenicillin (BP) prior to drug challenge with amoxicillin. However, the role of PST is increasingly questioned in the pediatric setting. To resolve the question of PST’s diagnostic accuracy, consecutive children with a history of non-life-threatening penicillin allergy referred to a tertiary-care allergy center were recruited to undergo double-blinded PST with PPL and BP prior to drug provocation to amoxicillin. Five of 158 participants (3.2%) presented with an immediate or accelerated reaction upon amoxicillin challenge, none of which were severe. Only one of these had positive PST (20%), compared to 15 of 153 amoxicillin tolerant participants (9.8%). The sensitivity and specificity of PST with PPL and BP for reacting upon amoxicillin challenge were 20% (95% CI: 0.5–71.6%) and 90% (95% CI: 84.4–94.4%), respectively. These results argue against the routine use of PST as a preliminary step to drug provocation with amoxicillin in this population, as it is unlikely to significantly alter pre-test probability of reacting to challenge.

Abstract Background Oral immunotherapy (OIT) is an emerging approach to the treatment of patients with IgE-mediated food allergy and is in the process of transitioning to clinical practice. Objective To develop patient-oriented clinical practice guidelines on oral immunotherapy based on evidence and ethical imperatives for the provision of safe and efficient food allergy management. Materials and methods Recommendations were developed using a reflective patient-centered multicriteria approach including 22 criteria organized in five dimensions (clinical, populational, economic, organizational and sociopolitical). Data was obtained from: (1) a review of scientific and ethic literature; (2) consultations of allergists, other healthcare professionals (pediatricians, family physicians, nurses, registered dieticians, psychologists, peer supporters), patients and caregivers; and patient associations through structured consultative panels, interviews and on-line questionnaire; and (3) organizational and economic data from the milieu of care. All data was synthesized by criteria in a multicriteria deliberative guide that served as a platform for structured discussion and development of recommendations for each dimension, based on evidence, ethical imperatives and other considerations. Results The deliberative grid included 162 articles from the literature and media reviews and data from consultations involving 85 individuals. Thirty-eight (38) recommendations were made for the practice of oral immunotherapy for the treatment of IgE mediated food allergy, based on evidence and a diversity of ethical imperatives. All recommendations were aimed at fostering a context conducive to achieving objectives identified by patients and caregivers with food allergy. Notably, specific recommendations were developed to promote a culture of shared responsibility between patients and healthcare system, equity in access, patient empowerment, shared decision making and personalization of OIT protocols to reflect patients’ needs. It also provides recommendations to optimize organization of care to generate capacity to meet demand according to patient choice, e.g. OIT or avoidance. These recommendations were made acknowledging the necessity of ensuring sustainability of the clinical offer in light of various economic considerations. Conclusions This innovative CPG methodology was guided by patients’ perspectives, clinical evidence as well as ethical and other rationales. This allowed for the creation of a broad set of recommendations that chart optimal clinical practice and define the conditions required to bring about changes to food allergy care that will be sustainable, equitable and conducive to the well-being of all patients in need.

Abstract Background The role and importance of skin barrier as an immunologic organ and as a potent way of sensitization is well known. However, antibiotics anaphylaxis following skin sensitization has not been reported. Case presentation We describe the first case of intravenous clindamycin anaphylaxis, with likely sensitization due to previous topical exposure to clindamycin gel for acne in a 14-year-old boy with history of atopy and mild atopic dermatitis. Conclusion This case highlights the potential sensitization to drug allergens, including antibiotics, via the skin.

Abstract Food allergy is defined as an adverse immunologic response to a food protein. Food-related reactions are associated with a broad range of signs and symptoms that may involve any body system, including the skin, gastrointestinal and respiratory tracts, and cardiovascular system. Immunoglobulin E (IgE)-mediated food allergy is a leading cause of anaphylaxis and, therefore, referral to an allergist for timely and appropriate diagnosis and treatment is imperative. Diagnosis entails a careful history and diagnostic tests, such as skin prick tests, serum-specific IgE and, if indicated, an oral food challenge. Once the diagnosis of food allergy is confirmed, strict elimination of the offending food allergen from the diet is generally necessary; however, in the case of cow’s milk and egg allergy, many allergic children are able to eat these foods in their baked form. This article provides an overview of the epidemiology, pathophysiology, diagnosis, and management of IgE-mediated food allergy.

An amendment to this paper has been published and can be accessed via the original article.