Food Oral Immunotherapy Research Articles

Safety and Feasibility of Peanut, Tree Nut, and Sesame Oral Immunotherapy in Infants and Toddlers in a Real-World Setting

Oral immunotherapy (OIT) for food allergy has been largely studied in older children within the context of clinical trials, and its availability has historically been limited for younger patients with food allergy. Data has shown that the most impact may actually be seen with the use of OIT in younger infants and toddlers. To evaluate the safety and feasibility of OIT in subjects younger than 24 months in a real-world setting using commercially available food products. This was a retrospective study of subjects 24 months and younger initiated on OIT for peanut, tree nut, or sesame allergy within the Scripps Clinic allergy department. Medical records were reviewed for data regarding initial oral food challenges (OFCs), OIT, and adverse outcomes. Fifty-two subjects under 24 months of age were initiated on OIT. Most subjects (84.6%) were on single food OIT, some (15.4%) were on multi-food OIT. No increased adverse outcomes were observed on multi-food OIT. Of the 59 initial OFCs, objective reactions occurred during 42 challenges, the majority being low grade reactions. During initial OFCs, 86.1% of peanut allergic children tolerated 1/8 of one Bamba stick with no reaction. The majority (73.1%) of subjects up-dosed at home and most (51.9%) had no reactions while up-dosing. Some had low grade cutaneous reactions, none requiring epinephrine or emergency evaluation. OIT in infants is safe and feasible to perform in a real-world setting using commercially available food products with at home up-dosing, thus increasing the availability of OIT for patients.

Monitoring for eosinophilic esophagitis in food oral immunotherapy.

Monitoring for eosinophilic esophagitis in food oral immunotherapy.

Food Sublingual Immunotherapy: Safety and Simplicity of a Real Food Updosing Protocol

BACKGROUNDSublingual immunotherapy (SLIT) using food extracts is safe and effective in desensitizing food allergy patients yet not often used in clinical practice. OBJECTIVESWe propose a cost-effective, expedited SLIT protocol using real food. METHODSFood allergy patients 5-50 years, median 11, initiated food SLIT in a single clinic setting. The daily maintenance dose was 4-11 mg protein in 0.1-0.5 ml volume, depending on the food. Some foods were available in liquid form at the local grocery (milk, egg white liquid, and cashew/walnut/sunflower/hazelnut milk), while others were prepared in the office using flour and 50% glycerin saline (peanut/sesame/wheat). The first cohort of 20 patients began dosing at a 1:1,000 dilution, the next 30 patients at 1:100 dilution. An exercise challenge was performed in a subset of patients on maintenance dosing to evaluate the need for a pre- or post-dose rest period. RESULTSThe 1:1,000 and 1:100 cohorts both completed day one without adverse reactions beyond itchy mouth. There were no systemic reactions requiring epinephrine throughout the study period and 88% reached their maintenance dose. Skin testing of 6-months-old peanut flour solution was not diminished from fresh solution and similar to food extract. Exercise challenge tests in 12 patients were negative. CONCLUSIONSAllergen extract food SLIT as used in published trials has limitations of cost and multiple office visits. Inexpensive real food, at the same or slightly higher protein dose, was well tolerated in 4 updose visits, a minimum of a week apart. Unlike food oral immunotherapy, a pre- or post-dose rest period may not be necessary.

Age-Related Food Aversion and Anxiety Represent Primary Patient Barriers to Food Oral Immunotherapy

BackgroundWhile oral immunotherapy (OIT) for food allergy is a reasonable treatment option, barriers to this procedure’s implementation have not been extensively evaluated from a patient perspective ObjectiveWe evaluated the barriers patients face during OIT administration, including anxiety and taste aversion, and evaluated the role of healthcare professionals, especially dietitians MethodsA survey in Canada and the US involved families currently enrolled in food OIT programmes ResultsOf responses from 379 participants, fear of reaction was the most common barrier to OIT initiation, with 45.6% reporting it being a “very significant” barrier with other fears reported. However, taste aversion represented the prominent obstacle to continuation. Taste aversion was associated with slower buildup (p=0.02), and reduction in dose (p=0.002). Taste aversion was a strongly age-dependent barrier for initiation (p<0.001) and continuation (p<0.002), with older children over 6 years of age reporting it as a very significant barrier (p<0.001). Boredom was reported as a concern for specific allergens such as peanut, egg, sesame, and hazelnuts (p<0.05), emphasizing the need for diverse food options. Notably, 59.9% of respondents mixed OIT foods with sweet items. Despite these dietary concerns, dietitians were underutilized, with only 9.5% of respondents having seen a dietitian and the majority finding dietitian support helpful with greater certainty about the exact dose (p<0.001) ConclusionsTaste aversion and anxiety represent primary patient-related barriers to OIT. Taste aversion was highly age-dependent, with older patients being more affected. Dietitians and psychology support were underutilized, representing a critical target to improve adherence and OIT success

Mobile App/Web Platform for Monitoring Food Oral Immunotherapy in Children: Longitudinal Clinical Validation Study.

Milk and egg allergies significantly impact the quality of life, particularly in children. In this regard, food oral immunotherapy (OIT) has emerged as an effective treatment option; however, the occurrence of frequent adverse reactions poses a challenge, necessitating close monitoring during treatment. This study aims to evaluate the ability of a new mobile/web app called OITcontrol to monitor milk and egg OIT. Patients undergoing milk or egg OIT were recruited and divided into 2 groups: the active group used the OITcontrol app in conjunction with standard written monitoring methods, whereas the control group relied solely on written diaries. Investigators documented hospital doses, hospital reactions, and administered treatments on the website. Patients recorded their daily allergen home-dose intake, home reactions, and administered treatments using the app. The following variables were compared between both groups: number and severity of hospital and reported home reactions, patient's adhesion to the OITcontrol app or written diary or both in terms of daily home-dose intake and home reactions recording, and treatment and dose adjustment compliance at home in case of reaction. Sixteen patients were assigned to be monitored using the OITcontrol app along with additional written methods (active group), while 14 patients relied solely on a written paper diary (control group). A similar distribution was observed in terms of sex, age, basal characteristics, allergen treated in OIT, premedication, and sensitization profile. Active patients reported a comparable number of hospital and home reactions compared with the control group. In terms of recording system usage, 13/16 (81%) active patients used the OITcontrol app, while 10/14 (71%) control patients relied on the written diary. Among active patients, 6/16 (38%) used both methods, and 1 active patient used only written methods. However, control patients recorded home reactions more frequently than active patients (P=.009). Among active patients, the app was the preferred method for recording reactions (59/86, 69%), compared with the written diary (15/86, 17%) or both methods (12/86, 14%; P<.001). Treatment compliance in home-recorded reactions was similar between both groups (P=.15). However, treatment indications after an adverse reaction were more frequently followed (P=.04) in reactions recorded solely in the app (36/59, 61%) than in the written diary (29/71, 41%) or both systems (4/12, 33%). Moreover, compliance with dose adjustments after a moderate-severe reaction in home-recorded reactions was higher in the active group than in the control group (P<.001). Home reactions recorded only in the app (16/19, 84%) were more likely to follow dose adjustments (P<.001) than those recorded in the written diary (3/20, 15%) or using both methods (2/3, 67%). The OITcontrol app appears to be a valuable tool for monitoring OIT treatment in children with food allergies. It proves to be a suitable method for recording daily home dose intakes and reactions, and it seems to enhance adherence to treatment indications following an adverse reaction as well as compliance with dose adjustments in home reactions. However, additional studies are necessary to comprehensively grasp the benefits and limitations of using the OITcontrol app in the management of OIT.

Food oral immunotherapy: Any distinguishing factors predicting the need of anti-IgE?

Oral immunotherapy (OIT) has gained popularity recently for IgE-mediated food allergy. Omalizumab (OMZ) has been used in patients (10–20%) who have too severe/frequent allergic reactions (AR) to continue OIT, to reduce these reactions. In this study, it was aimed to compare two groups of patients who completed OIT with and without OMZ and to seek determinants predicting the need of this treatment. It was also aimed to share the clinical findings regarding the long-term use of OMZ and the withdrawal process. Forty-one patients were started OIT and 93% could be desensitized. Two groups were similar in means of demographic characteristics, and clinical and laboratory findings. The patients who needed OMZ during OIT had also lower reaction doses during oral challenge (p = 0.037). Higher AR rate in this group declined after starting OMZ (p &lt; 0.001). The injection intervals of OMZ were gradually extended. Most patients were able to discontinue OMZ (81%). There were no severe reactions during drug withdrawal attempts. The low reaction thresholds during oral food challenge may give a clue about OMZ requirement during OIT. It may be an option to start the treatment before OIT if reaction was seen in the first few steps of the oral food challenge. For the sake of safety, extension of injection intervals should be preferred instead of abruptly stopping OMZ.

New Approaches to Food Allergy Immunotherapy

Food allergy is an increasing public health problem in children and adults. In addition to the risk of potentially severe reactions, food allergy can have a significant burden on quality of life, nutrition, cost of living, and social activities. Traditionally, treatment has primarily included strict food allergen avoidance and use of emergency medications to treat an allergic reaction. However, in recent years, there have been significant strides in the advancement of food allergy treatment, including the approval of the first and only approved therapy (peanut oral immunotherapy) for food allergy in 2020. Clinical trials have primarily focused on food allergen immunotherapy (oral, epicutaneous, sublingual). Building off of a foundation of promising data supporting the efficacy of food oral immunotherapy and our greater understanding of the underlying mechanism of immunotherapy, newer approaches, including alternative routes of delivery, adjuncts to therapy, modified allergens, and utilization in younger patients, aim to provide safer and more effective treatment approaches to the millions of patients burdened by food allergy.

Food Immunotherapy: Dissecting Current Guidelines and Navigating the Gray Zone.

Food allergy is a common, chronic disease that is burdensome for patients and families, with multiple dietary and social limitations and a significant psychological impact stemming from the fear of accidental exposures and potentially severe, life-threatening reactions. Until recently, the only management option consisted of strict food avoidance. Food allergen immunotherapy (food AIT) has emerged as an alternative, active intervention to strict food avoidance, with a multitude of research studies supporting its efficacy and good safety profile. Food AIT results in a raise of allergenic threshold, which provides several benefits to food-allergic patients, including protection from accidental exposures, potentially decreased severity of allergic reactions on unintentional exposures, and improvement in quality of life. In the last few years, multiple independent reports have been published proposing strategies to implement food oral immunotherapy in U.S. clinics, although formal guidelines are currently lacking. Because food immunotherapy is gaining traction, popularity, and interest among both patients and health care providers, many physicians look for guidance on how to implement this intervention in their daily practice. In other parts of the world, use of this treatment has prompted the development of various guidelines from allergy societies. This rostrum discusses currently available guidelines on food AIT from different areas of the world, describes and comments on their similarities and differences, and highlights unmet needs in this area of therapy.

Food Oral Immunotherapy: A Survey Among US Practicing Allergists Conducted as a AAAAI Leadership Institute Project and Work Group Report.

Food oral immunotherapy (OIT) is an active form of treatment for food allergies. Although research in this area has been ongoing for many years, the first US Food and Drug Administration-approved product for peanut allergy treatment became available only in January 2020. Limited data exist on OIT services offered by physicians in the United States. This workgroup report was developed to evaluate OIT practices among allergists practicing in the United States. The authors developed an anonymous 15-question survey and was subsequently reviewed and approved by the American Academy of Allergy, Asthma & Immunology Practices, Diagnostics and Therapeutics Committee before distribution to the membership. The American Academy of Allergy, Asthma & Immunology electronically distributed the survey to a random sample of 780 members in November 2021. In addition to questions specific to food OIT, the survey included questions on demographics and professional characteristics of the responders. A total of 78 members completed the survey, yielding a 10% response rate. Fifty percent of responders were offering OIT in their practice. There was a significant difference in experience in OIT originating from research trials in academic versus nonacademic centers. Generally, OIT practices were similar in both settings for the number of foods offered, the performance of oral food challenges before initiating treatment, the number of new patients to whom OIT was offered to per month, and age groups OIT to whom was offered. Almost all of the reported barriers to OIT were similar between settings: staff and time limitations, concerns about safety and anaphylaxis, the need for more education on how to perform, inadequate compensation, and that it was not a significant demand from patients. Clinic space limitations were significantly different and more prominent in academic settings. Our survey revealed interesting trends in the practice of OIT across the United States, with some significant differences arising when academic and nonacademic settings were compared.

Viewing Pediatric Food Oral Immunotherapy Through an Ethical Lens-A Narrative Systematic Review.

Food allergy remains a common problem and a lifelong condition for many children. In recent years food allergy management has increasingly involved conversations about food oral immunotherapy. While ethical considerations of autonomy, beneficence, non-maleficence, and justice implicitly inform these conversations, applying these principles can be complex, particularly in young children. Families of young children assume a role of surrogate decision maker and must balance immediate risks with the hope of longer-term benefits. To explore implementation of oral immunotherapy in children through an ethical lens. To evaluate OIT through an ethical lens, a literature search was conducted to explore currently published frameworks in this arena. Evaluation of the harm principle, the basic interest principle, and the best interest principle of parental decision making can be informative. Shared decision making continues to be central to the process of engaging with patient-family units to individualize the best care, at the right time, and minimize decisional discord. While OIT is well positioned to promote health and well-being, challenges to equity, sustainability, and organizational support must be considered to improve access for appropriate patients. While approaches to food OIT may be tailored to the individual context of each patient-family unit, ethical principles must guide decisions to initiate and continue therapy. Traditional ethical principles of autonomy, beneficence, non-maleficence, and justice remain cornerstones when considering the ethical context of OIT.

A 24‐h helpline for patients undergoing oral food immunotherapy: Lessons from Italian experience during the SARS‐CoV‐2 pandemic

A 24‐h helpline for patients undergoing oral food immunotherapy: Lessons from Italian experience during the SARS‐CoV‐2 pandemic

Comparing the risk of anaphylaxis requiring epinephrine in oral immunotherapy and subcutaneous immunotherapy: Areview of recent Canadian real-world literature.

The safety of pediatric food oral immunotherapy (Ped-OIT) has been depicted by some as less favorable than subcutaneous immunotherapy (SCIT) owing to the increased number of serious adverse events requiring epinephrine. Areview of real-world data comparing Ped-OIT and SCIT safety is necessary to guide shared decision making. Our aim was to compare the safety and adverse event profiles of peanut Ped-OIT and SCIT using Canadian real-word literature. We performed a retrospective review of recent Canadian real-world literature on peanut Ped-OIT and SCIT safety and adverse events. The incidences of systemic reactions requiring epinephrine were 11 in 270 patients (4.07%) and 12 in 41,020 doses (0.029%) in a multicenter study in British Columbia, Alberta, Manitoba, and Nova Scotia studying 270 preschool-age children treated with peanut OIT. Similarly, a multicenter study in South-Western Ontario examining 160 patients between the ages of 1 and 17 years who were treated with peanut OIT showed that the incidences of systemic reactions requiring epinephrine were 5 in 160 patients (3.1%) and 8 in 52,751 doses (0.015%). Asingle-center retrospective review of 380 patients receiving aeroallergen SCIT showed that the incidences of systemic reactions requiring epinephrine were 28 in 380 patients (7.4%) and 1 in 1047 injection visits (0.095%). These findings are comparable to those of a review of 860 patients in Ontario who received either aeroallergen or venom SCIT, in which the incidence of systemic reaction requiring epinephrine was 10 in 4242 injections (0.24%). Despite differences in the OIT protocols used and age groups studied, recent real-world data suggest that the safety of preschool peanut OIT or peanut OIT using a slower buildup schedule is comparable to that of SCIT.

Delayed‐type hypersensitivity gastrointestinal symptoms induced by food oral immunotherapy and efficiently treated by dupilumab: A case report

Delayed‐type hypersensitivity gastrointestinal symptoms induced by food oral immunotherapy and efficiently treated by dupilumab: A case report

L’importance de l’ETP pour une induction de tolérance orale alimentaire réussie

In the light of many children's difficulties to understand the goals of food oral immunotherapy (OIT) and to accept the fact of eating a food that was until then forbidden, we created a personal patient educational program dedicated to OIT. We present the course of this program, as well as the results of a study assessing its benefits through a patient survey conducted in 2020 on 50 children and their parents.

The Effects of Long-term Food Oral Immunotherapy on Compliance, Quality of Life, and Perceived Burden of Care

The safety and efficacy of food oral immunotherapy (OIT) has been extensively studied, however long-term maintenance OIT studies are limited. To better understand the durability of OIT long-term, larger studies on compliance, quality of life (QOL), and burden of treatment (BOT) are needed.

Value-Based, Cost-Effective Care: The Role of the Allergist-Immunologist

Asthma and allergic disease impact millions of patients and are associated with high costs. Up to 30% of all medical care involves wasted spending. Across the spectrum of care provided by the allergist-immunologist, there are opportunities to improve value and reduce medical waste. Several examples highlight this reality. Evidence suggests that most patients may receive cost-effective care in the management of chronic spontaneous urticaria without the need for laboratory testing. For patients with asthma, although a single maintenance and reliever therapy approach may be cost-effective, insurance-mandated therapy changes are not, and may harm patients. Biologics may be very effective in improving asthma control but are too expensive for this indication-as demonstrated by cost-effectiveness analyses and highlighted by the Institute of Clinical and Economic Review, which concluded that the value-based price for asthma biologics ranges between $6500 and 14,3000 per year. Early introduction may prevent food allergy, but screening before first introduction is neither necessary nor cost-effective, although early salvage food oral immunotherapy may result in improved quality of life and cost savings. Evidence does not support the presence of allergic disease as a risk factor for anaphylaxis to coronavirus disease 2019 vaccination, and risk-stratified vaccination approaches do not appear cost-effective. Allergen immunotherapy is a very cost-effective treatment option. The practice of allergy-immunology has continued to evolve in recent years and can provide a leading example of high-value practice.

Long-term medical treatment efficacy in patients with eosinophilic esophagitis and oral food immunotherapy.

Long-term medical treatment efficacy in patients with eosinophilic esophagitis and oral food immunotherapy.

Creating an (ethical) epistemic space for the normalization of clinical and "real food" oral immunotherapy for food allergy.

Researchers and sociologists have argued the consequences of standardization vis-à-vis clinical practice guidelines are diverse and argue they should be explored empirically. Sociologists have also argued that "best evidence" for the development of clinical practice guidelines is not restricted to randomized controlled trials and that other forms of knowledge should be embedded in and inform CPGs. There is little research concerning how other types of knowledge are mobilized and taken up in CPGs. This article presents the results of an ethnographic investigation in Canada between 2015 and 2020 of the development of a clinical practice guideline for immunotherapy for food allergy. My research shows that immunotherapy has become the source of controversy regarding whether immunotherapy should be offered in the clinic or remain experimental and whether it should be offered using food or commercial products. I argue that the clinical practice guideline for oral immunotherapy reaffirms what has been previously noted by sociologists; guidelines can serve normative purposes and are not merely technical documents. This case study is unique as it demonstrates how guidelines can serve as "community-making devices" to consolidate "epistemic communities" through the explicit and formal mobilization of ethical principles alongside other forms of "traditional" evidence. The mobilization of a multi-criteria approach that included ethical principles was mobilized in part to counter the de-legitimization and peripheralization of clinical and real food oral immunotherapy.

Optimal patient selection for oral immunotherapy.

Standard criteria for ideal patient selection with food oral immunotherapy (OIT) have yet to be determined. Although there are a handful of contraindications to consider before recommending OIT, most patients with confirmed immunoglobulin E-mediated food allergies are appropriate candidates. Success rates of OIT can vary widely and be influenced by several factors. Choosing the most appropriate candidate for an OIT program can mitigate risks and provide the best chance for patients to be successful.

Considerations for a shared decision-making conversation when initiating food oral immunotherapy.

Oral immunotherapy (OIT) is an office-based procedure that offers potential treatment of immunoglobulin E mediated food allergy. OIT has multiple benefits, e.g., the ability to desensitize the individual with food allergy, which shifts the eliciting dose threshold required in that individual to trigger an allergic reaction, and also potentially to decrease the severity of any resulting reactions. However, OIT is not a cure and has distinct risks, including the risk of allergic reactions (including anaphylaxis) from the therapy itself, the potential risk of developing eosinophilic esophagitis (or similar clinical symptoms without a formal biopsy), and logistical issues in coordinating when to give the daily dose, and there are still uncertain intermediate-to-long-term outcomes with regard to OIT. The decision to start OIT is complex and potentially nuanced. Shared decision-making is a process that allows the patient and family and the clinician to undergo a mutual discussion of the risks, benefits, alternatives, and other considerations with regard to a medical decision (such as starting OIT) whereby there is an exchange of information that allows the patient and family to formally clarify and express their values and preferences with regard to facets of the decision in this particular context. The goal is for the patient to be able to make a fully informed decision that is reflective of his or her goals, values, preferences, and desires. This article outlined some of the key considerations to discuss with parents and patients before enrolling in an OIT program with regard to the risks and benefits, to assist in engaging in shared decision-making and obtaining informed consent.