PURPOSE OF REVIEW:Food allergy immunotherapy strategies including oral, epicutaneous, and sublingual remain some of the most effective therapeutic options for food allergic patients and are currently the only therapeutic options that are expected to have the potential for long-lasting therapeutic benefits after therapy has ended. RECENT FINDINGS:Recent studies have identified novel ways of implementing food allergy immunotherapy, including the use of real-world foods for oral immunotherapy and sublingual immunotherapy. Other studies have uncovered key mechanisms for how these therapies induce desensitization to food allergens and sustained unresponsiveness. Notably, many of these mechanisms have the potential for monitoring or predicting therapeutic response. SUMMARY:The landscape of food allergy immunotherapy is changing to adapt to the shifting food allergy therapeutic landscape. Many studies are now shifting away from commercial or pharmaceutical products in order to increase accessibility with real world food options.

Oral immunotherapy (OIT) is effective for inducing desensitization to food allergens and continues to be investigated in many clinical trials, either alone or in combination with adjunct therapies. However, adverse events (AEs) such as gastrointestinal (GI) symptoms are common during OIT. These symptoms can pose a considerable management challenge for investigators adhering to clinical trial protocols with strict study windows where extended dosing interruptions are not feasible. GI symptom management practices in the previous clinical trials have usually been left to the discretion of each study site, resulting in a wide heterogeneity of management practices that could lead to substantial variability between sites. In the Omalizumab as a Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy (OIT) in Food Allergic Children and Adults (OUtMATCH) randomized controlled clinical trial (NCT03881696) assessing omalizumab and multiallergen OIT, a critical need for a unified approach for managing GI AEs was identified. To address this need, a subcommittee comprising investigators, both allergists and gastroenterologists, within and outside of the Consortium of Food Allergy Research, developed a working definition for persistent GI AEs during OIT along with a management plan to be used within the ongoing OUtMATCH trial. We present here the definition and management plan, along with illustrative case-based scenarios encountered during the trial. Implementing a management plan for GI AEs during OIT clinical trials has the potential to create standardization, enhance symptom monitoring, improve outcome classification, allow for stratification of AEs related to GI symptoms, and improve safety outcomes for study participants.

IgE-mediated food allergy and eosinophilic esophagitis (EoE) represent distinct yet interconnected manifestations of food-induced immune dysregulation. Rather than separate entities, emerging evidence supports a model that is on a continuum, in which clinical phenotypes are determined by antigen exposure patterns, dose, chronicity, and individual immune responses. This relationship has critical implications for food allergy immunotherapy, particularly oral immunotherapy. Among children with IgE-mediated food allergy, EoE prevalence is nearly 100-fold higher than the general population at 4.7%. During oral immunotherapy, gastrointestinal symptoms are common, with confirmed EoE developing in 1% to 10% of participants. Mechanistically, antigen avoidance favors IgE-mediated responses through T follicular helper cells, whereas sustained exposure promotes TH2-driven esophageal inflammation via pathogenic effector TH2 cells. Regulatory T-cell dysfunction appears central to this phenotypic switching. Clinical management requires risk stratification, systematic monitoring strategies, and individualized protocols that balance desensitization benefits against esophageal inflammation risks. Future directions include noninvasive diagnostic biomarkers, biologic therapies, and evidence-based prevention strategies. Understanding the food allergy-EoE continuum is essential for optimizing safety and efficacy of food allergen immunotherapy while minimizing complications.

BACKGROUND:The IMPACT trial (NCT01867671) demonstrated strong desensitization and the potential for remission with peanut oral immunotherapy (pnOIT) in 1- to 3-year-olds. Data on long-term outcomes of early intervention oral immunotherapy (OIT) are limited. OBJECTIVE:IMPACT-PLuS sought to assess the long-term efficacy, safety, and mechanistic changes related to early-life pnOIT. METHODS:Participants randomized in IMPACT (n = 146) were recruited. The primary outcome was long-term efficacy, defined as ongoing peanut consumption. Secondary outcomes included safety, peanut serology, and skin prick tests. Participants were categorized according to IMPACT treatment (pnOIT, placebo) and participation in any additional peanut allergy intervention apart from guidance given at the end of the IMPACT trial. Patients were grouped as follows: group A, pnOIT with no subsequent intervention; group B, pnOIT with subsequent intervention; group C, placebo OIT with no subsequent intervention; and group D, placebo OIT with subsequent intervention. RESULTS:Follow-up data were available for 78 of the 146 IMPACT participants (aged 9-14 years; 8-11 years after IMPACT enrollment). Fifty-eight received pnOIT in IMPACT. Overall, 80% (32/40) of group A were eating peanut at follow-up (48/58, 83%, of the entire IMPACT follow-up pnOIT group), with 35% (14/40) eating ≥1000 mg peanut. All 15 subjects from the IMPACT remission group were eating peanut at follow-up. Peanut reactions were reported by 35% (14/40) in group A, with epinephrine therapy received by 5. Compared with group C (placebo), group A had significantly lower levels of peanut and Ara h 2 IgE, and higher peanut and Ara h 2 IgG4. CONCLUSIONS:pnOIT initiated early in life can have long-term, sustainable impact, both clinically and immunologically.

The US Food and Drug Administration approval of omalizumab for the treatment of food allergy has opened the door for therapeutics targeting the underlying mechanisms that drive food allergy. Here we discuss both approved and novel investigational therapeutic strategies targeting these allergic pathways for the treatment of food allergy.

IntroductionShrimp is a common but understudied food allergen with relatively high rates of emergency department visits. Here we report the shrimp OIT outcomes in the MOTIF (NCT03504774) clinical trial and discuss some of the challenges with performing this study.MethodsIn this phase 2 clinical trial, 12 shrimp allergic participants aged 7–55 years (median age 21.5 years) were enrolled to receive shrimp OIT. Shrimp OIT was performed up to a maintenance dose of 1,000 mg shrimp protein by week 28 with desensitization to shrimp assessed by double-blind placebo-controlled food challenge at week 52 followed by switching to avoidance and assessing sustained unresponsiveness (SU) at week 58. The primary endpoint was the change in CD28 in CD4+ allergen specific (CD154+) T-cells at baseline and 52 weeks.ResultsShrimp OIT induced desensitization to a cumulative 4,043 mg shrimp protein in 58.3% (7/12) of the intention to treat and 87.5% (7/8) of the per protocol group after 52 weeks of shrimp OIT. Most shrimp OIT participants who remained in the study after desensitization (87.5%, 7/8) achieved SU. Although adverse events were common during shrimp OIT (75%), most were mild (Bock grade 1, 88%) and there were no severe (Bock grade 3+) reactions or use of epinephrine. No significant differences in CD28 expression were observed after shrimp OIT.ConclusionsShrimp OIT is safe and effective for the treatment of shrimp allergy. Most participants were successful and achieved SU after 6 weeks of avoidance.

Purpose of review This review aims to provide an overview of the current and future treatment options for children with food allergies (FAs), highlighting the latest research findings and the potential impact of these new approaches on improving patients’ and caregivers’ quality of life. Recent findings In the last decade, many promising approaches have emerged as an alternative to the standard avoidance of the culprit food with the risk of severe accidental reactions. Desensitization through oral immunotherapy has been introduced in clinical settings as a therapeutic approach, and more recently also omalizumab. In addition, alternative routes of administration for immunotherapy, other biologics, small molecules, probiotics or prebiotics, microbiota transplantation therapy, IGNX001, and PVX108 are being investigated. Summary The portfolio of available treatment options for food allergies is increasing but several relevant unmet needs remain. This review aims to provide a brief overview of the existing and future treatment options for IgE-mediated food allergies.

Access to the basophil activation test (BAT) has been hindered by the requirement for fresh blood analysis, specialized laboratory equipment, and advanced technical expertise. To address these issues, we have developed a hand-operated microfluidic sample preparation "μF-prep" device to perform the most time sensitive steps of the assay and stabilize the sample, effectively extending the time window before flow cytometry analysis. The μF-prep device performs concurrent basophil stimulation and staining for eight conditions in parallel. Barcoded staining of basophils allows the pooling of all conditions into one lyse/fix buffer tube for sample stabilization. After flow cytometry analysis, an XGBoost-enabled analysis pipeline unpools the eight conditions and generates basophil counts and activation levels directly from raw flow cytometry data. To characterize the μF-prep device, we stimulate whole blood samples from peanut-allergic and non-allergic donors. We compare μF-prep with a conventional BAT sample preparation protocol ("conv-prep"), and assess the stability of stimulated samples stored in the lyse/fix buffer. The μF-prep device performs sample preparation with <2 minutes of active user engagement. Our analysis pipeline shows excellent agreement with manual gating analysis. Compared with conv-prep, μF-prep exhibits similar activation levels at peanut doses of 1-100 ng mL-1, maximum activation levels, area under the dose response curve, and EC50 values. Activation levels of basophils from anonymous and presumed non-allergic donors in samples stored in the lyse/fix buffer for up to 7 days at 4 °C are similar to those analyzed on day 0. In summary, we demonstrate the potential of μF-prep to facilitate access to the BAT by simplifying sample preparation, stabilizing samples to remove the need for overnight blood shipping for flow cytometry analysis, and automating the data analysis pipeline.

BACKGROUND:Owing to limited treatment options for peanut allergy, patients remain at risk for allergic reactions due to accidental exposure. Epicutaneous immunotherapy (EPIT) is a novel treatment being investigated for peanut allergy. OBJECTIVE:This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial. METHODS:REALISE was a phase 3 trial in peanut-allergic children aged 4 through 11 years that included a 6-month, randomized, double-blind, placebo-controlled treatment phase, followed by an open-label, single-arm, active treatment period for up to 36 months. RESULTS:Of the 392 participants (male 54.8%; median age 7.2 y) who received at least 1 dose of treatment, 77.8% completed the 36-month active treatment. Mean adherence to treatment was high at 96.4%. Most participants (98.7%) experienced at least 1 treatment-emergent adverse event (TEAE); the majority were mild or moderate and decreased in frequency and severity over time. Most participants (94.6%) experienced at least 1 treatment-related TEAE. Local skin reactions were the most common treatment-related TEAE with the incidence decreasing from year 1 (87.8%) to year 3 (19.2%). Serious treatment-related TEAEs were reported in 2 participants. No specific safety signals were identified in the 14 participants enrolled with a history of severe anaphylaxis (Anaphylaxis Staging System grade 3). CONCLUSION:Consistent with previous phase 3 studies, long-term EPIT with VIASKIN peanut patch 250 μg was well tolerated with high adherence in peanut-allergic children aged 4 through 11 years (clinicaltrials.gov; NCT: NCT02916446).

BackgroundWe designed an oral immunotherapy (OIT) clinical trial for cashew allergy to further our understanding of immunological responses with treatment, including changes in allergen-specific T cells. This information can further assist with the design of efficacious and safe treatments.MethodsParticipants were built up to and maintained on 1 g of cashew flour protein. Double-blind, placebo-controlled food challenges (DBPCFCs) were conducted before and after dosing completion (week 52) and 6 weeks after dosing discontinuation (week 58). Desensitization (DS) and sustained unresponsiveness (SU) were defined as tolerating DBPCFC to a cumulative dose of 2043 mg of the allergen at weeks 52 and 58, respectively. ClinicalTrials.gov, number NCT03504774.ResultsWe enrolled 40 cashew allergic participants. In the Intent-to-treat (ITT) population, both the DS and SU rate to cashew was 65% (26/40). Among cashew-reactive cells, CRTH2+ CD4+ T cells decreased at week 52 and week 58 compared to baseline. Additionally, we also saw reduced baseline expression of cytokines TARC, EGF and IP10 among participants that achieved SU at 4043mg compared to those who achieved SU at 2043mg.ConclusionCashew OIT have efficacy and safety outcomes similar to other published OIT studies. Reductions in pathogenic allergen-specific T cell populations may contribute to the immune mechanisms underlying tolerance achieved towards cashew post-treatment.Clinical trial registrationClinicalTrials.gov, identifier NCT03504774.

BACKGROUND:The pivotal phase 3 EPITOPE trial, a 12-month, double-blind, placebo-controlled study of epicutaneous immunotherapy with the VIASKIN patch containing 250 μg of peanut protein (VP250), previously reported significant treatment response versus placebo in peanut-allergic toddlers aged 1 through 3 years. OBJECTIVE:To assess the interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study. METHODS:Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results. RESULTS:A total of 266 EPITOPE participants enrolled in the OLE study; 244 underwent month 24 DBPCFC (n = 166 VP250; n = 78 placebo). After 24 months of VP250, 81.3% reached an eliciting dose (ED) ≥1000 mg, 63.8% reached an ED ≥2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. No treatment-related anaphylaxis or serious treatment-related adverse events occurred during year 2 in this treatment arm. Local application-site reactions occurred less frequently in year 2 versus year 1. In placebo-treated EPITOPE participants, outcomes after 1 year of open-label VP250 were consistent with EPITOPE treatment results: 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, and 28.4% completed the DBPCFC without meeting stopping criteria; and there was 1 treatment-related anaphylaxis event. CONCLUSIONS:Two years of VP250 in young peanut-allergic children demonstrated continued increases in treatment effect without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children. CLINICALTRIALS:GOV: NCT03859700.

The recent United States Food and Drug Administration (FDA) approval of omalizumab for the treatment of food allergy has highlighted the potential of targeting the allergic pathways driving food allergy. Many promising therapeutic strategies are emerging that target different aspects of these pathways including immunoglobulin E, interleukin-4 receptor α, alarmins, and Bruton's tyrosine kinase. Several of these novel therapeutics have already been FDA approved for the treatment of other atopic diseases, greatly facilitating their potential translation to food allergy. Further research on these therapeutics can expand the tools available to allergists allowing them to better tailor therapeutics to the specific circumstances and needs of their patients.

Background: Data on severity of food allergy across nations are lacking. Building on the World Allergy Organization (WAO) DEFASE (Definition of Food Allergy Severity) score, we aim to explore its global applicability as a grading system for IgE-mediated food allergy (FA) severity. Methods: An international survey (WAO FASE Project) was conducted using an online questionnaire distributed to WAO members. The survey collected detailed data on diagnostic practices, therapeutic options, characteristics of FA patients, severity of reactions (including anaphylaxis), and eliciting doses of allergenic foods. In addition, FA management costs were examined (medical expenses, medication costs, and impact on quality of life and productivity). Results: We obtained information from 157 centers in 50 countries. FA management varied significantly across regions. Oral immunotherapy and omalizumab are widely used in Europe and North America. The use of advanced diagnostic tests (molecular diagnostics) vary widely between these regions. Thirty-five percent of patients with anaphylaxis exhibited severe symptoms (respiratory or cardiovascular compromise), with marked regional differences: more frequent in Western Asia (55.83%), Southern Africa (50%), and less frequent in South-Eastern Asia (12.5%) and Central America (21.72%). Approximately 1 in 4 patients reacted to less than half an age-appropriate portion of the allergenic food. Depending on the region, peanut, milk, egg, wheat, hazelnut, and peach allergies varied considerably. Economic resources and healthcare systems play an important role in determining access to diagnostic tests and therapeutic options, which have a direct impact on the severity and management of FA. Conclusions: With wide global disparities in access to diagnostic and therapeutic tools for food allergies, this condition entails a vast healthcare and economic commitment. The percentage of patients receiving a high severity diagnosis using DEFASE could be around 3%, similar to that of asthma patients diagnosed with severe refractory asthma.

Food allergy poses substantial social, economic, and quality of life burdens which are even heavier for families that are struggling with food insecurity. In the United States (US), food insecurity disproportionately affects vulnerable and historically marginalized communities, such as Latino/a/x and Black households. Targeting these disparities via our recent Food Equality Initiative (FEI) research intervention was challenging due to the barriers faced by the target underserved populations, which included poor digital literacy, language barriers, and limited access to necessary resources. These barriers hindered our efforts to promote access to nutritious and safe food options for food-insecure families, potentially further exacerbating health disparities. Here we discuss common challenges and opportunities associated with conducting research interventions in underserved communities in the US—leveraging our experiences designing and implementing an intervention to improve food allergy management through supplemental nutrition assistance in a predominantly Spanish-speaking, lower-income neighborhood in Northern California. We also provide recommendations for other researchers regarding how to tailor research strategies to address these challenges, and in so doing reduce health disparities and promote positive health outcomes for vulnerable and historically marginalized communities.

Background: Management of patients with food allergies is complex, especially in cases of patients with multiple and potentially severe food allergies. Although international guidelines exist for food allergy management, the role of the allergist in the decision-making process is key. Objective: Our aim was to investigate the management patterns and educational needs of practicing allergists treating patients with food allergies. Methods: An online survey was e-mailed to United States-based practicing allergists (N 5 2833) in November-December 2021. The allergists were screened for managing 1 or more patients (including >= 25% pediatric patients) with food allergies per month. The allergists responded to questions regarding food allergy management in response to 2 hypothetical pediatric case studies, their familiarity with available guidelines and emerging treatments, and their future educational preferences. A descriptive analysis of outcomes was conducted. Results: A total of 125 responding allergists (4.4%) met the eligibility criteria and completed the survey. The allergists prioritized written exposure action plans, patient-caregiver communication, prevention of serious reactions, and consideration of both food allergy severity and allergic comorbidities in the management of patients with food allergies. With regard to recommending biologics in the future, the allergists identified patient history of anaphylaxis and hospitalizations, food allergy severity, and allergic comorbidities as all being important factors to consider when deciding on appropriate treatment options. The allergists noted their ongoing educational needs, especially for current and emerging treatments for food allergies. Conclusion: With the treatment landscape for food allergies evolving rapidly, the decision-making priorities and continuing educational needs of allergists will be important in optimizing the management of patients with food allergies.

The IMPACT trial (NCT01867671) demonstrated strong desensitization and the potential for remission with peanut oral immunotherapy (OIT) in 1–4-year-olds. Data on long-term outcomes of early intervention OIT are limited. Eligible participants had previously been randomized in IMPACT (n=146). The primary outcome was long-term efficacy, defined as ongoing peanut consumption. Key secondary outcomes include safety and risk perception. Follow-up data was available for 39 participants ages 9-13 years (5-9 years after completion of IMPACT). At study completion, 25/39 were advised to introduce dietary peanut. At follow-up, 22/25 were eating peanut and 3/25 had returned to avoidance. Most reported eating a single type of peanut product, with 17/23 eating ≥ 3 times per week, 11 daily. Ingested peanut amounts varied with a maximum of: > 4000mg (n=4), 1000-4000mg (n=6), 300-1000mg (n=11), and <300 mg (n=1) in one serving. Gaps of 1-60 days (median 8 days) in exposure were reported. Compared to the initial end-of-study recommendations, the amount ingested was the same (n=15), less (n=8), or more (n=2). 9/25 reported ≥1 peanut reaction since the end of the study; 2 reported symptoms with most exposures and 5/9 needed epinephrine at least once. Overall, participants reported less perceived risk since the start of the IMPACT study. Five plus years after completing a peanut OIT trial as a young child, peanut remains in the diet for 88% of those given home recommendations, higher than seen in most prior OIT follow-up studies. Vigilance is still required with 1/3 of children reporting symptoms including those requiring epinephrine.

Despite the success of peanut oral immunotherapy (OIT), there is little insight into the safety, efficacy, and immune underpinnings of OIT to treat cashew or shrimp allergy. Cashew or shrimp allergic participants aged 7-55 years were enrolled in the phase 2 clinical trial - MOTIF (NCT03504774) and underwent cognate allergen-specific OIT to a maintenance dose of 1,000 mg until week 52. Oral food challenge (OFC) at weeks 52 and 58 evaluated desensitization and sustained unresponsiveness (SU) respectively to a cumulative allergen dose of 2043 mg. We examined immune changes in allergen-reactive CD4+ T cells and plasma at baseline, week 52, and week 58 using flow cytometry and Luminex. We enrolled 40 cashew and 12 shrimp allergic participants, of whom 25 cashew-treated (62.5%) and 7 shrimp-treated (58.3%) participants completed and passed week 58 OFC. Overall, cashew and shrimp OIT was safe with only mild (90%) or moderate (10%) adverse events, with gastrointestinal symptoms (31%) being the most common. OIT induced a significant increase in allergen-specific IgG4 at week 52 (q < 0.1). A trend of downregulation of Th2 and Th1 surrogate marker CRTH2 and CXCR3-expressing allergen-reactive CD4+ T cells was evident in cashew- and shrimp-treated participants respectively at week 52. Higher baseline plasma levels of TARC, EGF, and IP10 implied a lower likelihood of SU. Cashew and shrimp OIT could safely desensitize allergic study participants to respective allergen protein. Mechanistic analyses confirm readouts linked to successful desensitization and offer potential biomarkers for predicting SU that warrant further investigation.

Background Food allergies are common and are associated with substantial morbidity; the only approved treatment is oral immunotherapy for peanut allergy. Methods In this trial, we assessed whether omalizumab, a monoclonal anti-IgE antibody, would be effective and safe as monotherapy in patients with multiple food allergies. Persons 1 to 55 years of age who were allergic to peanuts and at least two other trial-specified foods (cashew, milk, egg, walnut, wheat, and hazelnut) were screened. Inclusion required a reaction to a food challenge of 100 mg or less of peanut protein and 300 mg or less of the two other foods. Participants were randomly assigned, in a 2:1 ratio, to receive omalizumab or placebo administered subcutaneously (with the dose based on weight and IgE levels) every 2 to 4 weeks for 16 to 20 weeks, after which the challenges were repeated. The primary end point was ingestion of peanut protein in a single dose of 600 mg or more without dose-limiting symptoms. The three key secondary end points were the consumption of cashew, of milk, and of egg in single doses of at least 1000 mg each without dose-limiting symptoms. The first 60 participants (59 of whom were children or adolescents) who completed this first stage were enrolled in a 24-week open-label extension. Results Of the 462 persons who were screened, 180 underwent randomization. The analysis population consisted of the 177 children and adolescents (1 to 17 years of age). A total of 79 of the 118 participants (67%) receiving omalizumab met the primary end-point criteria, as compared with 4 of the 59 participants (7%) receiving placebo (P<0.001). Results for the key secondary end points were consistent with those of the primary end point (cashew, 41% vs. 3%; milk, 66% vs. 10%; egg, 67% vs. 0%; P<0.001 for all comparisons). Safety end points did not differ between the groups, aside from more injection-site reactions in the omalizumab group. Conclusions In persons as young as 1 year of age with multiple food allergies, omalizumab treatment for 16 weeks was superior to placebo in increasing the reaction threshold for peanut and other common food allergens.

Asthma affects 25 million people in the United States, and its prevalence is increasing. Access to care and adherence to prescribed asthma-treatment programs remain the principal formidable challenges for asthma management. Telemedicine offers substantial opportunities for improved asthma care of patients across the full range of socioeconomic strata. Ever-improving digital tools for asthma assessment and treatment are key components of telemedicine platforms for asthma management. These include a variety of remote patient-monitoring devices, digital inhaler systems, and mobile-health applications that facilitate ongoing assessment and adherence to treatment protocols. Digital tools for monitoring treatment focus on tracking medication use, inhalation technique, and physiological markers such as peak-flow rate and pulse-oximetry. Telemedicine visits allow for elements of assessment via video, approximating or duplicating many aspects of in-person visits, such as evaluating a patient's general appearance, breathing effort, and cough. Challenges remain in ensuring equitable access to these technologies, especially in rural and low-income areas, and in maintaining patient privacy and data security in digital platforms.

At least one-third of children in the United States with food allergy have more than one allergy. Compared to individuals with a single food allergy, those with multiple allergens have increased burden of disease, as multiple foods can put them at risk for an allergic reaction following accidental ingestion. Oral immunotherapy (OIT) has shown promise and is now FDA approved to desensitize children with peanut allergy. OIT has also shown promise as a therapy for those with multiple food allergies, both alone and in combination with biologic therapies, including the most studied biologic—Omalizumab. OIT can be done simultaneously with multiple foods with comparable safety to single allergen OIT. Pilot studies have shown that adjunctive therapy with omalizumab can increase rates of successful desensitization in multi-food OIT, increase speed of desensitization to high maintenance doses, and reduce associated symptoms. Multi-food OIT with and without omalizumab has also been shown to improve quality of life measures in participants and caregivers. Additional potential therapies such as other biologics targeting the Th2 response, cross desensitization of allergens, and early prevention may be part of the multi-faceted approach for our food allergic patients.