Accidental Peanut Exposure Research Articles

Recurrent acute pancreatitis in a patient with peanut allergy

Peanut allergy is a common food allergy. Accidental peanut exposure can induce anaphylactic symptoms in allergic individuals. In rare cases, pancreatitis can be induced by food allergies. This report describes a 12-year-old girl with recurrent acute pancreatitis (AP) following a peanut allergy induced 8 years after the first episode. The patient experienced the first episode of AP at 4 years old when she accidentally consumed peanut powder ice cream. AP was recurrently induced 8 years later by an oral food challenge test with a small amount of peanuts, despite decreased specific IgE for peanuts and Arah2. This report is the first to demonstrate that AP, as a peanut-induced symptom, is difficult to tolerate over a long period in a patient with peanut allergy. The possibility of AP induction after accidental ingestion, oral food challenge, or oral immunotherapy for peanuts should be considered in patients with peanut allergy.

Omalizumab (Xolair) for food allergy.

Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria,1,2 has now also been approved for use in conjunction with food allergen avoidance to reduce IgE-mediated food allergic reactions caused by accidental exposure in patients ≥1 year old. Omalizumab is the first drug to be approved in the US to reduce allergic reactions to more than one food. Palforzia, an oral peanut allergen powder, was approved in 2020 to mitigate allergic reactions caused by accidental peanut exposure in patients with a confirmed peanut allergy.

Peanut (Arachis hypogaea) allergen powder-dnfp for the mitigation of allergic reactions to peanuts in children and adolescents

ABSTRACT Introduction Peanut allergy can result in severe, sometimes fatal hypersensitivity reactions that place a considerable burden on the lives of patients. This article reviews the first approved immunotherapy for the mitigation of allergic reactions following accidental peanut exposure, peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia®, Aimmune Therapeutics). Areas covered This article highlights the unmet need for patients with peanut allergy, describes the therapeutic landscape, and reviews the development of and clinical data for PTAH. Expert opinion PTAH offers a standardized preparation of peanut allergen, with a tolerability and efficacy profile clearly defined through its robust clinical development and trial program. In children 4–17 years old, PTAH provides a standardized, approved product that many clinicians sought prior to initiating oral immunotherapy. PTAH reduced the likelihood of more severe reactions following exposure to peanut protein; although peanut avoidance remains essential, PTAH will enable more individuals with peanut allergy to participate in activities of daily life with less anxiety.

Safety of peanut (Arachis hypogaea) allergen powder-dnfp in children and teenagers with peanut allergy: Pooled summary of phase 3 and extension trials

Peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; previously known as AR101) is a daily oral immunotherapy approved to mitigate allergic reactions after accidental peanut exposure in peanut-allergic individuals aged 4-17 years. We sought to comprehensively summarize the PTAH safety profile for up to ∼2 years of treatment. Safety and adverse event (AE) data from participants aged 4-17 years from 3 controlled, phase 3 and 2 open-label extension trials were pooled and assessed. Of the 944 individuals receiving ≥1 PTAH dose, median exposure was ∼49 weeks; most participants experienced ≥1 treatment-related AE (TRAE; n= 853; 90.4%). Atotal of 829 participants experienced TRAEs with a maximum severity of mild (497, 52.6%) or moderate (332, 35.2%); 24 participants (2.5%) experienced TRAEs graded as severe. Overall, 80 participants (9.5%) discontinued as a result of AEs; most experienced gastrointestinal symptoms and discontinued during the first 6 months. When adjusted for exposure, AEs and TRAEs occurred at a rate of 76.4 and 58.7 events per participant-year of exposure (PYE), respectively, during updosing; AEs and TRAEs decreased to 23.0 and 14.2, respectively, during 300 mg maintenance. Overall, exposure-adjusted rates of systemic allergic reactions were 0.12 events/PYE (mild), 0.11 events/PYE (moderate), and 0.01 events/PYE (severe [anaphylaxis]). The safety profile of PTAH was consistent across trials, manageable, and improved over time. AEs were predominantly mild to moderate, and all grades declined in frequency with continued treatment. These data can be used to facilitate shared decision-making discussions with patients and families considering treatment with PTAH.

Incidence of anaphylaxis and accidental peanut exposure: Asystematic review.

BackgroundPeanut allergy (PA), a common food allergy, is increasing in prevalence and is associated with high rates of anaphylaxis. Prevalence of food‐related anaphylaxis is higher in children and adolescents than in adults, and the pediatric incidence is increasing. We conducted a systematic literature review and meta‐analysis to determine the incidence of peanut‐induced anaphylaxis in children and/or adolescents with PA.MethodsLiterature searches were conducted using the PubMed database and through supplemental methods. Eligible articles for inclusion were peer‐reviewed studies published in English that reported the incidence of anaphylaxis in pediatric PA using the 2006 National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network criteria, sample size, and follow‐up duration. Incidence rates were calculated as person‐years at risk or a crude incidence rate was calculated. Meta‐analyses of pooled data were conducted using the I 2 statistic as the measure of heterogeneity.ResultsA total of 830 citations were screened; 8 met the study inclusion criteria and were selected for review. Pooled meta‐analysis estimates of the incidence of (1) anaphylaxis among children/adolescents with food allergies, (2) anaphylaxis among children/adolescents with PA, and (3) accidental exposure to peanuts among children/adolescents with PA were 3.72 cases per 100 person‐years (95% confidence interval [CI] = 2.35, 5.10), 2.74 cases per 100 person‐years (95% CI = 1.42, 4.05), and 12.28 cases per 100 person‐years (95% CI = 11.51, 13.05), respectively.ConclusionsThe risks of anaphylaxis among children with food allergies and those with PA contribute to the serious overall burden of PA and food allergy for children and their families.

Safety of Peanut (Arachis Hypogaea) Allergen Powder-dnfp in Children and Teenagers With Peanut Allergy: Pooled Analysis From Controlled and Open-Label Phase 3 Trials

PeanuT (Arachis Hypogaea) allergen powder-dnfp (PTAH; previously known as AR101) is a once-daily oral immunotherapy recently approved by the FDA (PALFORZIA™) to mitigate allergic reactions following accidental peanut exposure in peanut-allergic individuals aged 4-17 years. Longer-term data will further characterize the PTAH adverse event (AE) profile.

The global burden of illness of peanut allergy: A comprehensive literature review.

Peanut allergy (PA) currently affects approximately 2% of the general population of Western nations and may be increasing in prevalence. Patients with PA and their families/caregivers bear a considerable burden of self‐management to avoid accidental peanut exposure and to administer emergency medication (adrenaline) if needed. Compared with other food allergies, PA is associated with higher rates of accidental exposure, severe reactions and potentially fatal anaphylaxis. Approximately 7%–14% of patients with PA experience accidental peanut exposure annually, and one‐third to one‐half may experience anaphylaxis, although fatalities are rare. These risks impose considerably high healthcare utilization and economic costs for patients with PA and restrictions on daily activities. Measures to accommodate patients with PA are often inadequate, with inconsistent standards for food labelling and inadequate safety policies in public establishments such as restaurants and schools. Children with PA are often bullied, resulting in sadness, humiliation and anxiety. These factors cumulatively contribute to significantly reduced health‐related quality of life for patients with PA and families/caregivers. Such factors also provide essential context for risk/benefit assessments of new PA therapies. This narrative review comprehensively assessed the various factors comprising the burden of PA.

Peanut Allergen Powder-dnfp: A Novel Oral Immunotherapy to Mitigate Peanut Allergy.

To review data on efficacy and safety of peanut allergen powder-dnfp (PAP; Palforzia), a novel oral immunotherapy for peanut allergy, a common food allergy. A PubMed/CINAHL search in English was performed from inception to June 30, 2020, using the search words peanut allergy, desensitization, ARA101, and peanut oral immunotherapy. Published phase 2 and 3 clinical trials, documents presented to the Food and Drug Administration, and supplemental study documentation were reviewed. Articles evaluated PAP's pharmacology, pharmacokinetics, mechanism of action, efficacy, and safety. PAP was efficacious and safe for treatment of peanut allergy in mostly Caucasian children, 4 to 17 years old. A key phase III clinical trial showed a statistically significant difference (primary end point) between PAP 600 mg and placebo groups (67.2% vs 4%; P < 0.001). During initial dose escalation and updosing phases, gastrointestinal and respiratory tract allergic reactions (ARs) were more common in the PAP group. More epinephrine rescue was used in the PAP group. Oral immunotherapy for desensitization of peanut allergy was shown to reduce the severity of reactions if accidental allergen exposure occurs. Risk evaluation and mitigation strategy certification is required for pharmacies, health care providers, and clinics. More data in real-world populations will enhance its effectiveness. In patients 4 to 17 years old, PAP mitigated ARs, including anaphylaxis, that may occur with accidental peanut exposure. Although there are risks, it was efficacious in more than two-thirds of participants in phase 2 and phase 3 efficacy trials.

Effect of Epicutaneous Immunotherapy Versus Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial

To assess the efficacy and adverse events of epicutaneous immunotherapy with a peanut patch among children with peanut allergy.The study included 356 children with peanut allergy aged 4 to 11 years without a history of severe peanut-related anaphylaxis who showed objective signs and symptoms of reactivity at an eliciting dose of ≤300 mg of peanut protein during a double-blinded, placebo-controlled food challenge.This study was a phase 3, randomized, double-blinded, placebo-controlled multicenter trial. Study participants were stratified into low- (≤10 mg) and high-eliciting dose (10–300 mg) subgroups on the basis of participants’ screening eliciting dose. Participants were then randomly assigned into groups receiving a daily epicutaneous patch containing 250 µg of peanut protein (n = 238) or a daily placebo patch (n = 118). Treatment response was defined as a posttreatment eliciting dose of ≥300 or ≥1000 mg of peanut protein for the pretreatment low- and high-eliciting dose subgroups, respectively. The treatment effect of the immunotherapy was determined by the response rate difference between the treatment and placebo groups after 12 months. A margin of 15% was selected as the lower bound of the 95% confidence interval (CI) for determining a positive trial result. The incidence of treatment-emergent adverse events (TEAEs) was also followed in each group.After 12 months, the response rates of the treatment (35.3%) and placebo (13.6%) groups were compared, showing a difference of 21.7% that was statistically significant (P < .001). However, the resulting lower bound of the 95% CI was 12.4%, which did not achieve the pretrial 15% criterion for clinically relevant significance. The incidence of TEAEs was 95.4% in the treatment group and 89% in the placebo group, in which application site reactions were the most common TEAE observed in both groups. There were 4 TEAEs in 3 treatment group participants that were classified as moderate anaphylactic reactions, all cases were appropriately treated, and 2 of these participants permanently discontinued the study.This study demonstrated a statistically significant difference between response rates of the peanut patch and placebo patch groups on the basis of eliciting doses during food challenges before and after the 12-month trial period. The results could not be considered a positive trial because the lower bound of the 95% CI was not met.Epicutaneous immunotherapy stands as a candidate for therapy for children with peanut allergy who would benefit from desensitization and lower risk of potentially life-threatening anaphylaxis resulting from accidental peanut exposure. Given sparse historical data for the assessment of food allergy immunotherapy trials, the lower bound criterion for the 95% CI in this study was set at 15% under US Food and Drug Administration guidance but is considered by some to be arbitrary in nature. The failure of this study’s results to meet this preset criterion signifies the results may not be clinically significant, despite showing a statistically significant difference in response rate between the treatment and placebo groups. Nevertheless, this treatment option may offer some clinical benefit to a vulnerable population, but this should be weighed on the generally low incidence of severe reactions in light of appropriate food avoidance. A longer trial, beyond the 12-month duration of this study, may prove to show clinically relevant results and may offer further insight into the maintenance of desensitization.

Current perspectives on peanut allergy.

Peanut allergy is increasingly prevalent and for most patients is a life-long condition, with the potential to cause life-threatening reactions. Accurate diagnosis and appropriate management are essential to minimise risks due to accidental peanut exposure. Current management strategies focus on strict allergen avoidance and access to emergency medicines to treat potential reactions; however, active approaches are an area of intense research. Promising new methods of food allergen immunotherapy are set to change the approach to managing peanut allergic patients in the near future.

Removal of peanut allergen Ara h 1 from common hospital surfaces, toys and books using standard cleaning methods.

BackgroundIn children, a diagnosis of peanut allergy causes concern about accidental exposure because even small amounts of peanut protein could trigger an allergic reaction. Contamination of toys, books or other items by peanut butter in areas where individuals have eaten may occur in hospital waiting rooms and cafeterias. It is not known if hospital cleaning wipes are effective in removing peanut allergen.ObjectivesThe purpose of this study was to determine whether cleaning peanut contaminated items with common household and hospital cleaning wipes would remove peanut allergen.Methods5 mL of peanut butter was evenly smeared on a 12 inch by 12 inch (30.5 by 30.5 cm) square on a nonporous (laminated plastic) table surface, a plastic doll, and a textured plastic ball, and 2.5 mL was applied to smooth and textured book covers. Samples for measurement of Ara h 1 were collected prior to the application of the peanut butter (baseline), and after cleaning with a common household wipe and two commercial hospital wipes. A monoclonal-based ELISA for arachis hypogaea allergen 1 (Ara h 1), range of detection 1.95-2000 ng/mL, was used to assess peanut allergen on each item. The samples were diluted 1:50 for testing.ResultsAt baseline, there was no detectable Ara h 1 allergen on any item at baseline. Detectable Ara h 1 was detected on all products after applying peanut butter (range 1.2-19.0 micrograms/mL).After cleaning with any product, no Ara h 1 was detected on any item.ConclusionsTable surfaces, book covers and plastic toys can be cleaned to remove peanut allergen Ara h 1 using common household and hospital cleaning wipes. Regular cleaning of these products or cleaning prior to their use should be promoted to reduce the risk of accidental peanut exposure, especially in areas where they have been used by many children.

Evaluation of IgE Antibodies to Recombinant Peanut Allergens in Patients with Reported Reactions to Peanut

Background: Peanut may cause severe reactions in allergic individuals. The objective was to evaluate IgE antibodies to various recombinant (r) peanut and birch pollen allergens in relation to IgE levels to whole peanut extract and severe allergic reactions to peanut. Methods: Seventy-four Swedish peanut-allergic patients (age: 14–61 years) reported previous peanut exposure and associated symptoms using a questionnaire. Their IgE reactivity to peanut, birch pollen and individual allergen components was analyzed using ImmunoCAP®. Results: Of the 48 subjects sensitized to Ara h 1, 2 or 3, 60% had peanut-specific IgE levels >15 kU_A/l, while 100% of the subjects without detectable IgE to these allergens had low peanut-specific IgE levels (<10 kU_A/l). The levels of IgE to rAra h 8, rBet v 1 and birch pollen were highly correlated (r_S = 0.94, p < 0.0001). Fifty-eight patients reported adverse reactions after accidental or deliberate peanut exposure (oral, inhalation or skin) of whom 41 had IgE to rAra h 1, 2 or 3. Symptoms of respiratory distress were associated with sensitization to Ara h 1, 2 or 3 (56 vs. 18%, p < 0.01). Two cases of anaphylaxis were reported among the individuals sensitized to Ara h 1–3. IgE to rAra h 8, rAra h 9, profilin or cross-reactive carbohydrate determinants were not associated with severe symptoms. Conclusions: The results indicate that IgE reactivity to Ara h 1, 2 and 3 is associated with severe reactions after exposure to peanut in Swedish patients.

Parental satisfaction with oral peanut food challenges; perception of outcomes and impact on management of peanut allergy

Oral peanut food challenges (OPFC) are the 'gold standard' for diagnosing peanut allergy in children. However, there are few data on parental perception of such challenges. We aimed to investigate the parental experience of and satisfaction with OPFC and reported dietary management of children with a history of peanut allergy following OPFC. Telephone interviews were conducted with parents of children who had undergone an open-label OPFC at a specialist paediatric allergy centre. Forty-six of 76 eligible parents participated. Of those parents, 54% were very satisfied with the OPFC. The highest levels of satisfaction were reported in relation to (i) clarification of the severity of the child's peanut allergy (ii) the support provided by staff and (iii) determining the child was tolerant of peanut or assessed to be at low risk of anaphylaxis from accidental peanut exposure. When the outcome of the challenge was perceived to be equivocal, levels of parental satisfaction were lower. Other areas of dissatisfaction included difficulties inducing peanut ingestion, parental distress at seeing their child unwell and perception of inadequate follow-up. Ninety-four per cent of parents could not remember the amount of peanut ingested, and 24% could not remember whether management advice was given after the OPFC or reported that none was given. Reported compliance with recalled advice to avoid peanut was found in all cases but one, whilst recalled advice to reintroduce peanuts following a negative challenge was followed in 5/9 cases. Although 12 parents reported that their child had an allergic reaction caused by accidental exposure to peanut since the OPFC, only four were certain peanut was the cause. Comprehensive education, counselling and follow-up subsequent to an OPFC are required. Parents of children whose challenge outcome is inconclusive should be targeted for support.

Food-induced Anaphylaxis: Who, What, Why, and Where?

Food-induced anaphylaxis is a leading cause of anaphylaxis treated in emergency departments and hospitals around the world. Peanuts, tree nuts, fish, and shellfish are the most commonly implicated foods. Food-induced anaphylaxis may occur in any age group and with any food. However, food-induced anaphylaxis fatalities disproportionately affect adolescents and young adults with peanut and tree nut allergy. Individuals who have both IgE-mediated food allergy and asthma are at a higher risk for food-induced anaphylaxis fatality. Delayed administration of epinephrine is also associated with fatal outcome. Often, in fatal reactions, the food allergen is unknowingly ingested away from home, in settings such as restaurants and schools. Although avoidance of food allergens is critical, timely administration of epinephrine is also of great importance in the treatment of food-induced anaphylaxis. Patients, families, and caregivers must be well educated regarding the signs, symptoms and risk factors for anaphylaxis. They must also be counseled on the importance of strict food avoidance of the implicated food allergens, compliance with having self-injectable epinephrine available at all times, and the importance of timely administration of epinephrine, even when cutaneous symptoms are lacking.

Update on Peanut Allergy in Children

Unlike other food allergies commonly seen in childhood, peanut allergy is often severe and life-long. The current literature on pediatric peanut allergy focuses on the increasing prevalence, risk factors, genetics and clinical characteristics. Diagnosis of clinically-relevant peanut allergy involves the combination of patient history with testing for the presence of peanut-specific IgE. There is currently no available cure for food allergy, so primary therapy concentrates on the prevention of exposure to peanut and readiness to manage a reaction. Life-saving treatment of anaphylaxis secondary to accidental peanut exposure involves immediate epinephrine injection. Future research will involve the generation of novel therapeutic approaches including immunotherapy and vaccinations, which will hopefully improve the quality of life for peanut-allergic patients and their families. This article reviews the latest reported findings and ongoing scientific research on these topics.

Parental adherence to peanut-free lunch guidelines in schools in Montreal, Canada

Rationale The increasing prevalence of peanut allergy and the potential for fatal reactions has led to controversial attempts to eliminate peanuts from some Canadian school classrooms by such measures as implementation of peanut-free lunches. Given that classes vary in their level of guideline enforcement, we examined the level of parental adherence to a policy of peanut-free lunches. Methods With parental consent, a dietician inspected lunches for peanut products in 14 primary school classrooms implementing peanut-free policies. Parents and students had not been informed of the date of inspection. Parents also completed questionnaires regarding knowledge of policies designed to achieve peanut-free schools. Results 333 parents were invited to consent to inspection of their children's lunches and to complete questionnaires. 167 agreed to inspections and completed questionnaires (kindergarten, grades 1 to 3: n=37, 45, 38, and 47, respectively). 36 completed questionnaires only. No peanut-containing substances were found in the lunches inspected (0%, 1-sided 97.5% CI, 0 to 2.3%). When parents allowing inspections were compared with those only completing questionnaires, there was no significant difference between levels of awareness of guidelines (95.8% [95% CI, 91.6%, 98.3%], and 94.4% [81.3%, 99.3%]). Parents not consenting to lunch inspections were as likely to have a peanut-allergic child in school as those consenting (8.3% [95% CI, 1.8%, 22.5%], and 10.8% [6.5%, 16.5%]). Conclusions Implementation of peanut-free guidelines was successful in the classrooms surveyed as measured by adherence to guidelines. However, further evaluation of their effectiveness in both eliminating peanut and decreasing accidental peanut exposure is required before widespread implementation.

The Natural History of Peanut Allergy in Young Children and Its Association with Serum Peanut-Specific IgE

Purpose of the Study. To characterize adverse reactions after accidental peanut exposure in young children with peanut allergy and to determine the usefulness of serum peanut-specific immunoglobulin E (IgE) levels during follow-up.Study Population. One hundred two children were identified who had clinical peanut hypersensitivity before 4 years of age. Inclusion criteria included 1) a convincing history of clinical peanut hypersensitivity and/or a positive double-blind, placebo-controlled food challenge (DBPCFC) response to peanuts and 2) a positive skin prick test response to peanuts.Methods. Research subjects were contacted at least yearly to track adverse reactions caused by accidental exposure to peanuts. Nineteen participants discontinued their participation in the study or were lost to follow-up, leaving 83 for inclusion in the analysis. Peanut-specific serum IgE levels were determined in 51 of 83 subjects using the Pharmacia CAP system (Uppsala, Sweden).Results. Thirty-one of 53 (58%) of the subjects followed for 5 years experienced adverse reactions from accidental peanut exposure. Regardless of the nature of their initial reaction, the majority with subsequent reactions (31/60; 52%) experienced potentially life-threatening symptoms. The group with isolated skin symptoms (11/51; 22%) had lower serum peanut-specific IgE levels (median: 1.25 kUa/L vs 11.65 kUa/L; P = .004; Wilcoxan rank sum) than the group with respiratory and/or gastrointestinal symptoms (40/51; 78%). There was no threshold level below which only skin symptoms appeared to occur. Of note, 4 subjects had negative DBPCFC results to peanuts during the follow-up period.Conclusions. The majority of children with peanut allergy followed for up to 5 years will have adverse reactions from accidental peanut exposure. Symptoms may not be consistent with symptoms reported during initial reactions. A minority of children with peanut allergy can lose their clinical hypersensitivity.Reviewer’s Comments. This report addresses 2 common questions asked by parents of children with peanut allergy: a) will the reactions become progressively worse? and b) will the reactions ever subside? Despite appropriate counseling on peanut avoidance, the majority of the children experienced an accidental peanut ingestion during follow-up. Moreover, initial clinical reactions involving only the skin can subsequently progress to involve the respiratory and/or gastrointestinal systems. A minority of subjects with low serum peanut-specific IgE levels developed oral tolerance to peanut. This investigation has expanded the growing body of evidence in this research area and has provided practical clinical information for addressing allergic reactions to peanuts. With the inevitability of accidental ingestions, the general trend for worsening of clinical reactions with subsequent exposures, and the inability to predict severity of future reactions, the take-home messages should be that all patients with peanut allergy need proper education about the potential seriousness of future accidental exposures and self-injectable epinephrine to manage future, severe allergic reactions.

A Voluntary Registry for Peanut and Tree Nut Allergy: Characteristics of the First 5149 Registrants

Purpose of the Study. To characterize adverse reactions after accidental peanut exposure in young children with peanut allergy and to determine the usefulness of serum peanut-specific immunoglobulin E (IgE) levels during follow-up. Study Population. One hundred two children were identified who had clinical peanut hypersensitivity before 4 years of age. Inclusion criteria included 1) a convincing history of clinical peanut hypersensitivity and/or a positive double-blind, placebo-controlled food challenge (DBPCFC) response to peanuts and 2) a positive skin prick test response to peanuts. Methods. Research subjects were contacted at least …

Subsequent reactions were common and often more serious than the initial reactions of children with peanut allergy

(2000) J Pediatr 137, 749. Vander Leek TK, Liu AH, Stefanski K, et al. . The natural history of peanut allergy in young children and its association with serum peanut-specific...

Children's adverse reactions to subsequent peanut exposure were often more serious than symptoms experienced in initial reactions

Vander Leek TK, Liu AH, Stefanski K, et al. The natural history of peanut allergy in young children and its association with serum peanut-specific IgE. J Pediatr2000 Dec; 137 :...