EpiPen Research Articles

Evaluation of the triggers and the treatment models of anaphylaxis in pediatric patients.

Anaphylaxis is an acute, life-threatening systemic hypersensitivity reaction. We aimed to evaluate the demographic and clinical characteristics of patients presenting with anaphylaxis, as well as triggers and risk factors, and to determine the rate of adrenaline auto-injector (AAI) usage. The study was planned in the pediatric allergy outpatient clinic over a 1-year period. The data of children diagnosed with anaphylaxis were evaluated retrospectively; demographic characteristics, causes of anaphylaxis, and treatment modalities were recorded in the created study form. Eighty children (29 females) with a median age of 6.5 years (range: 1 month-17 years) were evaluated. The most common triggers were foods under 2 years of age (73%), and drugs (70%) above 2 years of age. Nearly half of the anaphylaxis episodes (n=41, 51.3%) occurred at home. Cutaneous and respiratory symptoms were the most commonly reported complaints (98.8%). The median age of the patients at the first attack with severe anaphylaxis (n=29, 36.3%) was significantly higher than the rest (p:0.007). The age at onset of the reaction (p:0.006) and occurrence of the reaction in hospital conditions (p<0.001) were determined to be significant risk factors for severe anaphylaxis. Most of them received antihistamines (95.7%) and corticosteroids (91.3%), while 78.3% received adrenaline. Only 9.5% of patients with recurrent episodes of anaphylaxis used AAIs. Foods in infants and drugs in older children were the leading causative allergens of anaphylaxis. The most common clinical manifestations were respiratory and cutaneous symptoms. The older age at onset of the reaction and the occurrence of the reaction in hospital conditions were determined to be significant risk factors for severe anaphylaxis. It was determined that the frequency of AAI use was low among patients and their families.

Diagnosis and treatment of Hymenoptera venom allergy: S2k Guideline of the German Society of Allergology and Clinical Immunology (DGAKI) in collaboration with the Arbeitsgemeinschaft für Berufs- und Umweltdermatologie e.V. (ABD), the Medical Association of German Allergologists (AeDA), the German Society of Dermatology (DDG), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNOKC), the German Society of Pediatrics and Adolescent

Diagnosis and treatment of Hymenoptera venom allergy: S2k Guideline of the German Society of Allergology and Clinical Immunology (DGAKI) in collaboration with the Arbeitsgemeinschaft für Berufs- und Umweltdermatologie e.V. (ABD), the Medical Association of German Allergologists (AeDA), the German Society of Dermatology (DDG), the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNOKC), the German Society of Pediatrics and Adolescent

Management Of Anaphylaxıs In Pedıatrıc Populatıon.

Although an increase in the incidence of childhood anaphylaxis has been reported, it remains underdiagnosed. Foods are the most common triggers for anaphylaxis, particularly cow's milk, hen's egg, and nuts. Other common causes of anaphylaxis in children and adolescents include venom and drugs. The skin is the most commonly affected organ, but approximately 10% of patients with anaphylaxis may present without skin symptoms, which can lead to misdiagnosis. Recognition of anaphylaxis is a great challenge in children, possibly due to a lack of vigilance among patients, caregivers, and healthcare professionals, but also in part due to discrepancies in the clinical definition of anaphylaxis. In addition, anaphylaxis in infants often poses a distinct challenge because the wide spectrum of clinical manifestations and the inability of infants to describe their symptoms may hinder prompt diagnosis and treatment. Given the rapid onset of anaphylaxis and its unpredictable severity, rapid assessment and appropriate treatment are critical. Although the morbidity and mortality associated with anaphylaxis are potentially preventable with the timely administration of life-saving epinephrine, anaphylaxis is still undertreated worldwide. Long-term management of pediatric anaphylaxis is a patient-centered, multidimensional approach that focuses on the recognition of anaphylaxis, the use of epinephrine auto-injectors, and prevention of recurrences. Therefore, close communication and collaboration between the child, caregivers, healthcare professionals, and schools is the cornerstone of long-term care. This paper is designed to provide a comprehensive overview of current perspectives and concepts related to anaphylaxis in the pediatric population in light of recent guidelines and literature.

Imunoterapija kod pacijenata sa prvim tipom preosetljivosti na Hymenoptera venome

Hymenoptera venom allergy (HVA) is an anaphylactic reaction that occurs after the sting of Hymenoptera insects: honeybee (Apis mellifera), wasp (Vespula vulgaris) or hornet (Vespa crabo). Hymenoptera insects can cause IgE-mediated hypersensitivity reactions in insect-sensitized patients, ranging from local to severe systemic reactions and even fatal anaphylaxis. Systemic allergic reactions (SAR) after Hymenoptera insect stings have been reported in up to 7.5% of adults and up to 3.4% of children. They can be limited to the skin or cause severe reactions such as dizziness, dyspnea, nausea, and loss of consciousness, shock, cardiac or respiratory arrest. Patients with HVA are advised to carry an emergency kit consisting of an epinephrine auto-injector (AAI), H1-antihistamines and corticosteroids depending on the severity of the previous SAR. The only treatment that can potentially prevent SAR is immunotherapy with the appropriate venom (VIT). Venom immunotherapy (VIT) has been reported to be effective in 77%-84% of patients treated with bee venom and in 91%-96% of patients treated with wasp venom. The latest European Academy of Allergy and Clinical Immunology (EAACI) guidelines provide evidence-based recommendations for the use of VIT. It is recommended in children and adults who are hypersensitive to the venom because it leads to a significant improvement in quality of life-compared to wearing an adrenaline auto-injector. By receiving increasing doses of venom over 3 to 5 years, VIT leads to a change in the immune response and tolerance to the respective venom. Molecular diagnostics, which uses recombinant allergens, enables detection of true sensitization and thus improves the selection of appropriate venom for long-term VIT. This review aims to provide information on immunotherapy recommendations, as well as risk factors for SAR during and after VIT.

Anaphylaxis: Long-term management and resources.

Background: Anaphylaxis is an acute life-threatening event that requires emergent diagnosis and treatment. However, focus on prevention of anaphylaxis is essential in reducing anaphylaxis recurrences and associated mortality. Objective: This literature review was aimed to be a comprehensive resource for practicing allergists in managing anaphylaxis in the long term. We discussed the role of the allergist in the long-term outpatient management of anaphylaxis through identifying risk factors, allergen avoidance, prevention of recurrences, and patient education. Methods: A medical literature search that focused on several areas of long-term management of anaphylaxis was conducted. Results: Patients evaluated by an allergist are more likely to have their anaphylaxis trigger identified, to have their underlying mast cell disorder diagnosed, and to receive desensitization or allergen immunotherapy. Allergists can prevent fatal anaphylaxis by preventing and treating anaphylaxis in patients with ischemic heart disease and by optimally treating patients with comorbid asthma. Allergists can offer specific prevention strategies for allergenic trigger and cofactor avoidance. Education should be focused on patients with a higher risk for recurrence of anaphylaxis, such as those patients with a history of severe symptoms or anaphylaxis, with a peanut and/or tree nut trigger, or with a history of asthma, or female gender. Patient counseling involves providing individualized action plans at each visit and discussing proper use, storage, and safety of epinephrine autoinjectors. Multiple doses of epinephrine need to be prescribed to those who are at risk for severe food-induced, venom immunotherapy-related, or venom-induced anaphylaxis. Wording on medical identification products should be reviewed by the allergist. Anaphylaxis resources for health-care providers are summarized in the article. Conclusion: Ongoing education, providing personalized anaphylaxis action plans, reducing risk factors, and avoiding triggers are key to anaphylaxis prevention and long-term management.

Current situation of anaphylaxis in Japan: Data from the anaphylaxis registry of training and teaching facilities certified by the Japanese Society of Allergology – secondary publication

BackgroundAnaphylaxis is a potentially fatal severe systemic hypersensitivity reaction that causes symptoms in multiple organs such as the skin, respiratory tract, and gastrointestinal tract; however, no nationwide epidemiological survey on anaphylaxis has been conducted in Japan. This survey aimed to elucidate the triggers and treatment of anaphylaxis in Japan. MethodsBetween February 2015 and October 2017, we prospectively collected clinical data on the triggers and treatment of patients who developed anaphylaxis or were admitted to the emergency room with anaphylaxis in the training and teaching facilities of the Japanese Society of Allergology. ResultsThis study included 79 of the 451 affiliated facilities (18%), and a total of 767 patients were enrolled; 73% of them were aged <18 years and 7% had in-hospital triggers. The most common triggers were food (68%), drugs (12%), food-dependent exercise-induced anaphylaxis (5%), insects (4%), and oral immunotherapy (3%), with drugs being the most common in-hospital trigger and food being the most common out-of-hospital trigger. Intramuscular injection of adrenaline was administered therapeutically to 38% of the patients, with 10% requiring multiple doses. Adrenaline auto-injectors were used in 12% of out-of-hospital patients. ConclusionsThe present survey revealed the most common triggers and treatments for anaphylaxis in Japan. Self-management and adrenaline administration as first-line treatment may not be done sufficiently. Therefore, it is necessary to thoroughly educate and train patients and physicians about anaphylaxis.

Ethical Considerations Surrounding Employment Mandated Coronavirus Disease 2019 Vaccination and Allergy Skin Testing for the Coronavirus Disease 2019 Vaccine.

Ethical Considerations Surrounding Employment Mandated Coronavirus Disease 2019 Vaccination and Allergy Skin Testing for the Coronavirus Disease 2019 Vaccine.

Factors associated with home epinephrine-treated reactions during peanut and tree-nut oral immunotherapy

BackgroundHome reactions requiring epinephrine administration, a marker of their severity, restrict the widespread use of oral immunotherapy (OIT), but their risk factors are largely not known. ObjectiveTo identify risk factors for such reactions during OIT to most allergenic foods. MethodsAll patients who began OIT for peanut, tree nuts, sesame, or egg allergy at the Shamir Medical Center between April 2010 and January 2020 were enrolled. The patients were instructed to use their epinephrine autoinjectors during reactions consisting of severe abdominal pain, significant shortness of breath, or lethargy, or whenever in uncertainty of reaction severity. Patients with and without home epinephrine-treated reactions (HETRs) were compared. ResultsA total of 757 OIT treatments for peanut (n = 346), tree nuts (n = 221; walnut n = 147, cashew n = 57, hazelnut n = 16, almond n = 1), sesame (n = 115), and egg (n = 75) allergies were administered to 644 patients. Eighty-three (10.9%) patients experienced HETRs. The highest rate of HETRs was experienced during walnut (20.4%) or hazelnut (25%) OIT, followed by peanut (9.8%), sesame (6.1%), egg (6.7%), and cashew (5.3%) OIT. Risk factors for HETRs included a reaction treated in an emergency department (ER) (P = .005) before starting OIT and a reaction treated with epinephrine during in-clinic induction (P < .001). Significantly fewer patients with (73.6%) than without (88.3%) HETRs achieved full desensitization (P = .001), but only a few patients with HETRs (8.4%) failed treatment. ConclusionPrevious reaction severity is the main predictor for HETRs during OIT. These reactions are more frequent during walnut and hazelnut OIT than during OIT for other foods studied. Most patients experiencing HETRs achieved desensitization.

Pharmacokinetic and pharmacodynamic comparison of epinephrine, administered intranasally and intramuscularly: An integrated analysis

BackgroundManual intramuscular epinephrine injection is the standard of care for treating severe allergic reactions and anaphylaxis. Epinephrine autoinjectors were approved on the basis of the assumption that their pharmacokinetic and pharmacodynamic profiles are equivalent to manual intramuscular injection; however, although there is emerging evidence for product-related differences in pharmacokinetic profiles, very little is known about the comparative pharmacodynamic profiles. ObjectiveTo compare pharmacokinetic and pharmacodynamic profiles of epinephrine delivered through manual intramuscular injection, autoinjectors, and intranasal spray. MethodsThis integrated analysis was based on data from 4 randomized cross-over phase 1 trials that compared the pharmacokinetics and pharmacodynamics of epinephrine using manual intramuscular epinephrine 0.3 mg injection, epinephrine 0.3 mg autoinjectors (Symjepi and EpiPen), and epinephrine 1 mg intranasal spray (neffy). ResultsData from 175 participants showed that although neffy (1.0 mg intranasal spray) resulted in a maximum concentration (258 pg/mL) that was lower than or comparable with manual epinephrine intramuscular injection (254 pg/mL), Symjepi (438 pg/mL) and EpiPen (503 pg/mL), it led to comparable increases in systolic blood pressure (maximum effect [Emax], 16.9, 10.9, 14.9, and 18.1 mm Hg, respectively). The effect of neffy on diastolic blood pressure was also markedly more pronounced than that of other products (Emax, 9.32, 5.51, 5.78, and 5.93 mm Hg, respectively). ConclusionIntranasal delivery of epinephrine using neffy increases systolic blood pressure more efficiently than do manual intramuscular injection and epinephrine autoinjectors, despite lower maximum plasma concentrations.

Development and Evaluation of a Mobile Web-based Food Allergy and Anaphylaxis Management Educational Program for Parents of School-aged Children with Food Allergy: A Randomized Controlled Trial

This study aimed to develop a mobile web-based food allergy (FA) and anaphylaxis management educational program for parents of school-aged children with food allergies and evaluate its effectiveness. A mobile program was developed based on a web-based teaching-learning system model. Its effectiveness was subsequently evaluated using a parallel, randomized controlled pre- and post-test design. This study included 73 parents of school-aged children with food allergies. These parents were randomly assigned to either the experimental (n=37) or control (n=36) groups. The experimental group participated in a 2-week mobile web-based educational program that covered major topics in FA and anaphylaxis management. These topics included an understanding of food allergies and anaphylaxis, learning techniques for using an epinephrine auto-injector, and developing an emergency action plan. An educational booklet was provided to the control group. Participants completed a pre-test and two post-test questionnaires to evaluate the impact of the program. The assessment tools were the Food Allergy Knowledge Test, Food Allergy Self-Efficacy for Parents, and Food Management and Adaptation Scale. The data were analyzed using descriptive statistics, a test of homogeneity for the pre-test, an independent t-test, and repeated measures ANOVA. The experimental group experienced greater improvement in the knowledge of FA (post-intervention t=14.51, p<.001; 2weeks post-intervention, t=16.15, p<.001), FA self-efficacy (post-intervention t=77.99, p<.001; 2weeks post-intervention, t=76.09, p<.001), and practice behavior in FA management (post-intervention t=28.10, p<.001; 2weeks post-intervention, t=27.98, p<.001) after web-based FA education. This study revealed improvements in the knowledge, self-efficacy, and practice behaviors of parents regarding FA and anaphylaxis management. Therefore, the mobile web-based educational program can contribute to the effective management of food allergies and anaphylaxis for parents of school-aged children. CRIS registration: KCT0007491.

EPINEPHRINE AUTOINJECTOR UTILIZATION AND ACCESS IN A NATIONALLY REPRESENTATIVE FOOD-ALLERGIC ADULT SAMPLE

<h3>Introduction</h3> Food allergy (FA) affects over 32 million people in the United States. Timely epinephrine access is vital to treat FA-induced anaphylaxis. Research has demonstrated that only about half of FA patients have immediate access to epinephrine autoinjectors (EAIs). With the rising prevalence of adult-onset FA, more research is needed to understand epinephrine utilization in FA adults. <h3>Methods</h3> An online, IRB-exempt survey was developed by a multidisciplinary team of patient advocacy groups, physicians, caregivers, and survey methodologists to capture FA community needs. A nationally representative sample of adult FA patients was recruited by Evaluative Criteria Inc. in May 2022. <h3>Results</h3> 1,006 FA adults completed the survey. Among the sample, 61% self-identified as Caucasian, 16% as Black, 15% as Hispanic, and 7% as Asian, Native American, or Other. Only 52% of adults reported having ever been prescribed an EAI. The top reported reasons for access gaps were "my doctor did not indicate it was really needed," and "I don't believe I need it." A history of EAI prescriptions was highest among those with private health insurance (59% through employer, 68% self-purchased) and lowest among those on Medicare (48%) and Medicaid (51%). Only 33% of adults reported having an unexpired EAI, and fewer (25%) always had access to EAIs. <b>Thirty-six percent</b> of adults believe that EAIs can cause life-threatening side effects. On average adults reported paying $476 (SD = $971) out-of-pocket in the past year for EAIs. <h3>Conclusions</h3> Expanding EAI use and access among FA adults should be a priority for physicians, patient advocacy organizations, and beyond.

EPINEPHRINE NASAL SPRAY (ARS-1) AND INTRAMUSCULAR INJECTION: PHARMACOKINETIC/PHARMACODYNAMIC DIFFERENCES AND DIFFERENTIAL AFFINITIES FOR ADRENERGIC RECEPTORS

<h3>Introduction</h3> Although considered clinically indistinguishable, pharmacokinetics (PK) and pharmacodynamics (PD) between epinephrine intramuscular (IM) injection devices and manual IM injection are different. Differences in PD profiles of epinephrine products affecting blood pressure (BP) were investigated. <h3>Methods</h3> This integrated analysis was based on 4 randomized, cross-over, phase 1 studies (175 participants) comparing epinephrine manual IM 0.3 mg injection, epinephrine 0.3 mg injection devices, and epinephrine 1 mg nasal spray (ARS-1) once and twice dosing. IRB approval was obtained by all clinical sites. <h3>Results</h3> Highest mean C_max values (pg/mL) were observed following epinephrine auto-injector (503), with ARS-1 (258) comparable to manual IM (254), with the trend similar with twice-dosing. Mean systolic BP (SBP) E_max change from baseline (mm Hg) and heart rate (HR) E_max change from baseline (bpm) were comparable between ARS-1 (16.9 and 13.6, respectively) and epinephrine auto-injector (18.1 and 14.4, respectively) compared to IM (10.9 and 12.8, respectively), despite expecting that HR would correlate with epinephrine concentration due to lower affinity of β-adrenergic receptors. This trend was observed with twice dosing where mean C_max with ARS-1 and epinephrine auto-injector were 486 pg/mL versus 654 pg/mL, respectively, and mean SBP E_max (mm Hg) and HR Emax (bpm), respectively, were 25.9 and 22.6 with ARS-1 and 26.7 and 22.7 with epinephrine auto-injector. <h3>Conclusion</h3> ARS-1 increased BP more efficiently than epinephrine auto-injector or manual IM injection despite differences in C_max and t_max. This is likely due to bypassing β2 receptor-mediated vasodilatation in the skeletal muscle and stimulating β1 receptors to increase HR.

PHARMACOKINETICS/PHARMACODYNAMICS AFTER SINGLE AND REPEAT ADMINISTRATION OF ARS-1, EPINEPHRINE AUTO-INJECTOR, AND MANUAL INTRAMUSCULAR INJECTION

<h3>Introduction</h3> ARS-1, an intranasal (IN) epinephrine spray, is under development as a needle-free alternative to manual intramuscular (IM) injection and epinephrine injection devices for allergic reactions. <h3>Methods</h3> A two-part, single- and repeat-dose, randomized, crossover, phase 1 study of ARS-1 (2.0 mg), epinephrine auto-injector (0.3 mg), and IM injection (0.3 mg) was conducted in healthy volunteers. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters were examined. IRB approval was obtained for this study. <h3>Results</h3> Forty-two subjects were included. Following single dose, mean C_max values were 753, 481, and 339 pg/mL for auto-injector, ARS-1, and IM injection, respectively. Median t_max (minutes) was shortest for auto-injector (7.5), then ARS-1 (30), and IM injection (45). After repeat dosing, PK characteristics were similar for ARS-1 and auto-injector. C_max was 992 and 1000 pg/mL for both ARS-1 treatments (right/right and left/right naris), median t_max 30 minutes, and 840 pg/mL for auto-injector (left/right thigh), median t_max 15 minutes. After single dose, PD responses were greater for ARS-1 compared with auto-injector and IM injection. Mean systolic blood pressure, diastolic blood pressure, and heart rate E_max values, respectively, were greater for ARS-1 (23.6 mmHg, 8.1 mmHg, and 17.3 bpm) versus auto-injector (18.2, 5.62, and 12.3) and IM injection (11.9, 5.48, and 9.71). After repeat dosing, ARS-1 improved PD responses versus auto-injector and IM injection. <h3>Conclusion</h3> PK parameters of single dose ARS-1 single were bracketed by IM injection and auto-injector, with repeat dosing similar to auto-injector. ARS-1 (single and repeat dosing) PD parameters were superior to auto-injector and IM injection.

DELAYED, PERSISTENT ANAPHYLAXIS AFTER AN ALLERGY INJECTION

<h3>Introduction</h3> Delayed or biphasic anaphylactic reactions are rare. We report a delayed onset, prolonged anaphylactic reaction which occurred twelve hours after the first dose of allergen immunotherapy. <h3>Case Description</h3> 35 year-old male with allergic rhinoconjunctivitis and many positive serum aeroallergen tests initiated allergen immunotherapy for severe persistent symptoms despite treatment with Fluticasone, Cetirizine, and Azelastine. Twelve hours after his first allergy injection, he developed pruritus, took a diphenhydramine and went to sleep. When he awoke the next morning, his spouse noted that his face, back, and chest were erythematous and the pruritus continued. He had scattered urticaria as well. He developed wheezing 24 hours after the injection and then again approximately 72 hours later which he treated with an Albuterol MDI. He did not seek medical attention at any point, but took diphenhydramine which only helped temporarily. He notes that he just "ignored the symptoms." He had an Epi pen in his possession but did not use it. The itching and rash persisted for approximately ten days and the wheezing remitted within five. Allergy injections were not reinitiated. <h3>Discussion</h3> This is an example of late-onset anaphylaxis which lasted greater than a week, likely due to lack of appropriate medical treatment. It is important to educate our immunotherapy patients on the signs of anaphylaxis as well as the possibility that though rare, symptoms can be delayed. In addition, it is important to emphasize the need for prompt medical attention in such situations.

DANGERS AT THE DINNER TABLE – A REPORT OF ANAPHYLAXIS TO LION'S MANE MUSHROOM

<h3>Introduction</h3> We report the first case of anaphylaxis after ingestion of Lion's Mane Mushroom, <i>Hericium erinaceus</i>, a mushroom with increasing culinary popularity. <h3>Case Description</h3> A 43-year-old male experienced abdominal pain, diarrhea, hives and swelling within minutes of consuming the Lion's Mane Mushroom, <i>H. erinaceus</i>. Brussel sprouts, bok choy, and an alcoholic beverage made with pineapple juice were also consumed. After taking Benadryl, symptoms resolved over 24 hours. These foods and other mushroom varieties were previously eaten without allergic symptoms and also tolerated since the incident, with the exception of <i>H. erinaceus</i>. The remainder of history and physical examination were unremarkable. Extract skin prick testing wheel/flare (mm): positive control (histamine) 4/5, negative control (normal saline) 0/0, and fresh food testing using <i>H. erinaceus</i> was 3/3, in duplicate. Skin testing using mushroom extract was negative. Based on positive skin testing to <i>H. erinaceus</i> and history consistent with anaphylaxis, we report the first known case of Lion's Mane Mushroom allergy. The patient was diagnosed with allergy to <i>H. erinaceus</i>, advised to strictly avoid <i>H. erinaceus</i> containing foods, and prescribed an epinephrine auto-injector. <h3>Discussion</h3> Expanding culinary interest and incorporation of mushrooms into dishes, including meat substitutes at vegan restaurants, will expose more patients to the Lion's Mane Mushroom. We report the first case of Lion's Mane Mushroom Allergy.

PHARMACOKINETICS STUDY OF EPINEPHRINE SUBLINGUAL FILM: RESULTS FROM THE FORMULATION AND DOSAGE SELECTION

<h3>Introduction</h3> We have previously published the results from a first in human study that identified a prototype producing pharmacokinetics (PK) and pharmacodynamics (PD) of a sublingual film using a novel prodrug epinephrine (DESF). Three commercially viable formulations, across two dosage strengths each, are explored to establish a bridge to the lead formulation identified in a previous first in human study. <h3>Methods</h3> EPIPHAST is a randomized, open-label, three-part adaptive design, crossover study in healthy adult subjects comparing the PK and PD of DESF. In its Phase 1, multiple oral film formulations and dosage strengths of DESF were evaluated to identify an intended final formulation. Sixteen healthy volunteers were selected for each formulation and dosage, or a 0.5 mg IM injection of epinephrine for comparison. <h3>Results</h3> Seven different configurations were examined, and PK parameters were measured. The two best formulations of DESF (Formulation 5: 10 mg and 12 mg) rapidly reached clinically meaningful blood concentrations, with a median Tmax of 15 minutes and 22.5 minutes, respectively. Mean Cmax values were 285pg/mL and 268pg/mL for the two configurations, respectively. Formulation 5 at 12 mg produced results most comparable to both the first in human study as well as those reported for IM injections of epinephrine. The adverse event profiles and tolerability were similar across all formulations and dosage strengths. <h3>Conclusion</h3> The findings show that DESF formulations can deliver sufficient blood concentrations of epinephrine sooner than that observed with the higher dose of IM epinephrine injection in line with existing epinephrine autoinjectors and without concerns for safety or tolerability.

AN UNUSUAL TRANSITION FROM CUTANEOUS TO SYSTEMIC MASTOCYTOSIS IN A PEDIATRIC PATIENT

<h3>Introduction</h3> Cutaneous mastocytosis (CM) occurs when abnormal mast cells accumulate in the skin whereas in systemic mastocytosis (SM), accumulation also occurs in organs such as the gastrointestinal tract, liver, spleen, or bone marrow. A transition from CM to SM has not been previously described in the pediatric population. <h3>Case Description</h3> An eight-month-old female presented with a three-month history of diffuse hyperpigmented macules over her entire body and was found to have a normal tryptase level of 7 ug/L, consistent with a diagnosis of CM. At 2.5 years of age, cutaneous lesions significantly increased prompting repeat tryptase level, which was elevated at 34 ug/L. Subsequent testing for serum KIT D816V mutation was negative. Over the next six months, tryptase levels continued to increase (43 and 46 ug/L), raising concern for systemic involvement. At 3 years of age, repeat serum KIT D816V mutation testing resulted positive, prompting performance of a bone marrow biopsy. Bone marrow analysis revealed mildly hypocellular marrow, trilineage hematopoiesis, and aberrant mast cell clusters (>15 cells per aggregate expressing KIT, CD2, and CD25 on flow cytometry) without evidence of malignancy. These findings diagnosed SM. The patient has been treated with an antihistamine regimen, carries an epinephrine autoinjector, and has been advised on avoidance of potential triggers of mast cell degranulation. <h3>Discussion</h3> A diagnosis of CM in a pediatric patient does not rule out the possibility of transformation to SM. Despite normal baseline tryptase levels, minimal mediator symptoms, and lack of organomegaly, frequent and watchful monitoring may be warranted in some patients.

RACIAL DISPARITIES IN FOOD ALLERGY ANAPHYLAXIS EDUCATION AND MANAGEMENT AMONG A NATIONALLY REPRESENTATIVE SAMPLE

<h3>Introduction</h3> Evidence suggests that food allergy (FA) is disproportionately burdensome among racial/ethnic minority populations. More data are needed to evaluate disparities in access to high-quality medical care and effective daily management. <h3>Methods</h3> This online, IRB-exempt survey was developed by a multidisciplinary team of patient advocacy groups, physicians, caregivers, and survey methodologists. A nationally representative sample of adults with FA was recruited by Evaluative Criteria Inc. in May 2022. Only adults who reported a multi-system reaction suggestive of anaphylaxis to a top-nine allergen completed the survey. <h3>Results</h3> 1,006 Adults completed the survey. Sixty-one percent identified as Caucasian, 16% as Black, 15% as Hispanic, and 7% as Asian, Native American, or Other. Compared to Caucasian respondents, Black respondents were significantly (p<.05) less likely to recognize symptoms of anaphylaxis and the need to administer epinephrine immediately during anaphylaxis. Despite similar rates of access to epinephrine autoinjectors, Black respondents were less likely (p<.05) to immediately give epinephrine when they experienced anaphylaxis. Though both segments report seeing an allergist and primary care physician (PCP) for FA at similar rates, Black respondents were significantly (p<.05) less likely to report their doctor discussed anaphylaxis risk and significantly (p<.05) less likely to say the PCP provided a referral to an allergist. <h3>Conclusion</h3> Efforts are needed to close the gap in anaphylaxis education between Black and Caucasian FA adults.

Identifying Modifiable Predictors of COVID-19 Vaccine Side Effects: A Machine Learning Approach.

Side effects of COVID-19 or other vaccinations may affect an individual’s safety, ability to work or care for self or others, and/or willingness to be vaccinated. Identifying modifiable factors that influence these side effects may increase the number of people vaccinated. In this observational study, data were from individuals who received an mRNA COVID-19 vaccine between December 2020 and April 2021 and responded to at least one post-vaccination symptoms survey that was sent daily for three days after each vaccination. We excluded those with a COVID-19 diagnosis or positive SARS-CoV2 test within one week after their vaccination because of the overlap of symptoms. We used machine learning techniques to analyze the data after the first vaccination. Data from 50,484 individuals (73% female, 18 to 95 years old) were included in the primary analysis. Demographics, history of an epinephrine autoinjector prescription, allergy history category (e.g., food, vaccine, medication, insect sting, seasonal), prior COVID-19 diagnosis or positive test, and vaccine manufacturer were identified as factors associated with allergic and non-allergic side effects; vaccination time 6:00–10:59 was associated with more non-allergic side effects. Randomized controlled trials should be conducted to quantify the relative effect of modifiable factors, such as time of vaccination.

Knowledge Levels of Pediatric Assistants on Anaphylaxis Management and Adrenaline Autoinjector Application Skills: Pretraining and Posttraining Evaluation

Aim: The study aimed to evaluate the knowledge levels of pediatric residents about the treatment of anaphylaxis and the correct application skill of adrenaline auto-injector (AAI) and to determine the contribution of short-term training to this level.&#x0D; Material and Method: A questionnaire form was distributed to evaluate the basic information about the anaphylaxis treatment. And, all participants were asked to demonstrate the use of AAI using demo devices and mannequins. This assessment was considered a ‘Pre-Test’. At the end of the training, the steps of AAI use were re-evaluated. The data coming from this re-evaluation were recorded as ‘Post-Test’.&#x0D; Results: A total of 110 pediatric residents were included in our study. Most of the participants (94.6%) correctly knew that the first drug to be administered in the treatment of anaphylaxis was adrenaline. And also, 99.4% of the participants knew that adrenaline treatment should be administered intramuscularly. When asked where to apply adrenaline, 94.6 of the participants gave the correct answer. When the AAI application technique is evaluated with the pretest; It was observed that frequent mistakes were made in some steps. With the Post-Test applied after the training almost all the participants were able to complete the steps flawlessly&#x0D; Conclusion: It is important to increase the knowledge level, identify faulty steps, if any, and repeat the training of physicians who are obliged to supervise the AAI application technique of patients during outpatient follow-ups.