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• W4282971867 abstract "The United States surpassed 54,000,000 total cases of coronavirus disease 2019 (COVID-19) by the end of 2021.1Centers for Disease Control and Prevention. Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory. 2022. Available at: https://covid.cdc.gov/covid-data-tracker/#trends_totalcases. Accessed February 9, 2022.Google Scholar During early pandemic contingency planning, recommendations were published advising the suspension of routine emergency department (ED) use after home treatment of anaphylaxis responding to a single dose of epinephrine provided symptoms promptly resolve without recurrence.2Shaker MS Oppenheimer J Grayson M Stukus D Hartog N Hsieh EWY et al.COVID-19: pandemic contingency planning for the allergy and immunology clinic.J Allergy Clin Immunol Pract. 2020; 8 (e5): 1477-1488Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar Shortly thereafter, a detailed anaphylaxis management algorithm tailored to at-home management during the COVID-19 pandemic was published.3Casale TB Wang J Nowak-Wegrzyn A. Acute at home management of anaphylaxis during the Covid-19 pandemic.J Allergy Clin Immunol Pract. 2020; 8: 1795-1797Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar These adaptations were devised with the goal for more selective health care utilization, so as to minimize risk of COVID-19 acquisition and to avoid overburdening health care facilities. An important underpinning for these guidelines is the perceived low risk to initial home observation after successfully treated anaphylaxis, on the basis of simulated economic modeling for peanut-triggered anaphylaxis.4Shaker M Kanaoka T Feenan L Greenhawt M. An economic evaluation of immediate vs non-immediate activation of emergency medical services after epinephrine use for peanut-induced anaphylaxis.Ann Allergy Asthma Immunol. 2019; 122: 79-85Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar Though the extent to which such adapted guidelines are currently in use by allergy providers remains unclear, each successive wave of SARS-CoV-2 has continued to heighten the importance of critical analysis of reflexive health care utilization practices for the management of anaphylaxis.A rationale for post-reaction monitoring in the ED is the rapid detection and management of biphasic anaphylaxis. Yet, biphasic reactions are rare (0.18%-14.7% of anaphylaxis events) and possibly trigger-specific.5Shaker MS Wallace DV Golden DBK Oppenheimer J Bernstein JA Campbell RL et al.Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis.J Allergy Clin Immunol. 2020; 145: 1082-1123Abstract Full Text Full Text PDF PubMed Scopus (201) Google Scholar When food is implicated as a trigger for anaphylaxis, Lee et al6Lee S Bellolio MF Hess EP Erwin P Murad MH Campbell RL. Time of onset and predictors of biphasic anaphylactic reactions: a systematic review and meta-analysis.J Allergy Clin Immunol Pract. 2015; 3 (e1-e2): 408-416Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar reported in 2015 a protective effect for biphasic anaphylaxis (odds ratio, 0.62 [0.4-0.94]), though this was not redemonstrated in a recent analysis (odds ratio, 0.89 [0.68-1.17]).5Shaker MS Wallace DV Golden DBK Oppenheimer J Bernstein JA Campbell RL et al.Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis.J Allergy Clin Immunol. 2020; 145: 1082-1123Abstract Full Text Full Text PDF PubMed Scopus (201) Google Scholar To explore this question in the context of revised definitions of anaphylaxis,7Dribin TE Sampson HA Camargo CA Jr Brousseau DC Spergel JM Neuman MI et al.Persistent, refractory, and biphasic anaphylaxis: a multidisciplinary Delphi study.J Allergy Clin Immunol. 2020; 146: 1089-1096Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar we obtained institutional review board approval and retrospectively reviewed data from our clinical research center from 2011 to 2017. Our cohort involved highly peanut allergic children (median 4.5 years of age) previously unexposed to investigational drug or food immunotherapy who participated in 113 double-blind, placebo-controlled food challenges (DBPCFCs) to peanut to determine eligibility for entry into clinical trials. All participants were required to have a clinical history of peanut allergic reaction and evidence of sensitization or high-titer sensitization if no history of peanut ingestion. Participants then underwent peanut DBPCFC to confirm allergy and establish the baseline threshold. Background characteristics, DBPCFC details, and exclusion criteria are found in Table 1. Each of the entry oral food challenges analyzed was positive, whereas 44 challenges (39%) resulted in a diagnosis of anaphylaxis per NIAID criteria, and just 1 challenge (0.9%) met the criteria for biphasic anaphylaxis (Table 1). Epinephrine was administered promptly for anaphylaxis treatment, with a median time of 5 (interquartile range, 0-12) minutes after applicable symptom onset. No cases of persistent or refractory anaphylaxis were identified.Table 1Pooled Demographic Information, Medical Comorbidities, Baseline Peanut Allergy Evaluation for Study Cohort, DBPCFC Characteristics, and Biphasic Anaphylaxis CharacteristicsDemographic characteristicsN125 Age, median (interquartile range), y4.5 (2.5-8) Male74 Female51 White112 African American4 Native American2 Asian5 Mixed2Medical comorbidities Atopic dermatitis89 Asthma51 Other food allergies61Baseline peanut allergy evaluation Peanut sIgE, median kUA/L (interquartile range)61.6 (14-160) Peanut SPT, median mm (interquartile range)13 (9-19)Entry DBPCFC characteristics for study participants PnOIT4 (NCT01814241)8 doses: 1, 5, 15, 50, 75, 100, 250, 500 mg; 15-30 min increments TLC (NCT01373242)5 doses: 25, 50, 100, 250, 575 mg; 10-20 min increments FARE SLIT (NCT02304991)6 doses: 3, 10, 30, 100, 300, 557 mg; 10-20 min incrementsWhen symptomatic, patients were observed for 2 h post-challenge in all studiesExclusion: history of severe anaphylaxis (hypotension/shock, neurologic impairment including cyanosis or hypoxemia [SpO2 < 92%], confusion, collapse, loss of consciousness, or incontinence) Biphasic anaphylaxis DBPCFC characteristics Biphasic anaphylaxis (N = 1/113)5 doses: 1, 5, 15, 50, and 100 mg at 0, 10, 20, 30, and 40 min, respectively;43 min skin rash—diphenhydramine;55 min gastrointestinal symptoms—epinephrine, prompt resolution;185 min wheezing/cough—epinephrine, prompt resolution;245 min rash;305 min resolution of rash;395 min patient dischargedAbbreviations: DBPCFC, double-blind, placebo-controlled food challenge; sIgE, specific immunoglobulin E; SPT, skin prick test. Open table in a new tab Even among the most highly peanut sensitized children with large peanut skin prick test wheal size, markedly elevated levels of peanut specific immunoglobulin E, and in the majority of cases with a prior reaction history, it is most telling that biphasic anaphylaxis events were not observed at a clinically significant frequency. Our data are strengthened by the rich clinical trial setting which provides precise symptom chronology, rigorous objective and subjective symptom criteria, and post-challenge adverse event data unavailable to outpatient or ED settings. By reporting our experiences, we hope to increase the adoption of targeted recommendations designed to reduce reliance on health care utilization after anaphylaxis is successfully treated among patients for whom no risk factors for biphasic anaphylaxis (eg, severe initial presentation, >1 dose of epinephrine for initial management) or barriers to home observation (eg, unavailability of adult trained in rendering post-reaction care, additional doses of epinephrine, or access to ED or emergency medical service care) are identified.Despite an emerging sentiment that routine ED visits are not necessary in all cases of successfully treated anaphylaxis, many resources continue to endorse this approach. Anaphylaxis management plans, for example, advise 4 hours of observation in the ED after epinephrine is used for the treatment of anaphylaxis, even if symptoms resolve. These management plans are widely circulated throughout clinics, childcare centers, and schools and may deserve a closer look in the context of revised approaches to post-reaction care.An important consideration is that the safety-driven yet reflexive coupling between epinephrine administration and subsequent ED utilization may paradoxically reduce epinephrine use, by presenting unexpected obstacles to some patients. For example, patients susceptible to minimizing symptom severity (particularly those already subject to a variety of stressors) may justify epinephrine non-use during reactions when epinephrine use is warranted, to avoid a required trip to the ED after deployment of epinephrine. Recent publications identify this barrier to epinephrine use, citing avoidance of the ED during the COVID-19 pandemic as a factor in up to 20% of anaphylaxis cases in which epinephrine is not used.8Gabrielli S Protudjer JLP Gooding G Gerdts J Ben-Shoshan M. Anaphylaxis-related knowledge and concerns in Canadian families during the coronavirus disease 2019 pandemic.Ann Allergy Asthma Immunol. 2021; 127: 496-497Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar,9Glassberg B Nowak-Wegrzyn A Wang J. Factors contributing to underuse of epinephrine autoinjectors in pediatric patients with food allergy.Ann Allergy Asthma Immunol. 2021; 126 (e3): 175-179Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar This effect is likely to be observed during cases in which anaphylaxis symptoms are mild or subjective and when caregivers are inexperienced in recognizing symptoms or fearful of epinephrine self-administration. In addition, such an effect may be disparately observed among those patients already burdened by certain socioeconomic determinants of health, including financial strain, possibly widening health care disparities. Consequences of delay or omission of epinephrine during anaphylaxis treatment include a prolonged duration of symptoms and biphasic anaphylaxis, outcomes which are likely to ultimately require ED evaluation, despite the patient's original goals. Though this effect needs additional characterization, it may contribute to the well-described suboptimal rates of home epinephrine use among patients experiencing anaphylaxis.The COVID-19 pandemic provided the original impetus for a number of urgently needed changes across health care systems. Ad hoc changes in practice were adapted to normalize the decision to continue anaphylaxis observation at home, provided both treatment and response are timely and appropriate. These changes have accelerated an evolution to precision-based anaphylaxis management, though the safety implications resulting from these changes are poorly established. We would like to contribute further support to the low rate of biphasic anaphylaxis, by submitting our center's experience with a high-risk peanut allergy cohort undergoing entry oral food challenge. Our research observations are limited by the exclusion of patients at entry who have previously experienced an episode of severe anaphylaxis and by the infrequent occurrence of biphasic anaphylaxis during DBPCFC which may each reduce generalizability. However, our work importantly highlights that elevations in biomarkers for allergic sensitization to peanut are not independently predictive of food-triggered biphasic anaphylaxis. Although the setting of controlled clinical research as we have suggested may be ideal to precisely convey symptom chronology and timing of epinephrine administration, we acknowledge that anaphylaxis outside of a medically supervised setting is not as likely to be recognized nor treated with such rapidity. Yet, we are still hopeful that our work may both inform future research regarding biphasic anaphylaxis and encourage providers to make use of a more targeted approach to anaphylaxis counseling. Similar to previously recommended adaptations to anaphylaxis post-reaction care published at the onset of the pandemic,2Shaker MS Oppenheimer J Grayson M Stukus D Hartog N Hsieh EWY et al.COVID-19: pandemic contingency planning for the allergy and immunology clinic.J Allergy Clin Immunol Pract. 2020; 8 (e5): 1477-1488Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar,3Casale TB Wang J Nowak-Wegrzyn A. Acute at home management of anaphylaxis during the Covid-19 pandemic.J Allergy Clin Immunol Pract. 2020; 8: 1795-1797Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar we encourage providers to consider selective deferral of health care utilization for patients experiencing food-triggered anaphylaxis who lack biphasic anaphylaxis risk factors and barriers to home observation, even among children with biomarkers reflective of high degrees of peanut sensitization. Additional investigation of DBPCFC research cohorts may be useful in providing further post-reaction follow-up data and both mechanistic and clinical insight from which more robustly defined risk factors for biphasic anaphylaxis can be derived. As providers in allergy, we are uniquely positioned to lead the charge on providing more targeted guidance on routine care after the diagnosis of anaphylaxis and may even be positioned to reduce reliance on EDs. The United States surpassed 54,000,000 total cases of coronavirus disease 2019 (COVID-19) by the end of 2021.1Centers for Disease Control and Prevention. Trends in number of COVID-19 cases and deaths in the US reported to CDC, by state/territory. 2022. Available at: https://covid.cdc.gov/covid-data-tracker/#trends_totalcases. Accessed February 9, 2022.Google Scholar During early pandemic contingency planning, recommendations were published advising the suspension of routine emergency department (ED) use after home treatment of anaphylaxis responding to a single dose of epinephrine provided symptoms promptly resolve without recurrence.2Shaker MS Oppenheimer J Grayson M Stukus D Hartog N Hsieh EWY et al.COVID-19: pandemic contingency planning for the allergy and immunology clinic.J Allergy Clin Immunol Pract. 2020; 8 (e5): 1477-1488Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar Shortly thereafter, a detailed anaphylaxis management algorithm tailored to at-home management during the COVID-19 pandemic was published.3Casale TB Wang J Nowak-Wegrzyn A. Acute at home management of anaphylaxis during the Covid-19 pandemic.J Allergy Clin Immunol Pract. 2020; 8: 1795-1797Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar These adaptations were devised with the goal for more selective health care utilization, so as to minimize risk of COVID-19 acquisition and to avoid overburdening health care facilities. An important underpinning for these guidelines is the perceived low risk to initial home observation after successfully treated anaphylaxis, on the basis of simulated economic modeling for peanut-triggered anaphylaxis.4Shaker M Kanaoka T Feenan L Greenhawt M. An economic evaluation of immediate vs non-immediate activation of emergency medical services after epinephrine use for peanut-induced anaphylaxis.Ann Allergy Asthma Immunol. 2019; 122: 79-85Abstract Full Text Full Text PDF PubMed Scopus (37) Google Scholar Though the extent to which such adapted guidelines are currently in use by allergy providers remains unclear, each successive wave of SARS-CoV-2 has continued to heighten the importance of critical analysis of reflexive health care utilization practices for the management of anaphylaxis. A rationale for post-reaction monitoring in the ED is the rapid detection and management of biphasic anaphylaxis. Yet, biphasic reactions are rare (0.18%-14.7% of anaphylaxis events) and possibly trigger-specific.5Shaker MS Wallace DV Golden DBK Oppenheimer J Bernstein JA Campbell RL et al.Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis.J Allergy Clin Immunol. 2020; 145: 1082-1123Abstract Full Text Full Text PDF PubMed Scopus (201) Google Scholar When food is implicated as a trigger for anaphylaxis, Lee et al6Lee S Bellolio MF Hess EP Erwin P Murad MH Campbell RL. Time of onset and predictors of biphasic anaphylactic reactions: a systematic review and meta-analysis.J Allergy Clin Immunol Pract. 2015; 3 (e1-e2): 408-416Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar reported in 2015 a protective effect for biphasic anaphylaxis (odds ratio, 0.62 [0.4-0.94]), though this was not redemonstrated in a recent analysis (odds ratio, 0.89 [0.68-1.17]).5Shaker MS Wallace DV Golden DBK Oppenheimer J Bernstein JA Campbell RL et al.Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis.J Allergy Clin Immunol. 2020; 145: 1082-1123Abstract Full Text Full Text PDF PubMed Scopus (201) Google Scholar To explore this question in the context of revised definitions of anaphylaxis,7Dribin TE Sampson HA Camargo CA Jr Brousseau DC Spergel JM Neuman MI et al.Persistent, refractory, and biphasic anaphylaxis: a multidisciplinary Delphi study.J Allergy Clin Immunol. 2020; 146: 1089-1096Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar we obtained institutional review board approval and retrospectively reviewed data from our clinical research center from 2011 to 2017. Our cohort involved highly peanut allergic children (median 4.5 years of age) previously unexposed to investigational drug or food immunotherapy who participated in 113 double-blind, placebo-controlled food challenges (DBPCFCs) to peanut to determine eligibility for entry into clinical trials. All participants were required to have a clinical history of peanut allergic reaction and evidence of sensitization or high-titer sensitization if no history of peanut ingestion. Participants then underwent peanut DBPCFC to confirm allergy and establish the baseline threshold. Background characteristics, DBPCFC details, and exclusion criteria are found in Table 1. Each of the entry oral food challenges analyzed was positive, whereas 44 challenges (39%) resulted in a diagnosis of anaphylaxis per NIAID criteria, and just 1 challenge (0.9%) met the criteria for biphasic anaphylaxis (Table 1). Epinephrine was administered promptly for anaphylaxis treatment, with a median time of 5 (interquartile range, 0-12) minutes after applicable symptom onset. No cases of persistent or refractory anaphylaxis were identified. Abbreviations: DBPCFC, double-blind, placebo-controlled food challenge; sIgE, specific immunoglobulin E; SPT, skin prick test. Even among the most highly peanut sensitized children with large peanut skin prick test wheal size, markedly elevated levels of peanut specific immunoglobulin E, and in the majority of cases with a prior reaction history, it is most telling that biphasic anaphylaxis events were not observed at a clinically significant frequency. Our data are strengthened by the rich clinical trial setting which provides precise symptom chronology, rigorous objective and subjective symptom criteria, and post-challenge adverse event data unavailable to outpatient or ED settings. By reporting our experiences, we hope to increase the adoption of targeted recommendations designed to reduce reliance on health care utilization after anaphylaxis is successfully treated among patients for whom no risk factors for biphasic anaphylaxis (eg, severe initial presentation, >1 dose of epinephrine for initial management) or barriers to home observation (eg, unavailability of adult trained in rendering post-reaction care, additional doses of epinephrine, or access to ED or emergency medical service care) are identified. Despite an emerging sentiment that routine ED visits are not necessary in all cases of successfully treated anaphylaxis, many resources continue to endorse this approach. Anaphylaxis management plans, for example, advise 4 hours of observation in the ED after epinephrine is used for the treatment of anaphylaxis, even if symptoms resolve. These management plans are widely circulated throughout clinics, childcare centers, and schools and may deserve a closer look in the context of revised approaches to post-reaction care. An important consideration is that the safety-driven yet reflexive coupling between epinephrine administration and subsequent ED utilization may paradoxically reduce epinephrine use, by presenting unexpected obstacles to some patients. For example, patients susceptible to minimizing symptom severity (particularly those already subject to a variety of stressors) may justify epinephrine non-use during reactions when epinephrine use is warranted, to avoid a required trip to the ED after deployment of epinephrine. Recent publications identify this barrier to epinephrine use, citing avoidance of the ED during the COVID-19 pandemic as a factor in up to 20% of anaphylaxis cases in which epinephrine is not used.8Gabrielli S Protudjer JLP Gooding G Gerdts J Ben-Shoshan M. Anaphylaxis-related knowledge and concerns in Canadian families during the coronavirus disease 2019 pandemic.Ann Allergy Asthma Immunol. 2021; 127: 496-497Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar,9Glassberg B Nowak-Wegrzyn A Wang J. Factors contributing to underuse of epinephrine autoinjectors in pediatric patients with food allergy.Ann Allergy Asthma Immunol. 2021; 126 (e3): 175-179Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar This effect is likely to be observed during cases in which anaphylaxis symptoms are mild or subjective and when caregivers are inexperienced in recognizing symptoms or fearful of epinephrine self-administration. In addition, such an effect may be disparately observed among those patients already burdened by certain socioeconomic determinants of health, including financial strain, possibly widening health care disparities. Consequences of delay or omission of epinephrine during anaphylaxis treatment include a prolonged duration of symptoms and biphasic anaphylaxis, outcomes which are likely to ultimately require ED evaluation, despite the patient's original goals. Though this effect needs additional characterization, it may contribute to the well-described suboptimal rates of home epinephrine use among patients experiencing anaphylaxis. The COVID-19 pandemic provided the original impetus for a number of urgently needed changes across health care systems. Ad hoc changes in practice were adapted to normalize the decision to continue anaphylaxis observation at home, provided both treatment and response are timely and appropriate. These changes have accelerated an evolution to precision-based anaphylaxis management, though the safety implications resulting from these changes are poorly established. We would like to contribute further support to the low rate of biphasic anaphylaxis, by submitting our center's experience with a high-risk peanut allergy cohort undergoing entry oral food challenge. Our research observations are limited by the exclusion of patients at entry who have previously experienced an episode of severe anaphylaxis and by the infrequent occurrence of biphasic anaphylaxis during DBPCFC which may each reduce generalizability. However, our work importantly highlights that elevations in biomarkers for allergic sensitization to peanut are not independently predictive of food-triggered biphasic anaphylaxis. Although the setting of controlled clinical research as we have suggested may be ideal to precisely convey symptom chronology and timing of epinephrine administration, we acknowledge that anaphylaxis outside of a medically supervised setting is not as likely to be recognized nor treated with such rapidity. Yet, we are still hopeful that our work may both inform future research regarding biphasic anaphylaxis and encourage providers to make use of a more targeted approach to anaphylaxis counseling. Similar to previously recommended adaptations to anaphylaxis post-reaction care published at the onset of the pandemic,2Shaker MS Oppenheimer J Grayson M Stukus D Hartog N Hsieh EWY et al.COVID-19: pandemic contingency planning for the allergy and immunology clinic.J Allergy Clin Immunol Pract. 2020; 8 (e5): 1477-1488Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar,3Casale TB Wang J Nowak-Wegrzyn A. Acute at home management of anaphylaxis during the Covid-19 pandemic.J Allergy Clin Immunol Pract. 2020; 8: 1795-1797Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar we encourage providers to consider selective deferral of health care utilization for patients experiencing food-triggered anaphylaxis who lack biphasic anaphylaxis risk factors and barriers to home observation, even among children with biomarkers reflective of high degrees of peanut sensitization. Additional investigation of DBPCFC research cohorts may be useful in providing further post-reaction follow-up data and both mechanistic and clinical insight from which more robustly defined risk factors for biphasic anaphylaxis can be derived. As providers in allergy, we are uniquely positioned to lead the charge on providing more targeted guidance on routine care after the diagnosis of anaphylaxis and may even be positioned to reduce reliance on EDs." @default.
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• W4282971867 title "Peanut anaphylaxis in 2022: Decoupling epinephrine usage from emergency department evaluation" @default.
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