PUBLICATIONS
These Kaléo supported manuscripts and posters were collated by medical information and are not intended for promotional purposes.
Peer-Reviewed Manuscripts
Leeds S, et al. Pediatr Drugs. 2026. Online ahead of print.
- Epinephrine remains underutilized in infants and toddlers with suspected anaphylaxis, despite it being the recommended first-line treatment in this patient population
- Results from this narrative review found that barriers to appropriate epinephrine use include difficulty recognizing anaphylaxis symptoms, low prescribing and refill rates, low epinephrine carrying rates, inadequate training on epinephrine administration, caregiver fear and hesitation to use epinephrine, fears of contacting emergency medical services, and the use of other medications as first-line agents
- Healthcare providers can improve outcomes by educating caregivers on symptom recognition and epinephrine administration, the use of written anaphylaxis action plans, and shared decision-making on when to seek further medical care beyond at-home epinephrine use
- Broader system-level strategies, including improved access to epinephrine in childcare and community settings and expanded educational resources, are needed to increase timely treatment and reduce risks
Peer-Reviewed Manuscripts
Pistiner M, et al. Expert Rev Clin Immunol. 2026. Online ahead of print.
- This plain language review summarizes findings from 4 key studies that provide comprehensive evidence for parents and caregivers of infants and toddlers with serious allergic reactions, providing the tools necessary for recognition of serious allergic reactions and supporting the appropriate use of epinephrine
- Findings from these studies show that:
- Infants and toddlers may display signs and symptoms of serious allergic reactions differently than in older children and adults, and therefore, identification of a serious allergic reaction may benefit from the use of recently developed investigational modified criteria specific to infants and toddlers
- Epinephrine is often underused, but parents and caregivers are usually more confident in using epinephrine when they have a clearly defined allergy emergency action plan
- Prior experience administering epinephrine under healthcare supervision during an oral food challenge with a healthcare provider also significantly boosts parent and caregiver confidence
Peer-Reviewed Manuscripts
Guerlain S, et al. Ann Allergy Asthma Immunol. 2010;105(6):480-484.
Peer-Reviewed Manuscripts
Edwards ES, et al. Ann Allergy Asthma Immunol. 2013;110(3):189-193.e1.
Peer-Reviewed Manuscripts
Camargo CA, et al. JACI: In Practice. 2013;1(3):266-72.e1-3.
- This study evaluated preferences for the erstwhile design of Auvi-Q and EpiPen (using trainer devices) among 241 adults, 224 children, and 228 caregivers with and without experience of using an EAI device
- Auvi-Q was significantly favored over EpiPen (P<0.001) across all assessed domains (eg, method of instruction, device size and shape, ease of use and carrying)
- Strengths of this large, multicenter study included the size and diversity of the study population and addressed some limitations of previous studies by randomizing patients/caregivers according to prior EAI experience (with no further training) and the order in which devices were tested
Peer-Reviewed Manuscripts
Edwards ES. Clin Pediatr (Phila). 2013;52(9):890.
Peer-Reviewed Manuscripts
Edwards ES, et al. Ann Allergy Asthma Immunol. 2013;111(2):132-7.
Peer-Reviewed Manuscripts
Edwards ES, et al. Expert Opin Drug Deliv. 2015;12(5):751-762.
Peer-Reviewed Manuscripts
Greenberger PA, et al. Ann Allergy Asthma Immunol. 2017;119(4):333-338.
Peer-Reviewed Manuscripts
Ortiz G. Consultant for Pediatricians. Published online March 9, 2018.
- This article emphasizes the need for familiarity with the signs and symptoms of anaphylaxis unique to this patient population to administer timely treatment
- Using compassionate restraint to secure a child at the time of epinephrine injection, using a device with a shorter and automatically retracting needle, and minimizing device holding time on the child’s leg may prevent unintentional EAI-related injuries
Peer-Reviewed Manuscripts
Mahr TA. Contemporary PEDS Journal. 2018;36(6).
- This article provides examples of anaphylaxis symptoms that are unique to infants and toddlers, such as apparent contact rash from food (distinct from contact rash after vomiting in the crib), inconsolable crying, drooling, wheezing, trouble breathing, retching/repeat vomiting, or cyanosis
- Although epinephrine is the mainstay treatment for anaphylaxis for patients of all ages, some options may not be ideal for infants and toddlers
- Considerations of EAI design for infants and toddlers with anaphylaxis include lower dose and shorter needle length than those used in older children and adults
Peer-Reviewed Manuscripts
Hayden ML. J Nurse Pract. 2018;14(7):531-537.
- This article builds off the 2015 Practice Parameter update published by the American College of Allergy, Asthma, and Immunology (ACAAI) which listed 8 areas in anaphylaxis recognition and treatment for which evidence-based guidance is lacking
- The article presents 8 case studies for patients of all ages (from toddler to age 84 years) with anaphylaxis or suspected anaphylaxis who present with varying symptoms and who may be on concomitant medication for other conditions
- Nurse practitioners—who play a vital role in the assessment, diagnosis, and management of anaphylaxis—should use prior experience, best available evidence, and good clinical judgement to manage patients with anaphylaxis when evidence-based guidance is lacking
Peer-Reviewed Manuscripts
Ibrahim M and Kim H. Allergy Asthma Clin Immunol. 2018;14(32).
- This case study describes a pediatric patient with multiple food allergies who had an unintentional bone injection with her EAI during an allergic emergency as her skin-to-bone distance with compression at the vastus lateralis was less than the needle length of the device (12.7 mm)
- The study highlights the importance of evaluating the risk of unintentional bone injection and educating patients/caregivers on measures to mitigate potential bone injuries
Peer-Reviewed Manuscripts
Edwards E, et al. Allergy Asthma Proc. 2018;39(6):461-465.
- This validation study evaluated the ability of intended users to administer a 0.1-mg EAI with a needle length of 7.5 mm in patients with anaphylaxis who weigh 7.5 kg to 15 kg
- Fifteen participants (all parents of severely allergic children) successfully simulated administration of a clinically meaningful epinephrine dose on an infant manikin 24 hours after being trained on the device
Peer-Reviewed Manuscripts
Greenhawt M, et al. J Allergy Clin Immunol Pract. 2019;7(4):1148-1156.
- An expert panel of 8 members (allergist/immunologists, an ED physician, and a pediatrician) was convened to develop guiding principles and key considerations in infants with anaphylaxis to assist current practice, future guideline development, and research
- The panelists highlighted that timely administration of epinephrine is crucial for anaphylaxis treatment, independent of patient age
- The panelists called for emergency action plans tailored for infants/toddlers, periodic specialist follow-up for infants with anaphylaxis, and research to refine diagnostic criteria, identify biomarkers, and clarify risk factors and optimal epinephrine dosing and delivery in this age group
Peer-Reviewed Manuscripts
Kessler C, et al. Ann Allergy Asthma Immunol. 2019;123(3):256-262.
- This open-label, randomized, crossover, noninterventional human factors study compared usability and participant preference of 0.15-mg Auvi-Q vs EpiPen Jr EAIs in a simulated anaphylactic emergency scenario; participants were adults (18-5 years old) without severe allergies or prior EAI administration experience
- Among the 96 adults included in the study analysis, a significantly higher percentage were able to follow Auvi-Q device injection instruction and complete key injection tasks (ie, the minimum tasks required for a patient to receive an epinephrine dose; 94.8% and 72.9%, respectively; both P<0.001 vs EpiPen Jr); no digital/hand-injection errors would have occurred with Auvi-Q, whereas 14.6% of participants would have accidentally received a digital or hand injection with EpiPen Jr (P<0.001)
- Overall, significantly more participants preferred Auvi-Q over EpiPen Jr (91.7% vs 6.3%; P<0.001); the authors highlight the importance of device design on successful epinephrine administration in an allergic emergency
Peer-Reviewed Manuscripts
Shroba JA. J Am Assoc Nurse Pract. 2020;32(2):176-183.
- Nurse practitioners are often the first-line providers for infants (<2 years of age) in clinical settings and face challenges in diagnosing and treating infant anaphylaxis due to rapid onset of symptoms in multiple organ systems, under-recognition or misdiagnosis of another infantile disease (such as infectious diseases, autoimmune disorders, or asthma), and varying clinical presentation
- With new guidelines that encourage early introduction of potentially allergenic foods, the incidence of infant anaphylaxis may increase, and nurse practitioners should be prepared for this possibility
- Because specific criteria for the diagnosis of anaphylaxis in infants have not yet been developed, it is crucial.to educate caregivers on triggers of anaphylaxis and provide them with a management plan as well as a prescription for epinephrine as the first-line treatment for anaphylaxis
Posters
Zah V, et al. Poster presented at: Academy of Managed Care Pharmacy (AMCP) Nexus; October 19-23, 2020; virtual.
- This retrospective study utilized the IBM MarketScan Commercial Claims and Encounters Database to identify patients with an anaphylaxis claim from January 1, 2016, to October 31, 2019, and analyzed healthcare resource use and associated costs in nonmatched and matched patient populations who experienced anaphylaxis and were previously prescribed Auvi-Q vs other EAIs
- The final sample after propensity score matching consisted of 340 patients who were prescribed Auvi-Q prior to the index anaphylaxis event and 934 who were prescribed other EAIs
- Auvi-Q patients had significantly lower total cost of care excluding prescription costs over the 3-month post-anaphylaxis period (mean, $1,155 vs $1,582; P=0.036), significant savings in inpatient costs ($27 vs $189; P=0.042), and significantly less laboratory referrals (0.6 vs 0.8; P=0.001) compared with those prescribed other EAIs; ED visits and hospitalizations were similar between the groups
- No significant differences were found for outpatient or ED-related costs
Posters
Zah V, et al. Poster presented at: Academy of Managed Care Pharmacy (AMCP) Nexus; October 19-23, 2020; virtual.
- This retrospective study utilized the IBM MarketScan Commercial Claims and Encounters Database to identify patients with an anaphylaxis claim from January 1, 2016, to October 31, 2019, and compared real-world costs of care during a 3-month period following the anaphylactic event for propensity score–matched (PSM) patients with mild-to-moderate or severe anaphylaxis who had been prescribed Auvi-Q or another EAI within the year preceding the anaphylactic event
- A total of 249 patients were prescribed Auvi-Q and 613 were prescribed other EAIs; patients in the Auvi-Q cohort with mild-to-moderate anaphylaxis had significantly lower total costs of care excluding prescription costs ($621 vs $1412; P<0.001) and a lower proportion of patients with ≥1 ED visit during the anaphylactic episode (12.0% vs 27.5%; P=0.005) compared with their PSM other EAI counterparts
- Costs and healthcare resource consumption were also substantially lower in the Auvi-Q versus other EAIs severe anaphylaxis subgroups (costs of care excluding prescription costs, $1,476 vs $2,836; P=0.024 and number of hospitalizations, 0.006 vs 0.035; P=0.023)
Peer-Reviewed Manuscripts
Pistiner M, et al. J Allergy Clin Immunol Pract. 2021;9(1):311-320.e2.
- This national online survey was conducted among primary caregivers of children who experienced a food-induced allergic reaction at <36 months of age, identifying and inviting participants through the AAFA
- Among the 374 caregivers surveyed, the most frequently reported reactions were those involving skin (90%), swelling (59%), gastrointestinal symptoms (51%), and coughing/wheezing (45%), with milk, egg, and peanut as the most common triggers
- Symptom patterns differed by age, as infants (<12 months of age) versus toddlers (12-35 months of age) had more skin reactions (94% vs 86%; P=0.009), skin mottling (16% vs 8%; P=0.03), and ear pulling/scratching (16% vs 8%; P=0.03), whereas toddlers more often had throat itching (28% vs 8%; P<0.001) and coughing/wheezing (51% vs 38%; P=0.01), highlighting the differential presentation of anaphylaxis among nonverbal children
- Using infant- and toddler-tailored symptom groupings (the AAFA Infant Toddler Anaphylaxis Criteria) modestly increased the proportion of reactions classified as probable anaphylaxis compared with adult-oriented criteria (71% vs 65%), supporting the need for age-specific diagnostic criteria, action plans, and caregiver education for this population
Peer-Reviewed Manuscripts
Lieberman JA, et al. Ann Allergy Asthma Immunol. 2021;126:273-277.
- This national survey assessed the opinions of clinically active US pediatricians on whether 8 case-based scenarios of possible allergic reactions constituted anaphylaxis and warranted epinephrine use
- There was substantial disagreement among the 1,001 pediatricians who responded, with no case reaching strong consensus (≥86% agreement) and only about half of responses labeling scenarios as anaphylaxis (average, 53%) or warranting epinephrine (average 51%) overall; responses in most cases did not differ by sex, practice setting, or geographic location
- Across cases, an average of 5% of responses classified a scenario as anaphylaxis but indicated that epinephrine would not be used, and an average of 3% responses suggested epinephrine was warranted despite not calling the case anaphylaxis, highlighting persistent gaps in diagnosis and recommended first-line treatment (ie, epinephrine) and underscoring the need for unambiguous markers of anaphylaxis and education on epinephrine use
Peer-Reviewed Manuscripts
Robinson LB, et al. J Allergy Clin Immunol Pract. 2021;9(5):1931-1938.e2.
- This cohort study analyzed data from the Healthcare Cost and Utilization Project (HCUP) Nationwide Emergency Department Sample (NEDS) from 2006 to 2015 to assess trends in US ED visits for acute allergic reactions (AAR) and anaphylaxis among infants and toddlers (<3 years of age) and older children (3 to <18 years of age)
- Over the study period, ED visits for anaphylaxis among infants and toddlers increased from 15 to 32 visits per 100,000 population and from 20 to 50 per 100,000 ED visits (both Ptrend<0.001), indicating a rising burden of anaphylaxis in this age group
- Despite rising ED visits, the proportion of infants and toddlers with anaphylaxis who were hospitalized fell from 19% to 6%, while documented epinephrine use in the ED increased from 5% to 24% (both Ptrend<0.001), suggesting improved anaphylaxis management with more epinephrine use
- Most anaphylaxis in infants and toddlers was food-induced (75% in 2006 and 68% in 2015), with peanut frequently identified as a trigger; infants/toddlers more likely to be hospitalized were male, privately insured, from higher income families, and presenting to urban or metropolitan teaching hospital EDs, highlighting sociodemographic patterns in care
Peer-Reviewed Manuscripts
Robinson LB, et al. Allergy Asthma Proc. 2021;42(3):247-256.
- This retrospective cohort study used data from 2006 to 2015 from multipayer databases in New York and Nebraska to assess trends in emergency department (ED) visits and hospitalizations and associated costs among infants and toddlers (<3 years of age) with acute allergic reactions (AAR), including anaphylaxis
- The rate of ED visits for AAR (from 27.8 to 35.2 per 10,000 population) and for anaphylaxis (from 2 to 4.6 per 10,000 population) increased significantly from 2006 to 2015 (both Ptrend<0.001), whereas the rate of hospitalization for AAR and anaphylaxis remained stable (Ptrend=0.11 and 0.17, respectively)
- In the 1 year after the index ED visit for AAR or anaphylaxis, 5.1% and 5.9% of children had ≥1 AAR ED revisit and rehospitalization, respectively; total charges over time increased >4-fold for both AAR ED revisits (from $92,260 in 2009 to $423,049 in 2015) and for AAR rehospitalizations (from $39,689 in 2011 to $218,936 in 2015)
- Better implementation of strategies to prevent revisits and rehospitalizations among infants and toddlers with AAR is warranted, including adherence to anaphylaxis guidelines of allergists’ evaluations, access to weight-based EAIs, and parental education of allergen avoidance
Peer-Reviewed Manuscripts
Pistiner M, et al. J Allergy Clin Immunol Pract. 2023;12(2):364-371.e1.
- This national online survey was conducted by Asthma and Allergy Foundation of America (AAFA) to assess gaps in recognition and treatment of anaphylaxis in infants and toddlers (<36 months of age) by primary caregivers
- Of the 264 infants and toddlers with probable anaphylaxis, 131 (50%) did not receive epinephrine; a previous food allergy diagnosis was reported in 82 (62%) infants/toddlers who received epinephrine compared with 34 (26%) cases where epinephrine was not used (P<0.001)
- Among those with a previous food allergy diagnosis, epinephrine was used in 73/82 (89%) children who were prescribed an anaphylaxis action plan compared with 17/34 (50%) children who had a plan but did not receive epinephrine (P=0.001); the use of antihistamines or other medications were similar among children who did and did not receive epinephrine
- Results from this study demonstrated that during probable anaphylaxis, infants and toddlers with a previous food allergy diagnosis were more likely to be treated with epinephrine in a timely manner, which is associated with the provision of an anaphylaxis action plan, and the use of other medications like antihistamines for anaphylaxis was not associated with the administration of epinephrine
Peer-Reviewed Manuscripts
Theodorakakis M, et al. J Allergy Clin Immunol Pract. 2024;12(10):2838-2841.e1.
- This investigator-initiated, mixed-methods study explored parental perspectives and EAI use in 343 infants and toddlers who had a systemic allergic reaction from a positive oral food challenge (OFC) as part of a larger study designed to collect prospective data on clinically indicated infant and toddler OFCs
- During the study period from September 2020 to August 2022, there were 9 infants and toddlers who experienced an anaphylactic reaction during an OFC and were administered an EAI by their parents, who completed pre-interview surveys before patient discharge and qualitative surveys 48 to 72 hours after EAI administration
- The study found that parents had an overall positive experience administering EAIs to their child during an anaphylactic reaction, gained confidence for future EAI administration and recognizing anaphylaxis symptoms, and indicated that they would benefit from further information on how to proceed after a positive OFC
Posters
Zah V, et al. Value in Health. 2025;28(6):S375. Abstract presented at: International Society for Pharmacoeconomics and Outcomes Research (ISPOR); May 13-16, 2025; Montreal, Canada.
- This US retrospective commercial claims analysis used the Optum Research Database to identify patients with anaphylaxis who had ≥1 epinephrine auto-injector (EAI) claim between January and December 2023 to compare rates of hospitalization for anaphylaxis among users of Auvi-Q vs other EAIs
- The rate of inpatient hospitalizations per patient was 0.00039 for AUVI-Q (n=10,130) and 0.00052 for other EAIs (n=52,094), with a 23.81% relative rate reduction for the Auvi-Q cohort; the rate of inpatient hospitalizations per anaphylaxis event was 0.00153 for AUVI-Q and 0.00367 for other EAIs, with a 58.24% relative rate reduction for the Auvi-Q cohort
- Inpatient hospitalizations for anaphylaxis were lower among patients prescribed Auvi-Q vs other EAIs in this cohort of US patients from a commercial claims database