F E Simons

Johns Hopkins University, Baltimore, Maryland, United States

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Publications (363)2178.76 Total impact

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    ABSTRACT: Anaphylaxis is a serious allergic or hypersensitivity reaction, which is rapid in onset and sometimes can prove fatal. Although H2-antihistamines are often administered for emergency treatment in anaphylaxis, there is uncertainty about their effectiveness in this disease. To assess the benefits and harms of H2-antihistamines in the treatment of anaphylaxis. A systematic review was performed of randomized controlled trials and quasi-randomized controlled trials comparing H2-antihistamines with placebo or no intervention in patients with anaphylaxis. The authors failed to identify any eligible studies for inclusion in this systematic review. When H2-antihistamines are recommended for anaphylaxis treatment, the status of the evidence base supporting their use should be described. Well-designed randomized controlled trials investigating the role of H2-antihistamines in anaphylaxis treatment are urgently needed.
    Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 02/2014; 112(2):126-31. · 3.45 Impact Factor
  • Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 12/2013; 111(6):568-570. · 3.45 Impact Factor
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    ABSTRACT: Although anaphylaxis is recognized as an important life-threatening condition, data are limited regarding its prevalence and characteristics in the general population. We sought to estimate the lifetime prevalence and overall characteristics of anaphylaxis. Two nationwide, cross-sectional random-digit-dial surveys were conducted. The public survey included unselected adults, whereas the patient survey captured information from household members reporting a prior reaction to medications, foods, insect stings, or latex and idiopathic reactions in the previous 10 years. In both surveys standardized questionnaires queried anaphylaxis symptoms, treatments, knowledge, and behaviors. The public survey included 1,000 adults, of whom 7.7% (95% CI, 5.7% to 9.7%) reported a prior anaphylactic reaction. Using increasingly stringent criteria, we estimate that 5.1% (95% CI, 3.4% to 6.8%) and 1.6% (95% CI, 0.8% to 2.4%) had probable and very likely anaphylaxis, respectively. The patient survey included 1,059 respondents, of whom 344 reported a history of anaphylaxis. The most common triggers reported were medications (34%), foods (31%), and insect stings (20%). Forty-two percent sought treatment within 15 minutes of onset, 34% went to the hospital, 27% self-treated with antihistamines, 10% called 911, 11% self-administered epinephrine, and 6.4% received no treatment. Although most respondents with anaphylaxis reported 2 or more prior episodes (19% reporting ≥5 episodes), 52% had never received a self-injectable epinephrine prescription, and 60% did not currently have epinephrine available. The prevalence of anaphylaxis in the general population is at least 1.6% and probably higher. Patients do not appear adequately equipped to deal with future episodes, indicating the need for public health initiatives to improve anaphylaxis recognition and treatment.
    The Journal of allergy and clinical immunology 10/2013; · 12.05 Impact Factor
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    ABSTRACT: The World Allergy Organization (WAO) Guidelines for the assessment and management of anaphylaxis are a widely disseminated and used resource for information about anaphylaxis. They focus on patients at risk, triggers, clinical diagnosis, treatment in health care settings, self-treatment in the community, and prevention of recurrences. Their unique strengths include a global perspective informed by prior research on the global availability of essentials for anaphylaxis assessment and management and a global agenda for anaphylaxis research. Additionally, detailed colored illustrations are linked to key concepts in the text [Simons et al.: J Allergy Clin Immunol 2011;127:593.e1-e22]. The recommendations in the original WAO Anaphylaxis Guidelines for management of anaphylaxis in health care settings and community settings were based on evidence published in peer-reviewed, indexed medical journals to the end of 2010. These recommendations remain unchanged and clinically relevant. An update of the evidence base was published in 2012 [Simons et al.: Curr Opin Allergy Clin Immunol 2012;12:389-399]. In 2012 and early 2013, major advances were reported in the following areas: further characterization of patient phenotypes; development of in vitro tests (for some allergens) that help distinguish clinical risk of anaphylaxis from asymptomatic sensitization; epinephrine (adrenaline) research, including studies of a new epinephrine auto-injector for use in community settings, and randomized controlled trials of immunotherapy to prevent food-induced anaphylaxis. Despite these advances, the need for additional prospective studies, including randomized controlled trials of interventions in anaphylaxis is increasingly apparent. This 2013 Update highlights publications from 2012 and 2013 that further contribute to the evidence base for the recommendations made in the original WAO Anaphylaxis Guidelines. Ideally, it should be used in conjunction with these Guidelines and with the 2012 Guidelines Update. © 2013 S. Karger AG, Basel.
    International Archives of Allergy and Immunology 09/2013; 162(3):193-204. · 2.25 Impact Factor
  • Vivian Hernandez-Trujillo, F. Estelle R. Simons
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    ABSTRACT: Background Few anaphylaxis education materials have been prospectively evaluated in randomized controlled trials. Objective Our objective was to evaluate the American Academy of Allergy, Asthma & Immunology Anaphylaxis Wallet Card (AAAAI-AWC) as an anaphylaxis education mini-handout for health care professionals. Methods We performed a randomized controlled study of the AAAAI-AWC with residents in general pediatrics at Miami Children's Hospital. Participants in the intervention group completed a pretest about anaphylaxis, heard a 3-minute PowerPoint presentation based on the AAAAI-AWC, reviewed the AAAAI-AWC, and discussed it with the presenter. After this, participants took a post-test immediately and a follow-up test 4 weeks later. Participants in the control group took the pretest, were handed an AAAAI-AWC, studied it briefly, then took the post-test immediately and the follow-up test 4 weeks later. Results Fifty-five residents participated. Regardless of the amount of time spent studying the AAAAI-AWC, when the pretests were compared with the post-tests and follow-up tests, residents in both the intervention and control groups were more likely to recognize anaphylaxis symptoms (P < .05), name asthma as the most common comorbid disease in children with fatal or near-fatal anaphylaxis (P < .05), and recall the names of epinephrine auto injectors (P < .05) and the epinephrine doses available in these auto injectors (P < .05). When the pretests were compared with the post-tests and the follow-up tests, residents in the intervention group were more likely than controls to identify the body organ systems involved in severe or fatal anaphylaxis correctly (P < .05). Conclusion The AAAAI-AWC is a practical, concise anaphylaxis education mini-handout for pediatric residents, a time-challenged group of health care professionals.
    The Journal of Allergy and Clinical Immunology: In Practice. 03/2013; 1(2):181–185.
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    Allergic Rhinitis and Its Impact on Asthma (ARIA). 01/2013;
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    ABSTRACT: Background Auvi-Q is a novel epinephrine autoinjector (EAI) that provides audio and visual cues for patients at risk for life-threatening allergic reactions. Objective We tested the preference for Auvi-Q or EpiPen with regard to method of instruction, preference to carry, device size, and device shape. Methods This large, multicenter, simulated-use study evaluated whether adults (aged 18-65 years), caregivers (parents/guardians aged 18-65 years of children aged 5-17 years), and children (aged 11-17 years), with and without experience in using an EAI, had a preference for the current design of Auvi-Q or the current design of EpiPen. Participants were given a scenario that involved anaphylaxis and were instructed to simulate use of an EAI. They received and tested each device individually according to the randomization assignment. After testing both devices, they completed a survey to indicate their preference for Auvi-Q versus EpiPen. Results Among all 693 participants combined, Auvi-Q was preferred over EpiPen on all study end points (P < .001). For experienced and inexperienced participants in all 3 groups (adults, caregivers, and children), Auvi-Q was preferred over EpiPen for method of instruction, preference to carry, and device size (all P < .001). The preference for Auvi-Q device shape was not significant among experienced children (P = .10); however, it was significant for inexperienced children (P = .04) and highly significant for experienced and inexperienced adults and caregivers (P < .001). Conclusion In this large multicenter, simulated-use study, Auvi-Q was preferred over EpiPen by experienced and inexperienced adults, caregivers, and children.
    The Journal of Allergy and Clinical Immunology: In Practice. 01/2013; 1(3):266–272.e3.
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    Zuber D Mulla, F Estelle R Simons
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    ABSTRACT: To determine if chronic pulmonary diseases adversely impact selected outcomes in hospitalised patients who have various allergic conditions including anaphylaxis. A population-based cohort study. A statewide hospital inpatient discharge database from Texas, USA, covering the years 2004-2007 was analysed. Patients with anaphylaxis and other allergic conditions were identified using the International Classification of Diseases, Ninth Revision, Clinical Modification codes. Within each group of patients (the overall group with various selected allergic conditions and the subgroup with anaphylaxis), the exposure variables were 11 chronic pulmonary diseases including asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis. Admission to an intensive care unit, a prolonged (>3 days) hospital stay, receipt of mechanical ventilation and death in hospital. Logistic regression was used to calculate adjusted OR and 95% CI for these four outcomes. 30 390 patients with allergic conditions were identified, of whom 2410 had anaphylaxis. The following results pertain to the subcohort of patients with anaphylaxis. Median age was 50 years (range 0-95 years) and 1470 (61%) were female. The hospital mortality was 2.7%. Although asthma was not associated with hospital mortality (OR=1.27, 95% CI 0.55 to 2.90), asthmatics had more than twice the odds of non-asthmatics of receiving mechanical ventilation (OR=2.45, 95% CI 1.81 to 3.33). Chronic bronchitis, COPD, emphysema and interstitial lung diseases (ILDs) were also associated with an increased risk of requiring mechanical ventilation. Chronic bronchitis and COPD were associated with a prolonged length of stay: OR=2.69 (95% CI 1.45 to 4.98) and OR=1.86 (95% CI 1.30 to 2.66), respectively. ILD was the only chronic pulmonary disease associated with an elevated risk of hospital mortality: OR=8.71 (95% CI 1.48 to 51.20). In this unique analysis of a large database, we found that asthma, COPD and other chronic pulmonary diseases increased the risk of adverse outcomes among hospitalised patients with anaphylaxis.
    BMJ Open 01/2013; 3(7). · 1.58 Impact Factor
  • Annals of Allergy, Asthma & Immunology. 01/2013; 111(6):568–570.
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    F Estelle R Simons, Aziz Sheikh
    BMJ (Clinical research ed.). 01/2013; 346:f602.
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    ABSTRACT: Patients with severe or difficult-to-treat asthma account for substantial asthma morbidity, mortality, and healthcare burden despite comprising only a small proportion of the total asthma population. TENOR, a multicenter, observational, prospective cohort study was initiated in 2001. It enrolled 4,756 adults, adolescents and children with severe or difficult-to-treat asthma who were followed semi-annually and annually for three years, enabling insight to be gained into this understudied population. A broad range of demographic, clinical, and patient self-reported assessments were completed during the follow-up period. Here, we present key findings from the TENOR registry in relation to asthma control and exacerbations, including the identification of specific subgroups found to be at particularly high-risk. Identification of the factors and subgroups associated with poor asthma control and increased risk of exacerbations can help physicians design individual asthma management, and improve asthma-related health outcomes for these patients.
    Current respiratory care reports. 12/2012; 1(4):259-269.
  • The Journal of allergy and clinical immunology 11/2012; · 12.05 Impact Factor
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    Journal of Allergy and Clinical Immunology. 11/2012; 130(5):1049–1062.
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    ABSTRACT: Allergic rhinitis (AR) and asthma represent global health problems for all age groups. Asthma and rhinitis frequently coexist in the same subjects. Allergic Rhinitis and its Impact on Asthma (ARIA) was initiated during a World Health Organization workshop in 1999 (published in 2001). ARIA has reclassified AR as mild/moderate-severe and intermittent/persistent. This classification closely reflects patients' needs and underlines the close relationship between rhinitis and asthma. Patients, clinicians, and other health care professionals are confronted with various treatment choices for the management of AR. This contributes to considerable variation in clinical practice, and worldwide, patients, clinicians, and other health care professionals are faced with uncertainty about the relative merits and downsides of the various treatment options. In its 2010 Revision, ARIA developed clinical practice guidelines for the management of AR and asthma comorbidities based on the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) system. ARIA is disseminated and implemented in more than 50 countries of the world. Ten years after the publication of the ARIA World Health Organization workshop report, it is important to make a summary of its achievements and identify the still unmet clinical, research, and implementation needs to strengthen the 2011 European Union Priority on allergy and asthma in children.
    The Journal of allergy and clinical immunology 10/2012; · 12.05 Impact Factor
  • F Estelle R Simons, Michael Schatz
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    ABSTRACT: Anaphylaxis during pregnancy, labor, and delivery can be catastrophic for the mother and, especially, the infant. Symptoms and signs can include intense vulvar and vaginal itching, low back pain, uterine cramps, fetal distress, and preterm labor. During the first 3 trimesters, etiologies are similar to those in nonpregnant women. During labor and delivery, common etiologies are β-lactam antibiotics, natural rubber latex, and other agents used in medical and perioperative settings. Important caveats in management include injecting epinephrine (adrenaline) promptly, providing high-flow supplemental oxygen, positioning the mother on her left side to improve venous return to the heart, maintaining a minimum maternal systolic blood pressure of 90 mm Hg to ensure adequate placental perfusion, and continuous electronic monitoring. Cardiopulmonary resuscitation and emergency cesarean delivery should be performed when indicated. In all women of child-bearing age, allergy/immunology specialists can help to prevent anaphylaxis in pregnancy through prepregnancy risk assessment and risk reduction strategies, such as confirming the etiology of systemic allergic reactions, providing written instructions for allergen avoidance, and initiating relevant immune modulation. In pregnant women the benefits versus risks of skin tests, challenge tests, desensitization, and initiation of immunotherapy with allergens should be carefully weighed; if possible, these procedures should be deferred until after parturition. Prospective interdisciplinary studies of anaphylaxis during pregnancy are needed.
    The Journal of allergy and clinical immunology 08/2012; 130(3):597-606. · 12.05 Impact Factor
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    ABSTRACT: During recent years our knowledge of the aetiology and pathogenesis of urticaria has advanced considerably allowing us to better characterize urticaria subtypes. However, although the classification of urticaria has undergone some revisions during this time (1), authors still use different names for the same type of urticaria, which has implications for comparing study outcomes and drug licensing. Consequently, there is an urgent need for a harmonized and universally accepted nomenclature and classification of urticaria and to avoid the routine use of the outdated aetiological term, chronic idiopathic urticaria (CIU).
    British Journal of Dermatology 07/2012; · 3.76 Impact Factor
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    ABSTRACT: The World Allergy Organization (WAO) Guidelines for the assessment and management of anaphylaxis published in early 2011 provide a global perspective on patient risk factors, triggers, clinical diagnosis, treatment, and prevention of anaphylaxis. In this 2012 Update, subsequently published, clinically relevant research in these areas is reviewed. Patient risk factors and co-factors that amplify anaphylaxis have been documented in prospective studies. The global perspective on the triggers of anaphylaxis has expanded. The clinical criteria for the diagnosis of anaphylaxis that are promulgated in the Guidelines have been validated. Some aspects of anaphylaxis treatment have been prospectively studied. Novel investigations of self-injectable epinephrine for treatment of anaphylaxis recurrences in the community have been performed. Progress has been made with regard to measurement of specific IgE to allergen components (component-resolved testing) that might help to distinguish clinical risk of future anaphylactic episodes to an allergen from asymptomatic sensitization to the allergen. New strategies for immune modulation to prevent food-induced anaphylaxis and new insights into subcutaneous immunotherapy to prevent venom-induced anaphylaxis have been described. Research highlighted in this Update strengthens the evidence-based recommendations for assessment, management, and prevention of anaphylaxis made in the WAO Anaphylaxis Guidelines.
    Current Opinion in Allergy and Clinical Immunology 06/2012; 12(4):389-99. · 3.40 Impact Factor
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    ABSTRACT: Patients with severe or difficult-to-treat asthma are an understudied population but account for considerable asthma morbidity, mortality, and costs. The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study was a large, 3-year, multicenter, observational cohort study of 4756 patients (n=3489 adults ≥ 18 years of age, n=497 adolescents 13-17 years of age, and n=770 children 6-12 years of age) with severe or difficult-to-treat asthma. TENOR's primary objective was to characterize the natural history of disease in this cohort. Data assessed semiannually and annually included demographics, medical history, comorbidities, asthma control, asthma-related health care use, medication use, lung function, IgE levels, self-reported asthma triggers, and asthma-related quality of life. We highlight the key findings and clinical implications from more than 25 peer-reviewed TENOR publications. Regardless of age, patients with severe or difficult-to-treat asthma demonstrated high rates of health care use and substantial asthma burden despite receiving multiple long-term controller medications. Recent exacerbation history was the strongest predictor of future asthma exacerbations. Uncontrolled asthma, as defined by the 2007 National Heart, Lung, and Blood Institute guidelines' impairment domain, was highly prevalent and predictive of future asthma exacerbations; this assessment can be used to identify high-risk patients. IgE and allergen sensitization played a role in the majority of severe or difficult-to-treat asthmatic patients.
    The Journal of allergy and clinical immunology 06/2012; 130(2):332-42.e10. · 12.05 Impact Factor
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    ABSTRACT: Epinephrine is the drug of choice in the management of anaphylaxis. For first-aid treatment in the community, epinephrine autoinjectors (E-autos) are commonly prescribed, but are underutilized. In our laboratory, we developed a series of first-generation rapidly-disintegrating sublingual tablets (RDSTs) containing 40mg of epinephrine. One RDST had similar bioavailability to epinephrine 0.3mg from an auto-injector, as confirmed in a validated rabbit model, while other formulations containing different non-medicinal ingredients (NMIs) and with similar in vitro characteristics demonstrated much lower bioavailability. Subsequently, we evaluated the effect of changing the grade and proportion of NMIs, specifically mannitol and microcrystalline cellulose (MCC), on the in vitro characteristics of second- and third-generation RDSTs. Weight variation, content uniformity, breaking force, and friability were tested using official USP methods. Novel validated methods that simulate ambient conditions of the sublingual cavity were developed to test disintegration time, wetting time, and dissolution. Using these methods, it was possible to measure the effects of making small changes in NMIs on the in vitro characteristics of the formulations. The RDST formulation that resulted in the best in vitro characteristics contained the optimum proportion of mannitol and a specific ratio of coarse and fine particle grades of MCC. Appropriate comparative testing resulted in the selection of the RDST with the optimum in vitro characteristics.
    European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V 06/2012; · 3.15 Impact Factor
  • Elinor Simons, Scott H Sicherer, F Estelle R Simons
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    ABSTRACT: The optimal time for transferring responsibilities for anaphylaxis recognition and epinephrine auto-injector use from adults to children and teenagers has not yet been defined. To determine whether pediatric allergists have age-specific goals for beginning to transfer responsibilities for anaphylaxis recognition and epinephrine auto-injector use from parents and caregivers to children and teenagers at risk of anaphylaxis in the community. Members of the American Academy of Pediatrics Section on Allergy and Immunology (AAP-SOAI) were surveyed about when they typically begin to transfer these responsibilities from adults to children and teenagers. Eighty-eight allergists responded to the survey, 97.7% of whom provided service to children and teenagers with food allergies. Few allergists expected to begin transferring responsibilities for anaphylaxis recognition and epinephrine auto-injector use to children younger than 9 to 11 years. By the time their patients reached age 12 to 14 years, however, most allergists expected them to be able to describe some anaphylaxis symptoms (95.4%), demonstrate how to use an epinephrine auto-injector trainer (93.1%), begin carrying self-injectable epinephrine (88.2%), recognize the need for epinephrine (88.1%), learn to self-inject epinephrine (84.5%), and be able to self-inject epinephrine (78.6%) (cumulative data). The allergists rated the following as "very important" readiness factors for beginning to transfer responsibilities: medical history, developmental level, and ability to demonstrate auto-injector technique. Most pediatric allergists expected that by age 12 to 14 years, their patients should begin to share responsibilities with adults for anaphylaxis recognition and epinephrine auto-injector use; however, they individualized the timing based on assessment of patient readiness factors.
    Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 05/2012; 108(5):321-5. · 3.45 Impact Factor

Publication Stats

8k Citations
2,178.76 Total Impact Points


  • 2013
    • Johns Hopkins University
      • Department of Pediatrics
      Baltimore, Maryland, United States
    • Texas Tech University Health Sciences Center
      • Department of Obstetrics and Gynecology
      Lubbock, TX, United States
  • 2009–2013
    • Nova Southeastern University
      • College of Pharmacy
      Florida, New York, United States
  • 1982–2013
    • University of Manitoba
      • • Faculty of Medicine
      • • Faculty of Pharmacy
      • • Department of Pediatrics and Child Health
      • • Department of Immunology
      Winnipeg, Manitoba, Canada
  • 2012
    • University of Toronto
      • Hospital for Sick Children
      Toronto, Ontario, Canada
    • Centre Hospitalier Universitaire de Montpellier
      Montpelhièr, Languedoc-Roussillon, France
  • 2007–2012
    • The University of Edinburgh
      • Centre for Population Health Sciences
      Edinburgh, SCT, United Kingdom
  • 2011
    • French Institute of Health and Medical Research
      Lutetia Parisorum, Île-de-France, France
    • Massachusetts General Hospital
      • Division of Rheumatology, Allergy & Immunology
      Boston, MA, United States
  • 2010
    • Charité Universitätsmedizin Berlin
      • Department of Dermatology, Venerology and Allergology
      Berlin, Land Berlin, Germany
    • Brigham and Women's Hospital
      • Department of Medicine
      Boston, MA, United States
  • 1989–2010
    • Health Sciences Centre Winnipeg
      Winnipeg, Manitoba, Canada
  • 2008
    • University of Padova
      • Department of Pediatrics
      Padova, Veneto, Italy
    • University of Mississippi Medical Center
      • School of Medicine
      Jackson, MS, United States
  • 2006
    • American Academy of Allergy Asthma & Immunology
      Philadelphia, Pennsylvania, United States
  • 2002
    • University of California, San Diego
      San Diego, California, United States
  • 1986–1996
    • Government of Manitoba, Canada
      Winnipeg, Manitoba, Canada
  • 1975
    • University of Washington Seattle
      • Department of Medicine
      Seattle, WA, United States