Thomas B Casale

University of South Florida, Tampa, Florida, United States

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Publications (300)2183 Total impact

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    ABSTRACT: Allergen immunotherapy (AIT) is a guidelines-approved, disease-modifying treatment option for respiratory allergies, including allergic rhinitis (AR) induced by pollen. The various AIT regimens employed to date in pollen-induced AR can be classified as continuous (i.e. year-round) or discontinuous (i.e. pre-seasonal alone, co-seasonal alone or pre- and co-seasonal). Pre-and co-seasonal regimens are typically used for sublingual allergen immunotherapy (SLIT) and have economic and compliance advantages over perennial (year-round) regimens. However, these advantages must not come at the expensive of poor efficacy or safety. The results of recent double-blind, placebo-controlled, randomized clinical trials show that pre- and co-seasonal SLIT is safe and effective in patients with AR induced by grass pollen (treated with a tablet formulation) or by birch pollen (treated with a liquid formulation). Progress in SLIT has been made in defining the optimal dose of major allergen, the administration frequency (daily), the duration of pre-seasonal treatment (four months) and the number of treatment seasons (at least three). Post-marketing, "real-life" trials of pre- and co-seasonal birch or grass pollen SLIT regimens have confirmed the efficacy and safety observed in the clinical trials. In the treatment of pollen-induced AR, pre- and co-seasonal SLIT regimens appear to be at least as effective and safe as perennial SLIT regimens, and are associated with lower costs and good compliance. Good compliance may mean that pre- and co-seasonal SLIT regimens are inherently more effective and safer than perennial SLIT regimens. When considering the pre- and co-seasonal discontinuous regimen in particular, a 300 IR five-grass-pollen formulation is the only SLIT tablet with a clinical development programme having provided evidence of short-term, sustained and post-treatment efficacy.
    12/2015; 5(1). DOI:10.1186/s13601-015-0061-z
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    J Bousquet, H J Schunemann, J Fonseca, B Samolinski, C Bachert, G W Canonica, T Casale, A A Cruz, P Demoly, P Hellings, [...], J Wright, B P Yawn, P K Yiallouros, O M Yusuf, H J Zar, M E Zernotti, L Zhang, N Zhong, M Zidarn, J Mercier
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    ABSTRACT: Several unmet needs have been identified in allergic rhinitis: identification of the time of onset of the pollen season, optimal control of rhinitis and comorbidities, patient stratification, multidisciplinary team for integrated care pathways, innovation in clinical trials and above all patient empowerment. MASK-rhinitis (MACVIA-ARIA Sentinel NetworK for allergic rhinitis) is a simple system centred around the patient which was devised to fill many of these gaps using Information and Communications Technology (ICT) tools and a clinical decision support system (CDSS) based on the most widely used guideline in allergic rhinitis and its asthma co-morbidity (ARIA 2015 revision). It is one of the implementation systems of the Action Plan B3 of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA). Three tools are used for the electronic monitoring of allergic diseases: a cell phone-based daily visual analogue scale (VAS) assessment of disease control, CARAT (Control of Allergic Rhinitis and Asthma Test) and the e-Allergy screening (Premedical system of early diagnosis of allergy and asthma based on online tools). These tools are combined with a clinical decision support system (CDSS) and are available in many languages. An e-CRF and an e-learning tool complete MASK. MASK is flexible and other tools can be added. It appears to be an advanced, global and integrated ICT answer for many unmet needs in allergic diseases which will improve policies and standards. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Allergy 07/2015; DOI:10.1111/all.12686 · 6.00 Impact Factor
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    ABSTRACT: Electronic cigarettes (EC) are battery-powered nicotine delivery systems that have increased in popularity since they entered the US market. EC has been reported to contain less carcinogens than traditional cigarettes, cause less acute lung effects in healthy individuals, and may help with smoking cessation. It has also been viewed as a potential safer alternative for asthmatic smokers, but its effects on lung functions are unclear. However, EC do carry some harmful aspects as they contain formaldehyde and formaldehyde-forming hemiacetals as well as potentially toxic particulate matter that deposits on surfaces. EC are an increasingly popular device that could serve as a gateway into traditional cigarette smoking or illicit drugs. The popularity of EC has brought with it money from large tobacco corporations and mass marketing. Lack of regulation has generated product inconsistency and potential health hazards. This review highlights what is known and what still needs to be answered about EC. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
    07/2015; 3(4):498-505. DOI:10.1016/j.jaip.2015.05.022
  • Thomas B Casale
    07/2015; 3(4):519-520. DOI:10.1016/j.jaip.2015.04.014
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    ABSTRACT: Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242). The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis. Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies. Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma. Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
    06/2015; 69. DOI:10.1016/j.jaip.2015.04.015
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    ABSTRACT: New treatment options are required for patients with asthma not sufficiently controlled with inhaled therapies. In a Phase 2a trial, CYT003, a toll-like receptor-9 agonist immunomodulator, improved asthma control during inhaled glucocorticosteroid reduction in patients with allergic asthma. This double-blind Phase 2b study assessed the efficacy and safety of CYT003 in patients with persistent moderate-to-severe allergic asthma not sufficiently controlled on standard inhaled glucocorticosteroid therapy with/without long-acting beta-agonists. Overall, 365 patients received seven doses of subcutaneous CYT003 (0.3, 1, or 2 mg) or placebo as add-on therapy to conventional controller medication. Change from baseline in Asthma Control Questionnaire score was the primary outcome; secondary outcomes included change in forced expiratory volume, Mini Asthma Quality of Life Questionnaire, and safety. All groups, including placebo, showed a clinically important improvement in Asthma Control Questionnaire score; however, there was no significant difference between the CYT003 and placebo groups at Week 12 (least-squares mean difference 0.3 mg: -0.027 [95% confidence interval -0.259-0.204]; 1 mg: 0.097 [-0.131-0.325]; 2 mg: 0.081 [-0.148-0.315]). No significant differences were seen in secondary outcomes. CYT003 was well tolerated; the most common treatment-emergent adverse events were injection site reactions. Due to lack of efficacy, the study was prematurely terminated at the end of the treatment phase with no further follow-up. Toll-like receptor-9 agonism with CYT003 showed no additional benefit in patients with insufficiently controlled moderate-to-severe allergic asthma receiving standard inhaled glucocorticosteroid therapy with or without long-acting beta-agonists. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Allergy 06/2015; DOI:10.1111/all.12663 · 6.00 Impact Factor
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    ABSTRACT: A patient's knowledge of his/her allergic condition and treatment is a key factor in adherence and effectiveness. To assess patients' understanding of allergy and acceptance of allergen immunotherapy on the basis of (i) information given by their physician at the time of prescription and (ii) a new communication template viewed some months later, we performed an Internet-based survey of patient panels in France, Germany, Spain, the USA and Russia. The survey participants were either recent "early abandoners" (having discontinued allergen immunotherapy before the end of the prescribed course) or "non-starters" (having decided not to initiate a course of allergen immunotherapy recommended by their physician). All participants completed an on-line questionnaire immediately before and immediately after viewing the new communication template. The study's main objectives were to validate the new communication template and to assess its impact on anticipated willingness to initiate or resume allergen immunotherapy. We surveyed a total of 261 patients (France: 57; Germany: 51; Spain: 52; USA: 51; Russia: 50), comprising 127 "early abandoners" and 134 "non-starters". The mean time since symptom onset and selection for the study was 14.5 years. Subcutaneous allergen immunotherapy had been prescribed in 60 % of cases. Twenty-eight percent of the participants did not know for which allergy they were being treated. Early abandoners reported a perception of low effectiveness (39 %) and complained about expense (39 %) and practical constraints (32 %). Twenty-two percent of the non-starters feared side effects. The communication template was considered to be clear (by 92 % of the patients), convincing (by 75 %) and reassuring (by 89 %); 80 % of the participants felt better informed afterwards, and 67 % stated that viewing the communication template would have made them more likely to continue or initiate allergen immunotherapy (overall willingness score: 5.65 out of 10 before viewing and 7.1 out of 10 afterwards). After viewing a new communication template on allergy and allergen immunotherapy, patients participating in the survey felt better informed and more likely to initiate or complete this therapy. It now remains to investigate the communication template's effect on actual acceptance of and adherence to allergen immunotherapy.
    Allergy Asthma and Clinical Immunology 05/2015; 11(1). DOI:10.1186/s13223-015-0083-z
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    ABSTRACT: The global allergy community strongly believes that the 11(th) revision of the International Classification of Diseases (ICD-11) offers a unique opportunity to improve the classification and coding of hypersensitivity/allergic diseases via inclusion of a specific chapter dedicated to this diseases area in order to facilitate epidemiological studies, as well as to evaluate the true size of the allergy epidemic. In this context, an international collaboration has decided to revise the classification of hypersensitivity/allergic diseases and to validate it for ICD-11 by crowdsourcing the allergist community. After careful comparison between ICD-10 and 11 beta phase linearization codes we identified gaps and trade-offs allowing us to construct a classification proposal, which was sent to the European Academy of Allergy and Clinical Immunology (EAACI) Sections, Interest Groups, Executive Committee as well as the World Allergy Organization (WAO) and American Academy of Allergy Asthma and Immunology (AAAAI) leaderships. The crowdsourcing process produced comments from 50 of 171 members contacted by e-mail. The classification proposal has also been discussed at face-to-face meetings with experts of EAACI sections and interest groups and presented in a number of business meetings during the 2014 EAACI annual congress in Copenhagen. As a result, a high level complex structure of classification for hypersensitivity/allergic diseases has been constructed. The model proposed has been presented to the WHO groups in charge of the ICD revision. The international collaboration of allergy experts appreciates bilateral discussion and aims to get endorsement of their proposals for the final ICD-11. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Allergy 03/2015; 70(6). DOI:10.1111/all.12604 · 6.00 Impact Factor
  • Farnaz Tabatabaian, Thomas B Casale
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    ABSTRACT: Allergy immunotherapy has been used to help alleviate symptoms of allergic diseases for over 100 years. In the setting of the recently approved sublingual immunotherapy, allergists are now faced with which therapeutic regimen to use in clinical practice, sublingual immunotherapy (SLIT) or subcutaneous immunotherapy (SCIT). Both SLIT and SCIT have been shown to be beneficial for the therapy of seasonal allergic rhinoconjunctivitis. Each therapeutic measure has its associated benefits. SLIT has a better safety profile with less systemic reactions and to date, no reported fatal reactions. SCIT, the primary method of allergen immunotherapy in the United States, has a slightly better efficacy profile and readily allows for treatment of polyallergic patients. This review focuses on how to incorporate SLIT into daily clinical practice and on how to choose SLIT versus SCIT.
    Allergy and Asthma Proceedings 03/2015; 36(2):100-4. DOI:10.2500/aap.2015.36.3830 · 3.35 Impact Factor
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    ABSTRACT: In patients with severe asthma, tiotropium improves lung function and exacerbation risk when added to high-dose inhaled corticosteroids plus long-acting β2 agonists. We aimed to assess the safety and efficacy of tiotropium in patients with moderate asthma who were symptomatic despite treatment with medium-dose inhaled corticosteroids. We did two 24-week, replicate, randomised, double-blind, placebo-controlled, parallel-group, active-comparator trials at 233 sites in 14 countries. Eligible patients were aged 18-75 years with symptomatic asthma and a pre-bronchodilator forced expiratory volume in 1 s (FEV1) of 60-90% predicted despite use of medium-dose inhaled corticosteroids, and had never smoked or were ex-smokers for 1 year or more with 10 pack-years or less. Patients were randomly assigned (1:1:1:1), with computer-generated pseudorandom numbers, to receive once-daily tiotropium 5 μg or 2·5 μg, twice-daily salmeterol 50 μg, or placebo, while maintaining inhaled corticosteroids. Patients and study investigators were masked to treatment allocation. Prespecified co-primary endpoints, assessed at week 24 in the full analysis set, were peak FEV1 response, measured within the first 3 h after evening dosing; trough FEV1 response; and responder rate assessed according to the seven-question Asthma Control Questionnaire (ACQ-7). These studies are registered with ClinicalTrials.gov, numbers NCT01172808 and NCT01172821. Between Aug 24, 2010, and Nov 13, 2012, we randomly assigned 2103 patients to the tiotropium 5 μg group (n=519), the tiotropium 2·5 μg group (n=520), the salmeterol group (n=541), or the placebo group (n=523); 1972 (94%) patients completed the study. Peak and trough FEV1 responses were significantly greater with tiotropium and salmeterol than with placebo and were similar in both studies. With pooled data, difference versus placebo in peak FEV1 was 185 mL (95% CI 146-223) in the tiotropium 5 μg group, 223 mL (185-262) in the tiotropium 2·5 μg group, and 196 mL (158-234) in the salmeterol group (all p<0·0001); difference in trough FEV1 was 146 mL (95% CI 105-188), 180 mL (138-221), and 114 mL (73-155; all p<0·0001), respectively. There were more ACQ-7 responders in the tiotropium 5 μg (OR 1·32, 95% CI 1·02-1·71; p=0·035) and 2·5 μg (1·33, 1·03-1·72; p=0·031) groups, and the salmeterol group (1·46, 1·13-1·89; p=0·0039), than in the placebo group. 48 (2%) of 2100 patients had serious adverse events (tiotropium 5 μg n=11, tiotropium 2·5 μg n=12, salmeterol n=11, placebo n=14). Once-daily tiotropium add-on to medium-dose inhaled corticosteroids reduces airflow obstruction and improves asthma control in patients with moderate symptomatic asthma. Patterns of response with both tiotropium doses were similar to those of salmeterol, and all active compounds had good safety and tolerability. Tiotropium is a safe and effective bronchodilator, and an alternative to salmeterol in this patient population. Boehringer Ingelheim. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet Respiratory Medicine 02/2015; 3(5). DOI:10.1016/S2213-2600(15)00031-4
  • Journal of Allergy and Clinical Immunology 02/2015; 135(2):AB227. DOI:10.1016/j.jaci.2014.12.1675 · 11.25 Impact Factor
  • Journal of Allergy and Clinical Immunology 02/2015; 135(2):AB1. DOI:10.1016/j.jaci.2014.12.937 · 11.25 Impact Factor
  • Journal of Allergy and Clinical Immunology 02/2015; 135(2):AB281. DOI:10.1016/j.jaci.2014.12.1857 · 11.25 Impact Factor
  • Jeffrey R Stokes, Thomas B Casale
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    ABSTRACT: Omalizumab is a monoclonal anti-IgE antibody that has been used to treat allergic asthma for over a decade. The use of omalizumab to treat other diseases has largely been limited to case reports until the recently reported large multicenter studies that have established omalizumab as an effective treatment option for chronic spontaneous urticaria. The utility of omalizumab to treat nonallergic asthma and allergic rhinitis and the added safety and therapeutic benefits in combination with allergen immunotherapy have been demonstrated in placebo-controlled trials. Data supporting the clinical efficacy of omalizumab in treating atopic dermatitis, physical urticarias, mast cell disorders, food allergy, and various other allergic disorders have shown promise in small clinical trials and case studies. More carefully designed, large clinical trials of high quality are needed to fully appreciate the potential of omalizumab in treating various allergic and nonallergic diseases. Copyright © 2015. Published by Elsevier Inc.
    01/2015; 3(2). DOI:10.1016/j.jaip.2014.10.010
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    Andrew Cooke, Adeeb Bulkhi, Thomas B Casale
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    ABSTRACT: Chronic urticaria (CU) is a common condition faced by many clinicians. CU has been estimated to affect approximately 0.5%-1% of the population, with nearly 20% of sufferers remaining symptomatic 20 years after onset. Antihistamines are the first-line therapy for CU. Unfortunately, nearly half of these patients will fail this first-line therapy and require other medication, including immune response modifiers or biologics. Recent advances in our understanding of urticarial disorders have led to more targeted therapeutic options for CU and other urticarial diseases. The specific biologic agents most investigated for antihistamine-refractory CU are omalizumab, rituximab, and intravenous immunoglobulin (IVIG). Of these, the anti-IgE monoclonal antibody omalizumab is the best studied, and has recently been approved for the management of CU. Other agents, such as interleukin-1 inhibitors, have proved beneficial for Schnitzler syndrome and cryopyrin-associated periodic syndromes (CAPS), diseases associated with urticaria. This review summarizes the relevant data regarding the efficacy of biologics in antihistamine-refractory CU.
    Targets & therapy 01/2015; 9:25-33. DOI:10.2147/BTT.S63839
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    ABSTRACT: G protein-coupled receptors (GPCRs) are important regulators of cell functions in asthma. We recently reported that RGS2, a selective modulator of Gq-coupled GPCRs, is a key regulator of airway hyperresponsiveness (AHR), the pathophysiologic hallmark of asthma. Since RGS2 protein levels in airway cells were significantly lower in asthmatics compared to non-asthmatics, we further investigated the potential pathological importance of RGS2 repression in asthma. The human RGS2 gene maps to chromosome 1q31. We first screened asthma patients for RGS2 gene promoter single-nucleotide polymorphisms (SNPs) and found significant differences in the distribution of two RGS2 SNPs (A638G, rs2746071 and C395G, rs2746072) between asthmatics and non-asthmatics. These two SNPs are always associated with each other and have the same higher prevalence in asthmatics (65%) as compared to non-asthmatics (35%). Point mutations corresponding to these SNPs decrease the RGS2 promoter activity by 44%. The importance of RGS2 down-regulation was then determined in an acute interleukin-13 (IL-13) mouse model of asthma. Intranasal administration of IL-13 in mice also decreased RGS2 expression in lungs by about 50% and caused AHR. Interestingly, although naïve RGS2 knockout (KO) mice exhibit spontaneous AHR, acute IL-13 exposure further increased AHR in RGS2 KO mice. Loss of RGS2 also significantly enhanced IL-13-induced mouse airway remodeling including peribronchial smooth muscle thickening and fibrosis without effects on goblet cell hyperplasia or airway inflammation in mice. Thus, both genetic variations and increased inflammatory cytokines can lead to RGS2 repression, which exacerbates AHR and airway remodeling in asthma.
    American Journal of Respiratory Cell and Molecular Biology 11/2014; DOI:10.1165/rcmb.2014-0319OC · 4.11 Impact Factor
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    ABSTRACT: The goal of asthma treatment is to control the disease according to guidelines issued by bodies such as the Global Initiative for Asthma. Effective control is dependent upon evaluation of symptoms, initiation of appropriate treatment and minimization of the progressive adverse effects of the disease and its therapies. Although individual outcome measures have been shown to correlate with asthma control, composite endpoints are preferred to enable more accurate and robust monitoring of the health of the individual patient. A number of validated instruments are utilized to capture these component endpoints; however, there is no consensus on the optimal instrument for use in clinical trials. The Asthma Control Questionnaire (ACQ) has been shown to be a valid, reliable instrument that allows accurate and reproducible assessment of asthma control that compares favourably with other commonly used instruments. This analysis provides a summary of the use of ACQ in phase II, III and IV asthma trials. Comparisons between the ACQ and other instruments are also presented. Our analysis suggests that the ACQ is a valid and robust measure for use as a primary or secondary endpoint in future clinical trials.
    Allergy 07/2014; 69(9). DOI:10.1111/all.12415 · 6.00 Impact Factor
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    British Journal of Dermatology 07/2014; 171(1):15-6. DOI:10.1111/bjd.13075 · 4.10 Impact Factor
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    ABSTRACT: The objective of Integrated Care Pathways for Airway Diseases (AIRWAYS-ICPs) is to launch a collaboration to develop multi-sectoral care pathways for chronic respiratory diseases in European countries and regions. AIRWAYS-ICPs has strategic relevance to the European Union Health Strategy and will add value to existing public health knowledge by: 1) proposing a common framework of care pathways for chronic respiratory diseases, which will facilitate comparability and trans-national initiatives; 2) informing cost-effective policy development, strengthening in particular those on smoking and environmental exposure; 3) aiding risk stratification in chronic disease patients, using a common strategy; 4) having a significant impact on the health of citizens in the short term (reduction of morbidity, improvement of education in children and of work in adults) and in the long-term (healthy ageing); 5) proposing a common simulation tool to assist physicians; and 6) ultimately reducing the healthcare burden (emergency visits, avoidable hospitalisations, disability and costs) while improving quality of life. In the longer term, the incidence of disease may be reduced by innovative prevention strategies. AIRWAYS-ICPs was initiated by Area 5 of the Action Plan B3 of the European Innovation Partnership on Active and Healthy Ageing. All stakeholders are involved (health and social care, patients, and policy makers).
    European Respiratory Journal 06/2014; 44(2). DOI:10.1183/09031936.00014614 · 7.13 Impact Factor
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    European Respiratory Journal 06/2014; · 7.13 Impact Factor

Publication Stats

7k Citations
2,183.00 Total Impact Points

Institutions

  • 2014–2015
    • University of South Florida
      • Division of Allergy and Immunology
      Tampa, Florida, United States
  • 2001–2014
    • Creighton University
      • • Division of Allergy & Immunology
      • • Department of Medicine
      Omaha, Nebraska, United States
  • 2013
    • University of Nebraska at Omaha
      Omaha, Nebraska, United States
  • 2006
    • The Immune Tolerance Network
      Seattle, Washington, United States
  • 2000
    • Northwest Asthma and Allergy Center
      Seattle, Washington, United States
    • Novartis
      Bâle, Basel-City, Switzerland
  • 1989–1998
    • University of Iowa
      • Department of Internal Medicine
      Iowa City, IA, United States
  • 1983–1985
    • National Institute of Allergy and Infectious Diseases
      Maryland, United States
  • 1984
    • National Institute of Allergy and Infectious Disease
      Maryland, United States