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1.  Targeted IgE Therapy for Patients With Moderate to Severe Asthma 
Biotechnology Healthcare  2004;1(3):56-61.
Bradley E. Chipps, MD, and Patricia L. Marshik, PharmD, review the clinical benefits of IgE-blocker therapy and who stands to benefit from it.
It is well established that the proinflammatory cytokine immunoglobulin E (IgE) is a primary contributor to development of allergic airway inflammation following allergen exposure. Recent data suggest that blocking the effects of IgE with omalizumab, a recombinant DNA-derived humanized monoclonal antibody that inhibits the binding of IgE, is an effective strategy for the treatment of asthma, particularly for moderate to severe asthma that is difficult to control with inhaled corticosteroids and traditional controller medications. Targeting specific steps in the inflammatory cascade with omalizumab improves daytime and nocturnal symptom control, reduces exacerbations, and decreases the need for inhaled corticosteroids and beta2 agonists. These benefits, along with improved daily functioning, have resulted in a clinically meaningful improvement in asthma-related quality of life for a substantial number of patients. This paper briefly reviews the contribution of IgE to the development of airway inflammation, discusses the clinical benefits of IgE-blocker therapy, and profiles the patient who stands to benefit from this new and innovative form of therapy.
PMCID: PMC3564312  PMID: 23390386
Airway inflammation; asthma; immunoglobulin-E blocker therapy; monoclonal antibody; omalizumab
2.  Key findings and clinical implications from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study 
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.
doi:10.1016/j.jaci.2012.04.014
PMCID: PMC3622643  PMID: 22694932
TENOR; severe or difficult-to-treat asthma; asthma control; asthma exacerbations; burden; medication; quality of life; allergy; IgE
3.  Assessment of asthma control and asthma exacerbations in the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) observational cohort 
Current Respiratory Care Reports  2012;1(4):259-269.
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.
doi:10.1007/s13665-012-0025-x
PMCID: PMC3485530  PMID: 23136642
Severe asthma; Difficult-to-treat asthma; Asthma control; Exacerbation
4.  Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses 
The Journal of Asthma  2014;51(6):603-609.
Background
The role of fixed airflow obstruction (FAO) in asthma is unclear. Objective: To assess the relationship between FAO and clinical features of asthma and the effect of FAO on treatment response. Methods: Post hoc descriptive analysis of data stratified by FAO category (screening post-albuterol FEV1/FVC
doi:10.3109/02770903.2014.895012
PMCID: PMC4162502  PMID: 24524222
Airflow limitation; airway inflammation; budesonide; combination therapy; formoterol; inhaled corticosteroid; lung function

Results 1-4 (4)