School absence and productivity outcomes associated with childhood asthma in the USA.

BACKGROUND: Previous studies have examined the association between childhood asthma and lost productivity; however, more data are needed to understand its impact. METHODS: This was a retrospective analysis of cross-sectional data in the nationally representative 2007-2013 Medical Expenditure Panel Survey (MEPS). School-aged children (SAC), children (age 6-11), and adolescents (age 12-17) with asthma were compared to those without asthma to examine annual missed school days. Adult parents/caregivers of SAC with asthma were compared to those of SAC without asthma to examine missed work days. The cost of premature asthma mortality for SAC was also estimated. Negative binomial regression was used for missed school days, and a two-part model structure was used for missed work days. All analyses controlled for sociodemographics and other covariates. RESULTS: There were 44,320 SAC of whom 5,890 had asthma. There were 43,496 employed adults with at least one child. SAC (6-17) with asthma missed 1.54 times the number of school days compared to SAC without asthma. Caregivers of SAC (6-17) with asthma missed 1.16 times the number of work days to care for others compared to caregivers of SAC without asthma. SAC in the USA missed an additional 7 million school days associated with asthma (3.7 million children and 3.3 million adolescent). There were 130 asthma deaths resulting in an annual cost of $211 million ($US 2015). CONCLUSIONS: Childhood asthma is associated with a significant school absence and productivity loss in the USA. Better treatment and asthma management programs are needed to alleviate this burden.

Omalizumab in children with uncontrolled allergic asthma: Review of clinical trial and real-world experience.

Asthma is one of the most common chronic diseases of childhood. Allergen sensitization and high frequencies of comorbid allergic diseases are characteristic of severe asthma in children. Omalizumab, an anti-IgE mAb, is the first targeted biologic therapeutic approved for the treatment of moderate-to-severe persistent allergic asthma (AA) that remains uncontrolled despite high-dose inhaled corticosteroids plus other controller medications. Since its initial licensing for use in adults and adolescents 12 years of age and older, the clinical efficacy, safety, and tolerability of omalizumab have been demonstrated in several published clinical trials in children aged 6 to less than 12 years with moderate-to-severe AA. These studies supported the approval of the pediatric indication (use in children aged ≥6 years) by the European Medicines Agency in 2009 and the US Food and Drug Administration in 2016. After this most recent change in licensing, we review the outcomes from clinical trials in children with persistent AA receiving omalizumab therapy and observational studies from the past 7 years of clinical experience in Europe. Data sources were identified by using PubMed in 2016. Guidelines and management recommendations and materials from the recent US Food and Drug Administration's Pediatric Advisory Committee meeting are also reviewed.

The national cost of asthma among school-aged children in the United States.

BACKGROUND: Recent research has quantified the national health care resource use (HCRU) and health care expenditure (HCE) burden associated with adult asthma; however, estimates specific to school-aged children are more than 2 decades old. OBJECTIVE: To estimate the national HCRU and HCEs attributable to asthma among school-aged children in the United States. METHODS: This was a cross-sectional retrospective analysis of school-aged children (aged 6-17 years) in the nationally representative 2007-2013 Medical Expenditure Panel Survey. All-cause HCRU and HCEs of school-aged children with asthma were compared with school-aged children without asthma, controlling for sociodemographics and comorbidities. HCRU encounters included emergency department (ED) and outpatient visits, hospitalizations, and prescriptions. Expenditures included total, medical, ED, inpatient, outpatient, and pharmacy. Negative binomial regression analyses were used for HCRU and Heckman selection with logarithmic transformation, and smearing retransformation was used for HCEs. RESULTS: There were 44,320 school-aged children of whom 5,890 had asthma. Children with asthma incurred a higher rate of all-cause annual ED visits (incidence rate ratio [IRR], 1.5; P < .001), hospitalizations (IRR, 1.4; P < .05), outpatient visits (IRR, 1.4; P < .001), and prescription drugs (IRR, 3.3; P < .001) compared with school-aged children without asthma. They incurred US$847 (2015 dollars) more annually in all-cause expenditures (P < .001). Private insurance and Medicaid paid the largest share of expenditures. Pharmacy and outpatient costs represented the largest proportion of total expenditures. On the basis of the nationally representative Medical Expenditure Panel Survey sample weights from 2013, the total annual HCEs attributable to asthma for school-aged children in the United States was US$5.92 billion (2015 dollars). CONCLUSION: Childhood asthma continues to represent a prevalent and significant clinical and economic burden in the United States. More aggressive treatment and asthma management programs are needed to address this national financial and resource burden.

Indicators of poorly controlled asthma and health-related quality of life among school-age children in the United States.

BACKGROUND: Poorly controlled asthma has far-reaching effects on school-age children and their parents, but little is known about the national impact on health-related quality of life (HRQoL). OBJECTIVE: To examine HRQoL associated with asthma and indicators of poorly controlled asthma in the United States. METHODS: This was a cross-sectional analysis of HRQoL among school-age children (age range, 6-17 years) with asthma in the nationally representative 2007-2013 Medical Expenditure Panel Survey (MEPS). Indicators of poor asthma control included the following: exacerbation in the previous 12 months, use of more than three canisters of short-acting beta agonist in 3 months, and annual asthma-specific emergency department or inpatient visits. Health status and HRQoL instruments included the following: the Columbia Impairment Scale (CIS), Child Health Questionnaire (CHQ), Children with Special Health Care Needs Screener (CSHCN), and self-perceived physical and mental health. Ordered logistic regression was used for ordered categorical variables, and logistic regression was used for binary variables. All regressions controlled for sociodemographics and other covariates. RESULTS: There were 44,320 school-age children in the MEPS, of whom 5890 had asthma. School-age children with indicators of poorly controlled asthma had higher odds of feeling unhappy and/or sad or nervous and/or afraid, and of having problems with sports and/or hobbies and schoolwork on the CIS. Results from the CHQ showed that parents of school-age children with asthma and indicators of poorly controlled asthma had higher odds of worrying about their child's health and future. Results from the CSHCN showed that school-age children with asthma and indicators of poorly controlled asthma were more likely to have special health care needs. School-age children with asthma and indicators of poorly controlled asthma had higher odds of having poor perceived physical health. CONCLUSION: This nationally representative study provided novel information on the burden of poorly controlled asthma on emotional problems, school-related and activity limitations, general health status, and worry among school-age children and their families as measured by validated instruments.

Omalizumab for the treatment of exacerbations in children with inadequately controlled allergic (IgE-mediated) asthma.

BACKGROUND: Many children with asthma continue to experience symptoms despite available therapies. OBJECTIVE: This study evaluated the efficacy and safety of omalizumab, a humanized anti-IgE mAb, in children with moderate-to-severe persistent allergic (IgE-mediated) asthma that was inadequately controlled despite treatment with medium-dose or high-dose inhaled corticosteroids (ICSs) with or without other controller medications. METHODS: A randomized, double-blind, placebo-controlled trial enrolled children age 6 to <12 years with perennial allergen sensitivity and history of exacerbations and asthma symptoms despite at least medium-dose ICSs. Patients were randomized 2:1 to receive omalizumab (75-375 mg sc, q2 or q4 wk) or placebo over a period of 52 weeks (24-week fixed-steroid phase followed by a 28-week adjustable-steroid phase). RESULTS: A total of 627 patients (omalizumab, n = 421; placebo, n = 206) were randomized, with efficacy analyzed in 576 (omalizumab, n = 384; placebo, n = 192). Over the 24-week fixed-steroid phase, omalizumab reduced the rate of clinically significant asthma exacerbations (worsening symptoms requiring doubling of baseline ICS dose and/or systemic steroids) by 31% versus placebo (0.45 vs 0.64; rate ratio, 0.69; P = .007). Over a period of 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001). Omalizumab significantly reduced severe exacerbations. Over a period of 52 weeks, omalizumab had an acceptable safety profile, with no difference in overall incidence of adverse events compared with placebo. CONCLUSION: Add-on omalizumab is effective and well tolerated as maintenance therapy in children (6 to <12 years) with moderate-to-severe persistent allergic (IgE-mediated) asthma whose symptoms are inadequately controlled despite medium to high doses of ICSs.

Use of intranasal corticosteroids in the management of congestion and sleep disturbance in pediatric patients with allergic rhinitis.

Allergic rhinitis affects a large number of children and exerts a considerable socioeconomic impact. It is underdiagnosed and inadequately treated, which predisposes children to potentially serious comorbidities. Allergic rhinitis symptoms may create nighttime breathing problems and sleep disturbances and have a negative effect on a child's ability to learn in the classroom. Although antihistamines have shown efficacy in relieving many symptoms, they have little effect on nasal congestion. This article summarizes the advantages of intranasal corticosteroids, including their effectiveness against congestion and excellent safety profile. Intranasal corticosteroids with minimal systemic bioavailability provide topical drug delivery that minimizes the potential for systemic side-effects.

How to choose an electronic medical record.

I chose a Windows-based file system over a server-based system with a proprietary database, or a web-based system which has both a proprietary database and which also required a full time Internet connection. My reasoning was that I found it uncomplicated. I was familiar with the Windows interface and it required little effort to enter my existing data and was simple to operate the system. If one laptop crashes, my other computers still work. I don't fear failure of an Internet connection source, a modem or a server, power surges or other possible single points of failure that might prevent my patient care. I can incorporate all document types, I can update jump drives with any needed medical information. I can share information instantly with other systems. I can store my own data in a flexible and open format. I have no maintenance contract and I can make changes in my system or can even change vendors at any time. Last but certainly not least, I do not need a highly trained technical staff to operate or maintain our system.

Considerations in difficult-to-control asthma.

BACKGROUND: Difficult-to-control asthma includes those patients who require treatment with high-dose inhaled glucocorticosteroid (ICS) plus a second controller and/or systemic glucocorticosteroids to manage. The exact percentage of "difficult to treat," "refractory," "severe," or "brittle" asthma is 3% to 10% of all asthmatic patients, but this group of asthmatics use the majority of resources for the entire asthmatic population. METHODS: Medline searches for the terms "difficult to control," "severe," "refractory," "brittle," and asthma were done and the results were reviewed. RESULTS: Patterns for difficult-to-control asthma emerge from concepts of compliance, comorbidity, and endotypes, which give the practitioner pathways for analyzing this subset of asthma patients. CONCLUSION: The ear, nose, and throat (ENT) physician can be of significant help to other asthma specialists in the recognition of the difficult-to-control asthmatic, as well as providing specific specialized diagnostic skills and the reinforcement of adherence to medical regimens.

Comparison of the efficacy of combined fluticasone propionate and olopatadine versus combined fluticasone propionate and fexofenadine for the treatment of allergic rhinoconjunctivitis induced by conjunctival allergen challenge.

BACKGROUND: One approach to treating allergic rhinoconjunctivitis is the concomitant use of an intranasal spray such as fluticasone propionate to alleviate nasal symptoms and a topical or systemic agent to relieve ocular symptoms. It has not yet been determined whether a topical or systemic agent is more effective for the latter purpose. OBJECTIVE: This study compared the efficacy of combined use of fluticasone and olopatadine with combined use of fluticasone and fexofenadine in the treatment of the signs and symptoms of allergic rhinoconjunctivitis. METHODS: This 2-site, randomized, double-masked, placebo-controlled, parallel-group study employed the conjunctival allergen challenge (CAC) model, a standardized method of inducing ocular and nasal signs and symptoms of allergic rhinoconjunctivitis. At visit 1, subjects underwent CAC to determine the dose of allergen required to elicit a positive reaction. The allergen dose was confirmed at visit 2, and, according to a randomization schedule, subjects were dispensed fluticasone, olopatadine, and placebo pill; fluticasone, fexofenadine, and tear substitute; or placebo nasal spray, placebo pill, and tear substitute. CAC took place at visit 3, after patients had used the assigned medications for 2 weeks. Study medication was instilled 2 hours before CAC, after which allergic signs and symptoms were graded on standardized scales. The primary efficacy variables were ocular itching, ocular redness, and overall nasal symptoms. RESULTS: Eighty subjects completed the study: 30 received fluticasone and olopatadine, 30 fluticasone and fexofenadine, and 20 placebo. Women constituted 63.8% of the study population and men 36.3%; 91.3% were white, 3.8% black, 2.5% Hispanic, 1.3% Asian, and 1.3% other. Concomitant use of fluticasone and olopatadine produced significantly greater improvements in ocular itching at 3 and 7 minutes after CAC compared with fluticasone and fexofenadine (P < 0.05). There were no significant differences in redness scores between groups; however, concomitant use of fluticasone and olopatadine produced significantly greater improvements in redness at 2 time points in each of the 3 vessel beds (ciliary, conjunctival, and episcleral) compared with placebo, and fluticasone and fexofenadine produced significantly greater improvement in redness at 1 time point in I vessel bed compared with placebo (both comparisons, P < 0.05). The 2 treatments had similar effects on total nasal symptom efficacy scores. CONCLUSIONS: In this study, concomitant use of the topical agents fluticasone and olopatadine was more effective than concomitant use of fluticasone plus fexofenadine for overall treatment of the signs and symptoms of induced allergic rhinoconjunctivitis.

Urban eye allergy syndrome: a new clinical entity?

BACKGROUND: A significant number of patients present with conjunctivitis that is not strictly speaking of allergic, infectious, or dry eye origin. Patients affected by this pseudo-allergic form of vasomotor or idiopathic conjunctivitis usually live in urban polluted areas and may be affected by a new clinical entity called the 'urban eye allergy syndrome'. SCOPE: To identify the incidence, pathogenesis and therapeutic response of this condition by collecting from the literature experimental evidence on the relationship between air pollution, allergy, and conjunctival disease. FINDINGS: Allergen susceptibility might be increased in areas with increased air pollutants. Both allergens and pollutants can directly initiate specific and nonspecific mucosal inflammation through several interweaving mechanisms. CONCLUSIONS: The present commentary introduces the concept of 'urban eye allergy syndrome' discussing inter-actions between air pollutants and pollens, the increase of allergic signs and symptoms by pollutants, the prevalence of urban allergy, preliminary data from a single restricted geographical area, and proposed mechanisms of action.

Allergic rhinitis: selective comparisons of the pharmaceutical options for management.

The depth and variety of pharmaceuticals available to manage the syndrome of allergic rhinitis is unparalleled. To arrive at a personal formulary, a physician would be well advised to understand what patients want and what they are willing to accept in terms of expense and adverse events. Patients want medications that are nonsteroidal, non habituating, produce no drowsiness, and could be used intermittently on demand only. This review is intended as an aid in comparing classes and formats of medications affecting nasal allergy.

Baboon syndrome induced by mercury - first case report in China.

A case of mercury-induced baboon syndrome was reported. A 31-year-old woman presented with itching papules and vesicles in the right axilla, which extended to the left axilla, arms, fossa poplitea, buttocks, and groin. A mercury thermometer was broken 2 days before exanthema. Patch testing to ammoniated mercury, mercury, mercuric chloride, and mercurochrome were positive. Blood and urine mercury level was marginally normal, yet showed a descending trend over time.

Unanswered clinical questions and speculation about the role of anti-immunoglobulin E in atopic and nonatopic disease.

As clinical experience with omalizumab increases, questions arise from clinicians that are not answered in the product insert or clinical reports. How does this drug really work? There surely must be more than the simple reduction of free IgE which, in and of itself, causes no disease. Can omalizumab be used in patients whose IgE level is below 30 or above 700 IU/mL? Can you treat a pregnant asthmatic woman with omalizumab? What are the updated risks for cancer? Is there a risk for omalizumab-treated patients who travel to parasite-endemic areas? What are the implications of skin-prick tests that remain positive after treatment? Does this drug prevent anaphylaxis with enough assurity to use it in conjunction with immunotherapy (IT) or rush IT? Are the complexes formed as a result of therapy problematic, therapeutic, or inconsequential? How long should this drug be used? It is the purpose of this review to examine these clinical issues and present common strategies for approaching each.

Unanswered questions and warnings involving anti-immunoglobulin E therapy based on 2-year observation of clinical experience.

The relatively rapid development and deployment of a clinically useful monoclonal antibody omalizumab has produced a number of questions still not answered despite massive research and many clinical trials. The mechanism of action as down-regulation of FceR1 receptors in the presence of low free immunoglobulin E (IgE) is incomplete. Some severe allergic asthmatic patients respond almost immediately, others take months, and some never respond. No accounting for the possible antigen sweeping by the complexes of IgG-IgE has been reported. Skin tests may remain positive for much longer than reported, raising the possibility of anaphylaxis with concomitant specific immunotherapy. Two cases of anaphylaxis to specific immunotherapy while being "covered" with anti-IgE are reported. Total IgE levels do not always rise as expected, six cases of static IgE levels in responders are reported. Total IgE levels do not dependably predict usefulness. Current guidelines for anti-IgE use in asthmatic patients may require reexamination as data from broad clinical experience are gathered.