Building Bridges for Asthma Care Program: A School-Centered Program Connecting Schools, Families, and Community Health-Care Providers.

Asthma imposes tremendous burden on children, families, and society. Successful management requires coordinated care among children, families, health providers, and schools. Building Bridges for Asthma Care Program, a school-centered program to coordinate care for successful asthma management, was developed, implemented, and evaluated. The program consists of five steps: (1) identify students with asthma; (2) assess asthma risk/control; (3) engage the family and student at risk; (4) provide case management and care coordination, including engagement of health-care providers; and (5) prepare for next school year. Implementation occurred in 28 schools from two large urban school districts in Colorado and Connecticut. Significant improvements were noted in the proportions of students with completed School Asthma Care Plans, a quick-relief inhaler at school, Home Asthma Action/Treatment Plans and inhaler technique (p < .01 for all variables). Building Bridges for Asthma Care was successfully implemented extending asthma care to at-risk children with asthma through engagement of schools, health providers, and families.

Building Bridges for Asthma Care: Reducing school absence for inner-city children with health disparities.

BACKGROUND: Children with asthma are at increased risk for experiencing health and educational disparities because of increased school absence. School nurses are well positioned to support asthma management and improve school attendance. OBJECTIVE: We sought to implement and assess the effect of the Building Bridges for Asthma Care Program on improving school attendance and measures of asthma control. METHODS: Children with asthma (age, 5-14 years) in the Denver Public School System (n = 240) and the Hartford Public School System (n = 223) were enrolled in the Building Bridges Program during the 2013-2014 and 2014-2015 school years and followed until the end of the second school year. The primary outcome was school absence, with secondary outcomes, including asthma control, measured based on Childhood Asthma Control Test or the Asthma Control Test scores and rescue inhaler use. RESULTS: Participants experienced a 22% absolute decrease in school absenteeism, the number of children with an Asthma Control Test/Childhood Asthma Control Test score of less than the control threshold of 20 decreased from 42.7% to 28.8%, and bronchodilator use greater than 2 times per week decreased from 35.8% to 22.9% (all changes were significant, P < .01). CONCLUSIONS: Children enrolled in the Building Bridges for Asthma Care Program experienced reduced school absence and improved asthma control.

Cost-effectiveness of an Evidence-Based Childhood Asthma Intervention in Real-World Primary Care Settings.

We present an incremental cost-effectiveness analysis of an evidence-based childhood asthma intervention (Community Healthcare for Asthma Management and Prevention of Symptoms [CHAMPS]) to usual management of childhood asthma in community health centers. Data used in the analysis include household surveys, Medicaid insurance claims, and community health center expenditure reports. We combined our incremental cost-effectiveness analysis with a difference-in-differences multivariate regression framework. We found that CHAMPS reduced symptom days by 29.75 days per child-year and was cost-effective (incremental cost-effectiveness ratio: $28.76 per symptom-free days). Most of the benefits were due to reductions in direct medical costs. Indirect benefits from increased household productivity were relatively small.

Bedroom allergen exposures in US households.

BACKGROUND: Bedroom allergen exposures contribute to allergic disease morbidity because people spend considerable time in bedrooms, where they come into close contact with allergen reservoirs. OBJECTIVE: We investigated participant and housing characteristics, including sociodemographic, regional, and climatic factors, associated with bedroom allergen exposures in a nationally representative sample of the US population. METHODS: Data were obtained from National Health and Nutrition Examination Survey 2005-2006. Information on participant and housing characteristics was collected by using questionnaires and environmental assessments. Concentrations of 8 indoor allergens (Alt a 1, Bla g 1, Can f 1, Fel d 1, Der f 1, Der p 1, Mus m 1, and Rat n 1) in dust vacuumed from nearly 7000 bedrooms were measured by using immunoassays. Exposure levels were classified as increased based on percentile (75th/90th) cutoffs. We estimated the burden of exposure to multiple allergens and used multivariable logistic regression to identify independent predictors for each allergen and household allergen burden. RESULTS: Almost all participants (>99%) had at least 1 and 74.2% had 3 to 6 allergens detected. More than two thirds of participants (72.9%) had at least 1 allergen and 18.2% had 3 or more allergens exceeding increased levels. Although exposure variability showed significant racial/ethnic and regional differences, high exposure burden to multiple allergens was most consistently associated with the presence of pets and pests, living in mobile homes/trailers and older and rental homes, and living in nonmetropolitan areas. CONCLUSIONS: Exposure to multiple allergens is common. Despite highly variable exposures, bedroom allergen burden is strongly associated with the presence of pets and pests.

Sensitization and Exposure to Pets: The Effect on Asthma Morbidity in the US Population.

BACKGROUND: Although pets are found in more than 50% of US homes, the effect of pet allergen exposure on asthma morbidity in the US population is not well documented. OBJECTIVE: To determine the effect of dog and cat allergen exposures on asthma morbidity in the US population. METHODS: The National Health and Nutrition Examination Survey is a representative sample of civilian US population. Data on asthma, dog and cat allergen levels in bedroom dust, as well as specific IgE to dog and cat were analyzed for all participants 6 years or older. RESULTS: Pets are common in the United States, with more that 50% of households having a dog or a cat or both. The prevalence of allergic sensitization in the National Health and Nutrition Examination Survey population was similar for dog and cat, with both being approximately 12%. Among those who were sensitized, exposure to elevated levels of pet allergens was associated with an increased prevalence of asthma and asthma attacks. Indeed, 44.2% of the asthma attacks were attributable to exposure to high levels of dog allergen in the bedroom among patients with asthma sensitive to dog and 30.3% were attributable to cat allergen exposure among the comparable cat-sensitive and exposed group. Projecting these results to the US population indicates more than 1 million increased asthma attacks each year for the dog-sensitive and exposed group and more than 500,000 increased asthma attacks for the cat-sensitive and exposed population of patients with asthma. CONCLUSIONS: Exposure to elevated levels of dog and cat allergens among those sensitized individuals with asthma is associated with excess asthma attacks. Reducing pet allergen exposures has the potential for a significant decrease in asthma morbidity.

Effectiveness of Evidence-Based Asthma Interventions.

BACKGROUND AND OBJECTIVES: Researchers often struggle with the gap between efficacy and effectiveness in clinical research. To bridge this gap, the Community Healthcare for Asthma Management and Prevention of Symptoms (CHAMPS) study adapted an efficacious, randomized controlled trial that resulted in evidence-based asthma interventions in community health centers. METHODS: Children (aged 5-12 years; N = 590) with moderate to severe asthma were enrolled from 3 intervention and 3 geographically/capacity-matched control sites in high-risk, low-income communities located in Arizona, Michigan, and Puerto Rico. The asthma intervention was tailored to the participant's allergen sensitivity and exposure, and it comprised 4 visits over the course of 1 year. Study visits were documented and monitored prospectively via electronic data capture. Asthma symptoms and health care utilization were evaluated at baseline, and at 6 and 12 months. RESULTS: A total of 314 intervention children and 276 control children were enrolled in the study. Allergen sensitivity testing (96%) and home environmental assessments (89%) were performed on the majority of intervention children. Overall study activity completion (eg, intervention visits, clinical assessments) was 70%. Overall and individual site participant symptom days in the previous 4 weeks were significantly reduced compared with control findings (control, change of -2.28; intervention, change of -3.27; difference, -0.99; P < .001), and this result was consistent with changes found in the rigorous evidence-based interventions. CONCLUSIONS: Evidence-based interventions can be successfully adapted into primary care settings that serve impoverished, high-risk populations, reducing the morbidity of asthma in these high-need populations.

NIAID, NIEHS, NHLBI, and MCAN Workshop Report: The indoor environment and childhood asthma-implications for home environmental intervention in asthma prevention and management.

Environmental exposures have been recognized as critical in the initiation and exacerbation of asthma, one of the most common chronic childhood diseases. The National Institute of Allergy and Infectious Diseases; National Institute of Environmental Health Sciences; National Heart, Lung, and Blood Institute; and Merck Childhood Asthma Network sponsored a joint workshop to discuss the current state of science with respect to the indoor environment and its effects on the development and morbidity of childhood asthma. The workshop included US and international experts with backgrounds in allergy/allergens, immunology, asthma, environmental health, environmental exposures and pollutants, epidemiology, public health, and bioinformatics. Workshop participants provided new insights into the biologic properties of indoor exposures, indoor exposure assessment, and exposure reduction techniques. This informed a primary focus of the workshop: to critically review trials and research relevant to the prevention or control of asthma through environmental intervention. The participants identified important limitations and gaps in scientific methodologies and knowledge and proposed and prioritized areas for future research. The group reviewed socioeconomic and structural challenges to changing environmental exposure and offered recommendations for creative study design to overcome these challenges in trials to improve asthma management. The recommendations of this workshop can serve as guidance for future research in the study of the indoor environment and on environmental interventions as they pertain to the prevention and management of asthma and airway allergies.

Can we predict fall asthma exacerbations? Validation of the seasonal asthma exacerbation index.

BACKGROUND: A Seasonal Asthma Exacerbation Predictive Index (saEPI) was previously reported based on 2 prior National Institute of Allergy and Infectious Diseases Inner City Asthma Consortium trials. OBJECTIVE: This study sought to validate the saEPI in a separate trial designed to prevent fall exacerbations with omalizumab therapy. METHODS: The saEPI and its components were analyzed to characterize those who had an asthma exacerbation during the Preventative Omalizumab or Step-Up Therapy for Fall Exacerbations (PROSE) study. We characterized those inner-city children with and without asthma exacerbations in the fall period treated with guidelines-based therapy (GBT) in the absence and presence of omalizumab. RESULTS: A higher saEPI was associated with an exacerbation in both the GBT alone (P < .001; area under the curve, 0.76) and the GBT + omalizumab group (P < .01; area under the curve, 0.65). In the GBT group, younger age at recruitment, higher total IgE, higher blood eosinophil percentage and number, and higher treatment step were associated with those who had an exacerbation compared with those who did not. In the GBT + omalizumab group, younger age at recruitment, increased eosinophil number, recent exacerbation, and higher treatment step were also associated with those who had an exacerbation. The saEPI was associated with a high negative predictive value in both groups. CONCLUSIONS: An exacerbation in children treated with GBT with or without omalizumab was associated with a higher saEPI along with higher markers of allergic inflammation, treatment step, and a recent exacerbation. Those that exacerbated on omalizumab had similar features with the exception of some markers of allergic sensitization, indicating a need to develop better markers to predict poor response to omalizumab therapy and alternative treatment strategies for children with these risk factors. The saEPI was able to reliably predict those children unlikely to have an asthma exacerbation in both groups.

Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma.

BACKGROUND: Long-acting beta-agonists (LABAs) have been shown to increase the risk of asthma-related death among adults and the risk of asthma-related hospitalization among children. It is unknown whether the concomitant use of inhaled glucocorticoids with LABAs mitigates those risks. This trial prospectively evaluated the safety of the LABA salmeterol, added to fluticasone propionate, in a fixed-dose combination in children. METHODS: We randomly assigned, in a 1:1 ratio, children 4 to 11 years of age who required daily asthma medications and had a history of asthma exacerbations in the previous year to receive fluticasone propionate plus salmeterol or fluticasone alone for 26 weeks. The primary safety end point was the first serious asthma-related event (death, endotracheal intubation, or hospitalization), as assessed in a time-to-event analysis. The statistical design specified that noninferiority would be shown if the upper boundary of the 95% confidence interval of the hazard ratio for the primary safety end point was less than 2.675. The main efficacy end point was the first severe asthma exacerbation that led to treatment with systemic glucocorticoids, as assessed in a time-to-event analysis. RESULTS: Among the 6208 patients, 27 patients in the fluticasone-salmeterol group and 21 in the fluticasone-alone group had a serious asthma-related event (all were hospitalizations); the hazard ratio with fluticasone-salmeterol versus fluticasone alone was 1.28 (95% confidence interval [CI], 0.73 to 2.27), which showed the noninferiority of fluticasone-salmeterol (P=0.006). A total of 265 patients (8.5%) in the fluticasone-salmeterol group and 309 (10.0%) in the fluticasone-alone group had a severe asthma exacerbation (hazard ratio, 0.86; 95% CI, 0.73 to 1.01). CONCLUSIONS: In this trial involving children with asthma, salmeterol in a fixed-dose combination with fluticasone was associated with the risk of a serious asthma-related event that was similar to the risk with fluticasone alone. (Funded by GlaxoSmithKline; VESTRI ClinicalTrials.gov number, NCT01462344 .).

From Design to Dissemination: Implementing Community-Based Participatory Research in Postdisaster Communities.

OBJECTIVES: To review how disasters introduce unique challenges to conducting population-based research and community-based participatory research (CBPR). METHODS: From 2007-2009, we conducted the Head-off Environmental Asthma in Louisiana (HEAL) Study in the aftermath of Hurricane Katrina in a Gulf Coast community facing an unprecedented triple burden: Katrina's and other disasters' impact on the environment and health, historic health disparities, and persistent environmental health threats. RESULTS: The unique triple burden influenced every research component; still, most existing CBPR principles were applicable, even though full adherence was not always feasible and additional tailored principles govern postdisaster settings. CONCLUSIONS: Even in the most challenging postdisaster conditions, CBPR can be successfully designed, implemented, and disseminated while adhering to scientific rigor.

Adapting and implementing an evidence-based asthma counseling intervention for resource-poor populations.

OBJECTIVE: To report implementation strategies and outcomes of an evidence-based asthma counseling intervention. The Head-off Environmental Asthma in Louisiana (HEAL) intervention integrated asthma counseling (AC) capacity and addressed challenges facing children with asthma in post-disaster New Orleans. METHODS: The HEAL intervention enrolled 182 children (4-12 years) with moderate-to-severe persistent asthma. Recruitment occurred from schools in the Greater New Orleans area for one year. Participants received home environmental assessments and tailored asthma counseling sessions during the study period based on the National Cooperative Inner City Asthma Study and the Inner City Asthma Study. Primary (i.e., asthma symptoms) and secondary outcomes (i.e., healthcare utilization) were captured. During the study, changes were made to meet the demands of a post-hurricane and resource-poor environment which included changes to staffing, training, AC tools, and AC sessions. RESULTS: After study changes were made, the AC visit rate increased by 92.3%. Significant improvements were observed across several adherence measures (e.g., running out of medications (p = 0.009), financial/insurance problems for appointments (p = 0.006), worried about medication side-effects (p = 0.01), felt medications did not work (p < 0.001)). Additionally, an increasing number of AC visits was modestly associated with a greater reduction in symptoms (test-for-trend p = 0.059). CONCLUSION: By adapting to the needs of the study population and setting, investigators successfully implemented a counseling intervention that improved participant behaviors and clinical outcomes. The strategies for implementing the AC intervention may serve as a guide for managing asthma and other chronic conditions in resource-poor settings.

Seasonal risk factors for asthma exacerbations among inner-city children.

BACKGROUND: Asthma exacerbations remain common, even in children and adolescents, despite optimal medical management. Identification of host risk factors for exacerbations is incomplete, particularly for seasonal episodes. OBJECTIVE: We sought to define host risk factors for asthma exacerbations unique to their season of occurrence. METHODS: This is a retrospective analysis of patients aged 6 to 20 years who comprised the control groups of the Asthma Control Evaluation study and the Inner City Anti-IgE Therapy for Asthma study. Univariate and multivariate models were constructed to determine whether patients' demographic and historical factors, allergic sensitization, fraction of exhaled nitric oxide values, spirometric measurements, asthma control, and treatment requirements were associated with seasonal exacerbations. RESULTS: The analysis included 400 patients (54.5% male; 59.0% African American; median age, 13 years). Exacerbations occurred in 37.5% of participants over the periods of observation and were most common in the fall (28.8% of participants). In univariate analysis impaired pulmonary function was significantly associated with greater odds of exacerbations for all seasons, as was an exacerbation in the previous season for all seasons except spring. In multivariate analysis exacerbation in the previous season was the strongest predictor in fall and winter, whereas a higher requirement for inhaled corticosteroids was the strongest predictor in spring and summer. The multivariate models had the best predictive power for fall exacerbations (30.5% variance attributed). CONCLUSIONS: Among a large cohort of inner-city children with asthma, patients' risk factors for exacerbation vary by season. Thus information on individual patients might be beneficial in strategies to prevent these seasonal events.

Prevalence of allergic sensitization in the United States: results from the National Health and Nutrition Examination Survey (NHANES) 2005-2006.

BACKGROUND: Allergic sensitization is an important risk factor for the development of atopic disease. The National Health and Nutrition Examination Survey (NHANES) 2005-2006 provides the most comprehensive information on IgE-mediated sensitization in the general US population. OBJECTIVE: We investigated clustering, sociodemographic, and regional patterns of allergic sensitization and examined risk factors associated with IgE-mediated sensitization. METHODS: Data for this cross-sectional analysis were obtained from NHANES 2005-2006. Participants aged 1 year or older (n = 9440) were tested for serum specific IgEs (sIgEs) to inhalant and food allergens; participants 6 years or older were tested for 19 sIgEs, and children aged 1 to 5 years were tested for 9 sIgEs. Serum samples were analyzed by using the ImmunoCAP System. Information on demographics and participants' characteristics was collected by means of questionnaire. RESULTS: Of the study population aged 6 years and older, 44.6% had detectable sIgEs, whereas 36.2% of children aged 1 to 5 years were sensitized to 1 or more allergens. Allergen-specific IgEs clustered into 7 groups that might have largely reflected biological cross-reactivity. Although sensitization to individual allergens and allergen types showed regional variation, the overall prevalence of sensitization did not differ across census regions, except in early childhood. In multivariate modeling young age, male sex, non-Hispanic black race/ethnicity, geographic location (census region), and reported pet avoidance measures were most consistently associated with IgE-mediated sensitization. CONCLUSIONS: The overall prevalence of allergic sensitization does not vary across US census regions, except in early life, although allergen-specific sensitization differs based on sociodemographic and regional factors. Biological cross-reactivity might be an important but not the sole contributor to the clustering of allergen-specific IgEs.

Lack of a relation between serum 25-hydroxyvitamin D concentrations and asthma in adolescents.

BACKGROUND: Decreased 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with an increased prevalence and severity of asthma and a lower response to inhaled corticosteroids. OBJECTIVE: The objective was to determine the association between serum 25(OH)D concentrations and asthma prevalence, severity, and response to asthma treatment. DESIGN: Secondary analyses were conducted in 2 samples of adolescents 12-20 y of age: 1) NHANES 2001-2006 (n = 6487), a cross-sectional nationally representative sample of the US population, and 2) a cohort of inner-city adolescents with asthma managed prospectively for 46 wk with guidelines-based therapy in the Asthma Control Evaluation (ACE; n = 226) trial. RESULTS: Mean (±SD) serum 25(OH)D concentrations in the NHANES and ACE samples were lower in African Americans than in non-African Americans (NHANES: 14.9 ± 6.5 compared with 23.0 ± 8.4 ng/mL, P < 0.0001; ACE: 11.2 ± 6.9 compared with 15.8 ± 7.1 ng/mL, P < 0.0001). In the NHANES sample, mean concentrations did not differ between participants without and with asthma (African Americans: 14.9 ± 6.4 compared with 15.0 ± 6.6 ng/mL, respectively, P = 0.87; non-African Americans: 23.0 ± 8.5 compared with 23.6 ± 8.2 ng/mL, respectively, P = 0.16). In the ACE models that used either a predefined cutoff (<20 ng/mL) or linear regression, 25(OH)D concentrations showed either no relation or minor contradictory correlations with indicators of asthma severity, treatment requirements, spirometry, or atopy/inflammation. CONCLUSION: In 2 samples of adolescents, overall serum 25(OH)D concentrations were low and were not consistently associated with the presence of asthma, multiple asthma characteristics, asthma morbidity, or response to treatment. The ACE trial was registered at clinicaltrials.gov as NCT0011441.

Reducing quality-of-care disparities in childhood asthma: La Red de Asma Infantil intervention in San Juan, Puerto Rico.

BACKGROUND AND OBJECTIVE: Although children living in Puerto Rico have the highest asthma prevalence of all US children, little is known regarding the quality-of-care disparities they experience nor the adaptability of existing asthma evidence-based interventions to reduce these disparities. The objective of this study was to describe our experience in reducing quality-of-care disparities among Puerto Rican children with asthma by adapting 2 existing evidence-based asthma interventions. METHODS: We describe our experience in adapting and implementing 2 previously tested asthma evidence-based interventions: the Yes We Can program and the Inner-City Asthma Study intervention. We assessed the feasibility of combining key components of the 2 interventions to reduce asthma symptoms and estimated the potential cost savings associated with reductions in asthma-related hospitalizations and emergency department visits. A total of 117 children with moderate and severe asthma participated in the 12-month intervention in 2 housing projects in San Juan, Puerto Rico. A community-academic team with the necessary technical and cultural competences adapted and implemented the intervention. RESULTS: Our case study revealed the feasibility of implementing the combined intervention, henceforth referred to as La Red intervention, in the selected Puerto Rican communities experiencing a disproportionately high level of asthma burden. After 1-year follow-up, La Red intervention significantly reduced asthma symptoms and exceeded reductions of the original interventions. Asthma-related hospitalizations and emergency department use, and their associated high costs, were also significantly reduced. CONCLUSIONS: Asthma evidence-based interventions can be adapted to improve quality of care for children with asthma in a different cultural community setting.

A multi-center ring trial of allergen analysis using fluorescent multiplex array technology.

BACKGROUND: Consistent performance of allergen assays is essential to ensure reproducibility of exposure assessments for investigations of asthma and occupational allergic disease. This study evaluated intra- and inter-laboratory reproducibility of a fluorescent multiplex array, which simultaneously measures eight indoor allergens in a single reaction well. METHODS: A multi-center study was performed in nine laboratories in the US and Europe to determine the inter-laboratory variability of an 8-plex array for dust mite, cat, dog, rat, mouse and cockroach allergens. Aliquots of 151 dust extract samples were sent to participating centers and analyzed by each laboratory on three separate occasions. Agreement within and between laboratories was calculated by the concordance correlation coefficient (CCC). RESULTS: Results were obtained for over 32,000 individual allergen measurements. Levels covered a wide range for all allergens from below the lower limit of detection (LLOD = 0.1-9.8 ng/ml) to higher than 6800 ng/ml for all allergens except Mus m 1, which was up to 1700 ng/ml. Results were reproducible within as well as between laboratories. Within laboratories, 94% of CCC were ≥ 0.90, and 80% of intra-laboratory results fell within a 10% coefficient of variance (CV%). Results between laboratories also showed highly significant positive correlations for all allergens (~0.95, p<0.001). Overall means of results were comparable, and inter-laboratory CV% for all allergens except Rat n 1 ranged between 17.6% and 26.6%. CONCLUSION: The data indicate that performance criteria for fluorescent multiplex array technology are reproducible within and between laboratories. Multiplex technology provides standardized and consistent allergen measurements that will streamline environmental exposure assessments in allergic disease.

Identifying infants at high risk of peanut allergy: the Learning Early About Peanut Allergy (LEAP) screening study.

BACKGROUND: Peanut allergy (PA) is rare in countries in which peanuts are introduced early into infants' diets. Learning Early About Peanut Allergy (LEAP) is an interventional study aiming to assess whether PA can be prevented by oral tolerance induction. OBJECTIVE: We sought to characterize a population screened for the risk of PA. METHODS: Subjects screened for the LEAP interventional trial comprise the LEAP screening study cohort. Infants were aged 4 to 10 months and passed a prescreening questionnaire. RESULTS: This analysis includes 834 infants (mean age, 7.8 months). They were split into the following: group I, patients with mild eczema and no egg allergy (n = 118); group II, patients with severe eczema, egg allergy, or both but 0-mm peanut skin prick test (SPT) wheal responses (n = 542); group III, patients with severe eczema, egg allergy, or both and 1- to 4-mm peanut wheal responses (n = 98); and group IV, patients with greater than 4-mm peanut wheal responses (n = 76). Unexpectedly, many (17%) in group II had peanut-specific IgE sensitization (≥ 0.35 kU/L); 56% of group III were similarly sensitized. In contrast, none of the patients in group I and 91% of those in group IV had peanut-specific IgE sensitization. Sensitization on skin testing to peanut (SPT response of 1-4 mm vs 0 mm) was associated with egg allergy and severe eczema (odds ratio [OR], 2.31 [95% CI, 1.39-3.86] and 2.47 [95% CI, 1.14-5.34], respectively). Similar associations were observed with specific IgE sensitization. Black race was associated with a significantly higher risk of peanut-specific IgE sensitization (OR, 5.30 [95% CI, 2.85-9.86]). Paradoxically, for a given specific IgE level, black race was protective against cutaneous sensitization (OR, 0.15 [95% CI, 0.04-0.61]). CONCLUSION: Egg allergy, severe eczema, or both appear to be useful criteria for identifying high-risk infants with an intermediate level of peanut sensitization for entry into a PA prevention study. The relationship between specific IgE level and SPT sensitization needs to be considered within the context of race.

Reassessment of omalizumab-dosing strategies and pharmacodynamics in inner-city children and adolescents.

BACKGROUND: Treatment regimens for omalizumab are guided by a dosing table that is based on total serum IgE and body weight. Limited data exist about onset and offset of omalizumab efficacy in children and adolescents or subgroups that most benefit from treatment. OBJECTIVES: Post hoc analyses were conducted to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) describe onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy differs by age, asthma severity, dosing regimen, and prespecified biomarkers. METHODS: Inner-city children and adolescents with persistent allergic asthma were enrolled in the Inner-City Anti-IgE Therapy for Asthma trial that compared omalizumab with placebo added to guidelines-based therapy for 60 weeks. RESULTS: Two hundred ninety-three of 889 participants (33%) clinically suitable for omalizumab were ineligible for dosing according to a modified dosing table specifying IgE level and body weight criteria. Baseline symptoms were comparable among those eligible and ineligible to receive omalizumab, but other characteristics (rate of health care utilization and skin test results) differed. The time of onset of omalizumab effect was <30 days and time of offset was between 30 and 120 days. No difference in efficacy was noted by age or asthma severity, but high exhaled nitric oxide, blood eosinophils, and body mass index predicted efficacy. CONCLUSIONS: A significant portion of children and adolescents particularly suited for omalizumab because of asthma severity status may be ineligible due to IgE >1300 IU/mL. Omalizumab reduced asthma symptoms and exacerbations rapidly; features associated with efficacy can be identified to guide patient selection.