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Background: Effectiveness of asthma treatment, including biologics, may be different in patients with higher body mass index (BMI)., Objective: To evaluate response to omalizumab (dosed by serum immunoglobulin E level and weight) by BMI category., Methods: Pooled data from 2 randomized, double-blind, placebo-controlled studies of adults with moderate-to-severe allergic asthma were analyzed by BMI category (<25 kg/m 2 [normal or underweight], n = 397; 25 to <30 kg/m 2 [overweight], n = 330; ≥ 30 kg/m 2 [obese], n = 268). Placebo-adjusted exacerbation rate reductions were evaluated by Poisson regression modeling. Changes from baseline in forced expiratory volume in 1 second, beclomethasone dipropionate (BDP) dose, Total Asthma Symptom Score, and Asthma Quality of Life Questionnaire were evaluated by analysis of covariance., Results: Greater placebo-adjusted exacerbation rate reductions (95% confidence interval) were observed with increasing BMI (normal or underweight, -37.4% [-69.0% to 26.8%]; overweight, -52.7% [-78.4% to 3.7%]; obese, -71.9% [-86.9% to -39.5%]). There were no differences in forced expiratory volume in 1 second improvement between BMI categories at week 16 (normal or underweight, 76.2 [5.3-147.1] mL; overweight, 98.1 [13.9-182.4] mL; obese, 69.1 [-18.9 to 157.2] mL). No differences in BDP dose reduction (µg) were noted between BMI categories (normal or underweight, 23.0 [15.7-30.3]; overweight, 22.5 [13.5-31.5]; obese, 16.6 [5.8-27.3]). Fewer patients in the higher BMI categories eliminated BDP use. There were trends for smaller improvements with higher BMI in Total Asthma Symptom Score (normal/underweight, -0.52 [-0.82 to -0.22]; overweight, -0.50 [-0.80 to -0.20]; obese, -0.39 [-0.77 to 0.00]) and Asthma Quality of Life Questionnaire (normal or underweight, 0.34 [0.16-0.52]; overweight, 0.34 [0.13-0.55]; obese, 0.15 [-0.08 to 0.39])., Conclusion: Omalizumab provides benefit to patients with moderate-to-severe allergic asthma, regardless of BMI., Trial Registration: Studies 008/009 were conducted before clinical trial registration was required, and therefore clinical trial registration numbers are not available., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Although asthma is typically characterized by bronchodilator responsiveness (BDR), fixed airflow obstruction (FAO) occurs in ∼50% of patients with severe asthma., Objective: Do FAO/BDR associate with efficacy of omalizumab, a monoclonal antibody that targets IgE?, Methods: In EXTRA, patients aged 12-75 years with inadequately controlled severe allergic asthma despite high-dose inhaled corticosteroids plus long-acting β 2 -agonists were randomized to omalizumab (n = 427) or placebo (n = 423) for 48 weeks of treatment. In this post hoc analysis, high/low BDR were defined as ≥12%/<12% increases in baseline forced expiratory volume in 1 second (FEV 1 ) after bronchodilator administration, respectively. FAO presence (+)/absence (-) were defined as baseline postbronchodilator FEV 1 /forced vital capacity <70%/≥70%, respectively. Poisson regression/analysis of covariance models were used to estimate exacerbation relative rate reductions (RRRs)/least-squares mean changes in FEV 1 , respectively., Results: In patients with high BDR, omalizumab reduced exacerbations more than placebo over the 48-week treatment period regardless of FAO status (RRR [95% confidence interval (CI)]: FAO+, 59.8% [17.7-80.4%]; FAO-, 44.3% [16.6-62.8%]). Omalizumab improved FEV 1 compared with placebo in the FAO-, high BDR subgroup (FEV 1 change from baseline [95% CI] for omalizumab vs placebo, 0.065 L [-0.071 to 0.201 L] to 0.236 L [0.112-0.359 L]) across 48 weeks. This was not observed in patients with low BDR, irrespective of FAO., Conclusion: Omalizumab was more efficacious than placebo at reducing exacerbations in patients with high, but not low, BDR, regardless of the presence of FAO. Lung function improvement primarily occurred in FAO-, high BDR patients, suggesting that asthma with low BDR may represent a difficult-to-treat phenotype., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Rationale: Blood eosinophil counts are used to inform diagnosis/management of eosinophilic asthma. Objectives: Examine blood eosinophil variability and identify factors affecting eosinophil levels to inform clinical interpretation. Methods: Post hoc analysis to understand eosinophil variability using data from four randomized controlled asthma trials. We examined 1 ) influence of intrinsic/extrinsic factors (comorbidities, medication, and patient history) using baseline data ( n  = 2,612); 2 ) monthly variation using placebo-treated patient data ( n  = 713); 3 ) stability of eosinophil classification (<150, 150-299, and ⩾300 cells/μl) in placebo-treated patients with monthly measurements over a 1-year period ( n  = 751); and 4 ) impact of technical factors (laboratory-to-laboratory differences and time from collection to analysis). Results: Of intrinsic/extrinsic factors examined, nasal polyps increased eosinophil levels by 38%, whereas current smoking decreased levels by 23%. Substantial seasonal differences in eosinophil counts were observed, with differences of ∼20% between July and January. Eosinophil levels between 150 and 299 cells/μl were least stable, with 44% of patients remaining in the same classification for seven of 10 measurements versus 59% and 66% of patients in the <150 and ⩾300 cells/μl subgroups, respectively. Measurements at different laboratories showed high association (Spearman's correlation coefficient, R  = 0.89); however, eosinophil counts were reduced, with longer time from collection to analysis, and variability increased with increasing eosinophil counts. Conclusions: Several intrinsic, extrinsic, and technical factors may influence, and should be considered in, clinical interpretation of eosinophil counts. Additionally, a single measurement may not be sufficient when using eosinophil counts for diagnosis/management of eosinophilic asthma.

Background: Comorbidities are common in asthma and may complicate treatment response., Objective: To examine response to omalizumab in patients with moderate-to-severe allergic asthma by asthma-related and allergic comorbidities., Methods: Patients aged 12 years or more from placebo-controlled 008/009 (n = 1071), EXTRA (n = 848), and INNOVATE (n = 419), and single-armed PROSPERO (n = 801) omalizumab studies were included. Poisson regression/analysis of covariance models were used to estimate adjusted exacerbation rates and forced expiratory volume in 1 second (FEV1) change from baseline after omalizumab initiation for subgroups by number of comorbidities (0, 1 [008/009]; 0, 1, ≥2 [EXTRA and INNOVATE]; 0, 1, 2, ≥3 [PROSPERO]). Self-reported comorbidities included allergic rhinoconjunctivitis, chronic rhinosinusitis, recurrent acute sinusitis, nasal polyps, atopic and contact dermatitis, urticaria, food allergy, anaphylaxis, other allergies, gastroesophageal reflux disease, eosinophilic esophagitis, and eosinophilic granulomatosis with polyangiitis., Results: In the EXTRA and INNOVATE studies, no consistent pattern was observed for placebo-corrected relative rate reduction in normalized asthma exacerbations among omalizumab-treated comorbidity subgroups. In PROSPERO, on-study exacerbation rates in the comorbidity subgroups were similar (0, 0.68; 1, 0.70; 2, 0.77; ≥3, 0.80). FEV1 improvements were observed throughout the study for omalizumab vs placebo for all comorbidity subgroups. There were no consistent differences in FEV1 improvements among comorbidity subgroups in 008/009, EXTRA, or INNOVATE. Similarly, no among-group differences were observed for FEV1 change from baseline at month 12 in PROSPERO (0, 0.05 L; 1, 0.08 L; 2, 0.00 L; ≥3, 0.04 L). The 95% confidence intervals overlapped substantially in all instances., Conclusion: In these analyses of placebo-controlled/single-armed studies, on-study exacerbation rates and FEV1 improvements with omalizumab treatment were similar irrespective of comorbidity burden., Trial Registration: ClinicalTrials.gov identifiers are as follows: EXTRA, NCT00314574 (https://clinicaltrials.gov/ct2/show/NCT00314574); INNOVATE, NCT00046748 (https://clinicaltrials.gov/ct2/show/NCT00046748); and PROSPERO, NCT01922037 (https://clinicaltrials.gov/ct2/show/NCT01922037)., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Frequent exacerbations are associated with greater FEV 1 decline in patients with asthma. The effect of omalizumab versus placebo on lung function in patients experiencing asthma exacerbations has not been previously examined., Objective: To evaluate the relationship between postbaseline (treatment phase) exacerbation status and lung function decline in children, adolescents, and adults treated with omalizumab versus placebo using data from 3 pediatric and adolescent/adult studies., Methods: Changes in percent predicted FEV 1 (ppFEV 1 ) and FEV 1 by treatment (omalizumab/placebo) and postbaseline exacerbation status (exacerbators/nonexacerbators) were assessed in patients aged 6 to 11 years (IA05, n = 576) and 12 to 75 years (EXTRA/INNOVATE pooled, n = 1202). Pediatric patients were examined at treatment weeks 12, 24, 28, 40, and 52, and adolescent/adult data at weeks 4, 12, 20, and 28., Results: Omalizumab-treated patients experienced larger increases in ppFEV 1 and FEV 1 compared with placebo-treated patients in the pediatric and pooled adolescent/adult populations. The response was observed in pediatric exacerbators, with significantly larger increases in ppFEV 1 and FEV 1 at week 12 (mean difference [95% CI], 4.11% [0.93%-7.30%], P = .011 for ppFEV 1 ; 80 [10-140] mL, P = .017 for FEV 1 ) and week 28 (mean difference [95% CI], 3.65% [0.11%-7.19%], P = .043 for ppFEV 1 ; 100 [30-170] mL, P = .007 for FEV 1 ). In the adolescent/adult population, both exacerbators and nonexacerbators derived similar benefit with omalizumab compared with placebo., Conclusions: Findings from this post hoc analysis suggest that omalizumab may confer some protection against lung function decline among patients who experienced exacerbations during treatment., (Copyright © 2020. Published by Elsevier Inc.)

Background: Greater severity in childhood asthma negatively impacts functioning and quality of life. Omalizumab is effective in children aged 6 years or older with moderate to severe persistent asthma, but predicting responsiveness in severe disease requires further study., Objective: To assess response to omalizumab treatment among children using indicators of asthma severity., Methods: Post hoc analyses of randomized placebo-controlled studies of omalizumab (Inner-City Anti-IgE Therapy for Asthma [ICATA], IA05, and Preventative Omalizumab or Step-up Therapy for Fall Exacerbations [PROSE]) stratified by body mass index, eosinophil count, fractional exhaled nitric oxide levels, and baseline severity indicators (baseline percent predicted FEV 1 , previous hospitalizations, asthma exacerbations). Poisson regression analysis examined exacerbation rate reductions for body mass index, biomarkers, and severity indicators., Results: Children aged 6 to 11 years in IA05 (N = 576; 56% white, 17% black, 26% other/missing), ICATA (N = 237; 55% black, 43% Hispanic), and PROSE (N = 342; 59% black, 35% Hispanic) were included. Trends indicative of greater exacerbation rate change ([omalizumab - placebo]/placebo) were observed for low baseline lung function (IA05 percent predicted FEV 1 : <90%, 36% reduction, 95% CI, -53.3 to -13.5; ≥90%, 22% reduction, 95% CI, -52.1 to 27.5), previous hospitalizations (ICATA: 46% reduction with, 95% CI, -69.7 to -3.9; 24% reduction without, 95% CI, -48.1 to 10.3), frequent baseline exacerbations (IA05: ≥3, 42% reduction, 95% CI, -60.4 to -14.1; <3, 20% reduction, 95% CI, -45.2 to -15.9), and high baseline eosinophil count (IA05: ≥300 cells/μL, 39% reduction, 95% CI, -56.4 to -14.7; <300 cells/μL, 5% reduction, 95% CI, -40.6 to 52.1)., Conclusions: Omalizumab reduces exacerbations in children with moderate to severe persistent allergic asthma, and may provide greater benefit in children with more severe asthma subtypes., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Severe/difficult-to-treat disease occurs in 5% to 10% of patients with asthma, but accounts for more than 50% of related economic costs. Understanding factors associated with persistent very poorly controlled (VPC) asthma may improve outcomes., Objective: To characterize persistent VPC asthma after more than 10 years of standard of care., Methods: The Epidemiology and Natural history of asthma: Outcomes and treatment Regimens (TENOR) II (N = 341) was a multicenter, observational study of patients with severe/difficult-to-treat asthma with a single, cross-sectional visit more than 10 years after TENOR I. Persistent VPC asthma was defined as VPC asthma at TENOR I and TENOR II enrollment; without VPC asthma was defined as well- or not well-controlled asthma at either or both visits. Multivariable logistic regression assessed long-term predictors of persistent VPC asthma using TENOR I baseline variables., Results: Of 327 patients, nearly half (48.0%, n = 157) had persistent VPC asthma. Comorbidities and asthma triggers were more frequent in patients with persistent VPC asthma than in patients without VPC asthma. Total geometric mean IgE was higher in patients with persistent VPC asthma (89.3 IU/mL vs 55.7 IU/mL); there was no difference in eosinophil levels. Lung function was lower in patients with persistent VPC asthma (mean % predicted pre- and postbronchodilator FEV 1 , 63.0% vs 82.8% and 69.6% vs 87.2%, respectively). Exacerbations in the previous year were more likely in patients with persistent VPC asthma (29.7% vs 9.0%, respectively). Predictors of persistent VPC asthma were black versus white race/ethnicity, allergic trigger count (4 vs 0), systemic corticosteroid use, and postbronchodilator FEV 1 (per 10% decrease)., Conclusions: The burden of persistent VPC asthma is high in severe/difficult-to-treat disease; management of modifiable risk factors, maximization of lung function, and trigger avoidance may improve outcomes., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Omalizumab improves clinical outcomes in patients with asthma. Several studies have shown lung function improvements with omalizumab; however, this has not been examined exclusively in adolescents., Objective: To assess the effect of omalizumab on lung function and eosinophil counts in adolescents with uncontrolled moderate-to-severe allergic asthma., Methods: In this post hoc analysis, data from adolescents aged 12 to 17 years from 8 randomized trials of omalizumab were pooled (studies 008, 009, and 011, and SOLAR, INNOVATE, ALTO, ETOPA, and EXTRA). Changes from baseline to end of study in forced expiratory volume in 1 second (FEV 1 ), percent predicted FEV 1 (ppFEV 1 ), forced vital capacity (FVC), and blood eosinophil counts were assessed by fitting an analysis of covariance model and calculating least squares mean (LSM) difference for omalizumab vs placebo., Results: A total of 340 adolescents were identified (omalizumab, n = 203 [59.7%]; placebo, n = 137 [40.3%]). Omalizumab increased all baseline lung function variables more than placebo by end of study: LSM treatment differences (95% confidence interval) were 3.0% (0.2%-5.7%; P = .035), 120.9 mL (30.6-211.2 mL; P = .009), and 101.5 mL (8.3-194.6 mL; P = .033) for ppFEV 1 , absolute FEV 1 , and FVC, respectively. The LSM difference demonstrated a greater reduction in eosinophil counts for omalizumab vs placebo: -85.9 cells/μL (-137.1 to -34.6 cells/μL; P = .001)., Conclusion: Omalizumab was associated with lung function improvements and circulating eosinophil counts reductions in adolescents with moderate-to-severe uncontrolled asthma. Findings emphasize the effect of omalizumab in young patients and the need to optimize treatment early in the disease course. https://clinicaltrials.gov/: NCT00314574, NCT00046748, NCT00401596., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study demonstrated high morbidity in patients with severe or difficult-to-treat asthma despite standard-of-care treatment., Objective: We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade., Methods: TENOR I was a multicenter observational study (2001-2004) of 4756 patients with severe or difficult-to-treat asthma. TENOR II was a follow-up study of TENOR I patients using a single cross-sectional visit in 2013/2014. Overall, the sites participating in TENOR II originally enrolled 1230 patients in TENOR I. Clinical and patient-reported outcomes were assessed, including very poorly controlled asthma based on National Heart, Lung, and Blood Institute guidelines., Results: A total of 341 (27.7%) patients were enrolled in TENOR II and were representative of the TENOR I cohort. The most frequent comorbidities were rhinitis (84.0%), sinusitis (47.8%), and gastroesophageal reflux disease (46.3%). Mean percent predicted prebronchodilator and postbronchodilator FEV 1 were 72.7% (SD, 21.4%) and 78.2% (SD, 20.7%), respectively. A total of 231 (72.9%) of 317 patients had positive test responses to 1 or more allergen-specific IgEs. The mean blood eosinophil count was 200/μL (SD, 144/μL). Eighty-eight (25.8%) patients experienced an asthma exacerbation in the prior 3 months requiring hospital attention, oral corticosteroids, or both. More than half (197/339 [58.1%]) had very poorly controlled asthma. Medication use suggested undertreatment., Conclusion: TENOR II provides longitudinal data to characterize disease progression, heterogeneity, and severity in patients with severe or difficult-to-treat asthma. Findings show continued morbidity, including a high degree of comorbid conditions, allergic sensitization, exacerbations, and very poorly controlled asthma, including reduced lung function., (Copyright © 2017. Published by Elsevier Inc.)

Background: Recent efficacy studies of asthma biologics have included highly enriched patient populations. Using a similar approach, we examined factors that predict response to omalizumab to facilitate selection of patients most likely to derive the greatest clinical benefit from therapy., Methods: Data from two phase III clinical trials of omalizumab in patients with allergic asthma were examined. Differences in rates of asthma exacerbations between omalizumab and placebo groups during the 16-week inhaled corticosteroid (ICS) dose-stable phase were evaluated with respect to baseline blood eosinophil counts (eosinophils <300/μL [low] vs ≥300/μL [high]) and baseline markers of asthma severity (emergency asthma treatment in prior year, asthma hospitalization in prior year, forced expiratory volume in 1 second [FEV 1 ; FEV 1 <65% vs ≥65% predicted], inhaled beclomethasone dipropionate dose [<600 vs ≥600 μg/day], and long-acting beta-agonist [LABA] use [yes/no])., Results: Adults/adolescents (N = 1071) were randomized to receive either omalizumab (n = 542) or placebo (n = 529). In the 16-week ICS dose-stable phase, rates of exacerbations requiring ≥3 days of systemic corticosteroid treatment were 0.066 and 0.147 with omalizumab and placebo, respectively, representing a relative rate reduction in omalizumab-treated patients of 55% (95% CI, 32%-70%; P = .002). For patients with eosinophils ≥300/μL or with more severe asthma, this rate reduction was significantly more pronounced., Conclusion: In patients with allergic asthma, baseline blood eosinophil levels and/or clinical markers of asthma severity predict response to omalizumab., (© 2017 The Authors Allergy Published by John Wiley & Sons Ltd.)

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., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Adherence to omalizumab is not well characterized and its association with asthma control has not been well established., Objective: To evaluate adherence in patients initiating omalizumab in the Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate to Severe Asthma (EXCELS) observational study., Methods: Adherence was assessed over 5 years using the proportion of patients who missed any dose, rates of doses missed, and proportions of patients with good (<10% doses missed) or poor (≥30% doses missed) adherence. Multivariable analyses identified independent predictors of good adherence. Associations between adherence and asthma control were assessed using the minimum important difference for the Asthma Control Test at various time points., Results: A total of 289 patients newly initiated on omalizumab completed 5 years of EXCELS. Of these, 83.0% on the 2-week dosing regimen (n = 152) and 65.0% on the 4-week dosing regimen (n = 137) missed at least 1 dose. More frequent dosing was associated with a larger number of missed doses. Older age (odds ratio per year 1.02, 95% confidence interval 1.01-1.03) and lower prebronchodilator percentage of predicted forced expiratory volume in 1 second (<76; odds ratio 1.88, 95% confidence interval 1.09-3.24) were independent predictors of good adherence., Conclusion: Adherence to omalizumab is characterized by distinct factors. Patients receiving the 4-week dosing regimen achieved better adherence than those treated every 2 weeks. Improved adherence could be associated with better asthma control. Age and lung function could interact with dosing frequency to affect patient adherence, thus warranting prospective planning at the time of prescribing to support long-term adherence., (Copyright © 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Omalizumab is a recombinant humanized monoclonal anti-IgE antibody approved in adults and adolescents with moderate-to-severe persistent allergic asthma inadequately controlled with inhaled corticosteroids (ICS). EXCELS is an ongoing prospective observational cohort study of approximately 5000 omalizumab-treated and >2800 non-omalizumab-treated patients aged ≥12 years., Objective: We evaluated concomitant medication use changes (total ICS dose [including monotherapy and combination therapy, fluticasone equivalent], short-acting beta-agonists [SABA], and leukotriene modifier [LTM]) over 2 years among subsets of patients enrolled in EXCELS., Methods: Patient subsets included "new starts" (omalizumab initiated at baseline [n = 549], "established users" (omalizumab initiated >7 days before baseline [n = 4421]), and "non-omalizumab" patients (not treated with omalizumab [n = 2867])., Results: At baseline, mean ± SD total daily ICS doses were 680 ± 414 μg/d in new starts, 642 ± 431 μg/d in established users, and 548 ± 382 μg/d in non-omalizumab patients. From baseline through year 2, total ICS dose decreased in 65% of new starts (mean ± SD change, -393 ± 504 μg/d), 57% of established users (-287 ± 492 μg/d), and 54% of non-omalizumab patients (-232 ± 431 μg/d). At baseline, SABA use for new starts, established users, and non-omalizumab patients was 1.9, 1.3, and 1.4 puffs/d, respectively. At year 2, SABA use decreased in 65% of new starts, 55% of established users, and 54% of non-omalizumab patients. At year 2, LTM dose decreased in 52% of new starts, 44% of established users, and 40% of non-omalizumab patients., Conclusion: Omalizumab therapy initiation was associated with decreased doses of ICS, SABA, and LTM over 2 years of follow-up for the majority of patients in a "real-world" cohort study of moderate-to-severe allergic asthma patients., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.)

Objective: To determine the nature and extent to which asthma characteristics and management differ between allergy and pulmonary subspecialists., Patients and Methods: We used baseline data from 3342 adults enrolled in The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study, a multicenter, observational cohort recruited from subspecialty practices across the United States. Information on physician subspecialty, asthma history, allergic status, lung function, medication use, and recent health care use was collected from January 1, 2001, through April 30, 2004, via study coordinator-administered interviews and self-administered validated questionnaires., Results: In the TENOR study, 2407 patients (72%) were treated by allergists and 935 (28%) by pulmonologists. Patients treated by pulmonologists were more likely to be black, be less educated, and have lower incomes than those treated by allergists. Pulmonary patients had more severe asthma as indicated by physician assessment, Global Initiative for Asthma classification, lung function, and number of asthma control problems. Regular use of a short-acting beta-agonist and systemic corticosteroid use were also higher among pulmonologist-treated patients than allergist-treated patients, consistent with greater asthma severity. Although evidence of allergic disease was prevalent in both types of patients, those treated by an allergist were more likely to receive skin testing or immunotherapy. In multivariate analyses adjusted for demographic differences, patients treated by pulmonologists were more likely to report health care use for asthma in the past 3 months., Conclusion: In general, asthma patients treated by pulmonologists have lower socioeconomic status, have more severe disease, require more medication, and report greater health care use than those treated by allergists.

Background: Young patients with severe or difficult-to-treat asthma are an understudied population., Objective: To assess age-associated and gender-associated differences in children and adolescents in the observational study, The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens., Methods: Cross-sectional baseline data for patients greater than or equal to 6 years and less than or equal to 17 years (n = 1261) were stratified by age group (6-8, 9-11, 12-14, and 15-17 years). The chi(2) test for categorical variables and analysis of variance for continuous variables were used to identify differences among age groups, stratified by gender., Results: Most patients had moderate (55%) or severe (41%) asthma by physician assessment. Of those using greater than or equal to 3 long-term controllers (62%), 53% of children (6-11 years) and 44% of adolescents (12-17 years) reported an oral corticosteroid burst and 25% and 19%, respectively, had an emergency department visit in the previous 3 months; 10% and 15%, respectively, reported past intubation. In females, weight for age ranged between the 67th and 70th percentiles; height for age was between the 42nd and 54th percentiles (P < .01 among age groups). Lung function was lower in adolescents than children: prebronchodilator percent predicted forced expiratory volume in 1 second (FEV(1))/forced vital capacity was 0.92 (6-8 years) and 0.83 (15-17 years), P less than .05, in males; and 0.94 (6-8 years) and 0.87 (15-17 years), P less than .05, in females., Conclusions: Children and adolescents demonstrated high rates of health care use and loss of lung function, despite using multiple long-term controllers., Clinical Implications: Asthma treatments that prevent loss of lung function and reduce health care resource use are needed in young patients with severe or difficult-to-treat asthma.