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Transient increases in blood eosinophil counts have been observed in dupilumab clinical trials.To assess eosinophil counts and eosinophilia-related treatment-emergent adverse events (TEAEs) across 11 dupilumab clinical trials, comparing adult and adolescent patients with asthma and adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP), atopic dermatitis, and eosinophilic esophagitis.Eosinophil counts, rates of eosinophilia-related TEAEs or treatment-emergent eosinophilia (1,500 cells/μL), discontinuations, clinical symptoms, and efficacy in patients with asthma or CRSwNP with treatment-emergent eosinophilia are presented.Transient increases in mean eosinophil counts were observed in dupilumab-treated patients with asthma (mean range across studies at baseline: 349-370 cells/μL; week 4: 515-578 cells/μL), CRSwNP (baseline: 440-448 cells/μL; week 16: 595 cells/μL), and atopic dermatitis (baseline: 434-600 cells/μL; week 4: 410-710 cells/μL), followed by a decline starting by week 24 to baseline or lower. No increases were seen in patients with eosinophilic esophagitis (baseline: 310 cells/μL; week 4: 230 cells/μL). In dupilumab-treated patients across all studies, rates of eosinophilia TEAEs were 0% to 13.6%. Clinical symptoms associated with increased eosinophils were rare (seven of 4,666 dupilumab-treated patients, including six cases of eosinophilic granulomatosis with polyangiitis) and occurred only in patients with asthma or CRSwNP. Eosinophilia was not associated with reduced dupilumab efficacy.Transient increases in eosinophil counts with dupilumab treatment did not affect efficacy and were rarely of clinical consequence. It remains important for physicians to base judgment on individual patient history and baseline eosinophil counts and to be alert to hypereosinophilic symptoms.

BACKGROUND: Patients with asthma and/or chronic rhinosinusitis with nasal polyps (CRSwNP) experience recurrent respiratory tract infections. Dupilumab targets type 2 inflammation, a common underlying pathophysiology of both conditions, with proven efficacy. OBJECTIVE: To examine investigator-reported respiratory infection adverse events and anti-infective medication use with dupilumab versus placebo in patients with moderate-to-severe asthma or severe CRSwNP. METHODS: We performed a post hoc analysis of the pivotal phase 3 trials LIBERTY ASTHMA QUEST (NCT02414854) and LIBERTY NP SINUS-52 (NCT02898454) in moderate-to-severe asthma and severe CRSwNP, respectively. RESULTS: Investigator-reported respiratory infection events occurred at a significantly lower incidence in patients treated with dupilumab versus placebo, in both asthma (22% lower; P < .0001; 95% CI 0.71-0.85) and CRSwNP (38% lower; P

BACKGROUND About one-tenth of patients with difficult-to-treat chronic rhinosinusitis with nasal polyps (CRSwNP) have comorbid non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Dupilumab, a fully human monoclonal antibody that blocks the shared interleukin (IL)-4/IL-13 receptor component, is an approved add-on treatment in severe CRSwNP. This post hoc analysis evaluated dupilumab efficacy and safety in patients with CRSwNP with/without NSAID-ERD. METHODS Data were pooled from the phase 3 SINUS-24 and SINUS-52 studies in adults with uncontrolled severe CRSwNP who received dupilumab 300 mg or placebo every 2 weeks. CRSwNP, nasal airflow, lung function, and asthma control outcomes at Week 24 were evaluated, and treatment-subgroup interactions were assessed for patients with and without NSAID-ERD. RESULTS Of 724 patients, 204 (28.2%) had a diagnosis of NSAID-ERD. At Week 24, least squares mean treatment differences demonstrated significant improvements in nasal polyp score, nasal congestion (NC), Lund-Mackay computed tomography, 22-item Sinonasal Outcome Test (SNOT-22), Total Symptom Score (TSS), rhinosinusitis severity visual analog scale, peak nasal inspiratory flow (PNIF), six-item Asthma Control Questionnaire score, and improvement in smell with dupilumab versus placebo (all p

Background Frequent exacerbations are associated with greater FEV1 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 FEV1 (ppFEV1) and FEV1 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 ppFEV1 and FEV1 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 ppFEV1 and FEV1 at week 12 (mean difference [95% CI], 4.11% [0.93%-7.30%], P = .011 for ppFEV1; 80 [10-140] mL, P = .017 for FEV1) and week 28 (mean difference [95% CI], 3.65% [0.11%-7.19%], P = .043 for ppFEV1; 100 [30-170] mL, P = .007 for FEV1). 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.

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 FEV1, 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 FEV1 (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.

BACKGROUND: Type 2 inflammatory diseases often coexist in patients. Dupilumab targets type 2 inflammation and has demonstrated treatment benefits in patients with atopic dermatitis (AD), asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP) with an acceptable safety profile. OBJECTIVE: This post hoc analysis across five phase 3 studies in patients with moderate to severe AD or asthma, or severe CRSwNP, evaluated time of onset and duration of the treatment response. METHODS: Patients received subcutaneous dupilumab 200/300 mg or placebo. Assessments included the Eczema Area and Severity Index, Peak Pruritus Numerical Rating Scale, and Dermatology Life Quality Index in AD; pre-bronchodilator FEV1, daily morning peak expiratory flow, and symptom scores in asthma; and University of Pennsylvania Smell Identification Test, daily nasal congestion, and loss of smell scores in CRSwNP. RESULTS:At week 2 after the initiation of dupilumab versus placebo, 67.8% versus 36.5% of AD patients achieved a clinically meaningful benefit (Eczema Area and Severity Index: 50% or greater improvement; Peak Pruritus Numerical Rating Scale: 3 point or greater improvement; or Dermatology Life Quality Index: 4 point or greater improvement) (P < .001). Moreover, 61.6% versus 39.9% of asthma patients achieved improvements in pre-bronchodilator FEV1 of 100 mL or greater and 48.8% versus 26.3% achieved 200 mL or greater improvement (both P < .001); 33.2% versus 5.6% of CRSwNP patients regained a sense of smell (P < .001). Treatment effects further improved or were sustained to the end of treatment. CONCLUSIONS: Clinically meaningful responses were achieved rapidly after the first dupilumab dose in AD, asthma, or CRSwNP and were sustained throughout treatment (see Video in this article's Online Repository at www.jaci-inpractice.org). (C) 2022 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.

Background The human monoclonal antibody dupilumab blocks interleukin (IL)-4 andIL-13, key and central drivers of type 2 inflammation. Dupilumab, on background mometasone furoate nasal spray (MFNS), improved outcomes in the phase III SINUS-52 study (NCT02898454) in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). This posthoc analysis of SINUS-52 examined whether eosinophilic status of CRSwNP was a predictor of dupilumab efficacy. Methods Patients were randomized 1:1:1 to dupilumab 300 mg every 2 weeks (q2w) until week 52; dupilumab 300 mg q2w until Week 24, then 300 mg every 4 weeks until week 52; or placebo (MFNS) until week 52. Coprimary endpoints were change from baseline in nasal polyps score (NPS), nasal congestion (NC), and Lund-Mackay score assessed by CT (LMK-CT) at week 24. Patients (n = 438) were stratified by eosinophilic chronic rhinosinusitis (ECRS) status according to the Japanese Epidemiological Survey of Refractory Eosinophilic Rhinosinusitis algorithm. Results Dupilumab significantly improved NPS, NC, and LMK-CT scores versus placebo at week 24 in all ECRS subgroups (p < 0.001), with improvements maintained or increased at week 52 (p < 0.001). There was no significant interaction between ECRS subgroup (non-/mild or moderate/severe) and dupilumab treatment effect for all endpoints at weeks 24 and 52 (p > 0.05), except LMK-CT at week 24 (p = 0.0275). Similar results were seen for the secondary endpoints. Dupilumab was well tolerated across all ECRS subgroups. Conclusion Dupilumab produced consistent improvement in symptoms of severe CRSwNP irrespective of ECRS status. Therefore, blood eosinophil level may not be a suitable biomarker for dupilumab efficacy in CRSwNP.

Severe asthma affects an estimated 5–10% of the total asthma patient population [1]. Various demographic factors, such as sex, age, obesity and age of onset, have been associated with asthma disease severity [2, 3], and the efficacy of asthma treatments has previously been found to vary depending on patient demographics [4, 5]., Dupilumab treatment versus placebo improved exacerbation rate and lung function outcomes in patients with uncontrolled moderate-to-severe asthma and high type 2 biomarkers at baseline, regardless of baseline characteristics in the phase 3 QUEST study https://bit.ly/3yR7MlD

The Global Initiative for Asthma report recommends consideration of add-on biologics for patients with type 2 inflammation (blood eosinophils ≥150 cells/μL, fractional exhaled nitric oxide [Feno] ≥20 parts per billion or allergic asthma) whose asthma cannot be controlled by high-dose inhaled corticosteroids. In QUEST (NCT02414854), add-on dupilumab versus placebo was efficacious in patients with uncontrolled, moderate to severe asthma, including those with eosinophils greater than or equal to 150 cells/μL and/or Feno greater than or equal to 25 parts per billion.To assess dupilumab efficacy in patients with a type 2 phenotype in the presence or absence of allergic asthma phenotype.Patients aged 12 years or older received add-on dupilumab 200/300 mg versus matched placebo every 2 weeks for 52 weeks. Allergic asthma phenotype was defined as baseline serum total IgE greater than or equal to 30 IU/mL and 1 or more perennial aeroallergen-specific IgE level greater than or equal to 0.35 kU/L. Annualized rate of severe asthma exacerbations and changes from study baseline in prebronchodilator and postbronchodilator FEVOf 1902 patients in QUEST, 83.3% had eosinophils and/or Feno above Global Initiative for Asthma thresholds; 56.9% had evidence for allergic asthma. Dupilumab significantly reduced the rate of severe asthma exacerbations in patients with (48.8%) and without (64.0%) evidence of allergic asthma and improved prebronchodilator and postbronchodilator FEVIn patients with type 2 biomarkers over Global Initiative for Asthma thresholds, dupilumab significantly reduced exacerbations and improved lung function. Efficacy was not impacted by allergic status.

Background: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for IL‑4/IL-13, key and central drivers of type 2 inflammatory diseases, including allergic asthma. In VENTURE (NCT02528214), add-on dupilumab 300mg q2w significantly reduced OCS dose and severe exacerbations and improved FEV1 in patients (pts) with OCS-dependent, severe asthma. Dupilumab was generally well tolerated. Aim: To assess dupilumab efficacy in VENTURE pts with and without an allergic phenotype (serum total IgE ≥30IU/mL and ≥1 perennial aeroallergen-specific IgE ≥0.35kU/L at baseline [BL]). Methods: Percent reduction in OCS dose at Week 24, annualized severe exacerbation rate (AER), and change from BL at Week 24 in pre-BD FEV1 (L) were assessed post hoc in pts with and without an allergic asthma phenotype. Results: BL characteristics were generally similar in pts with (n=86) and without (n=124) an allergic phenotype. Dupilumab reduced OCS dose by 73% and 69% vs BL and by 32% and 28% vs placebo in pts with and without an allergic phenotype, and reduced AER by 72% and 45% vs placebo, respectively. Dupilumab also improved pre-BD FEV1 in both groups (Table). Conclusions: Dupilumab significantly reduced OCS dose and AER and numerically improved lung function in patients with OCS-dependent, severe asthma regardless of allergic phenotype.

Background: The Asthma Quality of Life Questionnaire (AQLQ) includes items assessing the impact of asthma on sleep in patients (pts). Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL-4/IL-13, key and central drivers of type 2 inflammation in multiple diseases. In phase 3 VENTURE (NCT02528214), DPL 300mg every 2 weeks (q2w) vs placebo (PBO) reduced oral corticosteroid (OCS) maintenance dose and rate of severe asthma exacerbations and improved pre-bronchodilator FEV1 and health-related quality of life in pts with OCS-dependent, severe asthma. DPL was generally well tolerated. Aim: To assess the effect of DPL on pt-reported sleep outcomes in VENTURE. Methods: Four AQLQ items assess the impact of asthma on sleep on a scale of 1–7; scores of 6/7 indicate little/no impact of asthma. The proportion of pts with scores of 6/7 on the sleep-related items (#5, #20, #24, and #29) was evaluated at baseline (BL), Week (Wk) 12 and 24. Results: The proportion of pts reporting little/no impact of asthma on sleep-related items at BL was 17%–37%, suggesting that most pts experienced sleep impairment. A greater proportion of DPL pts vs PBO reported little/no impact of asthma on sleep at Wk 24 (P Conclusion: Pts with OCS-dependent, severe asthma had impaired sleep at BL. At Wk 24, a greater proportion of DPL pts reported waking up with asthma symptoms hardly any or none of the time vs PBO.

Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13, key and central drivers of type 2 inflammation in multiple diseases. In phase 3 QUEST (NCT02414854), add-on dupilumab 200 and 300 mg every 2 weeks reduced severe exacerbations, improved pre-bronchodilator forced expiratory volume in 1 s (FEVAdjusted annualized severe exacerbation rates over the treatment period, least squares (LS) mean change from baseline at Week 12 in pre-bronchodilator FEVDupilumab vs placebo reduced exacerbations and improved pre-bronchodilator FEVDupilumab reduced severe exacerbations and improved lung function and asthma control in subgroups of patients with type 2 asthma and high-dose ICS at baseline.NCT02414854.

Objective: To compare healthcare resource utilization (HCRU), healthcare expenditures, and work productivity and activity impairment within a general asthma population with persistent asthma and ev...

Objective: Certain populations suffer disproportionately from asthma and asthma morbidity. The objective was to provide a national descriptive profile of asthma control and treatment patterns among...

Objective: To evaluate the extent of documentation of asthma control and severity and associated characteristics among pediatric asthma patients in office-based settings. Methods: This cros...

Background: Dupilumab (DPL), a fully human mAb, blocks the shared receptor component of IL-4/IL-13, key and central drivers of type 2 inflammation. In phase 3 QUEST (NCT02414854), DPL 200/300mg every 2 weeks vs placebo (PBO) reduced severe asthma exacerbations and improved pre-bronchodilator (BD) FEV1 in patients (pts) with uncontrolled, moderate-to-severe asthma. Aim: To assess DPL efficacy in reducing severe asthma exacerbations in pts from QUEST overall ITT with and without clinically meaningful improvements (≥100 or ≥200mL) in pre-BD FEV1 at Week (Wk) 12. Methods: Annualized severe exacerbation event rate during the 52-week treatment period was assessed. Results: Of 1,902 pts (1,264 DPL/638 PBO), more DPL- vs PBO-treated pts had pre-BD FEV1 improvements of ≥100mL (780 [62%] vs 315 [49%]) and ≥200mL (619 [49%] vs 237 [37%]) at Wk 12. DPL 200/300mg vs PBO significantly (P Conclusions: More DPL- vs PBO-treated pts with moderate-to-severe asthma had clinically meaningful pre-BD FEV1 improvements of ≥100 or ≥200mL at Wk 12. During the 52-week treatment period, DPL significantly reduced severe exacerbations vs PBO regardless of pre-BD FEV1 improvement at Wk 12.

Background: Uncontrolled, moderate-to-severe asthma in patients (pts) with baseline (BL) blood eosinophils (Eos) ≥500 cells/µL can be difficult to treat. Dupilumab (DPL), a fully human monoclonal antibody, blocks the shared receptor component of IL-4/IL-13, key and central drivers of type 2 inflammation. In phase 3 LIBERTY ASTHMA QUEST (NCT02414854), add-on DPL 200/300mg every 2 weeks (q2w) vs placebo (PBO) reduced severe exacerbations, improved pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in pts with uncontrolled, moderate-to-severe asthma, with greater effects in pts with elevated type 2 biomarkers. Aim: To assess DPL efficacy in QUEST pts with BL blood Eos ≥500 cells/µL. Methods: Annualized severe exacerbation rates in the 52-week treatment period were analyzed using a negative binomial model. Least squares (LS) mean change from BL in pre-BD FEV1 (L) at Week 12 was analyzed using a linear mixed-effect model with repeated measures. Results: DPL 200/300mg q2w vs PBO significantly reduced severe exacerbations by 74.4%/71.3% (both P Table). At Week 12, DPL 200/300mg q2w vs PBO significantly improved pre-BD FEV1 by 0.28L/0.30L in pts with BL Eos ≥500 cells/µL (both P Conclusion: Dupilumab significantly reduced severe exacerbations and improved lung function in patients with BL blood Eos ≥500 cells/µL.

Introduction: Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL‑4/IL‑13. The efficacy and safety of DPL in asthma have been demonstrated up to 52 wks in phase (P) 2/3 studies. Aim: This open-label extension (OLE) study (NCT02134028) assessed long-term safety and efficacy of DPL in adult and adolescent patients (pts) who had completed a DPL asthma study (P2b DRI, P2 EXPEDITION, P3 QUEST or VENTURE). Methods: 2282 moderate-to-severe asthma or OCS-dependent severe asthma pts received add‑on SC DPL 300mg every 2 wks up to 96 wks. Treatment-emergent adverse events (TEAE), annualized rate of severe asthma exacerbations (AER) during the treatment period, and change from parent study baseline (BL) in FEV1 and biomarkers up to Wk 96 were assessed. Results: 2039 pts completed the OLE treatment period with a safety profile that was consistent with the shorter-duration parent studies (Table). The low unadjusted AER and improvement in FEV1 observed in the parent studies were sustained during the OLE. Similar efficacy was seen in pts with elevated type 2 biomarkers from DRI/QUEST. By Wk 96, blood eosinophils decreased to below-parent study BL levels in pts from DRI/QUEST and were near-parent study BL levels in pts from VENTURE; total IgE levels decreased by 82% (median % change from parent BL). Conclusion: Long-term use of dupilumab was well tolerated and showed sustained efficacy in asthma pts up to 96 wks.

Background: Type 2 (T2) inflammation is implied in the pathogenesis of several coexisting diseases. Objectives: To estimate proportion of patients (pts) with moderate-to-severe (m/s) asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) or atopic dermatitis (AD) with comorbidities linked to T2 inflammation. Additionally, severity of T2 comorbidities in m/s asthma and m/s CRSwNP pts was estimated. Methods: A convenience sample of physicians from US and EU5 (France, Germany, Italy, Spain and the UK) were contacted (JAN2017–FEB2020) to identify and review medical records of pts with asthma, CRSwNP, or AD (all m/s disease). Based on physician judgement, comorbidities linked to T2 inflammation and severity of comorbidities were reported. Results: 761 physicians identified pts with m/s asthma (n=899), m/s CRSwNP (n=683), or m/s AD (n=367). In m/s asthma pts, 60%, 15%, 17% had allergic rhinitis (AR), AD, CRSwNP; in m/s CRSwNP pts, 46%, 53%, 9% had asthma, AR, AD; in m/s AD patients, 31%, 41%, and 3% had asthma, AR, CRSwNP. In m/s asthma and m/s CRSwNP pts, a high proportion of T2 comorbidities presented as m/s disease (Figure). Conclusions: High proportions of pts with m/s asthma, m/s AD, and m/s CRSwNP had comorbidities linked to T2 inflammation. Given the high comorbidity burden, an integrated treatment approach addressing underlying T2 inflammation should be considered.

Background: Patients (pts) with chronic rhinosinusitis with nasal polyps (CRSwNP) and comorbid asthma often have more severe disease than pts without asthma. Dupilumab (DPL), a fully human mAb, blocks the shared receptor component for IL-4/IL-13, key and central drivers of type 2 inflammation in multiple diseases. In the SINUS-52 study (NCT02898454), DPL significantly improved outcomes in pts with CRSwNP and was well tolerated. Aim: To assess DPL effect on blood and nasal type 2 inflammatory biomarkers in pts with CRSwNP with/without comorbid asthma in the SINUS-52 trial. Methods: Biomarkers were evaluated in the placebo (PBO) and DPL groups in the safety population with (n=267)/without (n=180) a medical history of asthma. Results: Baseline (BL) median biomarker levels were higher in pts with comorbid asthma. DPL was associated with marked decreases in the concentration of blood biomarkers in pts with/without asthma from BL at Week (Wk) 52, while no meaningful changes were noted in the PBO arm. DPL vs PBO significantly reduced levels of all biomarkers in nasal secretions of pts with asthma and of nasal eotaxin-3 and IL‑5 in pts without asthma from BL at Wk 24 (Table). Conclusion: DPL suppressed both systemic (in blood) and local (in nasal secretions) type 2 inflammatory biomarkers in pts with CRSwNP with/without comorbid asthma.

Nationally, racial and ethnic disparities in childhood asthma plateaued from 2005 to 2013. We assessed trends in childhood asthma in Miami, Florida using Youth Risk Behavior Surveillance System (YRBSS) data and emergency department (ED) utilization and hospitalization rates by zip code population characteristics. Asthma prevalence in Miami did not vary significantly by race/ethnicity in YRBSS respondents in 2005 (16.2–17.2%, all groups), but rose in African–Americans and Hispanics and declined in Whites by 2013 to 27.9, 20.9 and 12.6%, respectively (P = 0.02). Median asthma ED visit rates rose from 106.8 (2006–2008) to 138.2 (2011–2013; P = 0.004) per 10,000 children. High-poverty and majority African–American zip codes were 6.3 and 7.3 times more likely to have asthma ED visit rates > 200 than others (P

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.

The degree of poorly controlled asthma and its association with missed school days and parental missed work days is not well understood.This was a retrospective analysis of missed school days and missed work days for school-aged children (SAC; aged 6-17) and their caregivers in the nationally representative 2007-2013 Medical Expenditure Panel Survey (MEPS). Indicators of poor asthma control included: exacerbation in previous 12 months; use of3 canisters of short-acting beta agonist (SABA) in 3 months; and annual asthma-specific (AS) Emergency Department (ED) or inpatient (IP) visits. Negative binomial regression was used for missed school days, and a Heckman two-step selection model was used for missed work days. All analyses controlled for sociodemographics and other covariates.There were 44,320 SAC in MEPS, of whom 5,890 had asthma. SAC with asthma and an indicator of poor control missed more school days than SAC without asthma: exacerbation (1.8 times more; p0.001);3 canisters SABA (2.7 times more; p0.001) and ED/IP visit (3.8 times more; p0.001). The parents/caregivers of SAC with asthma and an exacerbation missed 1.2 times more work days (p0.05), while those with SAC with asthma and an ED/IP visit missed 1.8 times more work days (p0.01) than the parents of SAC without asthma.This study provides evidence of the significant national burden of poorly controlled asthma due to missed school and work days in the United States. More effective and creative asthma management strategies, with collaboration across clinical, community and school-based outreach, may help address this burden.

BACKGROUND There are limited pediatric data about the use of omalizumab, especially the effectiveness and safety of omalizumab in the real-world management of allergic asthma. OBJECTIVE The objective of this study was to summarize the safety and efficacy of omalizumab in both randomized clinical trials (RCT) used for U.S. Food and Drug Administration registration and real-world studies (RWS) based on clinical care of children with moderate-to-severe asthma. METHODS Studies that evaluated omalizumab use in patients