Asthma Controller Medications Research Articles

Medicaid Expansion and Health Care Use Among Adults With Asthma and Low Incomes: The Adult Asthma Call-Back Survey.

Asthma disproportionately affects Black people and people with low incomes, but Medicaid expansion (hereinafter, expansion) data on these populations are limited. We investigated health care use among adults with asthma, before and after expansion, and examined whether asthma-related health care use after expansion varied by demographic characteristics. We analyzed data from the 2011-2013 and 2015-2019 Behavioral Risk Factor Surveillance System Adult Asthma Call-Back Survey on participants aged 18-64 years with current asthma and low incomes in 23 US states. We assessed 5 asthma-related outcomes, including medical visits (routine and emergency) and medication use, for expansion and nonexpansion groups. We used t tests to compare weighted percentages and 95% CIs, then performed adjusted difference-in-differences analyses. Secondary analyses stratified data by race, ethnicity, and sex. Primary analyses (N = 10 796) found no significant associations between expansion and any outcome. Analyses stratified by race and ethnicity found no significant changes (eg, asthma controller medication use among non-Hispanic Black participants in the expansion group was 24.1% [95% CI, 14.4%-37.5%] in 2011-2013 and 35.5% [95% CI, 27.0%-45.1%] in 2015-2019; P = .13). Use of asthma controller medication increased significantly among non-Hispanic Other participants in the nonexpansion group (2011-2013: 16.0% [95% CI, 9.5%-25.5%]; 2015-2019: 40.2% [95% CI, 25.5%-56.8%]; P = .01). Asthma-related hospitalizations decreased significantly among women in the expansion group: 2011-2013 (7.8%; 95% CI, 5.3%-11.3%) and 2015-2019 (3.5%; 95% CI, 2.5%-4.9%) (P = .009). Investigating factors other than health insurance (eg, social determinants of health) that influence the use of asthma-related health care could advance knowledge of potential strategies to advance health equity for adults with asthma and lower incomes.

Real-world users of triple therapy for asthma in the US.

For patients with asthma who remain symptomatic on a medium-dose inhaled corticosteroid/long-acting β2 agonist, addition of a long-acting muscarinic antagonist as a supplementary controller is a recommended option. However, real-world data on the characteristics and treatment patterns of these patients are limited. This study described the demographics and clinical characteristics of new users of single- or multiple-inhaler triple therapy and treatment patterns preceding triple-therapy initiation. This retrospective cohort study used medical and pharmacy claims data from the IQVIA PharMetrics Plus database. The study population comprised adults with asthma with or without chronic obstructive pulmonary disease (COPD) initiating triple therapy with single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; 100/62.5/25 μg) or multiple-inhaler triple therapy (MITT) between September 18, 2017, and September 30, 2019. Demographics, clinical characteristics, and treatment patterns in the 12 months preceding triple-therapy initiation were described (baseline period). A total of 12,395 patients were included. Among FF/UMEC/VI initiators with asthma (n = 1301), the mean age was 49.0 years and 59.3% were women. During the baseline period, 81.5% of patients used controller therapy, 94.7% used rescue medications, and 42.0% reported at least 1asthma-related exacerbation; the annual mean exacerbation rate was 0.96. Similar trends were observed among patients with asthma initiating MITT and patients with comorbid asthma-COPD initiating FF/UMEC/VI or MITT. In real-world practice, triple therapy is often utilized following other asthma controller medication use. High disease burden, as evidenced by substantial use of rescue medications and continued asthma-related exacerbations, suggests that patients may not have achieved adequate asthma control prior to triple-therapy initiation.

Improvement of asthma control in adult patients using extrafine inhaled beclomethasone/formoterol fixed combination as maintenance therapy as well as maintenance and reliever therapy – CONTROL study

IntroductionExtrafine formulation of beclomethasone/formoterol fixed combination (BDP/F pMDI HFA) is approved for both fixed maintenance and maintenance and reliever therapy (MART) of asthma, and recent data has proven that BDP/F pMDI HFA maintenance and reliever therapy is an effective alternative to other regimens. ObjectiveThis study aimed to assess the level of asthma control in a real-life setting in adult patients using extrafine BDP/F pMDI HFA fixed combination in a pressurized metered-dose inhaler (pMDI) as fixed maintenance dosing as well as maintenance and maintenance and reliever therapy. Additionally, we examined patients’ satisfaction with the inhaler device and compliance with therapy as essential factors determining asthma control. MethodsThis multicenter prospective non-interventional observational study lasted 4 months with 3 patient visits. We used the Asthma Control Questionnaire 7 (ACQ-7) to evaluate the degree of asthma control and Morisky Medication Adherence Scale (MMAS-4) to assess compliance. A self-developed questionnaire was used to assess satisfaction with the inhaler device. Results2179 patients using BDP/F pMDI HFA fixed combination as maintenance and reliever therapy or BDP/F pMDI HFA as maintenance therapy and SABA (short-acting beta2-agonist) as a reliever for at least 2 months were included. During the prospective follow-up, we observed an upward trend in the FEV1% (forced expiratory volume in 1 s) predicted values, improvement in the control of symptoms as indicated by a decline in the mean ACQ-7 score was noted (1.62 at Visit 1 vs. 1.21 at Visit 2 vs. 0.94 at Visit 3, p < 0.001) and increase in patients’ compliance (the number of patients that reported forgetting at times to take their medication was reduced from 49.7 % to 27.1 %, p < 0.001). At the same time, we noted a reduction in the number of as-needed doses used for symptom relief (p < 0.001). Most patients were satisfied with the pMDI, considered it easy and convenient to use, and preferred it to a dry powder inhaler (p < 0.001). ConclusionsThe use of extrafine BDP/F pMDI HFA as maintenance as well as reliever therapy seems to be associated with increased asthma control and better compliance to therapy.

The utility of the necessity-concerns framework (NCF) in explaining adherence and parental beliefs about controller medication in Saudi Arabian children with asthma

Objective This study aims to assess beliefs about asthma controller medications among parents of Saudi Arabian children with asthma and the association between these beliefs and medication adherence using the Necessity-Concerns Framework. Methods A cross-sectional survey was provided to parents of children with asthma when they brought their children to routine appointments at local public clinics between May 16 and July 10, 2018. Participants electronically filled out validated Arabic versions of the Medication Adherence Reported Scale (MARS) and Beliefs About Medications Questionnaire (BMQ). Descriptive statistics were used to characterize the study participants, while hierarchical linear regression analysis assessed associations between parental beliefs about controller medications and medication adherence. Results A total of 381 parents of children with asthma completed the study survey. The vast majority (89%) of study participants were non-adherent to their children’s prescribed medications while only 11% were adherent. Additionally, our study revealed a significantly positive association between adherence and parents’ beliefs in the necessity of the medication (p < .001), with concerns about the adverse effects of medication being negatively associated with parental adherence. A higher mean score for medication adherence was reported among the ambivalent groups compared to the accepting, indifferent, and skeptical groups. Conclusions Medication adherence among parents of children with asthma was relatively low. In addition, necessity beliefs were significantly associated with parental adherence to controller medications for their children with asthma. Further studies are warranted to investigate potential factors contributing to poor parental adherence and develop tailored interventions that support parental medication adherence for their asthmatic children.

Impact of a digital therapeutic on adult asthma

Abstract Background Asthma impacts 334 million people globally. Medication adherence is estimated at 50% worldwide. Digital therapeutics (DTx) may improve medication adherence and health outcomes. Methods Prospective, single cohort observational study of 104 adults with asthma managed on inhaled corticosteroids. Subjects had 90-day access to Aptar Digital Health respiratory platform: HeroTracker to monitor adherence, spirometer for lung function, and BreatheSmart mobile app with real-time alerts. Primary outcomes: asthma control, rescue medication use. Secondary outcomes: controller medication adherence, patient feedback. Results Subjects completed Asthma Control Test (ACT) at baseline (T0); 96% (N = 100) completed ACT at 90 days (T1). Between T0 and T1, ACT scores increased significantly (baseline: 16.5 ± 4.7; ΔT0 to T1: + 2.8, 95% CI (2.0, 3.6), p-value &amp;lt;0.001); rescue medication use decreased 44% ((95% CI: 14.1, 63.5), p-value = 0.008); adherence to controller medication decreased 10.7% ((95% CI: 6.4, 15.1), p-value &amp;lt;0.001). 82.5% of subjects reported platform very/somewhat easy to use, 97.5% rated spirometer very/somewhat easy to use, 92.5% reported alerts very/somewhat helpful. Platform rating mean score = 7.825/10 (1-10; 10=high). Conclusions DTx may improve asthma control and decrease rescue medication use. T1 medication adherence was 17% higher than global medication adherence. Patient feedback was positive.

Asthma routinization, family asthma management, caregiver depressive symptoms, and medication adherence in Head Start preschool children.

Medication adherence is suboptimal in childhood asthma. Children rely on caregivers to manage medication administration. It is important to detect families who are at risk for poor adherence or to identify potential areas that can assist families with better adherence to asthma medications in order to improve asthma outcomes. We investigated the association between asthma routines, family asthma management knowledge and skills, and caregiver depressive symptoms with daily controller medication adherence among Head Start preschool children in Baltimore City. Our study included 256 low-income urban preschool children who were prescribed a daily controller medication. Asthma routinization (by the Asthma Routines Questionnaire), family asthma management [by the Family Asthma Management System Scale (FAMSS)], and caregiver depressive symptoms (by the Center for Epidemiological Studies - Depression) were assessed at baseline. The medication possession ratio (MPR) to measure adherence to daily controller medications was calculated at baseline and 12 months from pharmacy fill records. Multiple regression models evaluated the relationship between asthma routinization, the FAMSS, the CES-D, and MPR. Results indicated that only 7% of families had an MPR above 80% at baseline, and 24% of caregivers had clinically significant depressive symptoms. Higher asthma medication routines were associated with higher MPR at baseline (b = 0.05, p = 0.03). Higher family asthma management was associated with higher MPR at both baseline (b = 0.04, p < 0.01) and 12 months (b = 0.05, p < 0.01). Our findings highlight the importance of family asthma management and maintaining medication routines over time to improve asthma controller medication adherence.

Asthma medication use and health care utilization evolution during pandemic times.

Pediatric asthma care was significantly impacted by the Coronavirus Disease (COVID-19) pandemic, with significant decline in asthma health care utilization noted early in the pandemic. We compared Emergency Department (ED) utilization rates and prescription fill rates of controller and quick relief asthma medications between March and December 2020 versus 2021 in a county-specific pediatric Medicaid population to evaluate for changes later in the pandemic. Our data showed an increase in ED utilization by 46.7% (p-.0371) in the second year of the pandemic. There was no significant change in prescription fills for reliever medications (p-.1309) during this time with increased ED utilization for asthma but there was a significant decline in controller medication fills (p-.0039). This data suggests a potential explanation for resurgence of asthma health care utilization because of decreased controller medication fill and use during a time frame that also saw increased viral positivity rates. The poor medication adherence rates despite this increase in ED visits suggests that new interventions may be needed to assist patients with asthma medication adherence.

New Caregiver Diagnoses of Severe Depression and Child Asthma Controller Medication Adherence.

Children with asthma who have depressed caregivers are known to be less adherent to medication regimes. However, it is less clear how adherence responds to a caregiver's new diagnosis of severe depression or whether there is a similar relationship with other serious caregiver diagnoses. The hypothesis is that adherence worsens both with new diagnoses of depression and possibly with new diagnoses of other serious conditions. This study follows a cohort of 341,444 continuously insured children with asthma before and after a caregiver's new diagnosis of severe depression or another serious health condition. The effect of a new depression diagnosis on a child's medication adherence is compared to the effect of new diagnoses of other common caregiver chronic conditions including diabetes, cancer, congestive heart failure, coronary artery disease, and chronic obstructive pulmonary disease. Results show that children's medication adherence declines following a caregiver's new diagnosis of severe depression, but that it also declines following a caregiver's new diagnosis of diabetes. There is no association with new diagnoses of the other caregiver chronic conditions examined. Children whose caregivers have a new diagnosis of depression or diabetes may be at increased risk of deterioration in their medication adherence. These caregivers may benefit from additional support and follow-up. The relationship between caregivers' health and children's medication adherence is complex and deserves further study.

The effects of benralizumab on airway geometry and dynamics in severe eosinophilic asthma: a single-arm study design exploring a functional respiratory imaging approach

BackgroundSevere eosinophilic asthma (SEA) is characterised by elevated blood/sputum eosinophil counts and airway inflammation, which can lead to mucus plug-mediated airway obstruction, increased exacerbation frequency, declines in lung function, and death. Benralizumab targets the alpha-subunit of the interleukin-5 receptor found on eosinophils, leading to rapid and near complete eosinophil depletion. This is expected to result in reduced eosinophilic inflammation, reduced mucus plugging and improved airway patency and airflow distribution.MethodsBURAN is an interventional, single-arm, open-label, uncontrolled, prospective, multicentre study during which participants will receive three 30 mg subcutaneous doses of benralizumab at 4-week intervals. This study will use functional respiratory imaging (FRI), a novel, quantitative method of assessing patients’ lung structure and function based on detailed, three-dimensional models of the airways, with direct comparison of images taken at Weeks 0 and 13. Patients aged ≥ 18 years with established SEA who may be receiving oral corticosteroids and/or other asthma controller medications, who are inadequately controlled on inhaled corticosteroid-long-acting β2-agonist therapies and who have had ≥ 2 asthma exacerbations in the previous 12 months will be included. The objectives of BURAN are to describe changes in airway geometry and dynamics, measured by specific image-based airway volume and other FRI endpoints, following benralizumab therapy. Outcomes will be evaluated using descriptive statistics. Changes in FRI parameters, mucus plugging scores and central/peripheral ratio will be quantified as mean percent change from baseline (Week 0) to Week 13 (± 5 days) and statistical significance will be evaluated using paired t-tests. Relationships between FRI parameters/mucus plugging scores and conventional lung function measurements at baseline will be assessed with linear regression analyses for associations between outcomes, scatterplots to visualise the relationship, and correlation coefficients (Spearman’s rank and Pearson’s) to quantify the strength of these associations.ConclusionsThe BURAN study will represent one of the first applications of FRI—a novel, non-invasive, highly sensitive method of assessing lung structure, function and health—in the field of biologic respiratory therapies. Findings from this study will increase understanding of cellular-level eosinophil depletion mechanisms and improvements in lung function and asthma control following benralizumab treatment.Trial registration EudraCT: 2022-000152-11 and NCT05552508

The Relationship Between Pediatric Attention-Deficit/Hyperactivity Disorder Symptoms and Asthma Management

PurposeChildren with comorbid Attention-Deficit/Hyperactivity Disorder (ADHD) and asthma are at an increased risk for adverse health outcomes and reduced quality of life. The objective of these analyses was to examine if self-reported ADHD symptoms in children with asthma are associated with asthma control, asthma controller medication adherence, quick relief medication use, pulmonary function, and acute healthcare utilization. MethodsWe analyzed data from a larger study testing a behavioral intervention for Black and Latinx children with asthma aged 10–17 years and their caregivers. Participants completed the Conners-3AI self-report assessment for ADHD symptoms. Asthma medication usage data were collected for 3 weeks following baseline via electronic devices fitted to participants' asthma medications. Other outcome measures included the Asthma Control Test, self-reported healthcare utilization, and pulmonary function measured by spirometry testing. ResultsThe study sample consisted of 302 pediatric participants with an average age of 12.8 years. Increased ADHD symptoms were directly associated with reduced adherence to controller medications, but no evidence of mediation was observed. Direct effects of ADHD symptoms on quick-relief medication use, health care utilization, asthma control, or pulmonary function were not observed. However, the effect of ADHD symptoms on emergency room visits was mediated by controller medication adherence. DiscussionADHD symptoms were associated with significantly reduced asthma controller medication adherence and indirectly with emergency room visits. There are significant potential clinical implications to these findings, including the need for the development of interventions for pediatric asthma patients with ADHD.

Predictors of adherence to controller medication in urban African American emerging adults with uncontrolled persistent asthma

Background African American emerging adults tend to have low adherence to asthma controller medication, as well as a disproportionate burden of asthma morbidity and mortality. This study explored constructs from the Information-Motivation-Behavioral Skills model as predictors of controller medication adherence in urban African Americans ages 18–29 (N=152) with uncontrolled asthma using multiple measures of self-reported adherence. Methods Structural equation modeling (SEM) was employed to test the hypothesized mediation model that specified the relationship among psychological distress, substance use, asthma knowledge, motivation, self-efficacy, and adherence. Results Results suggested that motivation is an important predictor of adherence to medication; moreover, higher self-efficacy was associated with higher motivation. Results also highlighted psychological distress as an important intervention target to improve medication adherence in emerging adults. Conclusions The model tested in this study may offer a feasible framework for beginning to understand adherence to controller medication in this population.

Impact of Treatment on Asthma Control in Quetta Pakistan

Background: Poorly controlled asthma may lead to decreased lung function, increase the risk of complications and more episodes of exacerbations, increased healthcare utilization, including more frequent hospitalizations and emergency room visits. Regular monitoring of asthma symptoms and lung function can help identify any potential issues in asthma control and ensure optimal management. Objectives: The study aims to assess the asthma control by the usage of asthma controller medications especially, corticosteroids, bronchodilators and leukotriene modifiers, among patients receiving treatment through well-validated questionnaire. Materials and Methods: A cross-sectional study with a sample of 361 was conducted in different public hospitals outpatient departments and clinics of Quetta Pakistan by using a convenience sampling technique. The Asthma Control Questionnaire (ACQ) was used to measure the asthma control of the asthmatic patients. The descriptive and inferential statistics have been done by using SPSS version 20 with a p value <0.05. Results: The study found that an average score of asthma control was 3.1±1.10 thereby indicating uncontrolled asthma with also 62.3% of study participants had uncontrolled asthma, no patient had controlled asthma. An increased number of medications including the use of corticosteroids and leukotriene modifiers posed an impact on asthma control of the study population. Conclusion: The study concluded that corticosteroids and leukotriene modifiers can be effective in asthma control and it is suggested for the future studies that route of administration and treatment guidelines must also be determined along with the asthma control to gain a complete picture of impact of treatment and management on any health outcomes.

Uncontrolled Asthma Among Children and Its Association With Parents' Asthma Knowledge and Other Socioeconomic and Environmental Factors.

Objective To estimate the frequency of uncontrolled asthma among asthmatic children from Jeddah and to analyze its association with parental asthma knowledge and other socioeconomic and environmental factors. Method A cross-sectional study was conducted at the Pediatrics Departments of King Abdulaziz University Hospital (KAUH) in Jeddah, Saudi Arabia, from July to December 2018. It involved the caregivers of 150 children with asthma, who were following at KAUH.A structured questionnaire was administered by a phone interview to collect the following: socioeconomic and environmental factors of asthma, answers to the Arabic version of the Asthma Control TestTM(ACT), and answers to the Arabic version of the caregiver Asthma Knowledge questionnaire (AKq). Result The frequencyof uncontrolledasthma was 32.7% (95%CI:25.2 - 40.8). Parents had myths about asthma such as "children with asthma should use asthma control medications (inhaled corticosteroids) only when they have symptoms" and "it's not good for children to use the inhaler for too long". Besides, we observed mixed results regarding parents' knowledge about the disease, with correct answers ranging from 56.0% to 88.7% depending on the item. Exposure to bakhoor (aromatic woodchips) at home (OR = 0.41, p=0.044), two or more ICU admissions during the past 12 months (OR = 3.30, p=0.030), and using a rescue inhaler even if there's no cough or wheeze when the child gets the flu (OR = 0.22, p=0.001) were the three independent factors of uncontrolled asthma among children. Conclusion Uncontrolled asthma concerns one-third of the asthmatic children following at our centre, representing a less concerning figure compared to the national data. The contribution of parents' knowledge to asthma control did not show significant results, although uncontrolled asthma may represent an opportunity to increase parents' knowledge and awareness. We emphasize the significance of exposure to bakhoor, the use of oral steroids, and the number of ICU admission as strong indicators for uncontrolled asthma in children. An adaptive national strategy should be designed to enable effective and personalized interventions, resources, and objectives for maximized benefits.

Adherence To Controller Therapy Among A Large, Diverse Sample Of Asthma Patients In The United States

Adherence to controller medication for persistent asthma is often suboptimal, contributing to uncontrolled symptoms and higher economic burden. We describe contemporary adherence estimates among a large, diverse real-world sample of US patients with asthma.

Urinary metabolites of polycyclic aromatic hydrocarbons and short-acting beta agonist or systemic corticosteroid asthma medication use within NHANES

BackgroundWithin cross-sectional studies like the U.S. National Health and Nutritional Examination Survey (NHANES), researchers have observed positive associations between polycyclic aromatic hydrocarbon (PAH) exposure and asthma diagnosis. It is unclear whether similar relationships exist for measures of acute asthma outcomes, including short-term asthma medication use to alleviate symptoms. We examined the relationship between markers of recent PAH exposure and 30-day short-acting beta agonist (SABA) or systemic corticosteroid use, an indicator for recent asthma symptoms. Materials and methodsFor 16,550 children and adults across multiple waves of NHANES (2005–2016), we fit quasi-Poisson multivariable regression models to describe the association between urinary 1-hydroxypyrene (a metabolite of PAH) and SABA or systemic corticosteroid use. We assessed for effect modification by age group and asthma controller medication use. All models were adjusted for urinary creatinine, age, female/male designation, race/ethnicity, poverty, insurance coverage, and serum cotinine. ResultsAfter controlling for confounding, an increase of one standard deviation of 1-hydroxypyrene was associated with greater prevalence of recent SABA or systemic corticosteroid use (PR: 1.06, 95% CI: 1.03–1.10). The results were similar among those with ever asthma diagnosis and across urine creatinine dilution methods. We did not observe effect modification by age group (p-interaction = 0.22) or asthma controller medication use (p-interaction = 0.73). ConclusionMarkers of recent PAH exposure was positively associated with SABA or systemic corticosteroid use, across various urine dilution adjustment methods. It is important to ensure appropriate temporality between exposures and outcomes in cross-sectional studies.

A new analytic tool for assessing the impact of the US Food and Drug Administration regulatory actions.

Develop and test a flexible, scalable tool using interrupted time series (ITS) analysis to assess the impact of Food and Drug Administration (FDA) regulatory actions on drug use. We applied the tool in the Sentinel Distributed Database to assess the impact of FDA's 2010 drug safety communications (DSC) concerning the safety of long-acting beta2-agonists (LABA) in adult asthma patients. We evaluated changes in LABA use by measuring the initiation of LABA alone and concomitant use of LABA and asthma controller medications (ACM) after the DSCs. The tool generated ITS graphs and used segmented regression to estimate baseline slope, level change, slope change, and absolute and relative changes at up to two user-specified time point (s) after the intervention. We tested the tool and compared our results against prior analyses that used similar measures. Initiation of LABA alone declined among asthma patients aged 18-45 years before FDA DSCs (-0.10% per quarter; 95%CI: -0.11% to -0.09%) and the downward trend continued after. Concomitant use of LABA and ACM was stable before FDA DSCs. After FDA DSCs, there was a small trend decrease of 0.006% per quarter (95% CI, -0.008% to -0.003%). We found similar results among those aged 46-64 years and patients with poorly-controlled asthma. Our results were consistent with previous studies, confirming the performance of the new tool. We developed and tested a reusable ITS tool in real-world databases formatted to the Sentinel Common Data Model that can assess the impact of regulatory actions on drug use.

Derivation of asthma severity from electronic prescription records using British thoracic society treatment steps

Background:Asthma severity is typically assessed through a retrospective assessment of the treatment required to control symptoms and to prevent exacerbations. The joint British Thoracic Society and Scottish Intercollegiate Guidelines Network (BTS/SIGN) guidelines encourage a stepwise approach to pharmacotherapy, and as such, current treatment step can be considered as a severity categorisation proxy. Briefly, the steps for adults can be summarised as: no controller therapy (Step 0), low-strength Inhaled Corticosteroids (ICS; Step 1), ICS plus Long-Acting Beta-2 Agonist (LABA; Step 2), medium-dose ICS + LABA (Step 3), and finally either an increase in strength or additional therapies (Step 4). This study aimed to investigate how BTS/SIGN Steps can be estimated from across a large cohort using electronic prescription records, and to describe the incidence of each BTS/SIGN Step in a general population.Methods:There were 41,433,707 prescriptions, for 671,304 individuals, in the Asthma Learning Health System Scottish cohort, between 1/2009 and 3/2017. Days on which an individual had a prescription for at least one asthma controller (preventer) medication were labelled prescription events. A rule-based algorithm was developed for extracting the strength and volume of medication instructed to be taken daily from free-text data fields. Asthma treatment regimens were categorised by the combination of medications prescribed in the 120 days preceding any prescription event and categorised into BTS/SIGN treatment steps.Results:Almost 4.5 million ALHS prescriptions were for asthma controllers. 26% of prescription events had no inhaled corticosteroid prescriptions in the preceding 120 days (Step 0), 16% were assigned to BTS/SIGN Step 1, 7% to Step 2, 21% to Step 3, and 30% to Step 4. The median days spent on a treatment step before a step-down in treatment was 297 days, whereas a step-up only took a median of 134 days.ConclusionWe developed a reproducible methodology enabling researchers to estimate BTS/SIGN asthma treatment steps in population health studies, providing valuable insights into population and patient-specific trajectories, towards improving the management of asthma.

The Impact of Caregiver Depression on Child Asthma Outcomes: Pathways and Mechanisms

Depression is common in caregivers of children with asthma and is associated with poor outcomes in their child. No prior studies have longitudinally examined caregiver depression remission as a predictor of improvement in child asthma control. This 2-site study examined whether the proportion of time a caregiver was in depression remission predicted subsequent child asthma control at exit. Caregivers (n= 205) with current major depressive disorder and their children, ages 7 to 17, with persistent asthma were observed every 4 weeks for 52 weeks. Caregiver depressive symptoms were measured using the 17-item Hamilton Rating Scale for Depression (HRSD). Child asthma was assessed with the (Childhood) Asthma Control Test (cACT/ACT) and spirometry, and depression with the Children's Depression Inventory (CDI). Linear regression analyses were conducted with change in cACT/ACT, CDI, and forced expiratory volume in 1 second (FEV1)% predicted as outcomes and proportion of time the caregiver was in remission (HRSD score ≤ 7) as the predictor. Multilevel mediation analyses examined the role of child depressive symptoms and asthma controller medication adherence. Children were, on average, 54.1% female and 11 years old. Caregiver proportion of time in HRSD-assessed remission of depression was a significant predictor of improvement in cACT/ACT, CDI, and FEV1% predicted. Child CDI score, but not medication adherence, mediated the relationship between caregiver HRSD scores and child asthma control scores. Improvement in caregiver depression positively influences child asthma outcomes partially through improvement in child depressive symptom severity. Caregiver depression screening and treatment might lead to improvement in child asthma outcomes.

EFFICACY OF TEZEPELUMAB IN PATIENTS WITH SEVERE, UNCONTROLLED ASTHMA GROUPED BY NUMBER OF ADDITIONAL ASTHMA CONTROLLER MEDICATIONS: RESULTS FROM THE PHASE 3 NAVIGATOR STUDY

EFFICACY OF TEZEPELUMAB IN PATIENTS WITH SEVERE, UNCONTROLLED ASTHMA GROUPED BY NUMBER OF ADDITIONAL ASTHMA CONTROLLER MEDICATIONS: RESULTS FROM THE PHASE 3 NAVIGATOR STUDY

One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study

Objective To assess the long-term safety of tezepelumab in Japanese patients with severe uncontrolled asthma. Methods This phase III, 52-week, open-label, single-arm study (NOZOMI, NCT04048343) evaluated the safety/tolerability of subcutaneous (SC) tezepelumab 210 mg every 4 weeks (Q4W) in Japanese patients aged 12–80 years with severe uncontrolled asthma using medium- to high-dose inhaled corticosteroids and at least one additional asthma controller medication, with/without oral corticosteroids. Exploratory outcomes included efficacy (asthma exacerbations, lung function, and asthma control), pharmacokinetic parameters, and immunogenicity. Results Among 65 patients (median age 52 years), 39 (60%) experienced 94 adverse events (AEs; predominantly nasopharyngitis [13/65]) of mild (49.2%), moderate (7.7%), or severe (3.1%) intensity. Two patients had transient injection site erythema related to tezepelumab. Four patients reported serious AEs unrelated to tezepelumab and one AE led to treatment discontinuation. AEs of special interest were infrequent and generally mild/moderate. Apart from a decrease in blood eosinophils (an expected pharmacodynamic effect), no notable trends/clinically relevant changes in hematology, clinical chemistry, or urinalysis parameters were observed. Among exploratory outcomes, tezepelumab was associated with a low annualized asthma exacerbation rate over the study period (0.11/patient-year), improved lung function (mean [standard deviation] change from baseline of 0.075 [0.226] L in pre-dose/pre-bronchodilator forced expiratory volume in 1 s), and better asthma control versus baseline (responder rate: 71.4% at Week 52). Conclusion Tezepelumab 210 mg SC Q4W in Japanese patients with severe uncontrolled asthma showed safety/tolerability profiles similar to international data, with low exacerbation rates and improvements in lung function and asthma control.