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ATS 2023 International Congress Asthma Highlights

The ATS 2023 international conference took place between May 19–24, 2023 in Washington DC, USA. The conference featured scientific sessions on a broad range of respiratory fields. Here we provide some highlights from the conference that focus on the insights and advances in the field of asthma.

Please use the accordions below to quickly access each topic covered in the highlights.

  • Unmet need

    Characteristics of Patients With Moderate-to-Severe Asthma and High Healthcare Costs in the United States

    Hwee J, et al.

    Abstract no A2557

    Objective: This study characterized the population with moderate-to-severe asthma by GINA steps and healthcare costs

    Methods:

    • A retrospective, cross-sectional study of Optum claims data
    • Population: Patients aged ≥18 years who were diagnosed with asthma in 2018 and 2019
    • Patient demographics and clinical characteristics were described for the overall asthma population and by GINA treatment step (3, 4, or 5) during the first 90 days of 2019
    • GINA Step 3-treated patients were further categorized into 2 groupsa based on asthma-related healthcare costs: Top 20% and top 10%

    Results:

    • The study population included 337,015 patients, with a mean age of 59.9 years and of whom 69% were female
      • Of these patients, there were 9.5%, 14.8% and 7.5% on GINA Steps 3, 4, and 5, with mean healthcare costs of $10,265, $12,293, and $22,601, respectively
    • Compared with the GINA Step 5 patients, patients in the GINA Step 3 Top 20% and Top 10% cost groups were older age, and had greater mean CCI scores (2.8 vs 4.0 vs 4.5, respectively)
      • The majority of patients in each of these three groups had elevated eosinophil levels (≥150 cells/µL); exacerbation frequencies and mOCS use were similar across groups
      • A higher proportion of patients in GINA Step 5 group used biologics compared with the GINA Step 3 Top 20% and Top 10% cost groups (16.8%, 1.4%, 1.4%, respectively)

    Key takeaways:

    • GINA Step 3-treated patients in the top healthcare cost categories were older and had similar exacerbation frequencies, higher blood eosinophil counts, a higher comorbidity burden, similar mOCS use, and lower biologic use than GINA Step 5-treated patients
    • These findings suggest a substantial unmet medical need in a group of patients with moderate-to-severe asthma

    aDefined based on the top cost categories; This study was funded by GSK (study ID:218223)

    Rates of Asthma Exacerbations Among Severe, Persistent Asthma Patients in the US Following Event Indicating Uncontrolled Disease

    Burnette AF, et al.

    Abstract number A6001

    Objective: To evaluate asthma exacerbations following events indicating uncontrolled disease

    Methods:

    • Retrospective data: Administrative claims data (2015–2020) consisting of a payer mix of commercial, Medicare Fee-For-Service, Medicare managed care, and Managed Medicaid
    • Patients with severe, persistent asthma were indexed hierarchically on asthma-related EUD including:
      • ≥1 hospitalization
      • ≥2 ED visits with SCS
      • 1 ED + ≥1 outpatient visit with SCS
      • ≥2 OP visits with SCS
    • A control cohort included matching patients with severe asthma and without any events
    • Inclusion criteria:
      • Aged ≥12 years
      • With 12 months pre- and post-index continuous enrollment
    • Exclusion criteria: Other major respiratory disease or biologic treatment at Baseline

    Results:

    • There were 180,736 patients with severe asthma identified across the 4-payer channels for the study including 90,368 patients with uncontrolled and 90,368 controlled asthma
    • Among patients with uncontrolled severe asthma, the proportion presenting ≥1 exacerbation during the follow-up period ranged from 63.9% among patients in the ≥2 ED cohort to 50.7% among patients with 1 ED visit + 1 other OP visit
    • Patients in the hospitalization and ≥2 ED visits groups were more likely to present with ≥2 exacerbations, with rates of 42.4% and 44.9%, respectively
    • Comparatively, 12.9% of patients with controlled, severe asthma experienced at least 1 exacerbation, while 3.2% experienced ≥2

    Key takeaways:

    • Patients with uncontrolled severe asthma exhibited markedly higher rates of disease exacerbations in the year following evidence of uncontrolled disease versus those with controlled asthma
    • Greater severity of the initial uncontrolled event was associated with an increased rate of exacerbations

    Predictors of Exacerbations Among Pediatric, Adolescent, and Adult Patients With Asthma in the United States

    Cameron A, et al.

    Abstract number A6645

    Objective: To examine predictors of asthma exacerbations among a large, diverse sample of children, adolescents, and adults with asthma in the United States

    Methods:

    • Patients aged ≥6 years were identified from administrative claims data from January 1, 2016, to December 31, 2017
    • Patients were included if they had data on the following: 1 asthma-related hospitalization or emergency room claim, or 2 other asthma related claims with different service dates, available pharmacy data, and 2 years of follow-up post-index datea
    • Asthma severity was estimated from GINA treatment steps (2018)
    • Predictors of ≥1 exacerbation at follow-up were measured and assessedb during Baseline

    Results:

    • Total patients included in the analysis: 2,885,419
      • Children: 21.5%; adolescents: 15.0%; and adults: 63.5%
      • Female sex: 56.7%
      • Patients with commercial insurance, Medical aid, Medicare advantage, and dual Medicaid/Medicare Advantage: 44.8%, 45.9%, 7.0%, and 2.3%, respectively
    • Asthma severity
      • Mild: 64.4%; moderate: 18.5%; severe: 17.1%
    • Exacerbation: Baseline: 6.5% (15.8.% children, 3.4% adolescents, 4.1% adults)
      • Follow-up: 4.9% (11.0% of children, 2.3% adolescents, 3.4% adults)
    • Baseline exacerbation was the strongest predictor of having exacerbations at follow-up among all age groups, with ~3–6 times the odds
    • Having Medicaid (vs commercial) coverage also increased the odds among all patients
    • Asthma-related comorbidities increased the odds of exacerbation (all ages), as did pneumonia (all ages), COPD and hypertension (adults), and GERD (adults/adolescents)
    • Age decreased the odds among children, adolescents, and adults aged ≥65 years
    • Severe asthma increased the odds among all patients, whereas moderate asthma increased the odds among children and adolescents

    Key takeaways: In this study, asthma exacerbationsc were reported among all types of patients but were more likely in patients with previous exacerbation(s), Medicaid coverage, asthma-related and other respiratory comorbidities, and severe asthma

    aBaseline and follow-up years; bUsing multivariable logistic regression models; cAsthma exacerbations were defined as a hospitalization with a primary diagnosis of asthma, or an emergency room visit or office/outpatient visit with asthma in any position and use of oral/injectable corticosteroids within 5 days of the visit

    Predictors of Asthma Exacerbation in a Large Retrospective Cohort and Role of Effect Modification by Female Sex and Race

    Althoff MD, et al.

    Abstract number A1303

    Objective: This study determined the predictors of asthma exacerbation in a large, single-center hospital system and investigated whether non-White women have a higher risk of exacerbation when accounting for environmental exposure

    Methods:

    • This retrospective cohort study included adults with asthma who visited University of Colorado Hospital (UCHealth) facilities from 2011 through 2019
    • Outcomes included: Number of exacerbations, identified by prescriptions for systemic corticosteroids
    • Negative binomial multivariable models were used to adjust for sex, age, race, BMI, tobacco use, T2 status, number of asthma medications, natural log of days followed, and TRAPa were used to identify predictors of exacerbations
    • The interaction between sex and race were evaluated in adjusted models

    Results:

    • The study population included 45,672 patients, of whom 4452 (9.7%) patients had ≥3 exacerbations
    • Female sex was associated with an increased rate of exacerbations (RR, 1.15 [95% CI, 1.11–1.20])
    • Other predictors of exacerbation were non-Hispanic White race (1.09 [1.03–1.15]), overweight and obese BMI (1.17 [1.11–1.23] and 1.26 [1.20–1.32], respectively), current tobacco use (1.18 [1.12–1.23]), T2 high endotype (1.07 [1.03–1.11]), and number of asthma medications (1.15 [1.14–1.17])
    • Age was associated with a decreased exacerbation risk (0.87 [0.86–0.88])
    • In the adjusted models, there was significant interaction between female sex and tobacco use (P=0.003) and female sex and non-Hispanic Black race (P=0.008), indicating further increased risk of exacerbation among female smokers and decreased risk among non-Hispanic Black female participants

    Key takeaways:

    • Female sex is a significant predictor of exacerbation
    • Female tobacco users were at a higher risk than either group alone, whereas non-Hispanic Black women had a lower exacerbation riskb

    aTRAP was defined as living within 500 feet of a major roadway and is a measure of chronic air pollution exposure; bThese effects were not attenuated after taking TRAP, a proxy for air pollution exposure, into account

    The Impact of Insomnia and Depression on Asthma Control

    Rhoads S, et al.

    Abstract number A3575

    Objective: To evaluate a group of patients with asthma and concurrent insomnia diagnoses to clarify the association between the disease processes of insomnia and depression, and identify future potential areas to target for improved patient quality of life

    Methods:

    • This retrospective chart review of patients with asthma at National Jewish Health included patients with insomnia who were matched by age, sex, CCI, and biologic therapy with patients who do not have insomnia
    • The presence of concurrent obstructive sleep disorders and mood disorders and asthma control in patients with and without insomnia were compared using the Chi-square test and t-test, respectively

    Results:

    • A total of 659 patients with asthma were included, of whom 89 had insomnia, and 89 did not have insomnia
    • Patients with insomnia were more likely to have a concurrent diagnosis of obstructive sleep apnea than those without insomnia (57.3% vs 18%; P<0.001)
    • Patients with insomnia were more likely to have a diagnosis of depression or anxiety than those without insomnia (68.5% vs 11.4%; P<0.001)
    • An average of 0.93 asthma exacerbations per year were reported among patients with insomnia and 0.59 among those without insomnia (P=0.039)

    Key takeaways:

    • A considerable interaction between insomnia, depression, and obstructive sleep apnea in individuals with asthma was observed
    • Despite matching for sex, age, biologic use, and additional comorbidities, the increased exacerbation rate among asthma patients with insomnia suggests that the presence of underlying sleep and mood disorders negatively affects asthma control

    The Association of Asthma Symptom Perception With Inhaled Corticosteroid Dosing in Older Adults With Asthma

    Agrawal N, et al.

    Abstract number A3123

    Objective: The study examined the association of symptom perception among older adults with asthma and inhaled corticosteroid dose

    Methods:

    • This study hypothesized that patients who over-perceivea asthma symptoms would be on higher doses of ICS
    • The study included patients with asthma aged >60 years who were recruited from primary care practices in New York City
    • Data on asthma symptom perception were captured twice a day for 30 days
    • Participants estimated their PEF and entered the value into an electronic peak flow monitor; then, they performed 3 PEF blows while blinded to actual PEF values
    • ICS dosage was obtained by chart review and categorized as none, low, medium, or high dose based on beclomethasone equivalent doses

    Results:

    • The study population included 337 patients, with a mean ageb of 68.1 (6.7) years, 84.3% of whom were female, 25.8% Black, and 49.6% LatinX
    • Overall, 264 (78%) of participants used ICS: 74 (22.0%) were on low dose ICS; 93 (27.6%) medium; and 97 (28.8%) high
    • The percent time with over-perceptionb while obstructed was 2.2% (7.1) for no ICS, 1.3% (6.3) for low ICS, 4.7% (14.7) for medium ICS, and 5.0% (17.7) for high ICS
    • In unadjusted analyses, increased percent time with over-perception was not associated with increased ICS dosage; however, increased over-perception when obstructed was associated with increased ICS dosage
    • After adjusting for age, sex, race/ethnicity, education, and monthly income, there was no difference in the percent time with over-perception at all times and when obstructed across different ICS dosage categories

    Key takeaways:

    • Over-perception of airway obstruction was not associated with higher doses of ICS
    • Additional research is warranted to better understand the relationship between symptom perception and medication usage including rescue therapies in older adults with asthma

    aOver-perception was defined as overestimating actual PEF by >10% and represented as a continuous variable. For this analysis, over-perception was specifically considered in the context of airway obstruction, defined as PEF <80; bData are presented as mean (SD)

  • Approaches to Treatment

    The MiSTIC Study Design: Medium Strength Triple Therapy Vs High Strength ICS/LABA for Adult Patients With Asthma Uncontrolled on Medium Strength ICS/LABA

    Kostikas K, et al.

    Abstract number A1310

    Objective: To compare the efficacy of medium-dose ICS/LABA/LAMA with that of high-dose ICS/LABA in patients with asthma uncontrolled on medium-dose ICS/LABA, and to elucidate the determinants of response to add-on LAMA vs doubling the dose of ICS

    Methods: Main Phase (26 weeks)

    • The first phase of this study was a multicenter, double-blind, placebo-controlled, 2-arm parallel group study with 1400 patients with inadequately controlled asthma (ACQ-7 score >1.5) on medium dose ICS/LABA (BDP/FORM 100/6 µg/actuation; 2 inhalations twice daily)
      • Patients included also has a history of exacerbations requiring corticosteroids in the last 3 years
    • Patients were randomized to 2 inhalations twice daily of:
      • MS: BDP/FORM/GB 100/6/12.5 µg/actuation
      • HS: BDP/FORM 200/6 µg/actuation
    • Primary objective: To demonstrate the superiority of MS BDP/FORM/GB vs HS BDP/FORM in terms of proportion of patients converting from having PAL at Baseline to no PAL over 26 weeks
    • Assessments: Spirometry; oscillometry; FeNO, blood eosinophil, and IgE levels; eDiary; ACQ; AQLQ; monitoring of adverse events; and asthma exacerbations

    Methods: Open-Label Extension Phase (24 weeks)

    • The second part included an optional, exploratory, open-label, 2-arm parallel group study with up to 800 participants who completed the main phase with a level of asthma control defined as ACQ-6 score <1.5 at Weeks 22 and 26, no exacerbations in Weeks 12–26, FEV1 drop <10% at Week 26 vs Week 0
    • Patients were randomized to 2 inhalations twice daily of:
      • MS: BDP/FORM/GB 100/6/12.5 µg/actuation if controlled
      • HS: BDP/FORM 200/6 µg/actuation if uncontrolled
    • Patients were followed up to Week 50
    • Main objective: To assess the proportion of patients with controlled asthma after 50 weeks (defined as ACQ-6 score <1.5 at Weeks 46 and 50, no exacerbations in Weeks 36–50, and FEV1 drop <10% at Week 50 vs Week 26)

    Key takeaways:

    • The MiSTIC study (NCT05018598) aims to address an important gap in evidence regarding the use of triple therapy in asthma, which can help optimize treatment strategies for GINA Steps 4–5

    Modulating the Level of ICS in Triple ICS/LABA/LAMA FDC: Effect Against Airway Hyperresponsiveness in a Human Ex Vivo Model of Severe Eosinophilic Asthma

    Rogliani P, et al.

    Abstract number A1311

    Objective: To assess whether the dose of BDP may modulate the efficacy of triple BDP/FORM/GB FDC in preventing airway hyperresponsiveness in a human ex vivo model of severe eosinophilic asthma

    Methods:

    • Human isolated bronchi were incubated overnight in sensitizing serum (1:10 v/v) and then challenged for 45 min with platelet‐activating factor (100 nM) to reproduce the ex vivo AHR condition
    • The CRCs to the MD (100/6/12.5) and HD (200/6/12.5) BDP/FORM/GB administered were constructed on the submaximal contractile tone elicited by histamine 30 µM (EC70)
    • The analysis of potency was performed on pEC50 (−log of EC50)
    • Data are reported as mean±standard error; statistical significance set for P<0.05

    Results:

    • The combination of BDP with FORM and GB as triple FDC exhibited a concentration-dependent bronchorelaxant response in human isolated airways submaximally precontracted by histamine
    • Compared with the MD BDP/FORM/GB, the HD BDP/FORM/GB significantly (P<0.001) improved the bronchorelaxant CRC
    • The maximal bronchorelaxant delta effect between the HD and MD BDP/FORM/GB was detected when comparing BDP/FORM/GB administered at 2/0.06/0.125 ng/mL and 1/0.06/0.125 ng/mL (+10.20±2.27%, P<0.01)
    • The HD BDP shifted the bronchorelaxant CRC elicited by FORM/GB leftward when compared with the MD BDP, with a significant increase in the potency of FORM/GB (pEC50 delta effect: 0.33±0.07, P<0.01)

    Key takeaways:

    • The study provides evidence that higher BDP concentrations significantly improved the bronchorelaxant potency by ≃0.3 logarithms and increased the bronchorelaxant effect by ≃0%, when compared with the FDC where BDP was combined at lower concentrations
    • The addition of LAMA to ICS/LABA improves the bronchorelaxant profile of the FDC, and the possibility of modulating the dose of the ICS may help to prevent AHR and further optimize the bronchorelaxant response to triple ICS/LABA/LAMA FDC in patients with severe asthma

    Efficacy of As-Needed Use of Albuterol-Budesonide in Patients With Moderate to Severe Asthma Who Are Adherent to Maintenance Therapy

    Papi A, et al.

    Abstract number A3055

    Objective: To assess the effects of albuterol–budesonide on severe exacerbation risk in patients, while on their ICS-containing maintenance therapy, who are adherent to maintenance therapy in this prespecified analysis of MANDALA (NCT03769090)

    Methods: This study included symptomatic patients (≥4 years) with ≥1 severe exacerbation in the previous 12 months treated for moderate-to-severe asthma with ICS-containing maintenance therapy

    • Mean adherence rate to maintenance therapy in the 10 days before randomization was ≥70%
    • Patients ≥12 years were randomized 1:1:1:
      • As-needed albuterol-budesonide 180/80 µg (N=1013)
      • As-needed albuterol-budesonide 180/160 µg (N=1013)
      • Albuterol 180 µg (N=1014)
    • Patients completed at least 24 weeks of randomized treatment while on their ICS-containing maintenance therapy throughout
    • Adherence was calculated by percentage of days patients reported taking maintenance therapy via eDiary entries
    • A prespecified analysis of time-to-first severe exacerbation was performed that followed up on patients until their average maintenance therapy adherence over 3 weeks fell below 70%
    • All data collected prior to randomized treatment discontinuation, change in maintenance therapy, or fall in thrice-weekly maintenance therapy below 70% were included

    Results:

    • Overall, 2590 patients were included in the analysis (albuterol/budesonide 180/160 μg, n=880; albuterol/budesonide 180/80 μg, n=850; albuterol 180 μg, n=860)
    • In patients with continued adherence, the risk of a severe exacerbation was reduced by 23% with albuterol/budesonide 180/160 μg (HR, 0.77; 95% CI, 0.61–0.97; P=0.029) and by 22% with albuterol/budesonide 180/80 μg (HR, 0.78; 95% CI, 0.62–0.99; P=0.037) vs albuterol

    Key takeaways:

    • Compared with albuterol, as-needed albuterol–budesonide exhibited a clinically meaningful reduction in severe exacerbation risk in patients who continued to be adherent to maintenance therapy post-randomization
    • Even for patients receiving consistent ICS therapy, an exacerbation can be prevented by treating the symptoms with albuterol and budesonide concomitantly

    Clinical Practices and Barriers to the Use of Single Maintenance and Reliever Therapy for Asthma

    Zaeh SE, et al.

    Abstract number A6006

    Objective: To understand pulmonary clinician practices regarding SMART including clinician perspectives concerning barriers to the implementation of SMART

    Methods:

    • An electronic survey administered through Qualtrics of pulmonary clinicians from a single academic medical center asking questions about their practice patterns using SMART and barriers to SMART implementation was conducted
    • Clinicians were asked to free text any other concerns they had about prescribing SMART at the end of the survey

    Results:

    • Of 41 pulmonary clinicians who completed the survey, 46% were male, 60% were White, 68% were aged 31–50 years, and 59% spent over half of their time in clinical work
    • Overall, 93% were aware that SMART was a component of updated asthma management. However, only 71% had prescribed SMART, among whom 72% prescribed SMART <40% of the time to patients who were eligible
    • Among the 85% who believed that SMART was an effective management strategy, 91% reported that SMART was more convenient for patients and 71% reported that SMART would reduce the risk of asthma exacerbations
    • The most common barriers to prescription of SMART included lack of insurance coverage (54%), lack of patient understanding regarding use of SMART (32%), and patient unwillingness to change their inhaler strategy to SMART (32%)

    Key takeaways:

    • Most clinicians do not routinely prescribe SMART owing to substantial barriers, although most pulmonary clinicians are aware of updated asthma guidelines recommending SMART and consider it effective
    • This study suggested improving insurance coverage, patient education, and self-management strategies to support patients in switching to SMART therapy

    Airway Efficacy and Systemic Activity With Different Inhaled Corticosteroid Containing Dosing Regimens in Patients With Persistent Asthma: A Structured Literature Review and Modeling Analysis

    Singh D, et al.

    Abstract number A2560

    Objective: This study explored airway efficacy/systemic activity profiles for proactive regular dosing with FF- and BUD-containing asthma therapies in mild and moderate-to-severe asthma, in addition to as-needed BUD/FORM in patients with mild asthma

    Methods:

    • The analysis involved a follow-up structured literature review and modelling analysis
    • Articles published in the PubMed and Cochrane Library databases from April 27, 2021, to March 3, 2022, were screened for predefined criteria: adult/adolescent population (≥12 years old); maintenance, as-needed/MART; persistent asthma severity (mild, moderate, or severe); study type (RCT, RWD, observational trial, meta-analysis, or SLR)
    • Articles that analyzed FF and BUD were selected for data extraction
    • Articles reporting ICS dose were used to simulate airway efficacy (bronchoprotection) and systemic activity (cortisol suppression) for PRD with FF- and BUD-containing regimens, and for as-needed BUD/FORM using a previously validated modelling method1

    Results:

    • After screening, 21a articles were included
    • Simulating airway efficacy and systemic activity in mild and moderate-to-severe asthma demonstrated that FF and FF/vilanterol provided more time with airway protection, less time without airway protection, and lower systemic activity than BUD and BUD/FORM, respectively, across comparable doses and adherence rates from 30% to 90%

    Key takeaways:

    • The ultra-long duration of action of FF, along with its high affinity for the glucocorticoid receptor, permits FF-containing regimens to offer notably greater airway protection and fewer systemic effects than BUD-containing regimens, especially in a low adherence scenario
    • These benefits may be particularly useful in the real world where suboptimal adherence is prevalent

    1. Daley-Yates, et al. Adv Ther. 2022;39(1):706–726.

    aOne article was published after the search period; This study was funded by GSK

    Once Daily Versus Twice Daily Inhaled Corticosteroids Plus Long Acting Beta2-Agonists in Patients With Moderate-to-Severe Asthma – A Meta-Analysis and Systematic Review

    Frent M, et al.

    Abstract number A4055

    Objective: This meta-analysis assessed the efficacy and safety of once-daily vs twice-daily administered ICS/LABA FDC in patients with moderate-to-severe asthma

    Methods:

    • Inclusion criteria: RCTs with a minimum duration of 24 weeks, that compared the efficacy and safety of once daily vs twice daily administered ICS/LABA combinations in patients with moderate-to-severe asthma
    • Outcomes included:
      • Change from Baseline in trough FEV1
      • Proportion of patients achieving asthma control
      • Rate of severe exacerbations
      • Safety

    Results:

    • The analysis included 5 RCTs (N=5414)
    • Compared with twice-daily, once-daily administered ICS/LABA treatment significantly improved trough FEV1 (mean difference=0.03 L, P<0.0001), significantly decreased the incidence of severe exacerbations (IRR=0.80, P=0.0161), and showed similar efficacy in the control of asthma symptoms (OR=1.10, P=0.13)
    • No difference in the incidence of AEs, SAEs, or AEs of special interest was observed between the FDCs

    Key takeaways:

    • Once-daily ICS/LABA combinations reduced exacerbations and improved lung function when compared with twice-daily ICS/LABA combinations in adults with moderate-to-severe asthma
    • However, both the dosing schedules showed similar control of asthma symptoms and safety profile

    Clinical Remission in Oral Corticosteroid (OCS)-Dependent Patients With Severe Asthma: An Analysis of the Andhi-IP and PONENTE Trials

    Menzies-Gow A, et al.

    Abstract number A4763

    Objective: This study analyzed data from the AIPa and PONENTEb trials to characterize OCS-dependentc patients with uncontrolled SEA receiving benralizumab who met a proposed composite definition of clinical remission

    Methods:

    • Eligible patients included those aged ≥18 years with bEOS count ≥150 cells/μL or a historical bEOS count ≥300 cells/μL in the last 12 months and receiving high-dose ICS and long-term OCS at Baseline
    • Patients who received placebo in ANDHI were excluded
    • Patients who achieved all 3 components (0 exacerbation, 0 OCS use, and ACQ-6 score <1.5) at 12 months (PONENTE)/18 months (AIP) were defined to be in CR
    • Baseline characteristics (ANDHI and PONENTE) were compared between patients who achieved CR and who did not (non-remission)

    Results:

    • The study population included 66 patients from AIP, and 312 patients from PONENTE; 28.8% achieved CR in AIP; 26.0% achieved CR in PONENTE
    • Patients who achieved CR had a shorter timed since diagnosis (AIP, 17.2 [11.42] years; PONENTE, 17.6 [13.97] years) than patients who did not (AIP, 25.5 [20.93] years; PONENTE, 23.1 [15.92] years)
    • Aged at asthma onset was higher for remission patients (AIP, 40.7 [15.26] years; PONENTE, 35.2 [18.59] years) than for non-remission patients (AIP, 28.3 [18.07] years; PONENTE, 28.6 [18.93] years)
    • Median OCS dosages were similar between the groups
    • Baseline ACQ-6 scoresd were lower for remission patients (AIP, 2.8 [0.70] years; PONENTE, 1.6 [1.19] years) than for non-remission patients (AIP, 3.2 [0.86] years; PONENTE, 2.3 [1.21] years)

    Key takeaways:

    • OCS-dependent patients in the AIP and PONENTE trials showed that those who achieved CR had a shorter time since asthma diagnosis, an older age at asthma diagnosis, and a lower ACQ-6 score
    • The findings highlight a need to diagnose and appropriately treat SEA as early as possible

    aA 56-week open-label extension of ANDHI (NCT03170271) during which OCS and other asthma therapies were tapered in patients who achieved asthma control on benralizumab; bA phase 3b, open-label, multicenter trial (NCT03557307) designed to evaluate rapid OCS tapering in patients with SEA on benralizumab; cDefined as a daily OCS dose ≥5 mg for ≥3 months; dData are presented as mean (SD)

    Impact of Extrafine Formulation Single-Inhaler Triple Therapy on Asthma Control and Health Related Quality of Life After Three Months of Treatment in Patients With Asthma: Trimaximize - A Real-World View From Germany, United Kingdom, Austria and Denmark

    Gessner C, et al.

    Abstract number A6649

    Objective: To highlight the characteristics, therapy pathways, and health-related outcomes of patients with moderate-to-severe asthma prescribed efSITT in real-world practice

    Methods:

    • TriMaximize is a multicenter, global, prospective non-interventional study
    • Demographic and clinical data were collected from patients’ medical files for 12–36 months following prescription
    • Changes in asthma control (ACT) and HRQoL (Mini-AQLQ) were assessed
    • This interim analysis was presented for the changes in asthma control and HRQoL in the first 582 patients from Germany, United Kingdom, Austria, and Denmark after 3 months of treatment with efSITT

    Results:

    • At inclusion, 77% and 23% of patients were receiving ICS/LABA and ICS/LABA/LAMA, respectively
    • At baseline, the mean ACT score for the overall population was 14.4 points and the mean Mini-AQLQ score was 4.1 points
    • After 3 months of treatment with efSITT, the mean change in ACT score from baseline in the Overall Population was 3.3 points (P<0.0001), and 3.7 points (P<0.0001) in patients on prior treatment with ICS/LABA. Both findings exceeded the MCID of 3 points
    • The mean change in Mini-AQLQ score from baseline in the overall population was 0.7 points (P<0.0001) and 0.9 points (P<0.0001) in patients on prior treatment with ICS/LABA, with both results exceeding the MCID of 0.5 points
    • The majority of patients (55.8%) achieved the MCID for Mini-AQLQ and were considered as responders
    • Of the subgroups of Mini-AQLQ responders, the mean change in ACT score from baseline was 5.8 points (P<0.0001)

    Key takeaways: This study reported a significant improvement in both asthma control and HRQoL in patients with moderate-to-severe asthma after 3 months of treatment with efSITT following a switch from ICS/LABA or ICS/LABA/LAMA

  • Patient-Reported Outcomes

    Addressing Uncontrolled Asthma Across Disease Severities Through Implementation of the Asthma Impairment and Risk Questionnaire (AIRQ) and the Asthma Checklist

    Beuther DA, et al.

    Abstract number A6000

    Objective: To examine Baseline data from an implementation study of AIRQ, a composite control instrument, and the Asthma Checklist, an expert opinion-based decision support tool, to determine how disease control and management choices differ across National Asthma Education and Prevention Program (NAEPP; 2007)

    Methods:

    • AIRQ, a 10-item, yes/no assessment comprising 7 impairment and 3 risk items, was completed at Baseline (0–1 yes responses: WC, 2–4: NWC, 5–10: VPC)
    • Clinicians reviewed AIRQ responses and indicated which Asthma Checklist items were considered
    • At Baseline, AIRQ control levels and therapy-based Asthma Checklist preference for patients with NWC and VPC asthma were compared across NAEPP pharmacotherapy steps (unadjusted ANOVA, Chi-square, and odds ratios [95% CI]; significance P≤0.05)

    Results:

    • Data from 694 patients aged ≥13 years were analyzed, of whom 70.2% were female, with a mean (SD) age of 46.5 (18.9) years
    • Of the study population, 31% were Step 1 (intermittent), 9% were Step 2 (mild persistence), 18% were Step 3 (moderate persistence), 11% were Step 4 (severe persistence), 17% were Step 5 (severe persistence), and 14 % were Step 6 (severe persistence); 46% were WC, 32% were NWC and 22% were VPC
    • The odds of having uncontrolled asthma were greater among Step 6 patients than among Step 1 patients (OR: 1.99 [95% CI, 1.21 to 3.26]) as were the odds of uncontrolled asthma being VPC (OR: 2.56 [95% CI, 1.35 to 4.84])
    • Asthma Checklist assessments and management choices relative to optimization of pharmacotherapy differed significantly among therapy steps, whereby approximately 80% of patients with uncontrolled Step 1 and 2 disease had appropriateness of their therapy assessed, 60% of patients with stepped-up therapy, and 10% of patients were referred to an asthma specialty center
    • Approximately 40%–50% of uncontrolled Step 6 patients were considered for asthma phenotyping, add-on or advanced therapies, or referral to a center

    Key takeaways:

    • Evaluation of both symptom impairment and exacerbation risk reveals that across the disease spectrum, many patients have uncontrolled asthma, although the level of prescribed pharmacotherapy is often used as a surrogate for asthma severity
    • The AIRQ and Asthma Checklist could increase awareness of uncontrolled disease and encourage therapy optimization, especially for patients with milder disease

    Cross-Sectional Associations Between the Chronic Airways Assessment Test and Clinical Characteristics in Asthma and/or COPD in the NOVELTY Study

    Jones PW, et al.

    Abstract number A3042

    Objective: To evaluate the cross-sectional validity of the CAAT in association with a range of clinical characteristics in patients with asthma and/or COPD using the NOVELTY (NCT02760329) baseline data

    Methods:

    • The clinical characteristics included physician‐assessed severity, post-bronchodilator FEV1, mMRC dyspnea grade, RSQ total score, and for patients with asthma or asthma + COPD, ACT score
    • The CAAT scores were analyzed as a continuous outcome with diagnosis (asthma, asthma + COPD, COPD), a single clinical characteristic, and the interaction between these as covariates

    Results:

    • The study population included 7828 patients (mean CAAT score 15.4 [SD 8.6]; mean post-bronchodilator FEV1 75.5% [SD 24.8%] predicted): 4138 with asthma, 991 with asthma + COPD, and 2699 with COPD
    • Higher CAAT scores were associated with worse levels of all clinical characteristics across diagnoses
    • The association between the CAAT score and each of the 5 clinical characteristics was similar across diagnostic groups
    • However, when compared with physician-assessed severity, the CAAT scores were consistently slightly lower in patients with asthma vs those with asthma + COPD or COPD

    Key takeaways: The CAAT demonstrated similar cross-sectional associations with physician-assessed severity, post-bronchodilator FEV1, mMRC dyspnea grade, RSQ total score, and ACT score across asthma, asthma + COPD, and COPD

    Associations Between the Chronic Airways Assessment Test and History of Physician-Reported Exacerbations in Asthma and/or COPD in the NOVELTY Study

    Jones PW, et al.

    Abstract number A3043

    Objective: To investigate the associations between the CAAT and physician-reported exacerbations in patients with asthma and/or COPD using the NOVELTY (NCT02760329) Baseline data

    Methods:

    • The CAAT scores were analyzed as a continuous variable
    • Exacerbations recorded by physicians at Baseline for the prior 12 months were categorized as those treated with antibiotics and/or OCS and those requiring/not requiring hospitalization
    • In each regression model, diagnosis (asthma, asthma + COPD, COPD), a single exacerbation measure, and the interaction between these were included as covariates

    Results:

    • The study population included 7828 patients (mean CAAT score 15.4 [SD 8.6]; mean post-bronchodilator FEV1 75.5% [SD 24.8%] predicted) of whom there were 4138 with asthma, 991 with asthma + COPD, and 2699 with COPD
    • Higher CAAT scores were associated with more exacerbations treated with antibiotics and/or OCS and more exacerbations requiring hospitalization across diagnoses
    • The association between the CAAT score and exacerbations treated with antibiotics and/or OCS showed the same trend across diagnoses; CAAT scores were consistently lower in asthma vs asthma + COPD and COPD by 1.8–3.4 points
    • The association between the CAAT score and exacerbation-related hospitalization also varied significantly by diagnosis
    • CAAT scores in patients with a history of exacerbation-related hospitalization were very similar across diagnoses, but they were lower in asthma vs asthma + COPD and COPD in patients with no history of exacerbation-related hospitalization

    Key takeaways:

    • The difference in association between the CAAT score and exacerbation rates between diagnostic groups may reflect CAAT performance differences or true biological differences
    • Potential factors for these differences between diagnoses for exacerbations treated with antibiotics and/or OCS include differences in exacerbation definitions and for exacerbation-related hospitalizations include differences in disease duration or exacerbation impact

  • Precision Medicine

    Novel Machine Learning Identifies Five Asthma Phenotypes Using Cluster Analysis of Real-World Data

    Wu C, et al.

    Abstract number A3014

    Objective: This study classified asthma phenotypic heterogeneity using RWD

    Methods:

    • This study used RWD from electronic health records of adult patients with asthma who visited the Cleveland Clinic between 2010 and 2021 and for whom pre- and post-BD spirometry measurements were available
    • Patients were excluded based on the following criteria: chronic pulmonary diseases, active smoker, ex smoker with >10-pack-year, and aged >80 or <6 years
    • An unsupervised machine learning (K-prototypes) was used to identify clustersa within the longitudinal cohort according to age, sex, race, BMI, spirometry (pre- and post-BD), and inhaled/systemic corticosteroid use
    • Baseline characteristics and clinical outcomes were compared between clusters

    Results:

    • The study population included 13,503 patients.
    • Five clusters were identified:
      • Cluster 1 (N=3816) included a young population with a mean ageb of 26.0 (9.1) years
      • Cluster 2 (N=1762) represented women (77.6%) with a mean BMIb of 44.4 (7.8) kg/m2 and a higher proportion of African Americans (28.9%)
      • Cluster 3 (N=3480) comprised patients with normal PFTs and a mean pre-BD FEV1b of 102.7% (12.1)
      • Cluster 4 (N=2717) included patients with mildly decreased post-BD FEV1b, 77.5% (13.6)
      • Cluster 5 (N=1723) included patients with the lowest pre-BD FEV1b (68.1% [15.0]) and highest change in FEV1 (25.8% [18.5])
    • Cluster 5 had the highest rate of severe asthma exacerbations requiring ED visits and hospitalization, and cluster 2 had the highest risk of non-severe acute asthma exacerbation per patient-year
    • Age, post-BD FVC, BMI, pre-BD FEV1, FEV1/FVC ratio, post-BD maximum percent change in FEV1, and asthma therapy class were the top covariates affecting patient classification

    Key takeaways: By applying machine learning algorithms to RWD, 5 meaningful phenotypic categoriesc of asthma could be identified. These phenotypes can be further tested prospectively to identify preventative strategies and refine personalized interventions in asthma

    aTo identify clusters, Elbow and average silhouette methods were used; bData are presented as mean (SD); cThe distinctiveness of clusters were evaluated by cross-validated F1 scores with LightGBM and featured importance with the SHAP: Cross-validation score of 0.96 indicates that patients were grouped into meaningful and distinguishable clusters

    Precision Medicine for Asthma and Eosinophilic Inflammation in Exacerbations

    Scott E, et al.

    Abstract number A3010

    Objective: To characterize the spectrum of asthma exacerbations across various domains in a well-defined real-world cohort of adults with asthma

    Methods:

    • The population included patients aged >18 years with evidence of an asthma exacerbationa
    • Demographics and the exacerbation frequency were compared across settings

    Results:

    • The total cohort population with asthma included 383,731 patients
    • A total of 13,748 asthma exacerbations were identified in 8369 adults
    • In the patients with exacerbations, 46% of adults had only 1 exacerbation, the median age at exacerbation was 39 years, 64% of women had exacerbations, and 64% of Black individuals experienced exacerbations
    • In comparison with other settings, inpatient exacerbations were more common in older people, with a higher proportion of females and a relatively low incidence of eosinophilia (52%; P<0.001 for all comparisons)
    • When compared with individuals without eosinophilia, those with inpatient exacerbations with elevated eosinophils at admission had a shorter median length of stay (3 vs 4 days, P<0.001), and a higher percentage of patients were discharged (93% vs 89%, P<0.001)
    Graph-thumbnail

    Key takeaways:

    • Individuals with elevated eosinophils at presentation for an exacerbation were likely to have a milder course, requiring fewer inpatient admissions, with a shorter length of stay, and a higher proportion of discharges to home than individuals who have severe asthma exacerbations without eosinophilic inflammation
    • This study highlights the variability of asthma and features associated with exacerbations in a real-world cohort across multiple domains

    aDefined by an encounter ICD-10 diagnosis

    The Validity of the Asthma Daytime Symptoms Diary (ADSD) and the Asthma Nighttime Symptoms Diary (ANSD) As Measures of Symptoms in Patients With Moderate-to-Severe Asthma

    Keeley T, et al.

    Abstract number A3033

    Objective: The study assessed longitudinal and cross-sectional psychometric properties of Asthma Daytime Symptom Diary/Asthma Night-time Symptom Diary in adults with moderate-to-severe asthma

    Methods:

    • This online survey included adult patients (≥16 years) with moderate-to-severe asthma for ≥2 years and receiving GINA 2020 Steps 3–5 medications
    • ADSD and ANSD were assessed, including reliability, construct validity, latent structure, differential item functioning, sensitivity to change, and thresholds for inferring meaningful change
    • The PGIS and 6 other PROMs supported the psychometric analysis of ADSD/ANSD

    Results:

    • The study population included 241 patients
    • For ADSD and ANSD, Week 1 goodness-of-fit indices for 1-factor models approached or exceeded recommended thresholds, with improvements observed in repeated modeling at Weeks 6 and 10
    • All individual items loaded positively at Week 1 (intraclass correlation coefficients >0.85) between Weeks 1 and 3, 3 and 6, and 6 and 10
    • Mean ADSD and ANSD summary scores at Weeks 1, 6, and 10 were higher with greater asthma severity (assessed by PGIS) and in poorly vs well-controlled asthma (assessed by ACT)
    • Expected patterns of change in mean ADSD and ANSD weekly summary scores between Weeks 1 and 6 and 1 and 10 were identified in PGIS-anchored improved, no change, and worsened subgroups

    Key takeaways: For patients with moderate-to-severe asthma, this study provides novel, early evidence of the longitudinal and cross-sectional psychometric measurement properties of ADSD/ANSD, with stability shown before and after a 3-week data collection break

    This study was funded by GSK (study ID:214135)

    Content Validity of the Asthma Daytime Symptom Diary and Asthma Nighttime Symptom Diary in Patients With Moderate to Severe Asthma

    Keeley T, et al.

    Abstract number A1292

    Objective: The study assessed a small population of patients with moderate-to-severe asthma for content validity of Asthma Daytime Symptom Diary/Asthma Nighttime Symptom Diary

    Methods:

    • The study involved 60-minute-long semi-structured telephonic interviews combining concept elicitation and cognitive debriefing
    • The study population included adults with asthma for ≥2 years receiving GINA 2020 Steps 4–5 medications and had experienced ≥1 severe asthma exacerbation in the prior year
    • CE helped explore asthma symptoms and health related quality of life impacts
    • CD helped assess understanding of instructions and response options, relevance of items, and appropriateness of the recall period for ADSD/ANSD

    Results:

    • The study population included 15 patients with a mean age of 47 years, of whom 87% were female, 80% had asthma for >20 years, 73% had >2 exacerbations in the last year, and 60% had poorly controlled asthma (mean ACT score: 14)
    • During CE, all patients reported experiencing ≥1 symptom assessed by the ADSD/ANSD
    • During CD, almost all patients demonstrated a good understanding of the instructions and response options
    • All ADSD items were relevant to most patients’ daytime experiences (n=15/15 for items 1–4 [difficulty breathing, wheezing, shortness of breath, chest tightness], n=9/15 for item 5 [chest pain], n=14/15 for item 6 [cough])
    • All ANSD items were relevant to most patients’ nighttime experiences (n=15/15 for items 1, 2, 3, 4, and 6; n=8/15 for item 5)

    Key takeaways:

    • Calculation of ADSD/ANSD average weekly scores helps account for day-to-day symptom variability. Meaningful change at the item level was largely consistent across items
    • The results suggest that, from the patient perspective, 1–2-point changes on the 0–10-point numeric rating scale indicate a meaningful improvement/worsening at both the item and total score levels
    • Findings support the content validity and use of ADSD/ANSD in patients with moderate-to-severe asthma in real-world and clinical studies

    This study was funded by GSK (study ID:214566)

  • Inhalers, Adherence, and Carbon Footprint

    Associations Between Asthma Control, Adherence and Short-Acting Beta2-Agonist (SABA) Use in Patients With Uncontrolled Asthma Using a Maintenance and Reliever Digital System (MRDS)

    Mosnaim G, et al.

    Abstract number A3021

    Objective: To examine the medication adherence and SABA reliever medication use, along with the association of each of these variables with patients’ final ACT scores, from the CONNECT2 (NCT04677959) study data

    Methods:

    • Inclusion criteria:
      • Received ≥1 dose of investigational medical product
      • Had ≥1 post-Baseline follow-up assessment
    • Adherence calculation: Based on daily percent adherence scores, averaged across the study period
    • Categorization of adherence: Low (<55%), medium (≥55% to ≤75%), or high (>75%)
    • Categories of SABA use (for this exploratory analysis): <2, 2 to <5, or ≥5 inhalations/week

    Results:

    • N=181; patients exhibited an average adherence of 75% and average weekly SABA use of 2.25 inhalations
    • Mean Baseline and final ACT scores were 14.7 and 19.1, respectively
    • Mean final ACT scores were between 19.2–20.4 and 15.3–18.1 for patients with <2 and ≥2 SABA inhalations/week, respectively

    Key takeaways:

    • Objectively measured lower SABA use was associated with higher ACT scores, regardless of adherence
    • The MRDS can be used to help physicians and case managers understand relationships between patients’ adherence, asthma control, and SABA use

    Inhaler Technique Maintenance in Patients With Uncontrolled Asthma Using a Maintenance and Reliever Digihaler System

    Wechsler ME, et al.

    Abstract number A1294

    Objective: To evaluate the inhaler technique among patients using the Maintenance (fluticasone propionate/salmeterol) and Reliever (albuterol sulfate) Digihaler System from the post hoc analysis of CONNECT2 (NCT04677959) study data

    Methods:

    • Definition of inhalation quality according to PIF, measured by the Digihaler electronic inhaler (a DPI):
      • Good inhalation (PIF 45 to <200 L/min)
      • Fair inhalation (PIF 30 to ≤44 L/min)
      • Low/no inhalation (PIF <30 L/min)
      • Air vent block (PIF ≥200 L/min)
      • No inhalation
      • Exhalation
    • Across patients (N=181), the proportions of inhalations meeting each category definition were averaged using each Digihaler for each week of the study

    Results:

    • During Week 1, patients gained familiarity with the required technique
    • This was followed by categorizing the inhalations performed by patients using the electronic inhaler technology as “good” or “fair,” which was consistently high (≥90% of inhalations) in all subsequent study weeks, without any evidence of technique decay
    • From Week 2 (88% and 87%) to Week 24 (95% and 87%), the rates of “good” inhalation were maintained with both the maintenance and reliever Digihalers, respectively

    Key takeaways:

    • Using an electronic inhaler device with a built-in flow sensor and app that gives feedback on inhalation quality maintained consistently good inhalation technique throughout the 24-week study
    • This may help patients with asthma with maintaining proper inhaler technique and disease self-management by having objective data on how well they use their inhalers

    Comparison of Extrafine Beclomethasone Dipropionate/Formoterol Fumarate (BDP/FORM) Dry Powder Inhaler (DPI) and Pressurized Metered-Dose Inhaler pMDI in Chinese Patients With Asthma: The FORTUNE Study

    Zheng J, et al.

    Abstract number A3038

    Objective: The FORTUNE studya compared a DPI formulation (NEXThaler) of the extrafine BDP/FORM FDC therapy and pMDI in Chinese patients

    Methods:

    • Population: Adult Chinese patients with well-controlled asthma, on regular treatment with low-medium dose ICS/LABA or high dose ICS monotherapy entered a 4-week run-in on BDP/FORM pMDI
    • Patients were treated with extrafine BDP/FORM 100/6 μg DPI or extrafine BDP/FORM 100/6 μg pMDI both given as 2 inhalations twice daily for 12 weeks
    • Primary efficacy endpoint: Change from Baseline in pre-dose morning PEF averaged over the entire treatment period
    • Secondary endpoints: Lung function parameters (pre-dose evening PEF, pre-dose morning FEV1), ACQ-6 score, symptom score, symptom-free days, and rescue medication use

    Results:

    • Study population, N=494 patients (BDP/FORM DPI, n=252 and BDP/FORM pMDI, n=242)
      • 88.7% completed the study (88.5% in DPI and 88.8% in the pMDI group)
    • Baseline subject characteristics were comparable between the groups (ageb, 41.7 [11.9] years; ACQ-6 scoreb, 0.13 [0.19]; pre-dose morning PEFb, 383.83 L/min [114.58], and pre-dose morning FEV1b, 96.42% [11.77])
    • The adjusted change from Baseline over the entire treatment period in pre-dose morning PEF was 6.86 L/min (95% CI, 2.80–10.93) for BDP/FORM DPI and 1.61 L/min (95% CI, −2.53 to 5.76) for BDP/FORM pMDI
    • Adjusted mean difference between the 2 treatments in the ITT analysis set was 5.25 L/min (95% CI, −0.56 to 11.06) with the lower limit of the 95% CI well above the predefined non-inferiority margin of −15 L/min
    • The proportion of subjects experiencing treatment-emergent adverse event were comparable between BDP/FORM DPI (48.4%) and BDP/FORM pMDI (49.6%) groups
    • Occurrence of asthma exacerbations was low and comparable between treatments

    Key takeaways: The DPI and pMDI formulations of extrafine BDP/FORM demonstrated similar efficacy and safety in Chinese patients with well-controlled asthma, thus supporting the new DPI formulation as an alternative treatment option in this population

    aA phase 3, multicenter, randomized, double-blind, double-dummy, 2-arm parallel-group, non-inferiority trial (NCT03453112); bData are presented as mean (SD)

    Medication Adherence in Severe Asthma Patients Enrolling in the NHLBI PrecISE Study

    Akuthota P, et al.

    Abstract number A4760

    Objective: To assess the level of adherence during the first half of the pre-randomization period to better understand the use of asthma controller therapy by patients enrolling in the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) study

    Methods:

    • Patient population:
      • Aged ≥18 years
      • Adherence to controller therapy was assessed with electronic medication sensors attached to their inhaler and a Qualtrics questionnaire as a backup
    • Approximately 4 weeks after the initial screening visit, another visit is scheduled during the run-in period
    • The days after enrollment until this second visit during which patients were documented to be prescribed controller medication constituted the assessment period
    • The assessment period for each patient was prior to being randomized to one of the interventions available in the study
    • After the run-in visit, total adherence of ≥70% was established as the requirement for advancing to randomization

    Results:

    Run-in period (n=207):

    • Patients aged ≥18–39 years (n=44)
    • Patients aged ≥40 years (n=163)

    Averaging between morning and evening controller doses, 50% patients recorded adherence of ≥70 with:

    • 39% among patients aged ≥18–39 years
    • 53% among patients aged ≥40 years

    Key takeaways:

    • Most patients aged ≥40 years achieved the threshold level of adherence during the run-in period
    • This study confirms that older patients with asthma have higher levels of adherence
    • Electronic monitoring can be crucial in confirming adherence eligibility in a clinical trial prior to randomization and in evaluating whether uncontrolled asthma is owing to poor adherence

    Limitations:

    • Sporadic issues with device connectivity or patient activation of the device
    • Inability to assess inhaler technique

    Physician and Patient Perspectives on Treatment Adherence in Asthma Management: Results From APPaRENT 1&2

    Canonica GW, et al.

    Abstract number A6324

    Objective: To assess physician and patient perspectives on treatment adherence and their alignment with GINA recommendations

    Methods:

    • Multinational, online surveys

    Survey period:

    • Physicians: July–August 2020
    • Patients: August–November 2021

    Inclusion criteria:

    • Physicians:
      • ≥3 years of clinical practice
      • ≥4 asthma patients per month
    • Patients:
      • History of asthma
      • Inhaler use ≥6 months

    Results:

    • More than 50% of patients (55%–68%) classified their asthma as moderate (APPaRENT 2)
    • Physicians considered only 28%–36% of patients had moderate asthma (APPaRENT 1 and 2)
    • According to physicians, approximately 63–78% of patients with moderate/severe asthma followed their daily asthma regimen (APPaRENT 1 and 2)
    • In both studies, 35–83% of patients with moderate asthma utilized their maintenance inhaler at least once daily
    • Only 3% of physicians reported that poor adherence to previous therapy was the most important factor for prescribing MART (APPaRENT 2)
    • Although 22–63% of physicians always provided patients an asthma action plan, only 4–11% of patients were estimated to always adhere to this plan (APPaRENT 2)

    Key takeaways:

    • The study showed that physicians might not consider patient adherence as a key factor for treatment decisions, despite GINA recommendations
    • According to APPaRENT, physician assessment and awareness of barriers to adherence were crucial to enhancing asthma treatment outcomes

    This study was funded by GSK (study ID:214325)

    Predictors of Adherence to Asthma Controller Medication Among Pediatric, Adolescent, and Adult Patients in the United States

    Cameron AE, et al.

    Abstract number A6644

    Objective: To examine predictors of controller medication adherence among a large, diverse sample of children, adolescents, and adults with asthma in the United States

    Methods:

    • Patients aged ≥6 years [Data period: January 1, 2016, to December 31, 2017] were included
    • Data type: 1 asthma-related hospitalization or emergency room claim, or 2 other asthma related claims with different service dates, available pharmacy data, 2 years of follow-up post-index datea
    • Asthma severity estimated from GINA treatment steps (2018)
    • Adherence calculated using PDC in each study year. PDC ≥0.80 was categorized as adherent

    Results:

    • Total patients included in the analysis: 580,316
      • Children: 19.9%; adolescents: 11.0%; and adults: 69.0%
      • Female sex: 59.2%
      • Patients with medical insurance and Medicaid: 46.7% and 40.6%, respectively
    • Asthma severity:
      • Mild: 26.4%; moderate: 34.7%; severe: 38.9%
    • Baseline: Mean PDC (SD): 0.63 (0.29) and 38.1% patients were adherent
    • Follow-up: PDC mean (SD): 0.61 (0.31) and adherent patients: 37.3%
    • Non-adherence at Baseline was the strongest negative predictor of adherence at follow-up among all age groups, decreasing the odds by ~88%
    • Having Medicaid (vs commercial) coverage also decreased the odds of adherence among all patients
    • Among adults, older age increased the odds of adherence by 36% (age 41–64) and 45% (age ≥65)
    • Comorbidity increases the odds of adherence, although this differs with age groups
    • Adherence associated with asthma severity:
      • Moderate and severe asthma: Negatively associated among adults
      • Severe asthma: Positively associated among children and adolescents

    Key takeaways:

    • This study found suboptimal adherence among asthma patients, with Baseline non-adherence, the strongest negative predictor of future adherence
    • This study recommends care management approaches considering age as well as other clinical and contextual factors

    aBaseline and follow-up years

    Association of Anxiety and Depression With Adherence to Inhaler in Patients With Asthma

    Alqarni AA, et al.

    Abstract number A6007

    Objective: This study assessed the prevalence of adherence to inhaler and investigated the associations of anxiety and depression with asthma inhaler adherence in adults

    Methods:

    • Study period: April 2022 to October 2022
    • Population: Patients with asthmaa aged ≥18 years who received maintenance inhaler therapy and had never smoked
    • Anxiety and depression were measured using the Hospital Anxiety and Depression Scale
    • Adherence to inhaler was assessed using the 10-item TAI scale

    Results:

    • This study included 111 patients with a mean ageb of 44±13 years; 74.7% were female
    • The prevalence of poor adherence (defined as a TAI score ≤45 of 50) was 46%
    • Significant negative correlations between low score of adherence to inhaler and anxiety as well as depression (r=−0.40, P<0.0001 and r=−0.36, P<0.0001, respectively) were observed
    • Anxiety and depression were associated with poor adherence to inhaler even after adjusting for age, gender, and BMI (adjusted β: −0.40, 95% CI, −0.6 to −0.21, P<0.001 and adjusted β, −0.39; 95% CI, −0.58 to −0.19, P<0.001, respectively)

    Key takeaways:

    • Poor adherence to inhaler is prevalent among patients with asthma, and asthma patients with anxiety and depression are more likely to report poor adherence to inhaler
    • Routine screening for anxiety and depression and implementing psychoeducation interventions should be considered in clinical practice to improve adherence to inhaler, asthma control, and quality of life

    aPatients were registered at a local pulmonary clinic; bData are presented as mean (SD)

    Adherence to Controller Therapy Among Patients With Severe Asthma Enrolled in a 6-Month Digital Intervention

    Elsey L, et al.

    Abstract number A3121

    Objective: The study determined if therapy failure is a result of poor adherence to controller therapy

    Methods:

    • Population: Patientsa aged ≥16 years with severe asthma
    • Patients were provided with a digital self-management platform (Propeller Health), which included EMM for compatible inhalers, and a paired mobile application providing feedback, education, and reminders to take medications
    • Patients completed a Baseline ACT upon enrollment and monthly thereafter in the application
    • Controller adherence was assessed at Baseline (Days 16–30) and at 3 (Days 76–90) and 6 (Days 166–180) months, by calculating the percent of daily actuations divided by expected actuations, capped at 100%

    Results:

    • This study included 99 patients with a mean ageb of 44 (15) years; 77% were female, and the mean baseline ACT score was 11
    • Daily adherenceb at Month 1 (n=93) was 84.2% (25.0); Month 3 (n=79), 74.3% (29.0); and Month 6 (n=67), 77.2% (30.0)
    • After 6 months, 60.6% of patients had a mean adherence >80%, and <10% of patients had a mean adherence of <25%

    Key takeaways:

    • Most patients maintained high levels of controller therapy adherence over 6 months, with approximately two-thirds of patients achieving adherence >80%
    • Electronic monitoring of inhaled controller therapy in patients with severe asthma can support decision-making for patients, warranting escalation to biologic therapy
    • Low adherence to inhaled medications is associated with lower adherence to biologics
    • Insights gained from EMM assessment can provide insights into personalizing care to improve patient outcomes

    aPatients participated in a service evaluation at 2 severe asthma centers in the UK; bData are presented as mean (SD)

    Reducing Potential Carbon Footprint by Maximizing the Benefits of the Inhaler

    Nagel M, et al.

    Abstract number A3149

    Objective: To compare modelled lung delivery of rescue medication via different valved spacers with facemask with the goal of providing optimum patient care while minimizing potential carbon footprint

    Methods:

    • Four different spacer types were evaluated using a breathing simulator (tidal volume=155 mL, I:E ratio=1:2, rate=25 cycles/min)
    • The facemask of each spacer (n=3) was attached to an anatomic model and the airway coupled to a breathing simulator via a filter to capture drug particles that penetrated as far as the carina
    • Five actuations of salbutamol (Ventolin Evohaler) were delivered at 30-s intervals and recovered from specific locations in the aerosol pathway via HPLC
    • The possible dose to the lungs for each pMDI/spacer was then compared using drug delivery data

    Results:

    • The masses (µg) of salbutamol delivered to modelled carina were:
      • Vortex with Frog Mask: 4.7±1.0 µg
      • OptiChamber Diamond with Medium Mask: 11.1±2.4 µg
      • AeroChamber Plus* Flow-Vu* Anti-Static VHC Medium Mask: 19.3±2.0 µg
      • Compact Space Chamber with Medium Mask: 4.0±3.0 µg

    Key takeaways:

    • Delivery of medicine can vary significantly depending on the pMDI/spacer system, which will have implications on the carbon footprint
    • The study found that when compared with conventional spacers, the AeroChamber Plus* Flow-Vu* spacer could possibly lower the carbon footprint by up to 5 times
    • By increasing the amount of each puff that reaches the lungs, the patient is likely to be relieved sooner and will need fewer puffs overall, potentially lowering the carbon footprint of the inhaler

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Footnotes

For abstracts, please visit the ATS site https://www.atsjournals.org/series/ajrccm-conference and enter the title in the search bar.

NOTE: Posters and scientific symposia presented at ATS 2023 are not available. Abstracts can be accessed freely and have been hyperlinked to the title IDs provided in the summaries.

Abbreviations

ACQ, Asthma Control Questionnaire; ACT, Asthma Control Test; ADSD, Asthma Daytime Symptom Diary; ANSD, Asthma Nighttime Symptom Diary; AQLQ, Asthma Quality of Life Questionnaire; AE, adverse event; AHR, airway hyper-responsiveness; AIP, ANDHI-In Practice; AIRQ, Asthma Impairment and Risk Questionnaire; ANOVA, Analysis of Variance; APPaRENT, Asthma Patients’ and Physicians’ Perspectives on the Burden and Management of Asthma; BDP, beclomethasone dipropionate; BD, bronchodilator; bEOS, blood eosinophil; BMI, body mass index; BUD, budesonide; CAAT, Chronic Airways Assessment Test; CCI, Charlson Comorbidity Index; CD, cognitive debriefing; CE, concept elicitation; CI, confidence interval; CONNECT2, CONNected Electronic Inhalers Asthma Control Trial 2; COPD, chronic obstructive pulmonary disease; CR, clinical remission; CRC, concentration-response curve; DPI, dry powder inhaler; EC50/70, a concentration eliciting 50%/70% of maximal contractility; ED, emergency department; efSITT, extrafine formulation single-inhaler triple therapy; EMM, electronic medication monitors; EUD, events indicated uncontrolled disease; FDC, fixed-dose combination; FeNO, fractional exhaled nitric oxide; FF, fluticasone furoate; FEV1, forced expiratory volume in 1 second; FORM, formoterol fumarate; FVC, forced vital capacity; GB, glycopyrronium bromide; GERD, gastroesophageal reflux disease; GINA, Global Initiative for Asthma; HD, high dose; HPLC, high-performance liquid chromatography; HR, hazard ratio; HRQoL, health-related quality of life; HS, high strength; ICS, inhaled corticosteroid; ICD, International Classification of Diseases; I:E, inspiratory:expiratory; IgE, immunoglobulin E; IRR, incidence rate ratio; ITT, Intent-to-Treat; LABA, long-acting beta-agonist; LAMA, long-acting muscarinic antagonist; MART, maintenance and reliever therapy; MCID, minimal clinically important difference; MD, medium dose; mMRC, modified Medical Research Council; mOCS, maintenance oral corticosteroid; MRDS, Maintenance and Reliever Digital System; MS, medium strength; NAEPP, National Asthma Education and Prevention Program; NHLBI, National Heart, Lung, and Blood Institute; NWC, not well controlled; OCS, oral corticosteroid; OP, outpatient; OR, odds ratio; PAL, persistent airflow limitation; PDC, proportion of days covered; PEF, peak expiratory flow; PFT, pulmonary function test; PIF, peak inspiratory flow; PRD, proactive regular dosing; PGIS, Patient Global Impression of Symptoms; pMDI, pressurized metered-dose inhaler; PROM, Patient Reported Outcome Measure; RCT, randomized control trial; RR, rate ratio; RSQ, Respiratory Symptoms Questionnaire; RWD, real-world data; SABA, short-acting beta-agonist; SAE, serious adverse event; SCS, systemic corticosteroid treatment; SD, standard deviation; SEA, severe eosinophilic asthma; SHAP, SHapley Additive exPlanations; SLR, systematic literature review; SMART, single maintenance and reliever inhaler therapy; T2, type 2; TAI, test of adherence; TRAP, traffic-related air pollution; VHC, valved holding chamber; VPC, very poorly controlled; vs, versus; WC, well controlled.

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NX-GBL-FVU-WCNT-230008 | Date of preparation: June 2023