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ERS 2022 International Congress asthma highlights

The ERS 2022 international conference took place this year between September 4–6 in Barcelona, Spain. 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.

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

  • Unmet need

    ICS-LABA prescribing in asthma (maintenance only and MART), clinical and symptom unmet need in Japan

    S. Zhang | Thematic poster

    • Background: The study quantified maintenance only (Mx) and MART ICS-LABA use and associated clinical and symptom burden in Japanese asthma patients (≥18 years), through point-in-time patient and physician survey (2018).
    • Result: 211 patients were on Mx and 57 on ICS-LABA as MART. Mx group had lower proportion of patients with history of at least 1 severe exacerbation in the last 12 months vs MART users group (15% vs 28%, respectively). The most commonly reported symptoms in the past 4 weeks were shortness of breath (Mx: 26.5% vs MART: 31.6%) and wheezing (Mx: 27.5% vs MART: 35.1%). The top reason for choosing Mx (62%) was sustained 24-hour symptom relief while improvement in shortness of breath was the top reason for choosing MART (54.4%), as reported by physician. 5.7% of Mx patients vs 26.1% of MART patients self-reported everyday SABA usage.
    • Conclusion: Different reasons were reported by physicians for prescribing ICS-LABA as Mx or MART. Daily rescue use was reported by a greater proportion of patients on MART, indicating either a lack of understanding of appropriate MART use or an unmet need for additional short relief medication.

    Systematic literature review of the impact of asthma control on patient outcomes

    A.Czira | Thematic poster

    • Background: This systematic literature review of observational studies evaluated the impact of asthma control on patient outcomes using data published between Jan 2016 and June 2020, on MEDLINE, MEDLINE In-Process, Embase, PsycINFO and conference proceedings. Patients aged ≥12 years with mod-to-sev asthma (including refractory/difficult-to-treat/persistent asthma, or patients on ICS/ LABA who reported asthma control and additional predefined clinical, HRQoL, and economic outcomes) were included from 151 studies.
    • Result: The proportion of patients with any exacerbation over 12-month period was higher in patients with uncontrolled asthma (39.3 – 83.2%) vs controlled asthma patients (10.6 – 37.3%). Studies using the AQLQ and SGRQ showed that better asthma control translates to improved HRQoL. Patients with uncontrolled or partially controlled asthma were more likely to experience exacerbations than patients with controlled asthma with OR ranging between (OR: 0.913, 95%Cl: 0.839-0.995 and 5.75, 95%Cl: 2.91-11.38) A study reported (over 1 year), 3 fold higher probability of frequent exacerbations for uncontrolled vs. controlled asthma OR: 3.05 (95%Cl: 1.77 – 5.25). Patients with poor asthma control showed greater odds of presenteeism and, in some cases, absenteeism, and incurred greater healthcare costs.
    • Conclusion: Worse clinical, HRQol, and economic outcomes were associated with lower levels of asthma control.

    Innovation in drug development: applying human factors to understand asthmatic patients’ needs

    M. Lombardini | Thematic poster

    • Background: This study aimed to identify the unmet needs of asthma patients through interviews with patients on the diagnostic process, symptoms, treatments, disease management and challenges with living with the disease. Interviews were conducted in the United Kingdom, Italy and Germany with mild (N=20) and severe (N=28) asthma patients.
    • Result: Result showed that the diagnostic process could be improved by providing more information on asthma (33%), about the different available treatments (33%) and by receiving a faster diagnosis (17%). The most reported symptoms were difficulty in breathing (>85%), coughing (>40%) and heavy feeling in the chest (>32%). The most common causes for triggering symptoms were related to allergies (34% of responses), the weather (26%) and physical exertion (15%). Overall challenges were associated with physical limitation (36%), social limitations (24%) and management of persistent symptoms (16%).
    • Conclusion: Study revealed several topics related to improving quality of life of asthma patients. Current findings can help pharmaceutical industries to improve the development of their products and generate new innovative solutions and concepts to enhance the patients’ quality of life.

    Impact of moderate to severe asthma from the patient’s perspective in Spain

    J. Dominguez-Ortega | Thematic poster

    • Background: ATLAS ASMA a cross-sectional observational study based on a self-administered online survey among adult asthma patients [n=132; 59.1% were mod-to-sev (moderate to severe) asthma] in Spain, which investigated the psychosocial impact of asthma on daily life activities. Validated questionnaires (ACT, Mini-AQLQ) and an ad-hoc survey were used to assess the primary endpoint: psychosocial impact of asthma on daily life from the patient perspective. Descriptive Result.
    • Result: 34 of 39 (87.2%) mild vs 41 of 49 (95.3%) mod-to-sev asthma patients described emotional impacts related to asthma such as less interest in previously enjoyable activities, mood alteration and anxiety/nervousness. Mod-to-sev patients showed higher emotional impact. Most relevant areas affected were leisure activities (67.0%) and sleep quality/quantity (52.3%). Patients perceived asthma affected them at work, school and home. Mean (SD) Mini-AQLQ was 5.0 (1.2), with environmental stimuli dimension showing the lower score. Mild patients obtained a higher mean (SD) Mini-AQLQ score than mod-to-sev patients (5.6 [1.0] vs 4.3 [1.1]). Most patients cited little limitation to intense efforts (20.5%) and were not at all limited in social activities (35.9%).
    • Conclusion: Study revealed asthma impact from patients’ perspective on HRQoL, as well as psychosocial and emotional effects resulting from asthma which were greater in moderate to severe asthma patients.

    From diagnosis to self-management: supporting the patient journey

    C. Vicente | Primary care session

    • The aim of this session was to recognize asthma patient's journey, learn how to support asthma patients and empower them in disease self-management, to define the barriers and ways to overcome, be able to build/work in multidisciplinary team.  
    • Patient's perception of asthma identified were physical and psychosocial consequences, difference between patient's and HCP's perception of asthma control and medications.  
    • Gaps in asthma are highly prevalent but poorly characterised. Current gaps in asthma approach are insufficient understanding, difficulties in diagnosis and access to treatment strategies, lack of quality of communication within health team and asthmatics. 
    •  Some of the approaches for asthma management identified were: asthma management strategies, multidisciplinary team, integrated care pathway.
    •  The study identified ways to organise an asthma review with the help of proactive engagement which involves systematic and individualized review that improves adherence and asthma control, supported by guidelines, reduced cost to the healthcare system and to the government and a role for telemedicine in asthma management. 

    Disease burden and treatment patterns among asthma patients and asthma patients on GINA 4/5 therapies in China

    V. Benson | Thematic poster

    • Background: The study described patients, disease characteristics and treatment patterns in asthma patients and asthma patients on GINA 4/5 therapies in China through Adelphi Respiratory Disease Specific Programme (point-in-time survey between Aug–Dec 2018).
    • Result: The summary provides results from two studies using patients from 8 provinces across China: Study 1 included asthma patients from China while study 2 included asthma patients on GINA 4/5–therapies from China.
    • In study 1 (765 patients): Physician-perceived asthma severity (n=764) was mainly mild (55%) or moderate (42%); only 3% severe. The top three symptoms were (past 4 weeks; n=757): shortness of breath during exertion (59%), productive cough (55%) and trigger-exposed shortness of breath (49%). Treatments prescribed (n=763) most often were ICS/LABA only (42%), ICS/LABA+LTRA (28%) and short acting SABA only (8%).
    • In study 2 (754 patients): Physician-perceived asthma severity (n=752) was mild (31%), moderate (32%) or severe (36%); 69% had ATS/ERS defined uncontrolled asthma. Top three symptoms were (past 4 weeks; n=748): shortness of breath during exertion (65%), productive cough (62%) and trigger exposed shortness of breath (55%). Treatments prescribed most often: ICS/LABA+LTRA (46%), ICS/LABA only (27%), ICS/LABA+LAMA (9%) and maintenance OCS (8%).
    • Conclusion: In China, GINA 4/5–treated asthma is associated with considerable symptom burden and exacerbation frequency. The majority of patients receive ICS/LABA treatment alone or in combination and remain uncontrolled.

  • Biomarkers and phenotyping

    Characteristics of patients and exacerbations in the ongoing Asthma: Phenotyping Exacerbations (APEX) studies

    A.Pradhan | Thematic poster

    • Background: This study evaluated APEX 1&2 longitudinal observational studies aiming to describe Asthma exacerbations in detailed manner. The studies included 200 participants (adults on GINA treatment steps 1-5) who had an asthma exacerbation 1 year prior to baseline (APEX-1) and between 2-5 years prior to baseline (APEX 2). Measurements included FeNO, sputum cell counts, and nasal lavage. These parameters were measured at baseline, at the point of an asthma exacerbation and at annual follow up which was for 3 years to assess phenotypic stability.
    • Result: Baseline characteristics were found to be different between APEX-1 and 2 including in mean ACQ (1.61 vs.1.22), FEV1 (2.45L vs. 2.54L), and A&E/urgent care episodes (2.72 vs. 1.5) while 48% of observed exacerbations requiring steroids (N=24) were associated with type 2 inflammation, raised FeNO (75%) and blood eosinophilia (47.7%).
    • Conclusion: Initial data were consistent with heterogeneous exacerbation inflammatory profiles.

    Increase in blood eosinophil count over time and sputum IL8 are associated with FEV1 decline in asthma

    S. Graff | Thematic poster

    • Background: Study aimed to determine predictive factors associated with accelerated FEV1 decline in adult asthma and evaluate if sputum IL8 are associated with FEV1 decline in asthma. Linear regression analysis was used to highlight predictive factors.
    • Result: In this study, 125 asthmatics were recruited and evaluated and re-evaluated at least 5 years later. Results demonstrated that post-bronchodilation FEV1 decline was 0.06 ± 2.44% predicted y-1 in the overall population. This multivariable analysis showed that an increase in blood eosinophils (BEC) over time (Δ BEC) (Regression Coefficient (95%CI): 0.002 (0.001 to 0.004), p=0.005)) and onset of asthma (0.04 (0.003 to 0.07), p=0.036) were independently associated with FEV1 decline. Sputum IL8 levels measured at baseline were higher (499 (408 - 603) pg/ml, p=0.0040) in patients with accelerated decline compared to others (143 (88 - 308) pg/ml).
    • Conclusion: Increase in blood eosinophil counts and later onset of asthma were associated with accelerated annual FEV1 decline. High sputum IL8 levels could be a risk factor for accelerated decline in asthma patients.

    Biomarkers for airway diseases in clinical practice

    F. Schleich | State of the art session

    • The aim of this oral presentation was to review roles of biomarkers in diagnosis, phenotyping, predicting response to treatment, predicting outcome and phenotyping exacerbations of Asthma.
    • It was suggested to measure FeNO as part of diagnosis of asthma, whereas serum IgE, blood eosinophils would not be used to diagnose asthma. In phenotyping asthma, if the sputum eosinophil count is 3% then it is eosinophilic asthma and if the sputum neutrophil count is 76% then it is neutrophilic asthma. If both sputum eosinophil and sputum neutrophil cell types are combined and elevated it is called mixed granulocytic asthma; and if both cell types are in normal range it is pauci-granulocytic asthma.
    • Role of biomarkers in predicting response to ICS was also discussed, patients having sputum eosinophils <2% do not improve FEV1 with ICS. Response to mepolizumab, dupilumab and tezepelumab were also discussed.
    • While predicting asthma outcome; higher the blood eosinophils the worse the outcome, increased BEC (blood eosinophil count) over time is a risk factor for decline in asthmatics with at least 5 year follow-up.
    • As per MEX study, during exacerbations in severe asthma treated with Mepolizumab, BEC remained low.

    Small airways in asthma: looking deep in the lungs

    M. Kraft | Symposium

    • The talk discussed the ATLANTIS study which aimed to determine the relevance of small air dysfunction in the clinical manifestation of asthma- small airway disease, to evaluate clinical methods to assess the abnormalities of airways, and to develop a questionnaire – Small airways dysfunction tool.
    • It was the largest study conducted in 29 centres, 4 continents, and 9 countries. 88% of patients included were Caucasian, which the speaker pointed out as an indication of lack of diversity in the study.
    • Tests of small airway function include impulse oscillometry, body plethosmography, and spirometry to assess small airway disease groups.
    • Univariate results of this study indicated that multiple small airway measurements correlate with asthma exacerbation and asthma control.
    • Multivariate results indicated that impulse oscillometry parameters predict exacerbations in a model that includes other predictors. FEV1 consistently correlated with asthma control and FEV1 and R5-R20 (impulse oscillometry parameter) correlated with quality of life.
    • The study concluded that small airway disease is present in 91% of the asthma population across all severities, particularly in severe asthma. R5-R20, AX, and X5 measured via impulse oscillometry can provide information about exacerbation rate, and thus small airways dysfunction predicts exacerbation.

    Late Breaking Abstract - Real world endotype stability and exacerbation rates in T2 low asthma

    A.Viinanen | Thematic poster

    • Background: The study defined T2 low asthma in real world data, assessed endotype stability over time, and  determined exacerbation rates using data from pulmonary department of Turku University Hospital, Finland during 2012-2018 (N = 9612). Follow-up assessed until 2021. Uncontrolled asthma defined by ACT score < 20, or ≥ 1 emergency/acute visits or hospitalization due to asthma. T2 low endotype defined by blood EOS consistently below 300 cells/µl and FeNO below 25 ppb during baseline.
    • Result: EOS and FeNO baseline data were available from 478 patients, of them 179 (37.4%) were T2 low. Of T2 low patients, 82% were women, median age was 49 years (IQR 39 – 60) and 65% had uncontrolled asthma. Follow-up data on EOS or FeNO were available for 100 T2 low patients; the T2 low endotype was stable in 82% of T2 low and in 77% of uncontrolled T2 low patients. The event rate for exacerbations requiring hospitalization or emergency room visits during follow-up was 6.6 per 100 patient years (95% CI 2.9 – 11.6) in T2 low, 9.2 (95% CI 3.7 – 16.9) in uncontrolled T2 low and 4.7 (95% CI 3.1 – 6.6) in non-T2 low group (p = 0.47).
    • Conclusion: The EOS/FeNO T2 low endotype was associated with a similar long-term exacerbation risk requiring hospital care as in non-T2 low asthma.

  • Approaches to treatment

    The clues for asthma diagnosis in primary care

    J. Kocks | Primary care session

    • This session covered different algorithms to assist healthcare professionals, especially those working in primary care, in implementing and improving the asthma diagnostic pathway.
    • The session provided an overview of ERS guidelines for the diagnosis of asthma in adults and EAACI logograms. ERS guidelines are based on 3 years of work to get the best way to diagnose asthma.
    • The EACCI guidelines are organised in different parts to make asthma diagnosis more effective. They cover symptoms that are suggestive of asthma and are less likely to be asthma. The EACCI guidelines are more appropriate for day to day practice as they are more practical.
    • The lecture addressed why there is need for an asthma diagnosis algorithm as there is no single test to define asthma, the primary care team need a feasible tool to identify people with asthma, people do not present with a diagnosis but with symptoms. New tests like FeNO and oscillometry might be more practical for primary care than spirometry. Algorithms and IPCRG jigsaw projects might be useful for asthma diagnosis.

    Treatment situation of patients with uncontrolled GINA 4 or 5 asthma in Germany

    D. Skowasch | Thematic poster

    • Background: Retrospective study described real-life management and implementation of the GINA recommendations in 54,000 patients with uncontrolled GINA 4/5 treated asthma through data from Jan to Dec 2019 in the IQVIA LRx prescription database and IQVIA Disease Analyzer.
    • Result: 52% of the uncontrolled patients were seen by a General Practitioner (GP) and a pulmonologist (P), 48% by only a GP. In patients with ≥ 1 drug prescribed by a P continued OCS- and/or SABA overuse (defined by ≥ 3 SABA Rx/year on days with no ICS-containing Rx or an OCS Rx score of ≥ 2/year, a P prescription scored 1, GP 0.75) for ≥ 2, 3, or 4 years were seen in 45%, 26%, and 16% of these patients, respectively. There were regular follow up visits to the P about once every 3 months (16 such patients/P/year). During the study year 2019 25,200 patients with uncontrolled asthma treated in a P practice in Germany received GINA 3 (0.4%), GINA 4 (76%) or GINA 5 therapy (24%). OCS was the most frequent GINA 5 therapy in 69% of the patients (biologicals in 37%, LAMA in 20%). In the year after initiation of biologics patients were able to reduce SABA by 28%, high dose OCS by 55%, and OCS exposure by 40%; cessation of OCS was possible in about 1/3.
    • Conclusion: Every second patient with uncontrolled GINA 4-5 treated asthma is regularly seen by a P. Treatment was not escalated beyond GINA 4 in ¾ of all cases. In GINA 5 low dose OCS was the most frequent add-on treatment.

    Implications of treatable traits and treatment choices on exacerbation risk in moderate-severe asthma

    A.Yorgancıoğlu | Thematic poster

    • Background: This study developed a model describing exacerbation risk in patients on regularly dosed FP, or combination therapy with FP/SAL or BUD/FOR. The study quantified the effects of symptom control (assessed by ACQ-5) and treatment on exacerbation risk in mod-sev asthma by simulating exacerbations and ACQ-5 profiles over 1 year using time-to-event and longitudinal model-based parallel study designs. In addition, to reflect clinical practice, patients on FP without adequate symptom control after 3 months were switched to FP/SAL (FPNR → FP/SAL).
    • Result: ACQ-5, BMI, sex and % predicted FEV1 were exacerbation risk factors distinct from treatment effect (p<0.01). Cumulative exacerbation events (%) were fewer in patients with well and not well controlled symptoms at baseline vs poor control (p<0.01). Switching from FP to FP/SAL significantly reduced ACQ-5 scores (p<0.01).
    • Conclusion: Irrespective of treatment, symptom control, BMI and sex contribute to exacerbation risk.

    Understanding physicians’ and patients’ perspectives on asthma management

    M. Tan | Thematic poster

    • Background: Study aimed to understand whether what drives specialists’ decisions in selecting asthma treatments is consistent with the priorities of mod-to-sev asthma patients. Data used from the Ipsos Severe Asthma Therapy Monitor an online medical chart review conducted among 110 specialists treating sev asthma patients in the US from Nov-Dec 2020 (Physician perceptual) and Ipsos Syndicated Severe Asthma Patient Community, an online qualitative study gathering perceptions from 216 patients with mod-to-sev asthma in France, Germany, Italy, Spain, UK, Canada, and Japan from April-September 2020 (Patient data).
    • Result: For both sampled specialists and patients, ‘improves quality of life’ (55% vs. 37%) and ‘reduces number of exacerbations’ (54% vs. 45%) are among the most important considerations when selecting asthma treatment. 56% of sampled specialists rated ‘reduces number of emergency room (ER) visits and hospitalizations’ as the most important attribute, followed by ‘reduces need for daily oral corticosteroids (OCS)’ (51%) and ‘reduces need for burst of OCS’ (48%). In comparison, ‘reduces ER visits and hospitalizations’ and ‘reduces OCS use’ are less important for sampled patients, with only 1 in 5 selecting these attributes.
    • Conclusion: Sampled specialists tend to emphasize more on preventing consequences of worsening asthma while sampled patients primarily want to see improvement in their overall wellbeing.

  • Clinical RCT data

    Effect of once daily (o.d.) mometasone/indacaterol/glycopyearronium (MF/IND/GLY) vs o.d. MF/IND and twice daily (b.i.d.) fluticasone/salmeterol (FLU/SAL) with respect to age, age at asthma-onset and BMI at baseline: Subgroup analysis from IRIDIUM study

    H. Kerstjens | Thematic poster

    • Background: IRIDIUM a 52-wk, Phase 3, randomised, double-blind, double-dummy, parallel-group study established the benefits of MF/IND/GLY vs MF/IND and FLU/SAL in patients with inadequately controlled asthma. The current analysis investigated the effects of high dose (HD) MF/IND/GLY (160/150/50µg) vs HD MF/IND (320/150µg) and HD FLU/SAL (500/50µg) with respect to age, age at asthma-onset and BMI at baseline.
    • Result: HD MF/IND/GLY improved trough FEV1 at Wk 26 and reduced exacerbations over 52 wks vs high-dose MF/IND and high-dose FLU/SAL across subgroups. Change in ACQ-7 scores were comparable between treatments at Wk 26. (Table)

    Table: Efficacy of MF/IND/GLY vs MF/IND and FLU/SAL according to baseline demographic subgroups in patients with inadequately controlled asthma

      High dose MF/IND/GLY vs high dose MF/IND High dose MF/IND/GLY vs high dose FLU/SAL
    FEV₁ Trough FEV₁ wk 26, Δ(95% CI), ml ACQ wk 26, Δ(95% CI), ml Asthma exacerbations 52 wk, RR (95% CI) Trough FEV₁ wk 26, Δ(95%CI), ml ACQ  wk 26, Δ(95% CI), ml Asthma exacerbations 52 wk, RR (95% CI)
          Moderate or severe Severe     Moderate or severe Severe
    Age at baseline, years
    ≥ 18 to <65

    65 (22 to 108)

    0.02 (-0.07 to 0.12)

    0.87 (0.69 to 1.10)

    0.84 (0.64 to 1.11)

    106 (63 to 150)*

    -0.09 (-0.19 to 0.001)

    0.62 (0.49 to 0.78)*

    0.55 (0.42 to 0.71)*
    ≥ 65

    52 (-43 to 146)

    0.04 (0.17 to 0.24)

    0.74 (0.46 to 1.20)

    0.59 (0.34 to 1.03)

    85 (-6 to 176)

    -0.04 (-0.23 to 0.16)

    0.71 (0.45 to 1.14)

    0.70 (0.41 to 1.20)
    Age of asthma onset, years

    ≥40

    55 (2 to 108)

    0.13 (0.02 to 0.24)

    0.83 (0.63 to 1.11)

    0.90 (0.65 to 1.24)

    112 (59 to 164)*

    -0.07 (-0.18 to 0.04)

    0.62 (0.47 to 0.82)

    0.58 (0.43 to 0.79)

    <40

    65 (7 to 124)

    -0.10 (-0.22 to 0.03)

    0.86 (0.63 to 1.18)

    0.64 (0.43 to 0.94

    96 (36 to 156)

    -0.10 (-0.23 to 0.03)

    0.66 (0.48 to 0.91)

    0.56 (0.38 to 0.82)
    BMI, kg/m2

    <25

    64 (-10 to 137)

    0.02 (-0.14 to 0.17)

    0.81 (0.55 to 1.21)

    0.75 (0.46 to 1.22)

    120 (51 to 190)

    -0.05 (-0.19 to 0.10)

    0.57 (0.40 to 0.83)

    0.47 (0.30 to 0.72)

    25 to <30

    118 (54 to 183)

    0.05 (-0.09 to 0.18)

    0.96 (0.68 to 1.36)

    0.85 (0.57 to 1.28)

    160 (93 to 226)*

    -0.05 (-0.19 to 0.09)

    0.69 (0.49 to 0.97)

    0.59 (0.40 to 0.87)

    ≥30

    -7 (-74 to 61)

    -0.007 (-0.015 to 0.13)

    0.77 (0.54 to 1.10)

    0.76 (0.51 to 1.13)

    25 (-45 to 95)

    -0.15 (-0.30 to -0.01)

    0.65 (0.46 to 0.94)

    0.68 (0.45 to 1.02)

    *p<0.0001
    Δ, least square mean treatment difference

    • Conclusion: Similar benefits of High-dose MF/IND/GLY were seen irrespective of baseline subgroups. Physicians looking to personalise treatment decision would be better served looking to patient preference factors (e.g., o.d./b.i.d. regimen, device type, availability of digital companion) than currently explored clinical parameters.

    Efficacy of once-daily medium- or high-dose mometasone/indacaterol/glycopyearronium (MF/IND/GLY) versus twice-daily high-dose fluticasone/salmeterol (FLU/SAL) to control nocturnal symptoms in patients (pts) with inadequately controlled asthma

    K. Chapman | Thematic poster

    • Background: This analysis of IRIDIUM study compared effects of medium dose MF/IND/GLY (80/150/50mg), and high dose of MF/IND/GLY (160/150/50mg) vs high-dose FLU/SAL (500/50µg) at wk 52, on nocturnal and early morning symptoms in inadequately controlled asthma patients.
    • Result: At Week 52, significant improvements in morning PEF were observed with both medium and high dose of MF/IND/GLY compared with high-dose FLU/SAL. In morning PEF (L/Min), the mean treatment differences (Δ) between medium dose of MF/IND/GLY with high dose of FLU/SAL and high dose of MF/IND/GLY with high dose of FLU/SAL were 28.5 (95% CI: 23.2 to 33.8; p<0.001) and 34.8 (95% CI: 29.5 to 40.1;p<0.001). Patients treated with high dose MF/IND/GLY showed significant improvement in percentage of symptom free mornings on awakening vs high dose FLU/SAL ∆ (95% CI): 3.8 (0.2 to 7.4; p=0.036). However, both doses of MF/IND/GLY vs high dose FLU/SAL showed only numerical improvements in night-time number of puffs of rescue medication [Medium dose vs high dose FLU/SAL ∆ (95% CI): -0.05 (-0.12 to 0.02;p=0.175); high dose vs high dose FLU/SAL ∆ (95% CI): -0.06 (-0.13 to 0.01;p=0.106), and percentage of nights with no awakenings [Medium dose vs high dose FLU/SAL ∆ (95% CI): 0.7 (-2.3 to 3.7; p=0.640); High dose vs high dose FLU/SAL ∆ (95% CI): 1.1 (-1.9 to 4.0;p=0.467).
    • Conclusion: The findings suggested that, both doses of once daily MF/IND/GLY improved lung function and symptom control throughout the day and night compared with twice daily high dose FLU/SAL.

    Efficacy of (o.d.) IND/GLY/MF vs free combination of (b.i.d) SAL/FLU & (o.d.) TIO in patients with uncontrolled asthma on prior LABA/ICS high-dose (GINA step 5): Result from ARGON study and subgroup analysis with respect to age, age at asthma-onset & BMI at baseline

    R. Van Zyl-Smit, C. Gessner | Thematic poster

    • Background: ARGON (NCT03158311), a 24-week, Phase 3b, multicentre, randomised, active-controlled study, evaluated the efficacy of o.d. IND/GLY/MF high-(150/50/160µg) and medium-dose (150/50/80µg) via Breezhaler vs concurrent administration of b.i.d. SAL/FLU high-dose (50/500µg) via Diskus & o.d. TIO (5µg) via Respimat in patients ≥18 years; ≥1 exacerbation in previous year; ACQ≥1.5; FEV1<85%, on prior LABA/ICS high-or medium-dose. ARGON study revealed that high- & medium-dose of IND/GLY/MF showed better or comparable outcomes vs high dose SAL/FLU & TIO. This summary provide Result of two subgroup analysis from ARGON:

      1. Patients uncontrolled on LABA/ICS high-dose;
      2. The subgroups defined with respect to age, age at asthma-onset & BMI at baseline.

    • Result: First subgroup analysis: Improvements in AQLQ score and trough FEV1, and reduction in annual exacerbations with high- and medium-dose IND/GLY/MF were similar vs high-dose SAL/FLU & TIO at Week 24 (Table).
    Table: Efficacy of HD IND/GLY/MF and MD IND/GLY/MF vs HD SAL/FLU & TIO 
      HD IND/GLY/MF vs HD SAL/FLU & TIO MD IND/GLY/MF vs HD SAL/FLU & TIO
    AQLQ score wk 24 Δ (95% CI)  0.003 (-0.140 to 0.146) -0.059 (-0.203 to 0.084)
    FEV1 Δ (95% CI) 0.070 (-0.002 to 0.141) 0.017 (-0.055 to 0.089)
    Asthma exacerbations (mild, mod, sev) 24 Wk, RR (95% CI) 1.16 (0.82 to 1.64) 1.08 (0.76 to 1.54)
    • Second subgroup analysis: Overall, high-dose IND/GLY/MF improved AQLQ score & trough FEV1, while medium-dose IND/GLY/MF showed comparable outcomes vs high-dose SAL/FLU & TIO. The treatment efficacy trends seen among baseline subgroups were same as that of overall study population.
    • Conclusion: Efficacy of IND/GLY/MF (high- and medium-dose) o.d. was similar to SAL/FLU high-dose b.i.d. & TIO o.d. in patients uncontrolled on high-dose LABA/ICS. Also, different patient characteristics (age, age of asthma onset & BMI) do not impact positive outcomes with the treatment.

    Predictors of treatment response to high-dose ICS/LABA or medium-dose ICS/LABA+LAMA and determinants of type of step-up treatment following medium-dose ICS/LABA in asthma patients - TAILOR study

    K. Verhamme, G. Brusselle | Thematic poster

    • Background: GINA recommends increasing dose of ICS to HD ICS/LABA or to add a LAMA on top of MD ICS/LABA in patients with uncontrolled, mod-to-sev asthma despite treatment with MD dose ICS/LABA. Current retrospective cohort study used data of adult asthma patients from Jan 2010 to April 2020, previously treated with MD ICS/LABA for ≥3 months and need of treatment step-up. 3 GP databases, were used to determine two aspects of these treatment choices: 
    1. Predictors of treatment response: Who responds best to these treatments [defined as ≥25% reduction in severe asthma exacerbation rate and/or improvement of lung function (increase in FEV1%≥7.5%)], and 
    2. Determinants of choice of treatment
    • Result: Predictors of treatment response: out of 11,893 adult patients with uncontrolled asthma and requiring treatment step-up (12% in IPCI, 6% in HSD, 1% in Aarhus and 81% in CPRD) 5,490 could be used to evaluate treatment response. % of treatment responders was 42% for patients on medium dose ICS/LABA/LAMA and 46% on high dose ICS/LABA.
    • In both exposure groups, a history of ≥ 2 severe asthma exacerbations [ORadj 4.8 (95% CI 2.0 - 11.7)(for MD) and 3.5 (95% CI 2.5 - 5.1)(for HD)] and increasing treatment duration [ORadj per month 1.3 (95% CI 1.2 - 1.3)(MD) and 1.3 (95% CI 1.3 - 1.4)(HD)] increased the chance of treatment response.
    • Determinants of choice of treatment: 6,126 patients were stepped up to MD ICS/LABA+LAMA and 18,947 patients to HD ICS/LABA. MD ICS/LABA+LAMA was more often prescribed to older patients, or patients with concomitant COPD, GERD or exacerbations in previous year and current or past smokers, and less to patients with atopic disorders.
    • Conclusion: There was comparable treatment response between type of step-up. In uncontrolled asthma patients on MD ICS/LABA, step-up with add-on LAMA was more likely than step-up to HD ICS/LABA in case of older age, current smoking, a history of asthma exacerbations and a concomitant diagnosis of COPD patients.

    Safety profile of triple ICS/LABA/LAMA FDC in the treatment of asthma: a meta-analysis

    L. Calzetta | Thematic poster

    • Aim: A pairwise meta-analysis was performed to assess the risk of overall SAEs, cardiovascular SAEs, and pneumonia reported as SAE in asthmatic patients treated with triple ICS/LABA/LAMA FDC vs. ICS/LABA FDC.
    • Result: Data from 7204 asthmatic patients were extracted from the CAPTAIN, IRIDIUM, TRIMARAN, and TRIGGER studies. Triple ICS/LABA/LAMA FDC vs. ICS/LABA FDC did not increase the risk of total SAEs (RR 0.99 95%CI 0.83 – 1.18) and cardiac SAEs (RR 0.74 95%CI 0.39 – 1.40), whereas the sensitivity analysis performed to resolve heterogeneity resulted in increased risk of vascular SAEs (RR 3.23 95%CI 1.05 – 9.90, P<0.05) (NOTE: Sensitivity analysis excluded some of the CAPTAIN data from the analysis). The level of ICS dose did not modulate the risk of pneumonia; in any case, pneumonia was the most frequent SAE (0.57%). These results were not affected by significant risk of bias and characterized by moderate to high quality of evidence.
    • Conclusion: Triple ICS/LABA/LAMA FDC is a safe pharmacological therapy in severe asthmatic patients characterized by a favourable safety profile and few potential drawbacks, namely the increased risk of vascular SAEs. [GSK note: the vascular SAE signal appeared to be driven by studies other than CAPTAIN].

  • Real world studies

    Improvement of asthma control, treatment adherence and health related outcomes after 3 months of treatment with extrafine single-inhaler triple therapy in asthmatics: a real-world view from Germany

    T. Greulich, C. Gessner, C. Gessner | Thematic poster

    • Aim: The TriMaximize a multicentre, multicountry prospective non-interventional study following asthmatics prescribed extrafine SITT (efSITT) for 1-3 years, aimed to provide a real-world view of the characteristics and therapy pathways in patients with mod-sev asthma prescribed efSITT (BDP/FOR/GLY) in real-world practice, and to characterize the effects of efSITT on asthma control, treatment adherence and HRQoL.
    • Result: Majority of the patients (75.9%) were on prior ICS/LABA treatment (open or fixed), and 24.1% on prior ICS/LABA/LAMA (open or fixed). In 39.9% of patients, poor symptom control under prior treatment was the main reason for switching to efSITT. Mean ACT score at baseline was 14.7 points (patients). After 3 months of treatment with efSITT, mean change from baseline in ACT score was 2.8 patients (p<0.0001) in the overall population and 3.2 patients (p<0.0001) in patients on prior ICS/LABA, exceeding the MCID of 3 patients.
    • At baseline the proportion of patients with a poor, medium or good adherence score (AS) was 28%, 27.5%and 44.4%, respectively. After 3 months of treatment with efSITT the proportion of patients with a poor AS decreased to 18.5%, while that of patients with a medium or good AS increased to 30.2% and 51.3%, respectively. 50.5% of patients with a poor or medium AS at baseline improved to a higher adherence.
    • Mean Mini AQLQ score at baseline was 4.2 points. After 3 months of treatment with efSITT, mean change from baseline was 0.7 points (p<0.0001) and 0.8 points (p<0.0001) in the overall population and in patients on prior ICS/LABA combination, respectively, with both Result exceeding the MCID of 0.5 points.
    • Conclusion: This was the first real-world study to report a significant improvement of asthma control, treatment adherence and HRQoL in patients with mod-sev asthma switched from ICS/LABA or ICS/LABA/LAMA to efSITT.

     

    Risk factors for corticosteroid- and antibiotic only-treated asthma attacks in the NOVELTY cohort, NOVELTY study population and future for NOVELTY

    S. Couillard | Oral presentation

    • Background: The study explored predictors for corticosteroid-and antibiotic only-treated attacks in NOVELTY study [(NCT02760329), a multi-country, prospective, observational] cohort. Asthma patients with baseline data for 15 candidate predictors including EOS and FeNO and data for exacerbation history (acute asthma requiring ≥3 days of CS and/or hospitalisation, or AB only) in the 1 year prior to and the 1 year post-baseline and not on biologics were included. Risk factors for annualised corticosteroid-and antibiotic only-treated attacks were determined using adjusted rate ratios.
    • Result: 961 with full predictors and outcomes data out of 4,753 patients with asthma were included. Significant predictors for corticosteroid-treated attacks were female sex (1.54 [1.08–2.21]), increased symptoms (Asthma Control Test 0.94 [0.91–0.97], for one unit) and a prior corticosteroid-treated attack (3.68 [2.69–5.03]); but not EOS and FeNO. Predictors for antibiotic only-treated attacks were low FEV1%(0.98 [0.96–1.00], for one unit), comorbid rhinosinusitis (2.42 [0.98–5.93]) and a prior antibiotic only-treated attack (4.24 [1.53–12.07]).
    • Conclusion: Risk factors for CS and AB only-treated attacks differed. In this subset of patients, contrary to clinical trial reports, type-2 biomarkers did not predict asthma attacks.

  • Impact of COVID 19 pandemic

    The impact of national lockdown in 2020 on admission rates for exacerbations in asthma; a nationwide cohort study

    L. Toennesen | Thematic poster

    • Background: Study aimed to evaluate weekly rates of in- and out of hospital asthma exacerbations prior to and during the Denmark national lockdown in patients (n=38,225; age >18 years) with ≥1 outpatient hospital contact with asthma as the primary diagnosis from Jan 2013-Dec 2017. Assessment included weekly asthma exacerbation rates from January 1, 2018, to May 22, 2020; and an interrupted time-series (ITS model) with March 12, 2020, as the point of interruption was conducted.
    • Result: An interrupted time-series (ITS model) with March 12, 2020, as the point of interruption showed no immediate changes in exacerbation rates during the first week after point of interruption. While in the following 10 weeks, a change in trend for exacerbations requiring hospitalisation: -0.75 [95% CI -1.39,-0.12],(p < 0.02) and a change in trend for all asthma exacerbations: -12.2 [95% CI -19.1,-5.4], (p<0.001) were observed.
    • Conclusion: After social distancing on March 12, 2020 in Denmark, a gradual decline in exacerbation rates during the following 10-weeks period was observed.

    COVID-19 real-world data (RWD) insights regarding exacerbations and serum Eosinophil levels in Asthma and Chronic Obstructive Pulmonary Disease (COPD)

    M. Cushion | Oral presentation

    • Background: The study investigated the frequency of exacerbations in Asthma and COPD patients, who have received standard of care inhaled GC therapy utilising electronic medical record (EMR) RWD encompassing the US (126M patients) and Europe (26.5M patients) for a pre-pandemic cohort (Feb 2019 –Feb 2020) (n=159,950) and a pandemic cohort (Feb 2021 - Feb 2022) (n=228,640). Exacerbation was defined as an ER visit with a primary diagnosis of Asthma/COPD. Most recent serum EOS measurement was used.
    • Result: Asthma population data only is presented here: Number of patients with serum eosinophil counts ≥150/µl; ≥300/µl, was 47,890; 24,000 (pandemic cohort) and 72,230; 36620 (pre-pandemic cohort). Number of patients receiving inhaled GCs; had an exacerbation and exacerbation rate was 21350; 7800 and 0.37 for pandemic cohort while it was 22,580; 10,290 and 0.46 for pre-pandemic cohort.
    • Conclusion: Exacerbation rates were clearly higher pre-COVID-19 than during the pandemic. The relative proportions of patients by eosinophil count between cohorts was similar.

  • Adherence

    Medication adherence and asthma control with once-daily indacaterol/glycopyrronium/mometasone (IND/GLY/MF) Breezhaler digital companion: interim analysis from Europe, Japan and Germany

    H. Woehrle | Thematic poster

    • Background: IND/GLY/MF once-daily via Breezhaler, can be prescribed as a co-pack with a digital companion (sensor + smartphone app [Propeller Health]) in Germany and Europe, while in Japan, it is dispensed separately at the physician’s discretion. The current interim analysis assessed treatment adherence and asthma control with IND/GLY/MF Breezhaler digital companion in patients (≥18 years) with asthma from Europe, Japan and Germany. Patients prescribed Breezhaler digital companion up to 180/90days (Europe/Japan and Germany) were included.
    • Result: Data from 451 (mean age: 48.7 years [Europe]) and 467 (Japan and Germany) patients were analysed. Median adherence for Europe was ≥92% at months 1, 3 and 6; while >85% for both Germany and Japan (at months 1 and 3). Proportion of patients with ≥80% mean adherence at 1 month was: 78.9%; 63.3%, 81.5% and 3 month was 67.6%, 57.1% and 70.8% for Europe, Japan and Germany respectively, while at 6 month was 70.4% for Europe. ACT scores improved over time (Europe n=247; Japan n=138; Germany n=196)); in Europe 21% more patients were well controlled at 1-month follow-up. At 1 month 34.2% (Germany) and 53.1% (Japan) of the patients were well controlled, respectively.
    • Conclusion: Patients using Breezhaler digital companion showed good medication adherence (≥92%over 6 months in Europe; >85% over 3 months in Japan & Germany) and improved asthma control.

    Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma: The INCA Sun randomized clinical trial

    R. Costello | Clinical trials session

    • Background: The 32-week multicenter, randomized, clinical trial compared treatment decisions guided by digital data on medication adherence, inhaler technique and peak flow against usual care in 220 severe uncontrolled asthmatic patients (>18 years with severe uncontrolled asthma (ACT score ≤19, ≥ 1 severe exacerbations in the last year despite daily 500-1000mcg FP/LABA >12 months). Patients were randomized to control (105) and active group (108). The active group had personalized biofeedback on inhaler adherence, technique, and PEF. The control group had usual care.
    • Result: 213 patients were randomized (control: 105; active: 108) and 200 completed the study. At wk 32, 11 (11%) active and 21 (21%) control patients required add-on biologic therapy (OR: 0.42, 95%CI [0.189-0.95], p=0.038), 3 of 19 (16%) active and 11 of 25 (44%) control patients (who started on FP 500 mcg/day) had a treatment escalation (addition of high dose ICS) (OR 0.26; 95%CI [0.07–0.99], p=0.049), 26 of 83 (31%) active and 13 of 73 (18%) control patients were reduced to FP 500 mcg/day (ICS reduction), (OR 2.11, 95%CI [1.01–4.74], p=0.047). No differences in asthma control, lung function, T2 inflammation, or exacerbations were found between the two groups.
    • Conclusion: Evidence-based care informed by digital data is a safe and cost-effective way to manage uncontrolled asthma

  • Carbon footprint

    Maximizing the benefit from the Inhaler In Order to Minimize Carbon Footprint

    M. Nagel | Thematic poster

    • Background: To provide optimum patient care and minimize the potential carbon footprint, the current study compared modelled lung delivery of rescue medication via 3 different valved spacers (AeroChamber Plus* Flow Vu*Ant-Static VHC Medium Mask; Paediatric Volumatic Spacer with Mask; AbleSpacer 2 Medium Mask). The spacers were evaluated by 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 anatomical model and the airway coupled to a breathing simulator via a filter to capture drug particles that penetrated as far as the carina. 5-actuations of salbutamol (Ventolin Evohaler) were delivered at 30-s intervals. Comparisons were made on drug delivery data looking at potential dose to the lungs for each pMDI/spacer. This potential delivery was then equated to a potential relative carbon footprint based upon the published data.
    • Result: The mass (µg) of salbutamol delivered to modelled carina were: 19.3±2.0 for AeroChamber Plus* Flow Vu*Ant-Static VHC Medium Mask; 7.8±1.0 for Paediatric Volumatic Spacer with Mask and 5.9±1.7 for AbleSpacer2 Medium Mask..
    • Conclusion: The use of the AeroChamber Plus* Flow-Vu* spacer could potentially reduce the carbon footprint by three fold compared to the alternative spacers.

    Carbon footprint of inhalers in respiratory treatment: SABA CARBON International

    A.Alzaabi | Thematic poster

    • Background: This observational study assessed the GHG emissions for SABA vs total inhaler use (all respiratory indications), and SABA overuse for asthma, in Africa, Asia-Pacific, Latin America, and the Middle East as part of the CARBON programme using IQVIA sales data (2018–2019) for inhalers. (all respiratory conditions) and SABINA III SABA prescription/ OTC purchase data for asthma (2019–2020). GHG emissions as CO2 equivalents (CO2e) per actuation or canister were used for calculations.
    • Result: In 23 of the 28 countries analysed, SABA use (as a proportion of total inhaler use) accounted for ≥50% of total inhaler use. SABA-related GHG emissions (as a proportion of total inhaler-related GHG emissions) accounted for >50% of total inhaler-related GHG emissions. Across geographic regions and economies, >90% of SABA was prescribed to asthma patients who were overusing SABA. Per capita GHG emissions linked to SABA overuse were 866 and 732 tonnes CO2 e/10,000 persons/year, with and without SABA OTC, respectively.
    • Conclusion: SABA comprises most of the inhaler use and inhaler-related GHG emissions, with overuse in asthma representing a potentially modifiable environmental impact. Reducing SABA overuse and HCRU can benefit both patients and the environment.

    Carbon footprint of maintenance and reliever therapy (MART) versus maintenance plus SABA (Mx+SABA) regimens for asthma: Result from the healthCARe-Based envirONmental cost of treatment (CARBON) programme

    J. Bell | Thematic poster

    • Background: The study modelled GHG emissions of ICS/formoterol MART and maintenance (Mx)+SABA regimens. Data was from SABA use IN Asthma (SABINA) I real-world study (to get total GINA step 3−5 patients prescribed ICS/LABA+/−SABA therapy in the UK), market share data (to estimate the number of ICS/LABA and SABA inhalers prescribed/year). Exacerbation rates managed by primary and secondary care were estimated from SABINA and the CO2e impact of resource use aggregated. Patients were classified into four treatment categories:
    1. DPI MART;
    2. pMDI MART;
    3. DPI ICS/ LABA Mx+SABA;
    4. pMDI ICS/ LABA Mx+SABA.
    • Result: For managing GINA 3−5 patients with inhaled therapies, total CO2 e/year was 585,527 tonnes, 97% of which was driven by Mx+SABA use. DPI MART had the lowest carbon footprint (7 kg/patient/year assuming 6 inhalers/year) compared with pMDI MART (116 kg/patient/year) and ICS LABA Mx+SABA regimens had the highest carbon footprint (DPI: 119 kg/patient/year; pMDI: 242 kg/patient/year), majority of which was driven by SABA inhalers.
    • Conclusion: DPI MART has lower GHG emissions vs pMDI MART and Mx+SABA.

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Footnotes

For abstracts, please visit ATS site https://www.abstractsonline.com/pp8/#!/10476 , enter the Abstract ID number or title in the search bar.

For symposium and posters, please visit ATS site https://conference.thoracic.org/program/eposters.php click E-poster tab followed by entering the E- poster ID number or title in the congress content search bar. NOTE: ATS-2022 congress credentials are required to access posters and scientific symposium while abstracts (except for scientific symposium) can be accessed freely and have been hyperlinked to the title IDs provided in the summaries.

Abbreviations

AB: antibody; ACT: asthma control test; ACQ: asthma control questionnaire; AE: adverse events; AHR: airway hyper-responsiveness; AQLQ: asthma quality of life questionnaire; BDP: beclomethasone dipropionate; b.i.d.: twice a day; BMI: body mass index; BUD: budesonide; COPD: chronic obstructive pulmonary disease; Contd: continued; CO2: carbon dioxide; CI: confidence interval; CPRD: clinical practice research datalink; CS: corticosteroid; DPI: dry powder inhaler; EACCI: European academy of allergy and clinical immunology; ED: emergency department; efSITT: extra fine single inhaler triple therapy; EHR: electronic health record; EOS: eosinophil; EPO: eosinophil peroxidase; ER: emergency room; ERS: European respiratory society; FeNO: fraction of exhaled nitric oxide; FDC: fixed dose combination; FEV1: forced expiratory volume in 1 sec; FLU: fluticasone; FOR: formoterol fumarate; FP: fluticasone propionate; GERD: gastroesophageal reflux disease; GC: glucocorticosteroid; GHG: green house gas; GOLD: global Initiative for chronic obstructive lung disease; GINA: global initiative for asthma; GLY: glycopyearronium; GP: general practice; HCP: healthcare professional; HCRU: health care resource utilization; HER: electronic health record; HR: hazards ratio; HRQoL: health related quality of life; IgE: immunoglobulin E; ICC: intra-class correlation coefficient; ICS: inhaled corticosteroid; IL: interleukin; ILCs: innate lymphoid cells; IND: indacaterol; IPCI: integrated primary care information; IPCRG: international primary care respiratory group; IRR: incidence rate ratio; LABA: long-acting β2-agonist; LCA: latent class analysis; LSM: least square mean; MART: maintenance and reliever therapy; MCID: minimal clinically important difference; MF: mometasone; MD: mean difference; MITT: multiple inhaler triple therapy; Mod: moderate; Mod-to-Sev: Moderate to severe; Mx: maintenance only; NHANES: national health and nutrition examination Survey; NL: Netherlands; OCS: oral corticosteroid; o.d.: once daily; OPD: outpatient department; OR: odds ratio; OTC: over the counter; PBMCs: peripheral blood mononuclear cells; pMDI: pressurized metered-dose inhalers; PIF: peak inspiratory flow; ppb: parts per billion; PRD: proactive regular dosing; PROMs: patient reported outcome measures; RR: rate ratio; RWD: real world data; SABA: short-acting beta-agonists; SAE: serious adverse events; SAL: salmeterol; SARP-3: severe asthma research program; SAMA: short-acting muscarinic antagonists; Sev: severe; SD: standard deviation; SE: standard error; SCS: systemic corticosteroid; SGRQ: st. george's respiratory questionnaire SMART: single maintenance and reliever therapy; SOC: standard of care; TIO: tiotropium; UK: United Kingdom; UMEC: umeclidinium; VHC: valved holding chambers; vs: versus.

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NX-GBL-FVU-WCNT-220001 | Date of preparation: April 2023