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  • Exploring different composite definitions of responders to biologic treatment for severe asthma (FULL BEAM Response)

    The International Severe Asthma Registry  (ISAR) ’s new study, “ Exploring definitions and predictors of response to biologics for severe asthma ” , published in The Journal of Allergy and Clinical Immunology: In Practice (JACI: In Practice) , explores the effectiveness of biologic treatments in adults with severe asthma. Given the variability in asthma response based on differing definitions, this study focuses on identifying predictors of response and examining residual symptoms post-treatment.   Including data from 21 countries and 2,210 patients, this study evaluates what response to biologic therapy means in real-life, explores different definitions of response, and identifies patients most likely to achieve it. Response is defined based on changes in four asthma outcome domains over a one-year period before and after initiating biologic treatment. These domains included asthma attacks (exacerbation rate), long-term oral corticosteroid dose, asthma symptoms (control), and lung function, measured by Forced Expiratory Volume in the first second (FEV1).    The study brings to light that the concept of treatment response is intricately tied to baseline severity, affecting clinical outcomes. For instance, a patient experiencing a 50% reduction in exacerbation rate following biologic therapy might still have a high rate of exacerbations post-treatment, indicating significant residual symptoms. This raises important questions about defining treatment success and determining appropriate therapeutic targets, and it suggests that a nuanced approach is needed to set goals that account not only for relative improvements but also for achieving clinically meaningful reductions in symptom burden.   Characteristics that predicted response to biologic treatment depended upon asthma outcome included in the response definition. For example, lung function responders were more likely to have higher pre-biologic FeNO and BEC (inflammatory biomarkers), were older at asthma onset, and had a shorter duration of asthma. Long-term oral corticosteroid use (LTOCS), asthma control and lung function responders were more likely to have higher pre-biologic BEC and presence of Type 2 (inflammatory) diseases, like chronic rhinosinusitis, allergic rhinitis and nasal polyposis. Interestingly, some characteristics increased the odds for response in one area but were reduced in another (see figure 1), giving us new insight into the idea of ‘response’, its complexity, and how it may be influenced by numerous factors Figure 1. Summary of associations between selected pre-biologic characteristics and response to biologic for each single-domain responder definition Abbreviations : AD: atopic dermatitis; AR: allergic rhinitis; BEC: blood eosinophil count; BMI: body mass index; CRS: chronic rhinosinusitis; FeNO: fractional exhaled nitric oxide; LTOCS: long-term oral corticosteroid; NP: nasal polyps.  * Statistically significant (p<0.05) association  The study found that response rates varied widely depending on the outcome measured. For example, 80% of patients showed a reduction in asthma exacerbations, while only 10% met the criteria for improvement across all four improvement criteria, suggesting that biologic response should be assessed across multiple domains to capture the full impact on patient health. Additionally, although many patients responded to biologic treatments, they still experienced significant symptoms. For instance, nearly half of the patients who initially had uncontrolled asthma continued to struggle with asthma control even after biologic therapy. Long-term non-reversible lung damage might also limit response in some patients, highlighting the importance of early intervention for optimum outcomes in asthma management. These findings emphasize that assessing and predicting response in real life is complex and variable, much like asthma itself, and that response can be seen as a journey, particularly underlining the importance of lung function in assessment of outcomes.   The key takeaway? The importance of having a patient-centred approach to biologic response interpretation, and the potential benefits of using predictors of response, such as baseline severity and lung function evaluation, to estimate how likely each patient is to respond.   To learn more about the study, please read the full publication   in The Journal of Allergy and Clinical Immunology: In Practice (JACI: In Practice) , as well as the accompanying slide deck .

  • Biologics for asthma prevent new-onset diabetes, major adverse cardiovascular events (MACE) as well as other oral corticosteroid (OCS)-related adverse events: Ground-breaking results from SOLAR II

    The real-world SOLAR II study shows that biologic initiators had 18% lower risk of developing any oral corticosteroid (OCS)-related adverse outcome compared to non-initiators, primarily driven by the reduced risk of developing diabetes (by 38%), MACE (by 35%), and anxiety/depression (by 32%; Figure 1) 1 . The authors highlight that the magnitude of rate reduction was comparable to those shown by available disease-specific agents. For example, statins reduce cardiovascular disease risk by 25%, coronary heart disease by 27% and stroke by 22%; 2  metformin reduces the odds of developing diabetes mellitus by 35% among individuals with pre-diabetes versus control groups. 3  The effectiveness of biologics in preventing OCS-related adverse outcomes and potential associated cost savings indicate the need for timely biologic initiation in patients with severe asthma. The SOLAR II study, “ Prevention of cardiovascular and other systemic adverse outcomes in patients with asthma treated with biologics ”, was published today in the American Journal of Respiratory and Critical Care Medicine . 1   It was selected as one of the journal’s articles for oral presentation at the prestigious session ‘NEJM, AJRCCM, JAMA, Discussions on the Edge: Reports of Recently Published Pulmonary Research’  at the American Thoracic Society (ATS) 2025 International Conference. Figure 1. Association between biologic initiation and risk of OCS-related adverse outcomes (5-year censoring). Major cardiovascular event includes heart failure, myocardial infarction or cerebrovascular accident. Abbreviations: Bx = biologic; CI = confidence interval; HR = hazard ratio; OCS = oral corticosteroid; VTE = venous thromboembolism The SOLAR II study was a longitudinal cohort study using prospective data (2017-2024) from 16 countries of the International Severe Asthma Registry  (ISAR) specifically collecting a number of OCS-related adverse events and from the Optimum Patient Care Research Database  (OPCRD; UK). A total of 42,908 patients (8,432 from ISAR and 34,476 from OPCRD) were included. There was no overlap between datasets. SOLAR II is the first study to show that initiating biologics reduces the risk of new-onset OCS-related adverse outcomes in severe asthma. It follows on from the SOLAR I study, which shows that biologic initiation in patients with severe asthma led to substantial reduction in total OCS exposure over two years, versus usual care. 4  The findings of both SOLAR I and SOLAR II highlight the value of biologic therapy in not only reducing OCS exposure but also preventing new-onset diabetes, MACE and other OCS-related adverse outcomes in patients with severe asthma. To learn more about the study, please read the full publication   in the American Journal of Respiratory and Critical Care Medicine, as well as the accompanying slide deck . The late-breaking SOLAR II poster will be presented at ATS 2025 on Tuesday 20th May, 11:30am-1:15pm, at the session ‘Late breaking and lung shaking abstracts’, located at Area F, Hall F (North Building, Exhibition Level), Moscone Center . The SOLAR II study was conducted by the Observational and Pragmatic Research Institute  (OPRI) and was partially funded by Optimum Patient Care Global  (OPCG) and AstraZeneca. The International Severe Asthma Registry  (ISAR) is operated by OPCG and co-funded by OPCG and AstraZeneca. ISAR  is a global adult severe asthma registry that standardizes data collection across >34,000 patients from 32 countries, making it the largest source of real-life data for the study of severe asthma epidemiology, outcomes and clinical management. 5  Since its establishment in 2017, ISAR has undertaken 26 research projects with 30 publications and 63 abstracts to date. In addition to advancing severe asthma research, ISAR supports clinical care for severe asthma through its quality improvement initiatives. 6 OPCRD  is a primary care database containing the electronic health records of >25 million patients from >1000 general practices across the UK (covering ~35% of the UK population). It facilitates real-world collection of patient-level diagnostic, clinical and prescribing information. OPCRD data has been used in 100 studies, with the achievement of 121 publications. OCPRD regularly collaborates with other databases and registries on asthma research. It has partnered with ISAR on numerous severe asthma research studies, including SOLAR II. To learn more please visit our website: www.isar.opcglobal.org . References 1.       Sadatsafavi M, Tran T, Scelo G, et al. Prevention of cardiovascular and other systemic adverse outcomes in patients with asthma treated with biologics. Am J Respir Crit Care  Med. In press 2.       Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2013, Issue 1. Art. No.: CD004816 3.       Patel D, Ayesha IE, Monson NR, et al. The Effectiveness of Metformin in Diabetes Prevention: A Systematic Review and Meta-Analysis. Cureus 2023;15(9):e46108 4.       Chen W, Tran T, Emmanuel B, et al. Impact of biologic initiation on oral corticosteroids in the International Severe Asthma Registry and the Optimum Patient Care Research Database: a pooled analysis. Eur Respir J  2024 64(suppl 68): PA2175. Presented at ERS 2024 5.       Canonica GW, Alacqua M, Altraja A, et al. International Severe Asthma Registry Mission Statement. CHEST 2020;157(4):805-814 6.       Larenas-Linnemann D, Rhee CK, Altraja A, et al. International Severe Asthma Registry (ISAR): 2017-2024 Status and Progress Update. Tuberc Respir Dis 2025;88(2):193-215

  • Minimizing Steroid Burden in Severe Asthma: Real-World Data Demonstrate Biologics as a Game Changer

    Drawing on data from over 5,600 severe asthma patients across real-world specialist and primary care settings in 22 countries, the SOLAR I study led by Drs. David Price and Wenjia Chen, “ Impact of biologic initiation on oral corticosteroid use in the International Severe Asthma Registry and the Optimum Patient Care Research Database: a pooled analysis of real-world data ”, was recently published in JACI: In Practice . The study showed that biologic initiation delivered substantial reductions in oral corticosteroid (OCS) use, a key challenge in severe asthma management due to the risks of cumulative steroid exposure. The SOLAR I study found that compared to non-biologic-initiators, patients with severe asthma who initiated biologics experienced earlier and substantially greater total OCS reductions, with more than twice the likelihood of reducing OCS daily dose by >75%, or complete cessation, in the first year (Figures 1 and 2). A jackknife sensitivity analysis further strengthened the robustness of the results, by showing consistent biologic initiation-associated OCS reductions across 23 settings in 22 unique countries. These findings highlight the need for rigorous, personalized OCS tapering strategies in real-world settings, and early biologic intervention with rigorous first-year monitoring. Figure 1. Association of biologic initiation on daily total OCS in the first and second year among patients with severe asthma for low dose and zero dose outcome. Abbreviations: Bx = biologic; CI = confidence interval; OR = odds ratio; Pr = probability. Figure 2. Association of biologic initiation on daily total OCS in the first and second year among patients with severe asthma for optimal reduction result. Abbreviations: Bx = biologic; CI = confidence interval; OR = odds ratio; Pr = probability. Optimal reduction: ≥75% reduction in total OCS daily dose from baseline (12 months prior to index date) to first or second year of follow-up. Following on from SOLAR I, the SOLAR II study showed that biologic initiators had 18% lower risk of developing any OCS-related adverse outcome compared to non-initiators, primarily driven by the reduced risk of developing diabetes (by 38%), major cardiovascular event (by 35%), and anxiety/depression (by 32%) ( Sadatsafavi M et al. Am J Respir Crit Care Med  2025 ). The findings of SOLAR I and II highlight the value of biologic therapy in minimizing steroid burden and preventing OCS-related adverse outcomes in patients with severe asthma. Read the full article of the SOLAR I study in JACI: In Practice  ( Full Publication  / Slide Deck ). Read the full article of the SOLAR II study in Am J Respir Crit Care Med  ( Full Publication  / Slide Deck ). Acknowledgement: This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was funded by AstraZeneca Ltd with in-kind contribution from Optimum Patient Care Global (OPCG). The study uses data from the International Severe Asthma Registry (ISAR), which is co-funded by OPCG and AstraZeneca. About OPRI     The Observational and Pragmatic Research Institute (OPRI) is an internationally recognized independent research organization dedicated to providing real-world evidence that supports best practices in chronic disease management in primary care. Learn more at  https://www.opri.org.uk/ . For media inquiries and additional information, please contact  https://www.opri.org.uk/contact .     About ISAR   The International Severe Asthma Registry (ISAR) is the first global adult severe asthma registry, providing a rich, standardized dataset to advance research, clinical practice, and policy in severe asthma care. Since its establishment in 2017, ISAR has recruited >34,000 patients from 30 countries, and undertaken 26 research projects with 30 publications and 63 abstracts. ISAR fosters international collaboration to improve outcomes for patients worldwide. It is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca. Learn more at  https://www.isar.opcglobal.org .    About OPCRD   The Optimum Patient Care Research Database (OPCRD) is a high-quality, longitudinal primary care database containing the electronic health records of >25 million patients from >1000 general practices across the UK. It facilitates real-world collection of patient-level diagnostic, clinical and prescribing information. Its data has been used in 100 studies, with the achievement of 121 publications. OCPRD collaborates with other databases and registries (including ISAR) on asthma research. Learn more at  https://opcrd.optimumpatientcare.org .

  • PREVAIL Trial Protocol: Early Intervention in Modifiable High-Risk COPD

    Our latest manuscript in the Journal of the COPD Foundation  describes the protocol for PREVAIL , the first clinical trial to test whether much earlier intervention in patients at high-risk of COPD flare-ups reduces respiratory and cardiac events. PREVAIL will evaluate the effectiveness of a novel quality improvement program ( CONQUEST ) that encourages the uptake of evidence and guideline-based strategies for the diagnosis and management of patients with modifiable high-risk COPD. PREVAIL is currently being conducted in primary care settings in both the UK and US. In each country, patients with diagnosed, or potential undiagnosed COPD will be identified, who are at high risk of future respiratory and cardiac events and are not receiving optimal management in accordance with guidelines. These patients are described as ‘modifiable high-risk' . Once identified, healthcare professionals receive clinical decision support, as part of the CONQUEST quality improvement program, to help them optimize the management of these patients. PREVAIL will assess patient health outcomes over an average of two years, comparing results between primary care sites that did and did not receive the CONQUEST program, to determine whether the CONQUEST program is effective. If found to be beneficial, the CONQUEST program could offer a scalable approach to improving the long-term health of people with modifiable high-risk COPD and provide learnings to healthcare professionals. Read the full protocol manuscript here: “ Pragmatic Evaluation of an Improvement Program for People Living with Modifiable High-Risk COPD versus Usual Care: Protocols for the Cluster Randomized PREVAIL Trial ” To learn more about the PREVAIL trial and the CONQUEST program, visit our websites: https://www.opri.sg/prevail   https://www.opcglobal.org/conquest The PREVAIL clinical trials are run by the Observational and Pragmatic Research International Limited (OPRI) . This research and the development of the CONQUEST program is co-funded by Optimum Patient Care Global Limited  and AstraZeneca .

  • International research collaboration affirms benefits of biologic therapies across broad severe asthma patient populations worldwide, but also highlights unmet treatment needs: Results from LUMINANT

    Singapore, [25 June 2024] – A new analysis of data from the International Severe Asthma Registry (ISAR) has revealed a spectrum of responsiveness among real-world patients with severe asthma who initiated biologic asthma therapies, most of whom were ineligible to participate in randomized controlled trials. Although many biologic initiators responded well, with higher proportions achieving super-responses than responses, around 40–50% did not meet the response criteria (Figure 1). The study, " Real-world biologics response and super-response in the International Severe Asthma Registry cohort (LUMINANT)" , was conducted by the Observational and Pragmatic Research Institute (OPRI), partially funded by Optimum Patient Care Global Ltd. and AstraZeneca, and is published in Allergy (European Journal of Allergy and Clinical Immunology) . [1]   Figure 1. Proportions of super-responders, responders, and non-responders across single domains among patients who did or did not initiate a biologic asthma therapy Abbreviation: FEV 1 , Forced expiratory volume in 1 second.   “Until now, there have been limited data on the outcomes of biologic asthma therapies outside of selected randomized controlled trial cohorts”, said Professor David Price, corresponding author, and Director of OPRI. “The LUMINANT study gives new insights affirming the effectiveness of biologic asthma therapies in the broader real-world severe asthma population, which is much more heterogenous. However, unmet treatment needs clearly remain, as half of the patients who initiated biologic therapies responded sub-optimally.”   ISAR Includes electronic medical records from 20,000 patients with severe asthma in 28 countries worldwide. This study grouped 8446 eligible adults with ≥24 weeks of follow-up into those who did or did not initiate biologic asthma therapies, and examined their treatment responses across four single outcome domains: forced expiratory volume in 1 second (FEV 1 ) increase by ≥100 mL, improved asthma control, annualized exacerbation rate reduction ≥50%, and any reduction in use of long-term oral corticosteroids (LTOCS). The corresponding criteria defining super-responses were: FEV 1 increase by ≥500 mL, new well-controlled asthma, no exacerbations, and LTOCS cessation or tapering to ≤5 mg/day.   Only 5.3% of patients in this study met standard randomized controlled trial inclusion criteria. Proportionally more biologic initiators had super-responses than responses (except for FEV 1 ) and responses/super-responses were more frequent in biologic initiators than in non-initiators; nevertheless, ~40–50% of initiators did not meet response criteria (Figure 1).   “It is encouraging to affirm that biologic therapies can improve outcomes for many patients with severe asthma in real-world settings”, said the lead investigator Professor Eve Denton. “However, there were no complete responses to the biologics used in these patients,  highlighting persisting unmet treatment needs. Our findings justify research to determine whether initiating biologics earlier may increase the likelihood of achieving a treatment response.”   To learn more about the study, please read the full publication  in Allergy  (Official journal of the European Academy of Allergy and Clinical Immunology), as well as the accompanying slide deck .   The Observational and Pragmatic Research Institute (OPRI) is an independent, internationally recognised research organisation which conducts studies that provide real-world evidence to support best practices for chronic disease management in primary care and make a difference to patients. https://www.opri.org.uk/   The International Severe Asthma Registry (ISAR) is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca.   To learn more please visit our website: www.isar.opcglobal.org .   Reference 1.   Denton E, Hew M, Peters MJ, Upham JW, Bulathsinhala L, Tran TN, et al. Real-world biologics response and super-response in the International Severe Asthma Registry cohort. Allergy 2024:  http://doi.org/10.1111/all.16178

  • Global disease burden of patients with severe asthma, regardless of biologic accessibility and receipt of biologic treatment: Results from EVEREST

    The EVEREST study published in the Journal of Asthma and Allergy , “Disease Burden and Access to Biologic Therapy in Patients with Severe Asthma, 2017–2022: An Analysis of the International Severe Asthma Registry” , has shed light on the significant global disease burden faced by patients suffering from severe asthma, including those without access to biologic therapies, those who were eligible but did not receive these treatments, and T2-targeted biologic recipients. The findings underscore the urgent need for improved healthcare resource utilization, increased access to biologics, and ongoing research on new treatment options to address the unmet needs of patients with severe asthma. Approximately 55% of patients who lacked access to biologics and 71% of patients who had access but did not receive biologics had uncontrolled asthma (Figure 1). Among T2-targeted biologic recipients, approximately one-third still had uncontrolled asthma and one-fifth experienced ≥2 exacerbations in the 12 months post-biologic initiation (Figure 2). Two-thirds of T2-targeted biologic recipients had asthma that remained suboptimally controlled despite biologic treatment. Figure 1. Proportions of patients with severe asthma who experienced ≥2 exacerbations, had uncontrolled asthma and received LTOCS during the 12 months before the index date. (The index date was the first visit recorded in ISAR with measurements meeting the group eligibility criteria; for biologic users, the index date was the ISAR visit that is closest to the date on first biologic.) Abbreviations: ISAR = International Severe Asthma Registry; LTOCS = Long-term oral corticosteroids Figure 2 . Proportions of patients with severe asthma who experienced ≥2 exacerbations, had uncontrolled asthma and received LTOCS in the 12 months post-biologic initiation.  (The index date was the first visit recorded in ISAR with measurements meeting the group eligibility criteria; for biologic users, the index date was the ISAR visit that is closest to the date on first biologic. For the subgroup of biologic recipients whose asthma remained suboptimally controlled, the index date was the date of the third dose of biologic treatment; among those who switched or stopped biologics, the index date was the ISAR visit closest to the date on first biologic.) Abbreviations: ISAR = International Severe Asthma Registry; LTOCS = Long-term oral corticosteroids The EVEREST study was a historical cohort study of patients enrolled in the International Severe Asthma Registry (ISAR), using data prospectively collected between December 2017 and May 2022. 9587 patients with severe asthma from 21 countries were included. The EVEREST study highlights the substantial challenges experienced by patients who are either denied access to biologics or who, despite being eligible, do not receive these advanced therapies. The research indicates that both groups endure a high disease burden; however, the specific outcomes and healthcare experiences differ significantly between them. Additionally, two-thirds of T2-targeted biologic recipients had a suboptimal response to their prescribed therapies, highlighting the importance of ongoing research and development of more effective therapy options for patients with severe asthma. The EVEREST findings call for collaborative efforts among healthcare providers, policymakers, and researchers to develop strategies that improve and standardize access to biologic therapies, optimize the allocation of resources, and enhance treatment pathways to ultimately reduce the disease burden associated with severe asthma. To learn more about the study, please read the full publication  in the Journal of Asthma and Allergy , as well as the accompanying slide deck .  The EVEREST study was funded by AstraZeneca. The International Severe Asthma Registry (ISAR) is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca. To learn more please visit our website: www.isar.opcglobal.org .

  • Switching or stopping biologic therapy was associated with worse clinical outcomes than continuing the initial therapy: Results from CLEAR

    A recently published study in Pragmatic and Observational Research , “ Real-world biologic use patterns in severe asthma, 2015–2021: the CLEAR study ”, shows that biologic initiation was associated with improved clinical outcomes compared with non-initiation. Among biologic initiators, switching or stopping biologic therapy was associated with worse clinical outcomes than continuing the initial therapy; however, there remained a need for improvements in outcomes among continuers. These findings call for collaborative efforts among policymakers, clinicians and researchers to increase access to biologic therapies and initiate biologic therapy earlier in eligible patients. As the biologics in this study target immunoglobulin E (omalizumab), interleukin (IL)-4/IL-13 (dupilumab) or IL-5 signalling (mepolizumab, reslizumab or benralizumab), ongoing research on how to predict patient response to these biologics is needed to inform clinical decision-making on selecting the ‘right’ initial biologic for the ‘right’ patient, to reduce the need for switching or stopping. Additionally, further research on new biologic therapies (e.g., the anti-thymic stromal lymphopoietin biologic tezepelumab) that have less restrictive eligibility criteria would be of value. Biologic initiators had fewer exacerbations, were less likely to have uncontrolled asthma and had a greater reduction in daily long-term oral corticosteroid (LTOCS) dose than non-initiators during the follow-up period. Approximately 54.1% of initiators and 66.5% of non-initiators experienced ≥1 exacerbations (annualized count; Figure 1A); 35.6% of initiators and 41.0% of non-initiators had uncontrolled asthma at last assessment (Figure 1B). Initiators had a greater reduction in daily LTOCS dose than non-initiators (adjusted β: −2.73 mg [95% CI: −4.77, −0.68]). Figure 1. Exacerbations (A) and asthma control (B) during the follow-up period among biologic initiators and non-initiators after IPTW. Outcomes were assessed at follow-up (after biologic initiation for initiators) using the closest available data to 12 months after the index date. The index date was the date of biologic initiation for initiators and ISAR enrolment for non-initiators. Abbreviations: IPTW = Inverse probability of treatment weighting; ISAR = International Severe Asthma Registry After biologic initiation, continuers had fewer exacerbations, were less likely to have uncontrolled asthma and had a greater reduction in daily LTOCS dose than switchers or stoppers at follow-up. The proportion of patients who experienced ≥1 exacerbations was 52.7% for continuers, 84.0% for switchers and 61.4% for stoppers (Figure 2A). The proportion of patients with uncontrolled asthma at last assessment was 33.3% for continuers, 67.1% for switchers and 50.1% for stoppers (Figure 2B). The reduction in daily LTOCS dose was smaller for switchers and stoppers than for continuers (adjusted β: 3.77 mg [95% CI: 1.71, 4.37] and 3.09 mg [95% CI: −0.27, 6.45] for switchers and stoppers, respectively, versus continuers). Nevertheless, it should be noted that among continuers, >50% had ≥1 exacerbation (Figure 2A) and one-third had uncontrolled asthma (Figure 2B). Figure 2. Exacerbations (A) and asthma control (B) during the follow-up period among biologic continuers, switchers and stoppers after IPTW. Outcomes were assessed at follow-up (after biologic initiation for initiators) using the closest available data to 12 months after the index date. The index date was the date of biologic initiation for initiators and ISAR enrolment for non-initiators. Abbreviations: IPTW = Inverse probability of treatment weighting; ISAR = International Severe Asthma Registry The CLEAR study was a multicentre, observational study of patients enrolled in the International Severe Asthma Registry (ISAR), using data collected between December 2015 and August 2021. 3,404 patients with severe asthma from 23 countries were included. To learn more about the study, please read the full publication   in Pragmatic and Observational Research , as well as the accompanying slide deck . The CLEAR study was funded by AstraZeneca. The International Severe Asthma Registry  (ISAR) is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca. To learn more please visit our website: www.isar.opcglobal.org .

  • A recent study shows a surprising improvement in respiratory outcomes when patients with asthma receive weight loss drugs.

    Singapore, [10 April 2025] – A large real world evidence study conducted by leading respiratory experts found patients with asthma who received Glucagon-like peptide1 receptor-agonists (GLP1-RAs) had reduced in emergency hospitalisations, antibiotic use and need for respiratory medication compared to a matched patient population.  The study, titled "The real-world impact of Glucagon-like peptide 1 receptor agonists on asthma control in people with high-risk asthma and obesity" shows that as well as the expected increase in weight loss patients with asthma also had improved asthma control.  This research was conducted using a large UK patient database of over 28 million patients and has just been published in this month’s issue of the medical journal Advances in Therapy .  The analysis identified 10,111 GLP1-RA exposed people and 50,555 unexposed controls. The exposed cohort had higher BMI and more uncontrolled asthma measured using two composite measures of asthma outcomes (Risk Domain Asthma Control (RDAC) and Overall Asthma Control (OAC)). Following the prescribing of the weight loss drug the exposed cohort lost more weight and had improved asthma control for both RDAC (Odds ratio 2.11 95% CI 1.90 to 2.36) and OAC (OR 2.10, 95%CI 1.81 to 2.45) scores.  GLP1-RA drugs appear to improve asthma control for people with obesity.    Professor Alan Kaplan, Medical director of LHIN Pulmonary Rehabilitation clinics in Ontario, Canada and the Observational and Pragmatic Research Institute, concluded, "Our findings suggest that GLP1-RAs have benefits on asthma control in people with obesity, and this information should contribute to the discussions around the decision to use these drugs."  Learn More   Read the full publication , ‘The Real-World Impact of Glucagon-Like Peptide 1 Receptor Agonists on Asthma Control in People with High-Risk Asthma and Obesity’, in the April 2025 issue of Advances in Therapy .  This study was funded and conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd.   About OPRI   The Observational and Pragmatic Research Institute (OPRI) is an internationally recognized independent research organization dedicated to providing real-world evidence that supports best practices in chronic disease management in primary care. Learn more at https://www.opri.org.uk/ . For media inquiries and additional information, please contact https://www.opri.org.uk/contact .

  • Innovative analysis predicts steroid-related health risks for people with asthma

    Singapore, [8 April 2025] – Groundbreaking research by the Observational and Pragmatic Research Institute (OPRI) has developed innovative models to predict individual patients’ risks of developing common health problems related to oral corticosteroid (OCS) treatment for asthma.    The study applied advanced statistical techniques to analyse longitudinal electronic medical records (EMR) from nearly 250,000 patients in the Optimum Patient Care Research Database (OPCRD) . The resulting models incorporated OCS prescriptions and onset of medical conditions, together with evidence on risk factors for common morbidities associated with OCS exposure, to predict the future risk of OCS adverse outcomes based on a patient’s unique risk factors and projected OCS use (Figure 1).   Figure 1. Risk of post-menopausal osteoporosis   Mean annual OCS prescriptions were categorized as none, low (<2/year), or high (≥2/year). Cox proportional hazard models for a hypothetical patient were input to survival analyses where only OCS prescriptions varied: unchanged (none to none, low to low, high to high); 1 category increase (none to low, low to high); 1 category decrease (high to low, low to none) – with all other variables held constant. Survival estimates were plotted to give the predicted incidence curve.  In these models, the risks of type 2 diabetes, hypertension, pneumonia, osteoporosis and 12 other OCS-related adverse outcomes significantly increased with projected categoric OCS use. For example, hazard ratios for a one-category increment were 1.55 for type 2 diabetes, 1.56 for post-menopausal osteoporosis, 1.05 for hypertension, and 1.67 for pneumonia (all p < 0.001).    “These real-world, data-driven insights empower clinicians to make informed decisions about reducing OCS use where possible, tailoring treatment to mitigate health risks for individual patients,”  said lead investigator Dr Brooklyn Stanley.    This first tool to assess individualised risk for multiple steroid-related conditions, offers clinicians a new decision-making aid that can be integrated with routine consultations to proactively identify patients at increased risk for future OCS-related morbidities, so that timely interventions can be initiated and OCS exposure minimized, consistent with current best practice in asthma management.    “This study clearly demonstrates the utility of EMR data for predictive analysis,”  said OPRI Director Professor David Price, “these new algorithms can be used to develop a web-based risk calculator that is compatible with EMRs and quality improvement tools internationally.”     Importantly, these real-world primary care EMR data showed that, once started, OCS prescription usually continued long-term; this highlights the unmet need to minimise OCS use, for example, by initiating steroid-sparing or biologic therapies earlier in the asthma treatment pathway. Although barriers such as cost and accessibility remain, this study underscores the potential benefit of shifting from OCS overuse toward precision asthma medicines.    "This research is another important step toward precision medicine in asthma care and underscores the importance of adopting steroid-sparing treatment options,”  said Soram Patel, AstraZeneca Senior Global Medical Affairs Leader.  “ By helping clinicians assess individual patient risks, we can significantly reduce avoidable long-term health risks associated with over-reliance on OCS."     Learn More   Read the full publication , ‘Predicting Risk of Morbidities Associated with Oral Corticosteroid Prescription for Asthma’, in the March 2025 issue of Pragmatic and Observational Research.   This research project was partly funded by AstraZeneca and the Observational and Pragmatic Research Institute.    About OPRI   The Observational and Pragmatic Research Institute (OPRI) is an internationally recognized independent research organization dedicated to providing real-world evidence that supports best practices in chronic disease management in primary care. Learn more at https://www.opri.org.uk/ . For media inquiries and additional information, please contact https://www.opri.org.uk/contact .

  • Ground-breaking new study from ISAR uncovers the power of asthma tests BEC and FeNO to predict effectiveness of biologic therapies in Severe Asthma

    A new real-world research study from ISAR, the International Severe Asthma Registry , reveals the strength of the asthma tests (biomarkers) BEC (Blood Eosinophil Count) and FeNO (Fractional exhaled Nitric Oxide) in predicting which severe asthma patients will benefit the most from treatment with biologics, driving critical progress in delivery of targeted, precision medicine in asthma care. The study, published in Frontiers in Immunology   and entitled “ Association between pre-biologic T2-biomarker combinations and response to biologics in patients with severe asthma " utilises data across 23 countries and 3,751 patients. Crucially, the results indicated BEC and FeNO levels were strongly linked to the magnitude of lung function improvement following commencement of biologic therapy (specifically anti-IL5/5R [Anti-Interleukin 5/5R] or anti-IgE, [Anti-Immunoglobulin E]). Patients with the highest baseline (prior to biologic treatment) levels of the biomarkers achieved average improvements of 200 mL in the lung function result FEV1 (Forced Expiratory volume in one second), compared to patients with the lowest levels who achieved less than a third of the average improvement in FEV1 (Figure 1). Figure 1 : Association between improvement in lung function and highest pre-biologic Blood Eosinophil Count. Anti IgE: Anti-Immunoglobulin E, Anti-IL-5/5R: Anti-Interleukin 5/5R, Anti-IL4Rα: Anti-Interleukin 4α, BEC: Blood Eosinophil Count, FEV1: Forced Expiratory volume in one second.   In addition, the findings highlight a clear link between improvement in asthma symptoms and BEC for patients receiving the biologic therapy anti-IL5/5R. Following the treatment, the likelihood of having uncontrolled asthma symptoms among those with high BEC levels was almost half that of those with low pre-biologic BEC. Notably, pre-biologic biomarkers were not found to be strongly linked to extent of reduction specifically to asthma attacks before and after biologic treatment, with most patients having clear improvements in asthma attack frequency with biologic therapy regardless of drug type or biomarker levels. Professor David Price, a lead researcher and corresponding author, comments “Our study advances understanding of the associations between biomarkers and asthma outcomes, offering results which can be harnessed as tools in selection of the most effective treatments for individual patients, and driving positive change in asthma care”. Conducting the study through ISAR offered a unique opportunity to study the connections between biomarkers and asthma outcomes following biologic therapy in a large group of severe asthma patients in real-world practice. Patients in the study had a high burden of disease prior to commencing biologics, with almost 70% having uncontrolled asthma symptoms, underscoring the urgency for change. This study brings to light new possibilities in targeting of asthma therapy and, moreover, emphasises the potential for earlier intervention and prevention of lung function decline in asthma patients.   To learn more about the study, please read the full publication  in Frontiers in Immunology, as well as the accompanying slide deck . About ISAR The International Severe Asthma Registry is a global collaborative initiative to gather anonymous, longitudinal, real-life data for patients with severe asthma. ISAR offers a rich source of real-life data for scientific research to understand and improve symptoms, treatments, and patient outcomes for severe asthma. To learn more please visit our website: www.isar.opcglobal.org .

  • New ISAR Research Sheds Light on Asthma Exacerbation Rates: Great Variability Found Across Nations

    The International Severe Asthma Registry  is a global collaborative initiative to gather anonymous, longitudinal, real-life data for patients with severe asthma. ISAR offers a rich source of real-life data for scientific research to understand and improve symptoms, treatments, and patient outcomes for severe asthma. The latest breakthrough research from the ISAR, as detailed in the recent publication in Chest , has unveiled an interesting landscape of variability in severe asthma exacerbation rates across diverse countries. Led by a diverse team of researchers, including Dr. Tae Yoon Lee and senior authors Prof. Wenjia Chen and Prof. Mohsen Sadatsafavi, this multinational study meticulously analysed data from biologic-naïve patients across 17 countries participating in ISAR, with a specific focus on asthma exacerbation rates and their inherent between-country variations. The findings showed that individuals sharing similar patient characteristics, yet coming from different countries, had greatly varied rates of severe exacerbation. ranging between 0.04 in Argentina to 0.88 in Saudi Arabia (interquartile range: 0.13–0.54). Remarkably, these variations persist even after rigorous adjustments for patient- and disease characteristics and sampling variability (interquartile range: 0.16–0.39). These findings highlight the presence of unidentified patient-specific factors and/or systemic intricacies contributing to the observed variations. It is imperative that disease management guidelines acknowledge and address such between-country variability. To optimize treatment strategies effectively, there is a pressing need for the development of risk prediction models calibrated specifically for each jurisdiction. To learn more about the study, please read the full paper in Chest , as well as the accompanying slide deck . Acknowledgement: This research project is supported by the Ministry of Education, Singapore, under the Academic Research Fund Tier 1 (FY2022—2025).

  • Thirty-year trends analysis reveals continuous overuse of systemic glucocorticoids to treat patients with asthma in the United Kingdom

    Singapore, [19 April 2024] – Analysis of data from the Optimum Patient Care Research Database (OPCRD) has shown high rates of systemic glucocorticoid (SGC) prescription for asthma in the United Kingdom (UK), which have persisted despite the availability of alternative steroid-sparing strategies and treatments.   The study, Trends in Systemic Glucocorticoid Utilization in the United Kingdom from 1990 to 2019: A Population-Based, Serial Cross-Sectional Analysis , was conducted by the Observational and Pragmatic Research Institute (OPRI), co-funded by AstraZeneca, and is published in the March issue of Pragmatic and Observational Research . (1) Relative contribution of conditions of interest (a)  to total SGC dose per year Abbreviations: COPD, chronic obstructive pulmonary disease; SGC, systemic glucocorticoid; SLE, systemic lupus erythematosus. (a) Other category includes: ankylosing spondylitis, myasthenia gravis, sarcoidosis, uveitis, autoimmune bullous, eczema, nephrotic syndrome, scleritis, vasculitis, autoimmune hepatitis, gout, polymyalgia, Sjogren’s syndrome, Bell’s palsy, iritis, psoriasis, carditis, multiple sclerosis, psoriatic arthropy, and temporal arteritis.   “These are concerning findings”, said Professor David Price, corresponding author, and Director of OPRI. “The numbers of patients with asthma and COPD in the UK are increasing and any SGC exposure, even occasional short-term use, increases patients’ risk of diabetes, osteoporosis, cardiovascular diseases and other health conditions – even death.”   The OPCRD holds electronic medical records from >20 million patients from >1000 UK general practices. For each year from 1990 to 2019, OPRI researchers determined SGC exposure among patients aged 5 years and above who had asthma, COPD, nasal polyps, Crohn’s disease, rheumatoid arthritis, ulcerative colitis, or systemic lupus erythematosus. Asthma was consistently the greatest contributor to SGC utilization; asthma and COPD accounted for more than two-thirds of UK patients prescribed SGCs every year since 1990. The data showed declines in SGC prescriptions for Crohn’s disease, ulcerative colitis, and rheumatoid arthritis since the introduction of biologic therapies, as well as for severe asthma; however, SGC prescriptions for non-severe asthma and for COPD increased. The relative contribution of COPD to the OCS burden approximately doubled over time, while no biologic therapies for COPD were approved during the observation period.   “These results highlight urgent needs to raise awareness about the adverse consequences of SGC use and to adopt alternative steroid-sparing strategies and treatments that can reduce this largely avoidable burden”, said Professor Price.   To learn more about the study, please read the full publication  in the Pragmatic and Observational Research as well as the accompanying slide deck below. The Observational and Pragmatic Research Institute (OPRI) is an independent, internationally recognised research organisation which conducts studies that provide real-world evidence to support best practices for chronic disease management in primary care and make a difference to patients. https://www.opri.org.uk/   For media inquiries and additional information, please contact https://www.opri.org.uk/contact   Reference (1) Menzies-Gow AN, Tran TN, Stanley B, Carter VA, Smolen JS, Bourdin A, Fitzgerald JM, Raine T, Chapaneri J, Emmanuel B, Jackson DJ, Price DB. Trends in Systemic Glucocorticoid Utilization in the United Kingdom from 1990 to 2019: A Population-Based, Serial Cross-Sectional Analysis. Pragmat Obs Res . 2024;15:53-64. https://doi.org/10.2147/POR.S442959

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