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- Beyond RCTs: Real-World Data Reveals Common Downstream Pathways to Severe Asthma Exacerbations
Pathways that predict severe asthma attacks (exacerbations) were found to be similar, with matching strength of prediction, in both clinical trials (Randomised Controlled Trials, RCTs) and real-world data (RWD) settings in the new International Severe Asthma Registry (ISAR) study “ Interactive Pathways of Key Prognostic Factors in Severe Asthma: A Bayesian Network Comparison of Clinical Trials & Real-World Data ” . Recently published in CHEST , this study performed a novel Bayesian Network (BN) analysis that integrated machine learning with expert knowledge to map how factors interact to influence exacerbation risk, addressing the important question of whether these factors may differ between RCTs and RWD settings. The RCT cohort included 345 adult patients from the placebo arms of two large international clinical trials. The real-world cohort comprised 6,814 adults not on specialist biologic therapies enrolled in ISAR. Both cohorts focused on patients with severe asthma, with a primary outcome of occurrence of severe asthma exacerbations during a 365-day follow-up period. In both RCT and RWD settings, two clear pathways to exacerbations were found (Figure 1). Firstly, the blood marker (biomarker) Immunoglobulin E (IgE) influenced the biomarker BEC (Blood Eosinophil Count) to predict severe exacerbations. Secondly, history of severe exacerbation directly predicted future severe exacerbations. Understanding the impact of these factors can provide critical support to decision making in clinical care, shaping patient outcomes. Figure 1: Final Bayesian Networks learned under RCTs (A) and ISAR (B) settings OCS: Oral Corticosteroids, BEC: Blood Eosinophil Count, IgE: Immunoglobulin E, FEV1: Forced Expiratory Volume 1 second, FVC: Forced Vital Capacity Factors leading to these key predictors were more complex in the ISAR cohort than in the RCT population, reflecting the broader range of patient characteristics and clinical management in routine care. Importantly, these richer interactions highlight additional opportunities for reducing exacerbation risk in RWD settings, targeting clinical and biological pathways that are less visible in RCT environments. How can this study impact care in severe asthma? Dr. Wenjia Chen, Assistant Professor of Public Health and a leading author of the study, concludes “These findings suggest that RWD does not contradict RCT evidence; rather, it extends the evidence by confirming core mechanisms while also revealing additional upstream pathways that shape risk in real-world patients. Combining both data sources may support more personalized and adaptable risk prediction and management strategies for severe asthma patients”. To learn more about the study, please read the full publication in CHEST, as well as the accompanying slide deck . Acknowledgement : This work was supported by the Singapore National Medical Research Council – Open Fund – Young Individual Research Grant (MOH-001337-00), the International Severe Asthma Registry ( ISAR) Expert Panel and the Observational and Pragmatic Research Institute (OPRI). ISAR is operated by Optimum Patient Care Global (OPCG) and co-funded by OPCG and AstraZeneca. We thank all investigators, collaborators, and patients who contributed to this research. 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. It fosters international collaboration to improve outcomes for patients worldwide. ISAR is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca. Learn more at https://www.isar.opcglobal.org .
- Mexico vs Global Severe Asthma Study Shows Steroid Reduction Benefits and Need for Targeted Treatments
Long-term oral corticosteroid (LTOCS) use has been found to be lower in Mexican patients than globally and may be associated with impact to critical health outcomes, with potentially oral corticosteroid-related diseases found to be less common in Mexican patients. These findings are reported in the real-world study, “ Severe asthma patients’ characteristics in Mexico versus International Severe Asthma Registry (ISAR) Global ” , recently published in Current Allergy and Asthma Reports . The study compares characteristics of ISAR Mexican patients (n=438) with those of the global ISAR population (n=17,567), with characteristics analysed at the point of initiation of specialist biologic therapies, or at first assessment following enrolment to the registry for those not initiated on biologics . ISAR is a global adult severe asthma registry that collects data from over 37,000 patients across 32 countries. It was established in 2017 by a group of international severe asthma experts in collaboration with Optimum Patient Care Global (OPCG) and AstraZeneca. Further to these results and of particular significance, treatment with specialist biologic therapy was higher in Mexico at 79% compared to under 50% for the global severe asthma population. Mexican patients were additionally found to have had better lung function than patients in the global comparison. While many positive patient outcomes are being achieved in this population, the study also highlights key unmet needs and the potential to drive further change. Though reduced exposure to long-term oral corticosteroids may have lessened corticosteroid-related diseases for Mexican patients, this change may also be linked to having more asthma attacks (exacerbations), worse asthma control, and greater short-term corticosteroid use than the global population (Figure 1). The study also found more Mexican patients had positive allergy tests, at ~80% vs ~67% globally, and subsequently, Type 2 (T2) comorbidities (those linked to allergy and eosinophils) were more common and numerous in Mexican patients (Figure 2). However, the characteristics described (particularly allergic tendency, number of exacerbations and reduced steroid-related health problems) are noted by the authors to increase the likelihood of response to biologic therapy, highlighting the potential impact of escalation in treatment pathways for this population. Importantly, since poorer asthma control and greater exacerbations impact rates of remission in asthma, earlier intervention may also be critical to achieving change. How do the findings of this study impact clinical practice, and what are the next steps to enable improvement to patient care? Lead author of the study, Dr Désirée Larenas-Linnemann, Allergist and Pediatrician, concludes “Reducing the rate of severe asthma exacerbations and improving asthma control should be key goals in Mexican severe asthma patients, be it with enhanced inhaled therapy or, if these goals are not reached within a reasonable time with inhalers, through prompt initiation of biologics”. To learn more about this study on patient characteristics of ISAR Mexico versus the ISAR global population, please read the full publication in Current Allergy and Asthma Reports, as well as the accompanying slide deck . To learn more about the ISAR global study of comorbidities (PRISM I), please read the full publication and press release . Figure 1: Comparison of clinical characteristics (the four domains of remission) between ISAR Mexican patients and the global ISAR population. = p<0.05; ** = p<0.001 Abbreviations: CS = corticosteroids; FEV1 = Forced Expiratory Volume in one second; Mex = Mexican patients; NS = not significant Figure 2: Frequency of allergic (A) and oral corticosteroid-related (B) comorbidities in ISAR Mexico versus ISAR Global patients. = p<0.05; * = p<0.01; *** = p<0.001; NS = not significant ISAR is conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was co-funded by Optimum Patient Care Global (OPCG) and AstraZeneca Ltd. ISAR is operated by OPCG and 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 >37,000 patients from 32 countries, and achieved 40 publications. ISAR fosters international collaboration to improve outcomes for patients worldwide. Learn more at https://www.isar.opcglobal.org . References 1. Larenas-Linnemann D et al. Current Allergy and Asthma Reports , (2026) 26:25. https://doi.org/10.1007/s11882-026-01264-7 2. Scelo G, Torres-Duque CA, Maspero J, et al. Analysis of comorbidities and multimorbidity in adult patients in the International Severe Asthma Registry (PRISM I). Ann Allergy Asthma Immunol 2024;132(1):42-53. https://doi.org/10.1164/rccm.202305-0808OC
- Real-World Study Led by Observational and Pragmatic Research Institute Suggests GLP-1 Receptor Agonists May Reduce COPD Exacerbation Risk in Patients with Type 2 Diabetes
An international real-world study coordinated by the Observational and Pragmatic Research Institute (OPRI) suggests that glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may be associated with fewer exacerbations and reduced corticosteroid use in patients living with chronic obstructive pulmonary disease (COPD) and type 2 diabetes (T2D). The findings, published in Pragmatic and Observational Research , are based on data from a large UK primary care population. COPD and T2D frequently coexist and contribute to a high burden of morbidity and healthcare utilisation. Although GLP-1 RAs are primarily used for metabolic control [JT1] , growing evidence indicates they may also influence respiratory outcomes. In this retrospective matched cohort study including 4,479 patients initiating GLP-1 RA therapy and matched controls, treatment initiation was associated with significantly fewer COPD exacerbations, fewer oral corticosteroid prescriptions, and lower hospital resource utilisation during 12 months of follow-up. “These results highlight the importance of exploring treatments beyond traditional respiratory therapies when managing patients with COPD and complex cardiometabolic comorbidities,” said Prof. Bernardino Alcázar-Navarrete , respiratory physician at the University of Granada and Hospital Universitario Virgen de las Nieves . “The study provides clinically meaningful real-world evidence suggesting that GLP-1 receptor agonists could potentially modify exacerbation risk, opening new avenues for integrated and personalised care strategies.” Investigators note that the observed benefits may reflect anti-inflammatory mechanisms, weight reduction, or systemic metabolic effects, although causal conclusions cannot be drawn from observational data alone. The authors emphasise that prospective randomised clinical trials are needed to confirm whether GLP-1 RAs can play a disease-modifying role in COPD. The study was led by OPRI with contributions from an international network of academic partners across Europe, Canada, and Asia, reinforcing the growing interest in multidisciplinary approaches to cardiometabolic and respiratory multimorbidity. To view read the full publication in the Prag Obs Res .
- New Study Reveals Heart Health Indicators and COPD Symptom Severity Predict Major Future Heart and Lung Events in COPD
A new study from the Observational and Pragmatic Research Institute has shown that long-term heart and lung risks can be predicted in people with chronic obstructive pulmonary disease (COPD), a common lung condition, using information already captured in primary care. This research responds to a long‑standing need for better ways to assess combined heart and lung risks in this patient group, as traditional cardiac risk tools are not optimised for people with COPD – a key evidence gap identified by the International Cardiovascular and Respiratory Alliance in 2025 . Real-world primary care data, collected as part of routine clinical consultations, provides an excellent opportunity for deriving and validating a statistical model predicting the future risk of serious heart and lung events, tailored to patients with COPD. Using data from the UK’s Optimum Patient Care Research Database ( OPCRD ), researchers developed a COPD-specific model to forecast the risk of these events – collectively called Major Adverse Cardiovascular and Respiratory Events (MACRE) – including heart attacks, severe COPD flareups, and deaths from any cause. The study found sixty-one demographic and clinical factors that helped predict a patient’s MACRE risk over both five- and ten-year periods. Importantly, heart-health indicators (or a patient's cardiovascular risk profile) and COPD symptom severity (based on a patient’s reported breathlessness score) were found to predict future risk of MACRE in five years (Figure 1). When tested in a large nationwide cohort, the model showed that these events were common: half of patients went on to experience a major heart or lung related event over the study period, which spanned a median of 10.5 years. However, importantly our model found that some patients were at much higher risk and may benefit most from preventative interventions. Figure 1 : Risk classification heatmap, showing the predicted risks of MACRE in the overall study cohort at five years, stratified by cardiovascular risk profile and the modified Medical Research Council (mMRC) score. Numbers on the right represent the predicted risks in percentages. Reflecting on the study, Professor Chris Gale , lead author and Professor at the University of Leeds, commented: “People living with COPD face a much higher risk of both heart and lung complications, yet clinicians do not have the tools to reliably assess that combined risk. Our study shows that information already collected during routine appointments can identify who is most vulnerable. This opens the door to earlier intervention, better monitoring, and ultimately improved outcomes for patients.” As one of the first models to use electronic medical records alone to predict combined cardiopulmonary risk in COPD, this study lays the groundwork for more refined tools to support earlier identification of high-risk patients. Further studies are now needed to build on this work, to facilitate the establishment of clinically actionable thresholds that guide cardiopulmonary interventions in COPD patients to prevent MACRE in real-world care. To view, read the full publication in the Pragmatic and Observational Research . Reference: Chris P. Gale, Mohit Bhutani, Jeffrey Shi Kai Chan, John Townend, Mehul S Patel, Mohsen Sadatsafav, William Henley, Cono Ariti, Victoria Carter, Amy Couper, Richard Hubbard, Janwillem W.H. Kocks, Rachel Pullen, Derek Skinner and David Price. Development and internal validation of a prediction model for major cardiovascular and respiratory events in chronic obstructive pulmonary disease: nationwide primary care electronic medical records cohort study. Pragmatic and Observational Research. 2026:17 551291. https://doi.org/10.2147/POR.S551291 This study was part funded by AstraZeneca, conducted by the Observational and Pragmatic Research Institute, and involved committee members of the International Cardiovascular and Respiratory Alliance ( ICRA ).
- Major GOLD Guideline Change for COPD
The Impact of OPRI, the University of Exeter, and OPCRD Data The 2026 update to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines marks a significant shift in how clinicians assess exacerbation risk in COPD. For the first time, just one moderate exacerbation in the previous year is now sufficient to classify a patient as higher risk, prompting earlier intervention and more proactive management. This change is underpinned by robust real-world evidence, particularly from a landmark study led by David Halpin and the Observational & Pragmatic Research Institute (OPRI) . The study was funded by OPRI and conducted in collaboration with the University of Exeter, where David is Honorary Professor of Respiratory Medicine. This study found that in newly diagnosed COPD patients, having even a single exacerbation in the year before diagnosis strongly predicts a higher risk of exacerbations in the following year, with risk increasing as the number or severity of prior events rises. The study used the OPC Research Database (OPCRD), a rich source of primary care data for epidemiology, with the findings of the study providing the critical evidence base for this global guideline revision. This is a prime example of how UK-based academic-industry partnerships can drive international best practice, directly improving patient care worldwide. Rates of moderate or severe exacerbations in the last 12 months after diagnosis with 95% confidence intervals, according to exacerbation history in the 12 months prior to diagnosis and whether maintenance therapy was started. Reference: Halpin DMG, Healey H, Skinner D, Carter V, Pullen R, Price D. Exacerbation history and blood eosinophil count prior to diagnosis of COPD and risk of subsequent exacerbations. Eur Respir J 2024; 64(4): 39147410. PubMed
- New Australian research identifies quality improvement program to reduce asthma and COPD exacerbations
The real-world observational study titled, " A 21-practice evaluation of an asthma and COPD quality improvement program ”, has found that the Achieving Clinical Audits Using Electronic Medical Records (ACAER) quality improvement program (QI), delivered by Optimum Patient Care (OPCA) in Australian primary care, may drive treatment change and reduce exacerbations among high-risk* asthma and COPD patients. Following the completion of the ACAER Asthma program, annual exacerbation rates reduced significantly, particularly in the asthma group (see Figure 1). The ACAER program also prompted a change in reliever or maintenance inhaled therapies with: 48% of asthma patients changing therapy in the first year, with 39% in the second year and 30% in the third year 59% of COPD patients changing therapy in the first year, with 51% in the second year and 38% in the third year Figure 1: Exacerbation rates per month before and after the program The study was conducted using electronic health records from the Optimum Patient Care Research Database Australia and followed 1,956 COPD and asthma patients aged 12 years and over who were at high risk of exacerbations and hospitalizations from 21 GP practices. Practices received ACAER program support involving high-risk patient identification and linked patient pre-visit questionnaires. The study occurred during the COVID-19 pandemic and illustrated sustained reductions over the 2021 post-intervention period, which is particularly relevant given that other studies have reported a rise in COPD exacerbation rates post-pandemic. Professor John Blakey the lead author and Head of the Department of Respiratory Medicine at Sir Charles Gairdner Hospital and Research Leader at the Institute for Respiratory Health, Western Australia commented: "The findings from this study highlight the crucial role of the Australian primary care system for enhancing the care of patients with asthma and COPD. Getting the basics right reduces the harm experienced by individuals from both exacerbations and their treatments, and helps take pressure off stretched emergency care services.” To view the full results of the 21-practice evaluation of the asthma and COPD quality improvement program in Australia, as well as further comments and information regarding the scope for change, read the full publication in the Journal of Asthma and Allergy . Practices interested in learning more or participating in the ACAER program can read full details here. *’High risk’ was defined as one or more exacerbations in the 2 years prior to the index date (the date the questionnaire was sent). Patients were excluded from the study if they had a diagnosis of any chronic respiratory condition other than asthma or COPD. About asthma and COPD Asthma and COPD are both significant public health concerns in Australia, with approximately 10.8% of people diagnosed with asthma and 2.5% of people diagnosed with COPD according to the Australian Institute of Health and Welfare in 2023. Both conditions affect the respiratory system and restrict airflow, which can make it difficult to breathe. They are also linked with significant disease burden and hospitalization. About OPCA/OPCRDA Optimum Patient Care Research Database Australia (OPCRDA) is a not-for-profit research database established and maintained by Optimum Patient Care Australia Pty Ltd (OPCA) – a social enterprise which provides accredited quality improvement programs to support healthcare providers across Australia with management of patients with chronic diseases.
- Type 2 (T2)-targeted biologics have utility in the management of T2-low asthma, but more effective therapies are needed: Implications of EMBER study
The real-world study, “ Response to biologics along a gradient of T2 involvement in patients with severe asthma: a data-driven biomarker clustering approach ”, was recently published in The Journal of Allergy and Clinical Immunology: In Practice . Five biomarker clusters along a gradient of T2 involvement were identified using a data-driven approach instead of the pre-defined thresholds used in prior studies. Biologic use (Anti-IgE, Anti-IL5/5R and Anti-IL4Rα) was associated with improved outcomes in all clusters but tended to be better at the higher end of the T2 spectrum. Interestingly, we demonstrated that T2-targeted biologics have utility in the management of triple-biomarker-low asthma. Further research is needed to identify pathways specific to T2-low asthma that can be targeted by treatment. The EMBER study included data from 3,675 patients across 23 countries in the International Severe Asthma Registry (ISAR). Of these patients, 16.4% were in Cluster A (T2-low, triple-biomarker-low), 20.4% were in Cluster B (high immunoglobulin E [IgE], intermediate blood eosinophil count [BEC]), 22.9% were in Cluster C (high BEC and fractional exhaled nitric oxide [FeNO]), 30.3% were in Cluster D (triple-biomarker-intermediate) and 10.0% were in Cluster E (triple-biomarker-high) (Figure 1). Figure 1. Biomarker clusters of patients with severe asthma, identified using Gaussian finite mixture models. Abbreviations: BEC = blood eosinophil count; FeNO = fractional exhaled nitric oxide; IgE = immunoglobulin E; T2: Type 2 In multivariable analysis, b iologic use was associated with improved outcomes in all clusters but tended to be better at the higher end of the T2 spectrum. For example, patients in cluster C had a significantly greater pre- to post-biologic increase in forced expiratory volume in 1 second (FEV 1 ) relative to cluster A (0.16 vs. 0.04L) (Figure 2). Although we observed clinical improvements across all clusters and biologic classes (Anti-IgE, Anti-IL5/5R and Anti-IL4Rα), among those treated with Anti-IL5/5R there was some evidence of more modest improvements for patients with triple-biomarker-low asthma. Anti-TSLP, a newer biologic therapy, was not included in the EMBER study. In other studies, patients with severe, uncontrolled asthma who were treated with Anti-TSLP experienced reductions in exacerbations versus placebo , independent of BEC, FeNO, or T2 status, but it was more effective in those with increased BEC and FeNO levels . 1-3 Figure 2. Change in FEV 1 pre- to post-biologic relative to Cluster A (T2-low). The data are presented as relative risk (RR) with 95% confidence intervals adjusted for pre-biologic outcome, age, sex, country, and pre-biologic long-term oral corticosteroid. The EMBER study has identified biomarker clusters along a gradient of T2 involvement in a large, international severe asthma population and showed that biologic use was associated with improved outcomes across all clusters and biologic classes. While the study findings indicate that T2-targeted biologics have utility in the management of T2-low asthma, more effective therapies are needed for these patients. To learn more about the EMBER study, please read the full publication in The Journal of Allergy and Clinical Immunology: In Practice, as well as the accompanying slide deck . The EMBER study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was co-funded by Optimum Patient Care Global (OPCG) and AstraZeneca Ltd. ISAR is operated by OPCG and 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 >35,000 patients from 29 countries, and achieved 36 publications. ISAR fosters international collaboration to improve outcomes for patients worldwide. Learn more at https://www.isar.opcglobal.org . References 1. Menzies-Gow AN, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med 2021; 384 : 1800–9. 2. Corren J, Menzies-Gow AN, Chupp G, Israel E, Korn S, Cook B, et al. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Am J Respir Crit Care Med 2023; 208 : 13–24. 3. Corren J, Parnes JR, Wang L, Mo M, Roseti SL, Griffiths JM, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med 2017; 377 : 936–46.
- Cracking the Code: New ISAR Study Reveals How T2- and Non-T2 Inflammatory Pathways Predict Severe Asthma Exacerbations
A novel Bayesian Network analysis on the International Severe Asthma Registry (ISAR) has identified key clinical and biological pathways that contribute to the risk of future severe exacerbations in patients with severe asthma. Leveraging real-world data from over 6,800 biologic-naïve adults across 17 countries, the study—recently published in CHEST under the title “ Prediction Pathway for Severe Asthma Exacerbations: A Bayesian Network Analysis ” —provides significant insights into how complex clinical factors interact to influence exacerbation risk. Using the Bayesian Network approach—a robust probabilistic model that integrates expert knowledge with machine learning—the researchers uncovered the relationships between key predictors and how they led to severe asthma exacerbations. Blood eosinophil count (BEC), fractional exhaled nitric oxide (FeNO), and percentage predicted FEV₁ were identified as both directly contributing as well as mediating the transition from past to future severe exacerbations. Chronic rhinosinusitis (CRS) influenced this transition indirectly by altering these biological markers. In a separate pathway, prior macrolide use also mediated the transition from past to future exacerbations, highlighting a non-T2 inflammatory pathway. “This study moves beyond identifying isolated predictors by elucidating how they interact within a broader clinical framework,” said PI Prof. Wenjia Chen. “It further provides an influence diagram and a counterfactual prediction framework for more informed risk stratification and actionable risk modification in severe asthma management.” By integrating clinical, functional, and inflammatory domains into a unified predictive framework, this study marks a significant advance toward precision medicine in severe asthma. The findings provide actionable insights that could inform risk stratification, guide targeted therapies, and ultimately improve patient outcomes worldwide. To learn more about the study, please read the full publication in CHEST, as well as the accompanying slide deck . Acknowledgement : This work was supported by the Singapore National Medical Research Council – Open Fund – Young Individual Research Grant (MOH-001337-00), the International Severe Asthma Registry ( ISAR) Expert Panel and the Observational and Pragmatic Research Institute (OPRI). ISAR is operated by Optimum Patient Care Global (OPCG) and co-funded by OPCG and AstraZeneca Ltd. We thank all investigators, collaborators, and patients who contributed to this research. 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. It fosters international collaboration to improve outcomes for patients worldwide. ISAR is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca. Learn more at https://www.isar.opcglobal.org .
- Breathing Easier: Our Quest to Transform COPD Management in Primary Care
Detailing the successful roll-out of our innovative quality improvement (QI) programme, CONQUEST, our latest article in Primary Health Care Research and Development draws out key insights and strategies for implementing QI across US integrated healthcare systems (IHS). CONQUEST promotes the adoption of evidence-based, guideline-led care within primary care settings to improve the management of chronic obstructive pulmonary disease (COPD) – a leading cause of death and disability in the US. In our manuscript, we outline the structured development and rollout of CONQUEST in three stages: 1) developing the QI programme, 2) recruitment and preparation of participating healthcare systems, and 3) implementation across three distinct US IHS. By sharing lessons learned along the way, our article aims to inform others looking to implement QI programmes, like CONQUEST, aimed at transforming routine clinical practice, particularly in the management of COPD within primary care. For a summary of the paper, check out our latest blog post on the Cambridge Core Blog . For further details, you can read the full research article: Practical strategies for achieving system change in the US: lessons and insights from the CONQUEST quality improvement program out now, in Primary Health Care Research & Development. CONQUEST is co-funded by Optimum Patient Care Global Limited and AstraZeneca .
- Australian research identifies significant opportunity to reduce major cardiac and respiratory events in people with COPD, a leading cause of preventable hospitalisations
This real-world study of Australian primary care data shows that high-risk* COPD, characterised by recent breathing flare-ups, is widespread, with 25% of patients with an existing diagnosis and over 35% of patients with a new diagnosis meeting high-risk criteria. The authors highlight that over 40% of patients diagnosed with COPD who are considered high-risk have no recorded maintenance inhaler therapy. In contrast, 16% of patients identified as potentially high-risk, but without a COPD diagnosis, were receiving prescribed reliever or maintenance inhaled therapy (shown in Figure 1). Figure 1. Inhaled therapy in the 12-month period before 1st January 2019 for already diagnosed, newly diagnosed and potential undiagnosed COPD patients meeting high-risk criteria. Further findings showed that in 2019 the already diagnosed high-risk COPD population could benefit from: Cardiac risk screening (92.9% of patients without an existing cardiac diagnosis) Spirometry or peak flow testing (87.5% of patients) Pneumococcal vaccination (90.4% of patients) Influenza vaccination (67.7% of patients) Electronic medical records from a large primary care database, the Optimum Patient Care Research Database Australia (OPCRDA), were analysed to focus on how quality standards from the global CONQUEST program can identify and highlight opportunities to maximise high-risk COPD care. This study Patterns of care in the management of high-risk COPD in Australia (2015–2019): an observational study for the CONQUEST quality improvement program ” is the latest release in a series of publications on the disease management and treatment of high-risk COPD patients, this study builds on the successes of studies in the UK and the US . Professor David Price, founder of the Observational and Pragmatic Research Institute (OPRI), commented, "The findings from this study highlight an opportunity to potentially reduce symptoms, exacerbations, and future cardiac events in high-risk COPD patients by implementing the actionable CONQUEST quality standards in Australian primary care’’. To view the full results of the CONQUEST Opportunity analysis in Australia, as well as further comments and information regarding the scope for change, read the full paper at The Lancet Regional Health – Western Pacific . ----------------------------------------------------------------------------------------------------------------------------- *Patients at high-risk were identified as those who had experienced ≥2 exacerbations, or probable exacerbations (for patients with suspected but undiagnosed COPD) in the previous 24 months. COPD (or probable COPD) exacerbations were defined as any of the following within patients’ EMR: explicit COPD exacerbation codes, key words or free text denoting COPD exacerbation, or a prescription of acute oral corticosteroids and/or antibiotics unless associated with coded evidence of alternative indication such as skin or urine infections and conditions requiring long-term or recurrent courses of oral steroids or prophylactic antibiotics. About COPD COPD is a significant public health issue in Australia, with approximately 5% of adults over the age of 45 diagnosed according to the Australian Institute of Health and Welfare in 2020. Characterised by persistent respiratory symptoms and airflow limitation, COPD is one of the leading causes of disease burden and hospitalisation. COPD often remains underdiagnosed and undertreated, highlighting the need for improved awareness, early detection, and access to effective management strategies. About CONQUEST CONQUEST is a collaborative, interventional COPD registry that drives long-term, targeted, patient-centred changes in COPD management. The promotion of expert and guideline-led care aims to reduce exacerbation frequency and improve health care outcomes. It comprises an integrated quality improvement program focusing on patients (diagnosed and undiagnosed) at a modifiable and higher risk of COPD exacerbations. CONQUEST is underpinned by four evidence-based Quality Standards developed by 11 experts internationally recognized in their field. CONQUEST is co-funded by AstraZeneca and OPC. About OPCA/OPCRDA Optimum Patient Care Research Database Australia (OPCRDA) is a not-for-profit research database established and maintained by Optimum Patient Care Australia Pty Ltd (OPCA) – a social enterprise which provides accredited quality improvement programs to support healthcare providers across Australia with management of patients with chronic diseases.
- Severe asthma biologic access criteria should consider long-term oral corticosteroid (LTOCS) users with low blood eosinophil counts (BEC): Implications of STAR study
The real-world study, “ Biomarker profile and disease burden associated with intermittent and long-term oral corticosteroid use in patients with severe asthma prior to biologic initiation in real-life (STAR) ”, was recently published in World Allergy Organization Journal . It showed that disease burden remained high among LTOCS users, irrespective of BEC (Figure 1). LTOCS users with low BEC (<150 cells/µL) were as likely as those with high BEC (≥150 cells/µL) to have uncontrolled asthma, exacerbations and evidence of irreversible airflow obstruction. This demonstrates the significant unmet need of LTOCS users with low BEC, who represent 29% of the LTOCS group and yet may not qualify for most biologic therapies in many countries. Biologic access criteria should consider LTOCS users with low BEC. Figure 1. Disease characteristics of patients with severe asthma treated with LTOCS by BEC cut-off. Abbreviations: BEC = blood eosinophil count; ED = asthma-related emergency department visit; exac = exacerbation; FeNO = fractional exhaled nitric oxide; FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; Hosp = asthma-related hospitalization; IgE = immunoglobulin E; LTOCS = long-term oral corticosteroids The STAR study included data (2003 – 2023) from 4,305 patients across 23 countries in the International Severe Asthma Registry (ISAR). Of these patients, 41% were LTOCS (>90 days in the last 12 months) users, 54% were intermittent OCS (iOCS: ≤90 days in the last 12 months, usually short courses for exacerbations) users, and 5% were non-OCS users. OCS use affects biomarker distributions pre-biologic initiation. As shown in Figure 2, median BEC was significantly lower in the LTOCS vs iOCS group (310 vs 400 cells/µL; p <0.001). Similarly, median IgE was significantly lower in the LTOCS vs iOCS group (154 vs 206 IU; p <0.001). FeNO appears to be less susceptible to OCS-induced suppression; median FeNO was significantly higher in the LTOCS vs iOCS group (40 vs 34 ppb; p <0.001). The effect of OCS on biomarkers could potentially lead to phenotype misclassification. OCS use should be considered when characterizing severe asthma, and earlier phenotyping prior to initiation of LTOCS is recommended. Figure 2. Pre-biologic BEC distribution according to OCS use for patients with severe asthma. Abbreviations: BEC = blood eosinophil count; OCS = oral corticosteroids The STAR study findings are valuable in describing the biomarker distributions and disease characteristics according to OCS use in a large, international cohort of patients with severe asthma pre-biologic initiation. They call for earlier phenotyping in the asthma management pathway and for biologic access criteria to consider LTOCS users with low BEC (<150 cells/µL) . To learn more about the STAR study, please read the full publication in the World Allergy Organization Journal, as well as the accompanying slide deck . Citation: Schleich F et al. World Allergy Organ J 2025;18:101066 [Open access license ]. The STAR study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global (OPCG), Sanofi and Regeneron Pharmaceuticals, Inc. ISAR is operated by OPCG and 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 31 publications and 63 abstracts. ISAR fosters international collaboration to improve outcomes for patients worldwide. Learn more at https://www.isar.opcglobal.org .
- Exploring definitions and predictors of severe asthma clinical remission post-biologic in adults (FULL BEAM Remission)
We are excited to share groundbreaking findings on remission as a therapeutic target in " Exploring definitions and predictors of severe asthma clinical remission post-biologic in adults (FULL BEAM remission) " , recently published in the American Journal of Respiratory and Critical Care Medicine . This International Severe Asthma Registry (ISAR) study, which spanned 23 countries and followed the asthma journeys of over 3,000 real-life patients with severe asthma, reported the prevalence of remission after starting biologic therapy and identified factors associated with achieving it. This study found that 1 in 5 patients with severe asthma met the criteria for clinical remission within a year of starting biologic treatments, increasing to 1 in 2 when focusing on the key outcomes of fewer asthma attacks and reduction of long-term oral steroid use (see Figure 1). This was consistent across all types of biologics tested. Figure 1: Percentage of patients in remission pre- and post-biologic treatment Abbreviations: LTOCS: long-term oral corticosteroid; ppFEV: percent predicted forced expiratory volume in one second. What is even more interesting is the profile of patients who benefited most from these treatments. Unlike former observations where patients with worse symptoms see greater response, remission was more likely in patients who had less severe asthma to begin with. The likelihood of remission was increased in those with fewer asthma attacks, lower oral steroid daily dose, better control of asthma symptoms and better lung function prior to biologic initiation. This suggests that starting treatment earlier, before the disease becomes too severe, could be crucial. Additionally, the study identified predictors of remission, with older age of onset and higher blood eosinophil counts linked with higher odds of remission, and asthma duration, where the likelihood of achieving remission decreased by 15% for every additional 10 years of asthma duration. Higher blood eosinophil counts were found to be particularly linked to higher odds of remission with the biologic therapy anti-IL5/5R (monoclonal antibodies targeting interleukin-5 or its receptor). In summary, patients with less severe disease and shorter asthma duration at initiation of biologic treatment had a greater chance of achieving remission. The study suggests the need for a shift in severe asthma treatment approaches, emphasizing the need to consider biologics earlier in the course of asthma, before progressing down the path of LTOCS use and before irreversible lung damage can occur. The take-home message? Early intervention with biologics could make a significant difference for patients with severe asthma, potentially leading to better long-term outcomes and higher chances of remission. To learn more about the study, please read the full publication in the American Journal of Respiratory and Critical Care Medicine (AJRCCM), as well as the accompanying slide deck .












