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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

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.

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.

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 .

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 .

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.

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 .

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 .

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 .

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

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 .

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 .