A first look at the global severe asthma population

-ISAR proudly announces publication of its first dataset, summarizing demographic and clinical characteristics of 4,990 patients with severe asthma from the USA, UK, South Korea, Italy, Australia, New Zealand and Singapore

Dr. Eileen Wang (MD, MPH)
Prof David Price (MD FRCGP)

The International Severe Asthma Registry (ISAR; http://isaregistries.org/) has come of age with the publication of its first dataset in CHEST. “The study, which is the first to describe the demographic and clinical characteristics of severe asthma patients around the world, is a landmark publication answering the World Health Organization’s call for better surveillance to map the magnitude of chronic respiratory diseases and monitor future trends,” explains Prof David Price (Director of both the Observational Pragmatic Research Institute, which analysed the data, and Optimum Patient Care, a co-founder of ISAR along with AstraZeneca). The results showed that patients with severe asthma predominantly developed asthma as adults, suffered from frequent flare ups (despite treatment with reliever/controller combinations, plus additional therapies and repeated oral corticosteroid courses in many cases), and had the type of disease likely to respond to new biologic therapies. “Biologic therapies have demonstrated an oral corticosteroid sparing effect, which is a huge plus, providing the potential to get severe asthma under control while reducing the risk for serious side effects caused by repeated and prolonged oral steroid therapy,” explains Prof Price. The whole initiative has been made possible via a collaboration with national/regional asthma registries, coming together to share not only anonymized and standardized, high-quality, patient-level data with ISAR, but also a common vision of how these data can be used to answer previously unanswerable questions. According to lead author Dr. Eileen Wang (National Jewish Health and University of Colorado School of Medicine, CO, USA), “the combined data from 4,990 patients paint a global picture of severe asthma as a disease associated with limited reversibility, high oral corticosteroid use, poor disease control and high morbidity and economic burdens”. The study also identified substantial inter-registry heterogeneity in patient age and asthma onset, treatment patterns, exacerbation rates and biomarker profiles. “These differences may be due to variations in local treatment practices, epidemiological patterns or access to specialized care and treatment, but may also be explained by the differences in type of asthma,” explains Prof Price. “This is just the start of what ISAR can allow us to answer”, continues Dr. Wang. “As it continues to grow and diversify, ISAR will become a rich and unparalleled resource for answering questions relating to the heterogeneity of asthma presentation, response to treatment, and morbidity/mortality across the world”. ISAR has prioritized numerous research projects to answer these outstanding questions, living up to its commitment to improve the lives of severe asthma patients at the global level.

Optimum Patient Care Ltd (OPC), specializes in delivering medical research and services to improve diagnosis, treatment and care of chronic diseases within family care and specialist practices, and has provided clinical services and supported real-life research for over 14 years. It drives a vision for inclusion of real-life data into all aspects of medical research while informing the translation of research into daily clinical practice via new technologies and clinical services. Over the past decade, OPC has proven its expertise in both health care service provision, and the collection of data for ethically approved research purposes, globally. In the UK, OPC has established one of the largest family medicine databases, called the Optimum Patient Care Research Database (OPCRD) which holds nearly seven million anonymized electronic health records from patients in primary care. Globally OPC has coordinated the delivery of several large-scale international registries including the iHARP database (https://iharp.org/ (link is external)) and the International Severe Asthma Registry (ISAR) (http://isaregistries.org/ (link is external)). More information can be found out about Optimum Patient Care at https://optimumpatientcare.org/

The Observational & Pragmatic Research Institute (OPRI; https://opri.sg/) founded by Prof David Price, is an independent research organisation with over 12 years of leadership and global experience in successful delivery of retrospective database studies, prospective pragmatic clinical trials and international patient registries. With a special focus on uncontrolled and severe asthma, OPRI has conducted several systematic, investigative and experimental (SIE) studies to aid the discovery and development of novel and innovative inhaler devices, precision medicine therapies and risk prediction tools such as biomarkers. This research has contributed to a growing body of real-world evidence illustrating the unmet needs, effectiveness, safety and value of biopharmaceutical and biotechnology in real world patient populations. OPRI (with its partner OPC) offers exclusive data sharing agreements to one of the largest primary care databases in the world, the Optimum Patient Care Research Database (OPCRD), which allows access to a network of over 700 GP practices and 8.8 million patients in the UK for bespoke data collection. OPRI also has a new and growing network of GP practices in Australia to translate research from study idea to clinical change.

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas: Oncology; Cardiovascular, Renal and Metabolism; and Respiratory. AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

National Jewish Health (NJH) is the leading respiratory hospital in the United States. Founded 120 years ago as a non-profit hospital, NJH today is the only facility in the world dedicated exclusively to ground-breaking medical research and treatment of patients with respiratory, cardiac, immune and related disorders. Patients and families come to NJH from around the world to receive cutting-edge, comprehensive, coordinated care. To learn more, visit the media resources page.

Mission statement from the first global severe asthma registry

The International Severe Asthma Registry (ISAR; http://isaregistgries.org/) came into existence back in 2017. Its goal was ambitious: to become the first real-life, adult, severe asthma registry in the world.

“That goal has now been realised with the invaluable help and support of national/regional severe asthma registries, and of our ISAR Study Group of international asthma experts,” says Prof David Price (Director of both the Observational Pragmatic Research Institute (OPRI), which analyses the data, and Optimum Patient Care, a co-founder of ISAR along with AstraZeneca).

ISAR currently contains data from 8366 patients with severe asthma from 19 registries and 31 countries around the world and continues to grow. “ISAR, has taken us all on a bit of an adventure, into previously unexplored severe asthma waters,” continues Prof Price, “and after more than 2 years on this journey, now is the time to stand back, take stock and examine our achievements”. The recently published ISAR mission statement does just that, summarising what ISAR is, its goals and objectives and the six key pillars that underpin it. ISAR’s strength comes from the collection of anonymised, patient-level, standardised and high-quality data, combined with data collection/database expertise and organisational, clinical, academic and publications oversight. “By acting as a global severe asthma data custodian, ISAR has the potential to describe the severe asthma population in its entirety and in partnership with OPRI is committed to conducting robust, clinically relevant research to improve diagnosis, disease stratification and even to identify new treatment targets,” explains Prof Price. “Of course, as with any journey there are challenges ahead. With so much data at our disposal, it’s important to harness that power to provide meaningful clinical oversight, ask the right questions and provide answers that will improve the lives of our severe asthma patients. ISAR has the potential to provide those answers not only to physicians, but also to patients, guideline developers and payers.”  

Optimum Patient Care Ltd (OPC), specialises in delivering medical research and services to improve diagnosis, treatment and care of chronic diseases within family care and specialist practices, and has provided clinical services and supported real-life research for over 14 years. It drives a vision for inclusion of real-life data into all aspects of medical research while informing the translation of research into daily clinical practice via new technologies and clinical services. Over the past decade, OPC has proven its expertise in both health care service provision, and the collection of data for ethically approved research purposes, globally. In the UK, OPC has established one of the largest family medicine databases, called the Optimum Patient Care Research Database (OPCRD) which holds nearly seven million anonymized electronic health records from patients in primary care. Globally OPC has coordinated the delivery of several large-scale international registries including the iHARP database (https://iharp.org/ (link is external)) and the International Severe Asthma Registry (ISAR) (http://isaregistries.org/ (link is external)). More information can be found out about Optimum Patient Care at https://optimumpatientcare.org/

The Observational & Pragmatic Research Institute (OPRI; https://opri.sg/) founded by Prof David Price, is an independent research organisation with over 12 years of leadership and global experience in successful delivery of retrospective database studies, prospective pragmatic clinical trials and international patient registries. With a special focus on uncontrolled and severe asthma, OPRI has conducted several systematic, investigative and experimental (SIE) studies to aid the discovery and development of novel and innovative inhaler devices, precision medicine therapies and risk prediction tools such as biomarkers. This research has contributed to a growing body of real-world evidence illustrating the unmet needs, effectiveness, safety and value of biopharmaceutical and biotechnology in real-world patient populations. OPRI (with its partner OPC) offers exclusive data sharing agreements to one of the largest primary care databases in the world, the Optimum Patient Care Research Database (OPCRD), which allows access to a network of over 700 GP practices and 8.8 million patients in the UK for bespoke data collection. OPRI also has a new and growing network of GP practices in Australia to translate research from study idea to clinical change.

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas: Oncology; Cardiovascular, Renal and Metabolism; and Respiratory. AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Press release to highlight the publication of ‘The ISAR Study Group, International Severe Asthma Registry: Mission Statement. CHEST 2019 Dec 12. pii: S0012-3692(19)34287-4. doi: 10.1016/j.chest.2019.10.051’

Development of the International Severe Asthma Registry (ISAR): a modified Delphi study

The story of this publication began several years ago when a group of like-minded asthma experts thought it would be rather a good idea to pool national resources and collect information on severe asthma in a single global registry. Simple, right?! Fast-forward a few months and the International Severe Asthma Registry (ISAR; http://isaregistries.org/) was born.

The concept of ISAR is simple”, explains Prof David Price (Co-founder of ISAR), “to open national/regional severe asthma registry borders and pool our data to generate a centralized severe asthma dataset. The resulting dataset would be the first global adult severe asthma registry in the world, permitting seamless information sharing between countries, and ultimately giving us a better insight into severe asthma on a global scale.

However, before ISAR could be built, the experts had to agree on a standardized list of variables to collect. And so the fun commenced! It was decided to use a modified Delphi process to reach consensus on a minimum set of variables to capture in ISAR.

Looking back, remarks Prof Price, “I’m really proud of what we managed to achieve. The Delphi panel consisted of 27 international experts in the field of severe asthma research; the process involved 3 iterative rounds; and from an initial 747 identified variables we agreed to collect 95 standardized core variables in ISAR.”

These variables cover patient details and medical history, co-morbidities, blood and sputum biomarkers, diagnostics, lung function, allergen testing, asthma control, medication, adherence and management plans. The full list is provided in the published article. ISAR is now fully operational and growing all the time. It currently contains longitudinal, real-life, standardized, high quality data on 5892 patients from 14 countries in Europe, North America, Middle East and Asia-Pacific and, continues to grow.

It’s been an exciting time in the field of severe asthma, says Prof Price. We’ve taken our first peek at the global severe asthma population, and due to standardization of variables across registries have been able make meaningful cross country comparisons in epidemiology, types of asthma and management practices. The sheer size of ISAR means that we will have sufficient statistical power to answer research questions, which until now have been beyond our grasp; questions like ‘who will respond best to treatment?’, and ‘who is likely to develop severe asthma?’. ISAR may also help us to identify new treatment targets, investigate the effectiveness of novel approaches and the feasibility of new asthma treatment paradigms.

ISAR is conducted by Optimum Patient Care Global Limited. OPC Global and AstraZeneca co-sponsor the initiative, and together with the Respiratory Effectiveness Group, ensure ISAR research is ethical, clinically appropriate and continues to bring genuine value to patients, public health, and healthcare.