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

The real-world SOLAR II study shows that biologic initiators had 18% lower risk of developing any oral corticosteroid (OCS)-related adverse outcome compared to non-initiators, primarily driven by the reduced risk of developing diabetes (by 38%), MACE (by 35%), and anxiety/depression (by 32%; Figure 1)1. The authors highlight that the magnitude of rate reduction was comparable to those shown by available disease-specific agents. For example, statins reduce cardiovascular disease risk by 25%, coronary heart disease by 27% and stroke by 22%;2 metformin reduces the odds of developing diabetes mellitus by 35% among individuals with pre-diabetes versus control groups.3 The effectiveness of biologics in preventing OCS-related adverse outcomes and potential associated cost savings indicate the need for timely biologic initiation in patients with severe asthma.  

The SOLAR II study, “Prevention of cardiovascular and other systemic adverse outcomes in patients with asthma treated with biologics”, was published today in the American Journal of Respiratory and Critical Care Medicine.1 It was selected as one of the journal’s articles for oral presentation at the prestigious session ‘NEJM, AJRCCM, JAMA, Discussions on the Edge: Reports of Recently Published Pulmonary Research’ at the American Thoracic Society (ATS) 2025 International Conference. 

Figure 1. Association between biologic initiation and risk of OCS-related adverse outcomes (5-year censoring). Major cardiovascular event includes heart failure, myocardial infarction or cerebrovascular accident. Abbreviations: Bx = biologic; CI = confidence interval; HR = hazard ratio; OCS = oral corticosteroid; VTE = venous thromboembolism  

The SOLAR II study was a longitudinal cohort study using prospective data (2017-2024) from 16 countries of the International Severe Asthma Registry (ISAR) specifically collecting a number of OCS-related adverse events and from the Optimum Patient Care Research Database (OPCRD; UK). A total of 42,908 patients (8,432 from ISAR and 34,476 from OPCRD) were included. There was no overlap between datasets.

SOLAR II is the first study to show that initiating biologics reduces the risk of new-onset OCS-related adverse outcomes in severe asthma. It follows on from the SOLAR I study, which shows that biologic initiation in patients with severe asthma led to substantial reduction in total OCS exposure over two years, versus usual care.4 The findings of both SOLAR I and SOLAR II highlight the value of biologic therapy in not only reducing OCS exposure but also preventing new-onset diabetes, MACE and other OCS-related adverse outcomes in patients with severe asthma.

To learn more about the study, please read the full publication in the American Journal of Respiratory and Critical Care Medicine, as well as the accompanying slide deck.

The late-breaking SOLAR II poster will be presented at ATS 2025 on Tuesday 20th May, 11:30am-1:15pm, at the session ‘Late breaking and lung shaking abstracts’, located at Area F, Hall F (North Building, Exhibition Level), Moscone Center.

The SOLAR II study was conducted by the Observational and Pragmatic Research Institute (OPRI) and was partially funded by Optimum Patient Care Global (OPCG) and AstraZeneca. The International Severe Asthma Registry (ISAR) is operated by OPCG and co-funded by OPCG and AstraZeneca.

ISAR is a global adult severe asthma registry that standardizes data collection across >34,000 patients from 32 countries, making it the largest source of real-life data for the study of severe asthma epidemiology, outcomes and clinical management.5 Since its establishment in 2017, ISAR has undertaken 26 research projects with 30 publications and 63 abstracts to date. In addition to advancing severe asthma research, ISAR supports clinical care for severe asthma through its quality improvement initiatives.6

OPCRD is a primary care database containing the electronic health records of >25 million patients from >1000 general practices across the UK (covering ~35% of the UK population). It facilitates real-world collection of patient-level diagnostic, clinical and prescribing information. OPCRD data has been used in 100 studies, with the achievement of 121 publications. OCPRD regularly collaborates with other databases and registries on asthma research. It has partnered with ISAR on numerous severe asthma research studies, including SOLAR II.

To learn more please visit our website: www.isar.opcglobal.org.

References

1.       Sadatsafavi M, Tran T, Scelo G, et al. Prevention of cardiovascular and other systemic adverse outcomes in patients with asthma treated with biologics. Am J Respir Crit Care Med. In press

2.       Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2013, Issue 1. Art. No.: CD004816

3.       Patel D, Ayesha IE, Monson NR, et al. The Effectiveness of Metformin in Diabetes Prevention: A Systematic Review and Meta-Analysis. Cureus 2023;15(9):e46108

4.       Chen W, Tran T, Emmanuel B, et al. Impact of biologic initiation on oral corticosteroids in the International Severe Asthma Registry and the Optimum Patient Care Research Database: a pooled analysis. Eur Respir J 2024 64(suppl 68): PA2175. Presented at ERS 2024

5.       Canonica GW, Alacqua M, Altraja A, et al. International Severe Asthma Registry Mission Statement. CHEST 2020;157(4):805-814

6.       Larenas-Linnemann D, Rhee CK, Altraja A, et al. International Severe Asthma Registry (ISAR): 2017-2024 Status and Progress Update. Tuberc Respir Dis 2025;88(2):193-215