There is an urgent need to transform care and improve outcomes in immune-mediated diseases where patients continue to face unacceptable outcomes such as permanent organ damage, uncontrolled disease activity and even death.1-4
Over recent years, Immunology has emerged as one of the fastest-growing fields of clinical research – second only to oncology – in terms of ongoing clinical trials.5
With a growing presence in Immunology, AstraZeneca intends to help patients with immune-mediated diseases move beyond symptom control to achieve remission, and one day, cure.
Following the science in immune-driven disease areas
Although clinical research in Immunology is fast-growing, there remains a high unmet need for many people with immune-mediated diseases who do not achieve disease control with existing therapies. 3,6,7 Through decades of research and increased scientific understanding of the underlying drivers of immune-driven diseases at the pathway level, we aim to unlock the complex nature of the diseases we are targeting, uncovering new treatment approaches and driving earlier intervention.
Our bold ambition in immunology – to make remission a treatment goal
We are continuing to follow the science to further unlock our understanding of complex immune-driven diseases. Our bold ambition in Immunology is to disrupt current treatment paradigms and make remission – not just symptom management – a goal for as many patients as possible.
Complex autoimmune diseases like lupus, a disease that can impact any organ and results in often-debilitating flares in disease activity, and immune-mediated inflammatory diseases like eosinophilic granulomatosis with polyangiitis (EGPA), remain challenging to diagnose and treat, and many patients today do not achieve remission.1,3,8-10 For example, people living with EGPA can often take more than four years to receive a diagnosis, and the path to diagnosis can be even longer (up to six years or more) in lupus.1,11 For patients with lupus, achieving disease control can be particularly challenging, and an estimated 10-15% will die prematurely due to lupus-related complications. 1,8
Despite the introduction of updated treatment strategies and novel therapies in systemic lupus erythematosus (SLE) and EGPA, oral corticosteroid (OCS) use still remains high.2,3,9 Although OCS can improve symptoms, long-term use is associated with poor quality of life and serious side effects, with an estimated 50% of patients with SLE developing irreversible organ damage within 5 years of their diagnosis due to their disease and existing treatments.3,9,12-14
Remission is a treatment target in guidelines for both SLE and EGPA. The recently updated international SLE treatment recommendations from the European Alliance of Associations for Rheumatology (EULAR) emphasise the need for prompt initiation of treatment aiming at remission, which is associated with improved clinical outcomes including reduced organ damage, fewer flares, reduced hospitalisation, reduced mortality and improved health-related quality of life. 8,15,16 The revised SLE treatment recommendations advise an OCS-sparing approach (a threshold of 5 mg per day or less) to significantly reduce disease progression and improve quality of life for patients.14
Similarly, treatment of EGPA is focused on preventing relapses and increasing the time spent in remission, as the number of relapses and duration of OCS use are associated with long-term organ damage.17,18 Global EGPA guidelines recognise both inducing and maintaining remission as a treatment goal and recommend that OCS use is kept to a minimum.19,20
A growing body of evidence is emerging, including examples from other chronic diseases, that could further inform guidelines to drive greater adoption of OCS-sparing strategies and enable physicians to safely and effectively taper their patients from OCS.
Shifting mindsets and implementing the latest treatment recommendations could bring clinical practice closer to other disease areas that have had success, and, ultimately, make a significant impact on the long-term health of people living with chronic immune-driven diseases.
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References
1. Lupus Foundation of America. Lupus facts and statistics. Available at: http://www.lupus.org/resources/lupus-facts-and-statistics [last accessed October 2023].
2. Diane Apostolopoulos, Eric F. Morand, It hasn’t gone away: the problem of glucocorticoid use in lupus remains, Rheumatology, Volume 56, Issue suppl_1, April 2017, Pages i114–i122, http://doi.org/10.1093/rheumatology/kew406 [last accessed October 2023]
3. Bell CF, Blauer-Peterson C, Mao J. Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States. J Manag Care Spec Pharm. 2021 Sep;27(9):1249-1259. doi: 10.18553/jmcp.2021.21002.
4. American Partnership for Eosinophilic Disorders. Eosinophilic Granulomatosis with Polyangiitis (EGPA). Available at: http://apfed.org/about-ead/eosinophilic-granulomatosis-with-polyangiitis/. [last accessed October 2023].
5. Leven, T, Norton M, Vaidyanathan S., Improving Care in Immune-Mediated Diseases. Accessible at: http://www.bcg.com/publications/2022/improving-research-and-development-in-pharma-industry-for-immune-mediated-diseases [last accessed October 2023].
6. Medscape. Systemic Lupus Erythematosus (SLE). Available at: http://emedicine.medscape.com/article/332244-overview [last accessed October 2023]
7. Olesińska M, et al. Quality of life in systemic lupus erythematosus and its measurement. Reumatologia. 2018; 56 (1): 45-54.
8. Ugarte-Gil MF, et al. Achieving remission or low disease activity is associated with better outcomes in patients with systemic lupus erythematosus: a systematic literature review. Lupus Sci Med. 2021;8:e000542. doi: 10.1136/lupus-2021-000542
9. Baldini C, et al. Clinical Manifestations and Treatment of Churg-Strauss Syndrome. Rheum Dis Clin N Am. 2010:36;527–543.
10. Wechsler ME, et al. Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis. N Engl J Med. 2017:376;1921-1932.
11. Moosig F, et al. A vasculitis centre based management strategy leads to improved outcome in eosinophilic granulomatosis and polyangiitis (Churg-Strauss, EGPA): monocentric experiences in 150 patients. Ann Rheum Dis. 2013;72:1011-1017
12. Segura BT, et al. Damage accrual and mortality over long-term follow-up in 300 patients with systemic lupus erythematosus in a multi-ethnic British cohort. Rheumatol. 2020; 59 (3): 524-533.
13. Ugarte-Gil MF, et al. Impact of glucocorticoids on the incidence of lupus-related major organ damage: a systematic literature review and meta-regression analysis of longitudinal observational studies. Lupus Sci Med. 2021; 8 (1): e000590.
14. Bruce IN, et al. Factors associated with damage accrual in patients with systemic lupus erythematosus: results from the systemic lupus international collaborating Clinics (SLICC) inception cohort. Ann Rheum Dis. 2015; 74: 1706-1713
15. Fanouriakis A, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. Published Online First: 12 October 2023. doi: 10.1136/ard-2023-224762.
16. Kandane-Rathnayake R, et al. Lupus low disease activity state and remission and risk of mortality in patients with systemic lupus erythematosus: a prospective, multinational, longitudinal cohort study. Lancet Rheumatol. 2022;4(12):e822-e830.
17. Raffray L, et al. Treatment of Eosinophilic Granulomatosis with Polyangiitis: A Review. Drugs. 2018 Jun;78(8):809-821
18. Robson J, et al. Glucocorticoid treatment and damage in the anti-neutrophil cytoplasm antibody-associated vasculitides: long-term data from the European Vasculitis Study Group trials. Rheumatology. 2015 Mar;54(3):471-81
19. Chung SA, et al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol. 2021 Aug;73(8):1366-1383.
20. Hellmich B, et al. EULAR recommendations for the management of ANCA-associated vasculitis: 2022 update. Ann Rheum Dis. 2023 Mar:ard-2022-223764
Veeva ID: Z4-59056
Date of preparation: November 2023