Each year, innovation continues to push the boundaries of science, resulting in research that delivers life-changing medicines to those who need it most. One company is propelling insights and learnings forward in immunology by understanding the underlying biology of a dysregulated immune system in chronic lung diseases and applying the learnings to other inflammatory diseases, like systemic lupus erythematosus (SLE). While the understanding of health and technology has continued to grow, there is an urgency to find solutions for those living with these chronic diseases.
Following the science to uncover new possibilities in SLE
When it comes to the development of new treatments, particularly in immunology, identifying common disease pathways and underlying disease drivers is a critical step. It’s through these efforts, the medical community can further decipher the signs and symptoms patients face — and possible ways to help control their disease.
Patients living with complex, immune-driven diseases can experience various impacts to their emotional and physical health throughout their journey.1 In particular, lupus is a serious, autoimmune disease that is highly heterogeneous and can affect many organs and cause a range of symptoms including pain, rashes, fatigue, swelling in joints, and fever.2-4 Despite the complexity of this disease, researchers have made headway in better understanding the pathways involved in lupus disease activity.5 Specifically, inflammatory cytokines, or immune cell survival mediators, such as type 1 interferons (IFN-1), IL-23, IL-6, TNF-a and B-cell activating factor (BAFF) have been studied in correlation with lupus.5
Regardless of this progress, there continues to be large gaps of time between research and treatments coming to market.6 Over the past several decades, clinical research has continued to evolve to find solutions for those living with SLE with many programs never making it to the finish line.7 In an effort to disrupt the status quo and provide treatment options, AstraZeneca followed its own scientific innovation in respiratory and research from other clinical programs in lupus to develop a new therapy with a mechanism of action that targets an underlying driver of disease.8-11
The first new SLE treatment for adults in over a decade12
The study of the IFN-1 pathway, which was pivotal in the development of this new treatment option for patients, has been known to play a key role in immunity and can be associated with increased disease activity.9,10 The team at AstraZeneca leveraged their understanding of this association to develop a new treatment class to block the activity of type 1 IFNs.10,13
The US approval of SAPHNELO™ (anifrolumab-fnia), the first IFN-1 receptor antagonist, for the treatment of moderate to severe SLE in adult patients who are receiving standard therapy, marked a historic milestone in lupus research.13,14 SAPHNELO is AstraZeneca’s first FDA-approved treatment in immunology. Additional SAPHNELO studies are planned.13,15 Patients should always speak with their healthcare provider about what treatment plan is best for them.
Paving the way for future innovation
“We are seeing an evolution in the way immune-driven diseases are being researched and treated, with new targeted therapies aiming to address the underlying drivers of the disease rather than simply managing the symptoms,” said Mina Makar, Senior Vice President, Respiratory and Immunology at AstraZeneca. “We have also evolved our efforts by following the science in order to disrupt current standards of care to continue delivering for patients. Starting with the recent approval of a new treatment to help people living with lupus, we are committed to continuing this innovation in immunology to find solutions that help patients achieve disease control.”
This is just the beginning, especially in the world of immunology, as we take insights and learnings to advance science and medicine forward. The medical community must come together by using research to inform solutions in order to ultimately bring hope to patients who need it most.
Learn more about recent scientific advancements and how AstraZeneca is pushing the boundaries of innovation in respiratory and immunology.
IMPORTANT SAFETY INFORMATION
Known history of anaphylaxis with SAPHNELO.
WARNINGS AND PRECAUTIONS
- Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Use caution in patients with severe or chronic infections. Avoid initiating treatment during an active infection and consider interrupting therapy in patients who develop a new infection during treatment
- Hypersensitivity Reaction Including Anaphylaxis: Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration. Events of angioedema have also been reported. Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis and infusion-related reactions, if they occur. Immediately interrupt administration and initiate appropriate therapy if a serious infusion-related or hypersensitivity reaction (eg, anaphylaxis) occurs
- Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO on the potential development of malignancies is not known
- Immunization: Avoid the use of live or live-attenuated vaccines in patients treated with SAPHNELO
- Use With Biologic Therapies: SAPHNELO is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies
The most common adverse reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster and cough.
In the controlled clinical trials, the incidence of infusion-related reactions was 9.4% in patients while on treatment with SAPHNELO and 7.1% in patients on placebo. Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness.
USE IN SPECIFIC POPULATIONS
Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, contact AstraZeneca at 1-877-693-9268.
There are insufficient data on the use of SAPHNELO in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving SAPHNELO.
Lactation: No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production.
Pediatric Use: The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age has not been established.
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations.
1 Greenfield J, Hudson M, Vinet E, et al. A comparison of health-related quality of life (HRQoL) across four systemic autoimmune rheumatic diseases (SARDs). PLoS ONE. 2017;12(12): e0189840.
2 Centers for Disease Control and Prevention. Systemic Lupus Erythematosus (SLE). Available at: https://www.cdc.gov/lupus/facts/detailed.html. Last accessed: October 2021.
3 Allen ME, Rus V, Szeto GL. Leveraging heterogeneity in systemic lupus erythematosus for new therapies. Trends Mol Med. 2021;27(2):152-171.
4 Kaul A, Gordon C, Crow MK, et al. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016;2:16039.
5 Zharkova O, Celhar T, Cravens PD, et al. Pathways leading to an immunological disease: systemic lupus erythematosus. Rheumatology (Oxford). 2017;56:i55–i66. doi: 10.1093/rheumatology/kew427.
6 Dall’Era M, Bruce IAN, Gordon C, et al. Current challenges in the development of new treatments for lupus. Ann Rheum Dis. 2019;78:729–735.
7 Merrill JT, Manzi S, Aranow C, et al. Lupus community panel proposals for optimizing clinical trials: 2018. Lupus Sci Med. 2018;5:e000258.
8 AstraZeneca 2021. SAPHNELO (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus. [Online] Available at: https://www.astrazeneca-us.com/content/az-us/media/press-releases/2021/saphnelo–anifrolumab–approved-in-the-us-for-moderate-to-severe.html. Last accessed: October 2021.
9 Crow M. Type I interferon in the pathogenesis of lupus. J Immunol. 2014;192 (12):5459-5468. doi:10.4049/jimmunol.1002795.
10 Crow MK, Olferiev M, Kirou KA. Type I interferons in autoimmune disease. Annu Rev Pathol Mech Dis 2019;14:369–393.
11 Wahren-Herlenius M, Dörner T. Immunopathogenic mechanisms of systemic autoimmune disease. Lancet. 2013;382(9894):819-831
12 Mullard A. FDA approves AstraZeneca’s anifrolumab for lupus. Nat Rev Drug Discov. 2021;20(9):658. doi:10.1038/d41573-021-00139-y.
13 SAPHNELO™ (anifrolumab-fnia) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021.
14 Lupus Research Alliance 2021. Lupus Research Alliance Applauds U.S. FDA Approval of AstraZeneca’s anifrolumab-fnia (Saphnelo™) for Systemic Lupus Erythematosus (SLE). [Online] Available at: https://www.lupusresearch.org/lupus-research-alliance-applauds-u-s-fda-approval-of-astrazenecas-anifrolumab-fnia-saphnelo-for-systemic-lupus-erythematosus-sle/. Last accessed: October 2021.
15 AstraZeneca. H1 2021 results. Available at: https://www.astrazeneca.com/content/dam/az/PDF/2021/h1-2021/H1_2021_results_presentation.pdf. Last accessed: October 2021.
US-57633 Last Updated 10/21