Disease Areas
Systemic Lupus Erythematosus (SLE)
Systemic Lupus Erythematosus
What is systemic lupus erythematosus (SLE)?
SLE is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues throughout the body. It can affect the skin, joints, kidneys, heart, lungs, brain and other organs.1
SLE is one of several complex and highly variable autoimmune diseases that fall under the broad term “lupus.” Lupus is often thought of as one disease, but it is a collection of diseases that shows up differently for each patient.1
Biogen is working to advance a lupus-focused pipeline, with potential to become the first company to offer multiple treatment options for SLE.
SLE Facts and Figures
3.4M
SLE affects up to 3.4 million people worldwide.2
9X
SLE is 9 times more common in women than men.3
2‑3X
People with SLE have a 2-3 times higher mortality rate than the general population.4
5‑9X
SLE is more common in Black people, who experience a 5-9-fold higher incidence.5
Understanding SLE
Symptoms of SLE can differ from person to person. Common symptoms can include fatigue, joint pain and swelling, skin rashes, hair loss, mouth sores, chest pain, kidney problems and sensitivity to sunlight. Some people may also experience neurological symptoms such as headaches, seizures or cognitive changes — like the inability to focus on complex tasks.1
Symptoms of SLE can often vary over time, with periods of flares and stable disease activity.
- 90% of SLE patients experience joint symptoms.6
- 90% of SLE patients experience skin symptoms.1
Why are new treatment options needed for SLE?
Despite current available therapies, many people living with SLE continue to experience active symptoms, frequent flares or intolerable side effects.7,8 Because SLE is a complex and heterogeneous disease with unique biological drivers in every individual, a “one-size-fits-all” approach does not work, and a wider range of targeted treatment options is urgently needed to help patients achieve stable, long-term disease management.9
Key challenges with current standard treatments include:
- Many people with SLE do not experience a significant reduction of symptoms in response to standard therapies, including fatigue.9,10
- Many treatments carry the risk of severe side effects over time and may also be contraindicated during pregnancy.8,11
- In a large, 2020, international, real-world survey of SLE patients, fewer than 20% of eligible SLE patients received targeted SLE therapies.12
"Given the broad symptoms, presentation and severity of lupus, having multiple approaches to addressing the disease may give doctors the opportunity to individualize how they treat people living with the disease."
- Diana Gallagher, M.D., Head of the Immune-Mediated and Neurodegeneration Development Unit
Our Clinical Studies for SLE
Discover all Biogen clinical studies in lupus
Biogen conducts clinical studies in SLE and other forms of lupus to evaluate the efficacy and safety of potential medicines. Click below to explore our active, recruiting studies.
Frequently Asked Questions
Biogen is applying its history in immune science and 20+ years of research to advance potential treatment options that target multiple points in the lupus disease (or inflammatory) cascade, including immune cells, inflammatory cytokines and the signaling pathways that drive disease activity. Through this approach, Biogen aims to help improve disease management while reducing reliance on steroids.
pDCs are innate immune cells that play a key role early in the lupus disease cascade. By producing large amounts of type I interferons, they contribute to the immune dysregulation and inflammation that characterize SLE.13
In people with SLE, these immune cells become overactive and migrate to vital organs like the skin and kidneys. The pDCs, which act like a switch, get stuck in the “on” position and release a flood of immune signals that drive tissue inflammation, leading to rashes, joint pain and kidney damage.13 By targeting this switch and turning it “off,” it may be possible to signal these cells to stop producing the inflammation that damages the body.13
CD40L is a protein used for communication between different types of immune cells. T cells use CD40L to activate B cells and other immune cells. In SLE, CD40L acts like a switch that gets stuck in the “on” position, causing T cells to over activate B cells and other immune cells, triggering inflammation and tissue damage associated with SLE.14 While some current treatments focus only on B cells, in preclinical studies, CD40L was shown to quiet both T cells and B cells and may have broad modulatory effects on SLE immunopathology.15
SLE occurs when the immune system mistakenly attacks the body's own healthy tissues. This triggers a complex network of immune cells, proteins and signaling molecules that drive inflammation. Because different components of the SLE disease cascade may play a more prominent role in different patients, symptoms and disease severity can vary widely from person to person.1
The exact cause of SLE is not fully understood. Researchers believe it develops through a combination of genetic, environmental and hormonal factors that affect the immune system. Certain triggers, such as infections, stress or sunlight exposure, may contribute to disease flares in some people.16
SLE can affect anyone, but it most commonly develops in women of reproductive age. Certain racial and ethnic groups have a higher risk of developing lupus and experiencing more severe disease.
SLE is more common in:
- Women compared to men, especially women of reproductive age, with a female to male ratio3 around 9:1.
- People who are Black (5-9-fold higher5), Hispanic or of Native American (2-fold or higher5) descent.
An SLE flare is a period when disease activity increases and symptoms become worse after a period of being relatively stable or better. A flare can range from mild to severe and may affect different organs. Working with a healthcare provider can help identify potential triggers and develop a plan to manage symptoms.7
Because SLE is a systemic disease, it can affect many parts of the body, including the kidneys, heart, lungs, brain, blood vessels and blood cells. However, skin and joint are the most common symptom manifestations patients notice. Early diagnosis and ongoing medical care are important to help manage disease activity and reduce the risk of complications.1,8,17
There is currently no cure for SLE. Current treatment options focus on helping control disease activity, reducing inflammation, managing symptoms and preventing organ damage. Researchers continue to study new approaches that may improve outcomes for people living with SLE.1
The current stardard of care for SLE involves managing the symptoms of each patient on a case-by-case basis using a combination of medications to control inflammation, prevent flares, and limit long-term organ damage. Because SLE is highly variable and presents differently in each individual, healthcare providers — typically rheumatologists — tailor treatment plans to a patient’s specific symptoms and disease severity.18
Common treatments for SLE can include1:
- Antimalarials.
- Glucocorticoids (often called steroids).
- Immunosuppressive therapies.
- Targeted therapies and biologics.
SLE is a chronic autoimmune disease that can affect multiple organ systems throughout the body (including the kidneys, joints, heart and brain), whereas CLE is a distinct autoimmune skin disease where inflammation is primarily limited to the skin and mucous membranes.20,21
- While up to 80% of people living with SLE will experience skin manifestations,22 CLE can occur completely on its own without any other organ involvement.20
1. Fava A, Petri M. Systemic Lupus Erythematosus: Diagnosis and Clinical Management. J Autoimmun. 2019;96:1-13. doi:10.1016/j.jaut.2018.11.001
2. Tian J, Zhang D, Yao X, Huang Y, Lu Q. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023;82(3):351-356. doi:10.1136/ard-2022-223035
3. Izmirly PM, Parton H, Wang L, et al. Prevalence of Systemic Lupus Erythematosus in the United States: Estimates From a Meta-Analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol. 2021;73(6):991-996. doi:10.1002/art.41632
4. Barber MRW, Falasinnu T, Ramsey-Goldman R, Clarke AE. The global epidemiology of SLE: narrowing the knowledge gaps. Rheumatology. 2023;62(Suppl 1):i4-i9. doi:10.1093/rheumatology/keac610
5. Lewis MJ, Jawad AS. The effect of ethnicity and genetic ancestry on the epidemiology, clinical features and outcome of systemic lupus erythematosus. Rheumatology. Published online December 10, 2016:kew399. doi:10.1093/rheumatology/kew399
6. Ceccarelli F, Govoni M, Piga M, et al. Arthritis in Systemic Lupus Erythematosus: From 2022 International GISEA/OEG Symposium. J Clin Med. 2022;11(20):6016. doi:10.3390/jcm11206016
7. Adamichou C, Bertsias G. Flares in systemic lupus erythematosus: diagnosis, risk factors and preventive strategies. Mediterr J Rheumatol. 2017;28(1):4-12. doi:10.31138/mjr.28.1.4
8. Van Vollenhoven RF, Mosca M, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis. 2014;73(6):958-967. doi:10.1136/annrheumdis-2013-205139
9. Ehrenstein MR, Shipa M. SLE is not a one-size-fits-all disease. J Exp Med. 2023;220(6):e20230559. doi:10.1084/jem.20230559
10. Kawka L, Schlencker A, Mertz P, Martin T, Arnaud L. Fatigue in Systemic Lupus Erythematosus: An Update on Its Impact, Determinants and Therapeutic Management. J Clin Med. 2021;10(17):3996. doi:10.3390/jcm10173996
11. Andreoli L, Bertsias GK, Agmon-Levin N, et al. EULAR recommendations for women’s health and the management of family planning, assisted reproduction, pregnancy and menopause in patients with systemic lupus erythematosus and/or antiphospholipid syndrome. Ann Rheum Dis. 2017;76(3):476-485. doi:10.1136/annrheumdis-2016-209770
12. Touma Z, Hoskin B, Atkinson C, et al. Systemic Lupus Erythematosus Symptom Clusters and Their Association With Patient‐Reported Outcomes and Treatment: Analysis of Real‐World Data. Arthritis Care Res. 2022;74(7):1079-1088. doi:10.1002/acr.24546
13. Furie R, Werth VP, Merola JF, et al. Monoclonal antibody targeting BDCA2 ameliorates skin lesions in systemic lupus erythematosus. J Clin Invest. 2019;129(3):1359-1371. doi:10.1172/JCI124466
14. Furie RA, Bruce IN, Dörner T, et al. Phase 2, randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate-to-severe active systemic lupus erythematosus. Rheumatol Oxf Engl. 2021;60(11):5397-5407. doi:10.1093/rheumatology/keab381
15. Clowse MEB, Isenberg DA, Merrill JT, et al. Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 2026;407(10545):2291-2304. doi:10.1016/S0140-6736(26)00691-4
16. Woo JMP, Parks CG, Jacobsen S, Costenbader KH, Bernatsky S. The role of environmental exposures and gene-environment interactions in the etiology of systemic lupus erythematous. J Intern Med. 2022;291(6):755-778. doi:10.1111/joim.13448
17. Spies E, Andreu T, Hartung M, Park J, Kamudoni P. Exploring the Perspectives of Patients Living With Lupus: Retrospective Social Listening Study. JMIR Form Res. 2024;8:e52768. doi:10.2196/52768
18. Felten R, Sagez F, Gavand PE, et al. 10 most important contemporary challenges in the management of SLE. Lupus Sci Med. 2019;6(1):e000303. doi:10.1136/lupus-2018-000303
19. Kandane-Rathnayake R, Louthrenoo W, Hoi A, et al. ‘Not at target’: prevalence and consequences of inadequate disease control in systemic lupus erythematosus—a multinational observational cohort study. Arthritis Res Ther. 2022;24(1):70. doi:10.1186/s13075-022-02756-3
20. Worm M, Zidane M, Eisert L, et al. S2k guideline: Diagnosis and management of cutaneous lupus erythematosus – Part 1: Classification, diagnosis, prevention, activity scores. JDDG J Dtsch Dermatol Ges. 2021;19(8):1236-1247. doi:10.1111/ddg.14492
21. Kuhn A, Aberer E, Bata-Csörgő Z, et al. S2k guideline for treatment of cutaneous lupus erythematosus – guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV). J Eur Acad Dermatol Venereol. 2017;31(3):389-404. doi:10.1111/jdv.14053
22. Grönhagen CM, Nyberg F. Cutaneous lupus erythematosus: An update. Indian Dermatol Online J. 2014;5(1):7-13. doi:10.4103/2229-5178.126020
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