Disease Areas
Cutaneous Lupus Erythematosus (CLE)
Cutaneous Lupus Erythematosus
What is cutaneous lupus erythematosus (CLE)?
CLE is a distinct and serious chronic autoimmune skin disease that occurs when the body’s immune system mistakenly attacks healthy skin tissue instead of protecting it. This leads to irreversible and disfiguring scars, inflammation, hair loss and rashes, most often on areas of the body that get the most sun.1 It is different from systemic lupus erythematosus (SLE), because the active inflammation is primarily limited to the skin.
CLE can also cause invisible symptoms in the form of emotional distress or depression2 and can significantly impact a person’s quality of life.3 Research has suggested these symptoms in people with CLE are as severe as those in people with diabetes or recent heart attack.4
There are currently no targeted treatments for CLE. Biogen is working to advance a lupus-focused pipeline, with potential to become the first company to offer a targeted treatment option for CLE.
CLE Facts and Figures
2M
About 2 million people worldwide are estimated to live with CLE.5
3‑5X
Black individuals experience CLE 3 to 5 times more often than white individuals.4
Understanding CLE
What are the symptoms of CLE?
The symptoms of CLE are both visible and invisible, as they can be physically and emotionally painful.
Common symptoms may include:
- Rashes and disfiguring scars: Usually appearing on sun-exposed areas like the face, neck, scalp, and hands.1,4
- Pain and itching: Active skin sores can burn, itch, or feel highly tender to the touch.6
- Extreme sun sensitivity: Even brief exposure to sunlight can trigger a painful flare or make existing rashes worse.4
- Permanent skin damage: Inflammation can potentially lead to permanent scars, dark or light skin patches (color changes), or cause hair loss.4,7
- Distress: Feelings of self-consciousness about personal appearance due to skin damage, which can lead to a sense of emotional and social isolation.2
- Depression: A sense of helplessness due to the chronic nature and incurability of the disease.2
Why are new treatment options needed for CLE?
Currently, there are no targeted treatments approved for CLE.4 Instead, doctors must rely on non-specific treatments and lifestyle recommendations, including:
- Sun protection.4
- Steroid creams or ointments.4
- Antimalarial pills (like hydroxychloroquine).4
Despite these options, many people with CLE face uncontrolled flares and ongoing skin damage.
"CLE not only leaves scars but can also have a profound emotional and social impact on those living with the disease. With no approved targeted disease-modifying treatments, options for people living with CLE are very limited. We're committed to advancing research aimed at impacting patient outcomes for diseases where options are limited or nonexistent."
Daniel Quirk, M.D., Chief Medical Officer 
Our Clinical Studies for CLE
Discover all Biogen clinical studies in lupus
Biogen conducts clinical studies in CLE 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 has been dedicated to lupus research for over twenty years and is working to advance modern, targeted options.
At Biogen, we see CLE as its own, separate condition with its own need for targeted treatments. Our goal is to develop treatment options that can target skin inflammation early, decreasing or preventing damage before it starts.
In people with CLE, specific immune cells called plasmacytoid dendritic cells (pDCs) move into the skin and become overactivated. When this happens, they release too many inflammation-causing proteins, which can lead to painful skin rashes and damage. A protein called BDCA2 (Blood Dendritic Cell Antigen 2) acts as a receptor on the surface of these pDCs and when activated, decreases production of these inflammation-causing proteins. By targeting the BDCA2 receptor, pDCs may stop driving the inflammation that damages the skin in patients with CLE.4,8
We do not fully understand why some people get CLE, but we know it is triggered by a combination of genetics and environment — especially exposure to sunlight and ultraviolet (UV) rays.4
Our immune cells protect us from germs, but in people with CLE, certain immune cells travel to the skin and become overactive. Once there, they release too many inflammatory proteins, setting off a continuous cycle of inflammation and skin damage.10
If active CLE inflammation is left untreated, it can cause irreversible damage to the tissue. This can leave behind permanent scars, uneven dark or light skin patches, and cause permanent hair loss (alopecia). Seeking early care is critical to prevent permanent damage.4,7
Systemic lupus erythematosus (SLE) is a disease that can affect organs throughout the whole body (like the kidneys, joints, and heart). CLE is a distinct disease where active inflammation is primarily limited to the skin.11,12 In some cases, CLE can progress to SLE.
While anyone can develop CLE, it is much more common in women.4 It also disproportionately affects people of color — specifically Black and Hispanic individuals — who often experience more severe skin symptoms and face greater barriers to receiving timely care from a dermatologist.4,13
Diagnosing CLE can be challenging because its symptoms often look like other skin conditions. A dermatologist will typically examine the skin and may perform a skin biopsy to confirm the diagnosis.14,15
Unfortunately, there are no approved targeted therapies specifically for CLE.
People with CLE have historically had to rely on topical steroids and antimalarial medications.4 These treatments often provide only temporary symptom relief, can carry significant side effects, and are not always effective, highlighting a major need for targeted CLE treatments.4
1. Okon LG, Werth VP. Cutaneous lupus erythematosus: Diagnosis and treatment. Best Pract Res Clin Rheumatol. 2013;27(3):391-404. doi:10.1016/j.berh.2013.07.008
2. Drenkard C, Theis KA, Daugherty TT, et al. Depression, stigma and social isolation: the psychosocial trifecta of primary chronic cutaneous lupus erythematosus, a cross-sectional and path analysis. Lupus Sci Med. 2022;9(1):e000697. doi:10.1136/lupus-2022-000697
3. Ogunsanya ME, Cho SK, Hudson A, Chong BF. Factors associated with quality of life in cutaneous lupus erythematosus using the Revised Wilson and Cleary Model. Lupus. 2020;29(13):1691-1703. doi:10.1177/0961203320951842
4. Klein B, Billi A, Abernathy-Close L, Kahlenberg JM. Cutaneous Lupus Erythematosus – From Pathogenesis to Targeted Therapy. Nat Rev Rheumatol. 2025;21(12):703-718. doi:10.1038/s41584-025-01318-6
5. Hocaoğlu M, Davis MDP, Osei-Onomah SA, et al. Epidemiology of Cutaneous Lupus Erythematosus Among Adults Over Four Decades (1976-2018): A Lupus Midwest Network (LUMEN) Study. Mayo Clin Proc. 2022;97(12):2282-2290. doi:10.1016/j.mayocp.2022.06.022
6. Ogunsanya ME, Brown CM, Lin D, Imarhia F, Maxey C, Chong BF. Understanding the disease burden and unmet needs among patients with cutaneous lupus erythematosus: A qualitative study. Int J Womens Dermatol. 2018;4(3):152-158. doi:10.1016/j.ijwd.2018.01.002
7. Childs B, Merola JF. From the Masterclasses in Dermatology 2025 Meeting: Practical Approaches to Cutaneous and Systemic Lupus for Dermatologists. J Clin Aesthetic Dermatol. 2025;18(10):40-47.
8. Wenzel J. Cutaneous lupus erythematosus: new insights into pathogenesis and therapeutic strategies. Nat Rev Rheumatol. 2019;15(9):519-532. doi:10.1038/s41584-019-0272-0
9. Lin A, Wakhlu A, Connelly K. Disease activity assessment in systemic lupus erythematosus. Front Lupus. 2024;2. doi:10.3389/flupu.2024.1442013
10. Werth VPP, Rönnblom L, Wenzel J, et al. Plasmacytoid dendritic cells in systemic and cutaneous lupus erythematosus: an evolving understanding. Front Immunol. 2026;17. doi:10.3389/fimmu.2026.1807771
11. 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
12. 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
13. Izmirly P, Buyon J, Belmont HM, et al. Population-based prevalence and incidence estimates of primary discoid lupus erythematosus from the Manhattan Lupus Surveillance Program. Lupus Sci Med. 2019;6(1):e000344. doi:10.1136/lupus-2019-000344
14. What Is Cutaneous Lupus? Cleveland Clinic. October 25, 2024. Accessed July 30, 2026. https://my.clevelandclinic.org/health/diseases/21601-cutaneous-lupus-skin-lupus
15. Lupus and Skin Rashes. Lupus Foundation of America. February 8, 2024. Accessed July 30, 2026. https://www.lupus.org/resources/lupus-and-skin-rashes
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