The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy status to litifilimab after a study showed it reduced skin disease activity by up to 48 percent in people living with cutaneous lupus erythematosus (CLE), a chronic skin condition with limited treatment options.

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Breakthrough therapy status is a special FDA designation meant to speed up the development and review of drugs that show early promise for serious conditions. It does not mean the drug is approved or proven to work. For people with CLE, this is an important step because there are no FDA-approved treatments specifically for CLE skin symptoms.

What Is Litifilimab, and How Does It Work?

Litifilimab is an investigational drug — not yet approved — that targets a protein called BDCA2, found on certain immune cells. In people with CLE, these cells are believed to help drive the inflammation that leads to rashes, pain, itching, and, in some cases, permanent skin damage or scarring. By binding to BDCA2, litifilimab helps reduce the production of inflammatory molecules that contribute to these symptoms.

Litifilimab is given as a subcutaneous injection — it’s injected just under the skin.

What Is the Breakthrough Designation Based On?

The FDA’s decision was based on results from a phase 2 clinical trial involving 132 adults with CLE, with or without systemic lupus. Participants received one of three doses of litifilimab or a placebo.

The main finding was that people who got a 150-milligram dose of litifilimab had a 47.9 percent improvement in skin disease activity after 16 weeks, measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity scale. This result was 33.4 percentage points higher than what was seen with placebo. Participants who took other dosages of litifilimab also showed significant improvements.

Side Effects: What’s Known So Far

Like all medications, litifilimab may cause side effects. In the clinical trial, the most common side effects included:

• Nasopharyngitis (cold symptoms)
• Headache
• Injection-site discoloration
• Joint pain
• Itching
• Upper respiratory infections, including influenza

Some people developed oral herpes infections and, in rare cases, herpes zoster (shingles). Most side effects were mild or moderate, but larger and longer studies are underway to better understand litifilimab’s safety.

What This Means for People Living With Cutaneous Lupus Erythematosus

CLE can be painful, cause visible skin changes, and have a major impact on emotional well-being. Many people don’t fully respond to current therapies, which aren’t designed specifically for CLE. Litifilimab’s breakthrough therapy status is an encouraging step, indicating that the FDA sees strong potential in this targeted treatment to improve daily life for people with CLE. For some, it could eventually help change the course of the disease.

Litifilimab is still under investigation and not approved for general use. Phase 3 clinical trials are ongoing, and it may take time before the treatment becomes widely available.

If you’re living with CLE, it can be helpful to know that new treatments are on the horizon. If you have questions about your options or are interested in clinical trials, talk with your healthcare provider. They can help you weigh the potential risks and benefits and decide what’s right for you.

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On MyLupusTeam, people share their experiences with lupus, get advice, and find support from others who understand.

Do you experience skin symptoms with lupus? Have you been diagnosed with CLE? Let others know in the comments below.