BIOGEN’S LITIFILIMAB OFFERS NEW HOPE TO PATIENTS WITH LUPUS SKIN DISEASE

Cutaneous lupus erythematosus (CLE), a type of lupus that affects the skin, is a chronic autoimmune disease. People with CLE often experience symptoms such as rashes, skin lesions, pain, photosensitivity, and itchy skin (pruritus). These symptoms can either come and go or worsen over time and become irreversible.

Currently, there are limited treatment options for people with lupus skin disease, with most causing harmful side effects.

Litifilimab (BIIB059) is a new lupus medication developed by Biogen and can potentially alleviate the disease in people with cutaneous lupus erythematosus (CLE).

Read on to learn more about lupus, available medications, and the new lupus drug of 2022 that can help treat people with lupus skin disease.

What Is Lupus?

Lupus is a chronic autoimmune disease characterized by your immune system attacking your own healthy tissues and organs. It causes inflammation that can affect different systems in your body, including your skin, blood cells, joints, lungs, heart, and brain.   

Usually, when your body encounters an invading pathogen (bacteria, viruses, fungi, toxic chemicals) or suffers an injury, it triggers your immune system. Your immune system responds by releasing inflammatory cells and cytokines, which result in inflammation.

However, in patients with lupus, the immune system causes inflammation in healthy tissues in the absence of pathogens or injury.

Lupus symptoms may differ from one patient to another depending on the body part affected by the disease. The most common signs and symptoms of lupus are listed below:

• A rash on the face that can spread across the nose and cheeks in the shape of a butterfly
• Raynaud’s syndrome (fingers and toes turning white or blue when they are cold or when the person is stressed)
• Headaches
• Malaise or extreme tiredness
• Low-grade fevers
• Hair Loss
• Joint pain, stiffness, or swelling (also a common symptom of arthritis)
• Pain in the chest when you take a deep breath

Lupus patients also report experiencing the following symptoms:

• Skin lesions that appear or worsen after sun exposure
• Mouth/nose sores
• Swelling in the hands, feet, or around the eyes
• Sjögren’s syndrome (dryness in the eyes and mouth)

In most people, these symptoms tend to come and go, known as lupus flares.  

There are three forms of lupus in adults:

• Systemic lupus erythematosus (SLE) is the most common form of lupus. It causes inflammation in different organs and systems, including the kidneys, joints, and skin. 

• Cutaneous lupus (lupus of the skin) causes a red, scaly rash on the skin.
• Drug-induced lupus develops after taking certain prescription drugs that cause inflammation around the lungs and joints.

Lupus increases the risk of infections, cancers, bone-tissue death, and pregnancy-related complications.

How Is Lupus Treated?

Treatment of lupus depends on the signs and symptoms the patient is experiencing. Medications most commonly used to manage lupus include the following:

• Antimalarial treatments: Hydroxychloroquine (Plaquenil), a medication used to treat malaria, is often the first-line treatment for patients with lupus. It regulates the immune system, helps improve skin symptoms, and reduces lupus flares. Antimalarial drugs can cause vision problems that may be temporary or irreversible.
• Nonsteroidal anti-inflammatory drugs (NSAIDs): NSAIDs, such as ibuprofen (Motrin IB, Advil) and naproxen sodium (Aleve), may help relieve symptoms associated with lupus, including joint pain and swelling. However, these medications increase the risk of allergic reactions and kidney and heart problems.
• Corticosteroids: Prednisone and other corticosteroids can help reduce inflammation and control systemic lupus. The higher the dose of corticosteroid drugs, the higher the risk of infections, diabetes, cardiovascular problems, and osteoporosis (bone thinning).
• Immunosuppressants: Azathioprine, Methotrexate, and Mycophenolate are medications that suppress the immune system and may help manage serious cases of lupus. Potential side effects of immunosuppressants include an increased risk of infection, cancer, liver damage, and reduced fertility.
• Biologic drugs: Rituximab, Belimumab, and Anifrolumab are biologic therapies that may reduce the symptoms of lupus in some people. They work by blocking the activity of cells involved in the immune system. Biologic drugs may cause diarrhea, nausea, and infections.

The FDA authorized the AstraZeneca medication Saphnelo (Anifrolumab) in 2021 to treat people with moderate to severe systemic lupus erythematosus (SLE) undergoing conventional therapy. It was the first new SLE treatment approved in over ten years. 

Anifrolumab, a human monoclonal antibody, was a first-in-class type I interferon (type I IFN) receptor antagonist – it can inhibit the action of type I interferons which play essential roles in inflammation.

Although Saphnelo does not cure lupus, studies show it effectively reduces SLE disease activity across different body systems. Possible side effects of Saphnelo (Anifrolumab) include serious infections, allergic reactions (hypersensitivity), increased risk of cancer, and bronchitis.

New Lupus Drug In 2022

More recently, scientists at Biogen developed a new lupus medication called Litifilimab (known as BIIB059).

What is Litifilimab?

Litifilimab is an anti-inflammatory medication that is being investigated as a potential treatment for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE).

How does Litifilimab work?

It is a monoclonal antibody that targets BDCA2 receptors found on human immune cells called Plasmacytoid Dendritic Cells (pDCs). 

When Litifilimab binds to these receptors, it inhibits the production of pro-inflammatory molecules, including type-I interferon (IFN-I), that cause inflammation and play a role in the pathogenesis of systemic and cutaneous lupus.

By doing so, this new lupus treatment may help reduce inflammation and improve symptoms in patients living with SLE or CLE. 

Scientific evidence supporting Litifilimab

A randomized clinical trial investigated the safety of single doses of Litifilimab (BIIB059) in patients with systemic lupus erythematosus (SLE).

Each participant received one dose of Litifilimab intravenously, and each patient received a different drug dose.

Side effects of Litifilimab were mild to moderate, and there were no reported serious adverse effects. 

The most commonly reported side effect of Litifilimab was upper respiratory tract infection. Other side effects included the following:

• A headache
• Herpes zoster infection
• Diarrhea
• Nasopharyngitis
• Urinary tract infection

The drug also inhibited the interferon pathway, which is involved in inflammation in the skin and blood of participants. 

The authors concluded that single doses of Litifilimab (BIIB059) were safe for patients with lupus and may have therapeutic potential. 

The New England Journal of Medicine has released the findings of a phase 2 Litifilimab trial including patients with SLE.

Adults with arthritis, SLE, and active skin disease randomly received either Litifilimab at a dose of 450 mg or a placebo.  

Treatment with Litifilimab in patients with SLE significantly reduced swollen and tender joints compared to the placebo over a 24-week timeframe. 

These findings suggest that Litifilimab, Biogen's new lupus medication, can dramatically reduce symptoms in people with systemic lupus erythematosus (SLE).In October 2022, Biogen launched a Global Phase 2/3 AMETHYST study evaluating the efficacy and safety of Litifilimab (BIIB059) in cutaneous lupus erythematosus (CLE) which affects the skin.

They announced administering the first dose of the investigational drug to a patient with CLE.  

Researchers at Biogen hope this clinical trial will offer new hope to people living with lupus who do not have enough effective treatment options for this disease.

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Sources:

• Treatment of systemic lupus erythematosus - PMC
• An Overview of Systemic Lupus Erythematosus (SLE) Pathogenesis, Classification, and Management - PMC
• Cutaneous lupus erythematosus: A review of the literature - PMC
• Lupus: An Overview of the Disease And Management Options - PMC

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