Disease of the Month – Systemic Lupus Erythematosus

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Systemic lupus erythematosus (SLE) is an autoimmune disorder where the body's immune system targets and damages healthy tissues
In this reprise of our Disease of the Month report, we present an enlightening description of SLE with a thorough study of epidemiology, market size, disease management, potential medicines, patient advocacy groups, and the key players involved
For a deep dive landscape, reach out to us at connect@pharmashots.com

Introduction

SLE is a chronic autoimmune disorder characterized by the body’s immune system attacking its tissues and organs. This immune dysregulation leads to widespread inflammation and damage affecting various body systems, including the skin, joints, kidneys, heart, lungs, brain, and blood vessels. Regardless of advances in SLE therapies, it poses significant morbidity and mortality.

SLE is one of the most common types of Lupus. Other types of Lupus include:

Cutaneous Lupus Erythematous: Lupus that affects only skin
Drug-Induced Lupus: Some medicines can lead to lupus symptoms as side effects. It is temporary, and the symptoms might stop after discontinuing such medicines
Neonatal Lupus: Babies can sometimes be born with Lupus. This happens when autoantibodies from mothers with Lupus cross the placenta. Not all babies born are diagnosed with Lupus, but a minor 2 percent can be at risk of getting affected with neonatal Lupus

Symptoms ^3,4

Symptoms of SLE may vary from person to person. Some of the common symptoms are:

Chest Pain
Fatigue, Fever, Weight Loss
Hair Loss
Mouth Sores
Swollen Lymph Nodes
Joint Pain and Swelling

Other symptoms based on the affected body part include:

Neurological: Headaches, weakness, numbness, seizures, vision problems, memory and personality changes
Gastrointestinal: Abdominal pain, vomiting, nausea
Heart: Inflammation in heart muscle or heart lining (pericardium)
Lung: Fluid accumulation in the pleural space, difficulty breathing, coughing up blood
Dermatological: Malar (butterfly) rash
Circulation: Clots in veins or arteries, inflammation of blood vessels, narrowing of arteries in response to cold (Raynaud’s phenomenon)
Hematological: Anemia, low WBCs or platelet count

Some of them may only show skin symptoms known as discoid lupus.

Causes ^3,4

The exact cause of SLE isn’t known, but several factors contribute to the disease.

Genetics: SLE is not associated with a specific gene, but people suffering from lupus have a family history of other autoimmune disorders
Environmental Factors: Exposure to certain factors such as UV rays, certain medications, viruses, physical or emotional stress, and trauma
Sex and hormones: SLE is more prevalent in women. They may face more intense symptoms during pregnancy and menstrual periods

Diagnosis ^3,4

The diagnosis of SLE relies on both clinical observations and laboratory test results.

Laboratory Tests:
- Autoantibodies: ANA (positive in >95% of SLE patients), anti-dsDNA, anti-Smith (Sm) antibodies
- Blood Tests: Complete blood count (CBC) for anemia, leukopenia, thrombocytopenia
- Urinalysis: To detect proteinuria and hematuria, indicating kidney involvement
Imaging and Biopsy: Renal biopsy may be necessary to assess the extent of lupus nephritis

Management and Treatment ^4,5

Currently, SLE has no cure, but its symptoms can be managed through available treatment:

NSAIDs: To treat inflammation and joint pain
Steroids: Corticosteroids to treat inflammation
Antimalarials: To reduce cholesterol and control kidney conditions. It can be used in addition to steroid creams for skin rashes
Disease-Modifying Anti-Rheumatic Drugs (DMARDs): to suppress the effects of an overactive immune system
Anticoagulants: Anticoagulants like Warfarin (Coumadin) are utilized for clotting disorders, such as antiphospholipid syndrome

Epidemiology ^6,7

Prevalence: SLE affects approximately 20 to 150 people per 100,000 worldwide, with varying rates depending on the population and region
Gender: The disease predominantly affects females, with a female-to-male ratio of about 9:1. It is most common in women of childbearing age (15-45 years)

Market Size ⁸

In 2023, the global SLE market size was valued at $2.7B and is estimated to reach $5.1B by 2032 registering a CAGR growth of 7.6% between 2024 and 2032.

Product Dashboard ⁹

Benlysta (BAFF inhibitor) is the only FDA-approved treatment designed to target BLyS/BAFF, an underlying cause of lupus and lupus nephritis:

Key Players in the Market

Clinical Trial Analysis ¹⁰

Based on the geographical distribution, the interventional and industry-sponsored clinical trials are classified in the below-mentioned graph into two groups based on their status: Active (recruiting; active, not recruiting; not yet recruiting; enrolling by invitation and suspended) and Inactive (withdrawn; terminated and trials with unknown status).

The maximum number of active trials is being conducted in the US, China, Spain, South Korea, France, Canada, Australia, UK, Italy, and Germany (as represented in the graph).

Patient Advocacy Groups (PAGs) for SLE

Several advocacy groups are working industriously to help improve the lives of patients with Systemic Lupus Erythematosus.

Patient Stories ^{11, 12}

1. Kacey C.

I was told when I was 14, I would have a stroke by 28 years old because of the symptoms my body was starting to produce. Unbeknownst to me at the time it was lupus. Officially diagnosed at 17 yrs. old, I made it to 29 years old before that stroke came. Through my twenties, what felt like a death sentence, I struggled with excruciating muscle pain, swelling and an assortment of internal ups and downs all the while trying to carve a life out in this world that everyone tells you at that age “the world is your oyster”.

The reality with lupus is that it’s really no oyster, it can be a dark abyss, that circles you like a shark. Every day you have to choose to find energy and light your own way, navigating unclear paths through what feels like squinted eyes. It’s hard for me to even admit I have it, to admit its existence gives it life, gives it energy I’m not willing to provide. I’ve hidden it as best I could for 18 years now. I did this because well I don’t look like a lupus patient. I’m lucky in ways. My skin isn’t as affected as many. I carry almost a guilt about it, not saying I don’t have skin issues, but they aren’t as prevalent as some.

All I ever wanted was to be normal, to not have my dreams taken away little by little, to do things I want to do. I live for everything. I’m always trying to be active, summers I fly fish, hike, and yes, I hunt. Winters I go downhill, backcountry, cross country ski, ice skating. I live in a cabin in the woods where I chop all my own wood. I plow my driveway; I wake up in below freezing temps to walk my dog even though I know no amount of bundling and hand warmers and heated vests will stop the Raynaud’s from painfully nipping me the entire way. It’s hard to admit you have lupus. It’s harder to live like you don’t have it. I’m starting after 18 years to admit I do but in between the major battles, I’m winning and every time an episode arises, I feel more ready to take it on because I know I’m truly living despite that shark that circles.

2. Caitlyn E

At 17, my life took an unexpected turn with the diagnosis of rheumatoid arthritis. Overnight, I transformed from a carefree teenager into a patient grappling with chronic pain and fatigue. As I navigated high school, I faced not only the physical challenges of my condition but also the judgment from those who couldn't see my invisible disability.

My health journey was far from over. A subsequent diagnosis of lupus added another layer of complexity to my daily struggles. Managing multiple chronic conditions became a delicate balancing act, each day a new challenge in pain management and maintaining normalcy.

Just as I was adapting to this new reality, my body had other plans. Inexplicably, I faced paralysis from the waist down. For a year, I underwent countless medical examinations as doctors struggled to understand my condition. Through sheer determination, I taught myself to walk again, an experience that became a powerful metaphor for my life's journey.

At 25, another blow came with a diagnosis of Avascular Necrosis, necessitating immediate hip replacement surgery. Finding a surgeon willing to perform such a procedure on someone my age was a three-year odyssey, during which I faced not only physical pain but also financial strain and social isolation. It took 3 times to get accepted for disability, and 5 years awaiting a trial.

Today, at 29, I've returned to my studies at California State University, Sacramento, with a renewed sense of purpose. My experiences have not only shaped my resilience but have also ignited a passion for understanding the human mind and its capacity for overcoming adversity. As I pursue my bachelor's degree in psychology, I continue to manage my health, including preparing for upcoming hip and knee replacements. As I continue to navigate life with chronic illness, I carry with me the knowledge that our challenges don't define us – our response to them does.

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