Disease of the Month – Sjögren’s Syndrome

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A rare autoimmune condition, Sjögren’s Syndrome is characterized by dry mouth and eye. The condition affects 0.5 to 1% of the global population of which 90% of patients are women
In this reprise of our Disease of the Month report, we bring an illuminating account of Sjögren’s Syndrome with deep dive analysis of epidemiology, market size, disease management, available therapies, patient advocacy groups, and the key players involved
For a curated report, reach out to us at connect@pharmashots.com

A chronic autoimmune disorder characterized by inflammation of the body's moisture-producing glands, Sjögren’s syndrome shows symptoms like dry mouth and eyes. The condition primarily affects the lacrimal glands and the salivary glands.

Sjögren’s syndrome often coexists with other autoimmune conditions such as lupus and rheumatoid arthritis. It affects mucous membranes and moisture-secreting glands in the mouth and eyes, reducing saliva and tears. Sjögren’s syndrome is typically diagnosed in older women.

Types of Sjögren’s Syndrome^1,2,3,4,6

There are two types of Sjögren’s Syndrome:

Primary Sjögren’s Syndrome: It develops on its own and isn’t caused by another medical condition
Secondary Sjögren’s Syndrome: It is caused by any other medical condition

Symptoms^1,2,3,4,6

The symptoms of Sjögren’s Syndrome are:

Dry Eyes
Dry Mouth
Vaginal Dryness
Dry skin
Dry nose and frequent nosebleed
Dry throat

In addition to dryness, Sjögren’s syndrome can cause other symptoms, including:

Joints pain
Muscle pain or weakness
Swollen lymph nodes
Fatigue
Brain fog
Loss of taste
Tooth decay (cavities) or loss
Skin rashes
Neuropathy
Heartburn or other types of indigestion
Light sensitivity

Causes^1,2,3,4,6

Sjögren’s syndrome can be triggered by other health conditions and viral infections, such as Hepatitis C, CMV, Epstein-Barr, HTLV, and COVID-19. Secondary Sjögren's syndrome can also be caused by autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, and lupus.

Diagnosis^1,2,3,4,6

With symptoms like other medical conditions, it becomes rather difficult to diagnose Sjögren’s syndrome.

There are some tests that help diagnose Sjögren’s syndrome:

Blood test
Ophthalmological tests
Salivary flow rate
Sialo-gram
Salivary scintigraphy
Chest X-ray or CT scan
Skin biopsy with nerve fiber stain
Urine testing
Biopsy

Epidemiology

According to the Cleveland Clinic report, there are approx. 2 million patients in the United States who have Sjögren’s Syndrome.

According to NIH, Sjögren’s syndrome has an incidence of approx. one-half of that of rheumatoid arthritis or affecting 0.5% to 1.0% of the population.

Market Size⁵

The global Sjögren’s Syndrome market size was valued at $242.8M in 2023 and is forecasted to reach a value of $330.9M by 2032 at a CAGR of 3.5% between 2023 and 2032.

Management and Treatment^1,2,3,4,6

The damaged parts of the body determine the course of treatment for Sjögren’s syndrome. Using over-the-counter eyedrops and drinking extra water are common ways that patients with Sjögren’s syndrome can manage their dry mouth and dry eyes. However, some people may require prescription drugs or even surgery.

Prescribed Eyedrops: Restasis (cyclosporine) or Xiidra (lifitegrast) are among the many prescribed eyedrops that help with moderate to severe dry eyes
Saliva-Producing Medications: Salagen (pilocarpine) and Evoxac (cevimeline) are among the many approved saliva-producing medications
Pain Relievers: Over-the-counter pain relievers like nonsteroidal anti-inflammatory drugs (NSAIDs), can help ease pain caused by arthritis symptoms and reduce swellings
Immunosuppressive Medications: Drugs like Plaquenil (Hydroxychloroquine) and Trexall (methotrexate) are among a few safe options that can be prescribed for Sjögren’s syndrome
Surgery: A minor surgical procedure is carried out to cork tear ducts responsible for draining tears from eyes (punctal occlusion)

Some common treatments for dryness in your eyes, mouth, or vagina include:

Artificial tears
Dry eye surgery
Special mouthwash or dental care products
Vaginal moisturizers or lubricants
Hormone therapy

Product Dashboard^7,8

Key Players in the Market¹⁰

Various pharma giants are working to provide treatment for Sjogren’s Syndrome with only Salagen being approved for treating symptoms of dry mouth in Sjogren's syndrome patients.

The table below depicts Salagen’s dosage form, dates of approval, and the company marketing the drug.

Clinical Trial Analysis⁹

As of April 23, 2024, about 96 interventional clinical trials have been registered worldwide for Sjögren’s syndrome

Some of the key molecules involved in the trials are Ianalumab (Novartis), dazodalibep (Amgen), deucravacitinib (BMS), telitacicept (Remegen), efgartigimod (Argenx), AMG-329 (Amgen), iscalimab (Novartis), baricitinib (Eli Lilly), anifrolumab (AstraZeneca).

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 and enrolling by invitation, suspended) and Inactive (withdrawn, terminated, and trials with unknown status).

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

Patient Advocacy Groups (PAGs) for Sjögren’s Syndrome

Patient advocacy for diseases like Sjögren’s Syndrome can be challenging owing to low prevalence, and limited patient care. Though PAGs are dedicatedly working to address the problems of Sjögren’s Syndrome patients and their families.