Immune‑mediated diseases, including autoimmune, autoinflammatory, and allergic conditions, are chronic and can disrupt life for years.1,2 

At Novartis, we are advancing bold science through a diverse and industry-leading pipeline focused on autoimmune, autoinflammatory, and allergic diseases.

We strive to elevate patients’ voices in our research and development. However, the challenges of immune-mediated diseases cannot be solved alone, so we convene with experts across health care, advocacy, and policy, united in a common purpose: offering renewed hope to patients. 

Defining Immune-Mediated Diseases 

Immune‑mediated diseases occur when the immune system becomes overactive or misdirected, responding when there is no real threat and attacking the body’s own tissues.3 Related conditions include: 

  • Autoimmune diseases: The immune system mistakenly attacks healthy tissue, seen in conditions like lupus and Sjogren’s disease.4
  • Autoinflammatory diseases: The immune system causes inflammation without a clear trigger, as in hidradenitis suppurativa (HS).2,5
  • Allergic diseases: The immune system overreacts to harmless substances, leading to conditions like food allergies.6

Immune-Mediated Diseases We Focus On

 

Chronic hives, also called chronic urticaria, is a long-lasting, serious condition marked by recurring episodes of itchy hives and/or deep tissue swelling (angioedema). It affects approximately 5% of the United States population, with women twice as likely to experience it.

There are two main types of chronic hives: chronic spontaneous urticaria (CSU), which occurs with no known external trigger, and chronic inducible urticaria (CIndU), which is caused by a specific trigger.

Understanding the broader experience of patients—including how chronic hives impacts their daily lives, their experience with symptom management, and gaps in knowledge about the condition—drives us to elevate the standard of care with the goal of bringing relief.  

Learn more

People with hidradenitis suppurativa (HS) can experience recurring boil-like bumps on their skin, often in intimate parts of the body. During flare-ups, these boils become inflamed, painful, and may burst, causing odor, leaking wounds, intense pain, and potentially irreversible scarring.

HS can make basic tasks like getting dressed difficult and may be associated with social withdrawal and depression. On average, it can take up to 10 years to receive a correct diagnosis, delaying access to appropriate care.

Building awareness and emphasizing early treatment are essential to ensure patients receive the care they deserve. 

Learn more

For many people, living with the thick, red, scaly patches of skin caused by plaque psoriasis (PsO) can mean a daily struggle with pain, discomfort and even depression. Additionally, plaque psoriasis on the scalp and nails may be a sign of higher risk for developing psoriatic arthritis.

Understanding day-to-day life with this disease, which may affect approximately 8 million American adults, is vital to ensuring those living with PsO are supported

People with psoriatic arthritis (PsA) can have multiple manifestations of the disease causing different problematic symptoms. Pain, stiffness and swelling can occur, and left untreated, lead to irreversible joint damage. People with PsA can sometimes experience skin plaques, which are raised patches of red skin that are thick, scaly, and itchy. There’s a need to help people with PsA find relief from symptoms that can be disabling. 

Waking up in the night because of back pain and being stiff and tired in the morning is a normal experience for people living with axial spondyloarthritis (axSpA), a form of inflammatory arthritis that affects the spine and other joints. By working together, we can help better address the needs of patients with axSpA. 

Sjogren’s disease (SjD) is a serious, autoimmune disease that can be progressive and may affect up to 4 million people in the U.S.— nine out of 10 women. While hallmark symptoms like dry eyes, dry mouth, fatigue, and joint pain are commonly recognized, SjD can also impact the entire body, including potential organ damage. 

Everyone’s experience with SjD is different, but many face physical, emotional, and economic burdens that often go unseen. Given the significant unmet need, accelerating the development of new treatment options is essential.

Learn more

Immunology by the Numbers

50M
Americans

50 million Americans have at least one autoimmune condition⁷

80%
of patients are women

Autoimmune diseases can disproportionately impact women, adding financial and social burdens⁸

~10
Years

People can wait up to 10 years for a diagnosis⁹

The Immune System: What Happens When It Gets Out of Balance 

The immune system is made up of several organs and cells, including white blood cells and proteins that work together to keep us healthy by10:

  • Stopping germs from getting in 
  • Fighting germs like bacteria and viruses 
  • Helping us heal if we get hurt or sick 

A healthy immune system can tell the difference between our body’s own cells and harmful threats.4

So, what happens when the immune system gets out of balance? It may go…

FromTo 
Detecting harmful threats, like viruses and bacteria4Responding to no real threats or targeting the wrong thing4
Activating only when needed, and calming down after a threat is gone4Overreacting or staying active for too long4
Helping protect healthy tissue4Causing chronic inflammation and/or attacking the own body4

Understanding why and how the immune system reacts in immune-mediated diseases is critical to evolving the approach to management and treatment. 

The Role of B Cells 
Close-up of pink liquid-filled pipette, lab setting implied.

B cells are white blood cells that help the body spot threats (like viruses and bacteria) and make antibodies fight them. They are essentially our immune system’s intelligence gatherer.11

Sometimes, B cells can mistakenly direct attacks towards healthy tissue. This can lead to autoimmune diseases such as lupus and systemic sclerosis—which is why these conditions are often called B-cell–driven diseases.12 

How T Cells Direct Immune Response 
A test tube rack on a microbiology lab bench.

T cells are another type of white blood cell. They may alert the B cells to identify and attack infected, foreign, or other dangerous cells.11

In some immune‑mediated diseases, T cells may stop working the right way. This can lead to ongoing inflammation and damage to healthy tissue.13 

However, research is exploring ways in which some types of T cells can help reset the immune system in situations where it may be wrongfully attacking the body.11,13 

Differentiating IgE and IgG Antibodies
Artistic rendering of immune response.

Antibodies are proteins produced by B cells that help neutralize or tag threats for destruction. Two important types of antibodies are immunoglobulin E (IgE) and immunoglobulin G (IgG).11 

IgE is linked to fast immune reactions to defend against parasites and external allergens and other toxins, while IgG is associated with a slower inflammatory response and long-term immunity.14

As with other elements in the immune system, both IgE and IgG antibodies can overreact, causing autoinflammatory and allergic diseases—triggering histamine release, ongoing inflammation and even anaphylaxis.15 

Shaping What’s Next in Immunology

Advancing immunology requires understanding the immune system, patient experiences, and barriers that stand in the way of better care.

Christy Siegel, SVP & US Therapeutic Area Head, Immunology, shares how Novartis is advancing bold science for people with immune-mediated diseases.

Learn more about what drives Christy’s leadership in immunology, and the work we are doing across the health care ecosystem.

Immunology: The Patient POV

Patient stories bring the lived experience of immune-mediated diseases to life. They reveal what life is really like for people navigating diagnosis, symptoms, and treatment—offering insights that help advance research and reduce barriers to care. By elevating patient voices, we deepen understanding, strengthen connections, and inspire hope for others.
sjogrens-disease-patient-tina-after-speaking-at-a-health-care-meeting-in-austin--texas

Living with Sjogren's: Tina's Story

Tina’s Sjogren’s diagnosis brought clarity after years of symptoms, inspiring her to raise awareness of this often-overlooked autoimmune disease.
HS patient, Katy, smiling at the camera.

Katy’s Path to Purpose

Katy transformed her painful journey with hidradenitis suppurativa (HS) into advocacy, building community and raising awareness for a condition often misdiagnosed.

Frequently Asked Questions in Immunology

What is the immune system and how does it work? 

Immunology is the field of medicine that studies the immune system—the organs and cells involved in protecting the body against infection and disease—and how it can become overactive or misdirected.16  

When the immune system responds appropriately, it helps keep us healthy. When it does not, it can trigger immune‑mediated diseases.1

This field examines how the immune system finds and fights against threats like infections, diseases, and foreign substances. Immunology also explores how the immune system sometimes becomes overactive or misdirected, responding when there is no real threat and attacking the body's own tissues.1,16

The complement system is part of the immune system’s first line of defense. When activated, the complement system targets foreign invaders, causing inflammation to prevent infection, and signaling other immune cells to respond. However, if the complement system becomes imbalanced, it can contribute to harmful inflammation or make it harder to fight infections.17 

The immune system is made up of several parts that work together to keep us healthy, including10,17: 

  • White blood cells: The immune system's primary defenders; these cells attack and eliminate harmful intruders  
  • Antibodies: Proteins that help identify and tag threats so other cells can destroy them 
  • The complement system: Proteins that serve as the front line of defense for the immune system—cleaning up damaged cells, helping the body heal after injury or infection, and destroying germs

What may trigger immune-mediated diseases? 

Genetics, environmental triggers, and other factors are thought to play a role in autoimmune and inflammatory diseases in which the immune system loses the ability to differentiate between harmful invaders and healthy tissue. As a result, it mistakenly attacks the body’s own cells, leading to inflammation and tissue damage.4,13 

Yes. Many immune-mediated diseases have a genetic component, which means some people are born with a higher risk. However, genetics are usually not the only factor involved, as environmental factors, along with other risk factors, may also help trigger disease onset.4  

Lifestyle factors like smoking and the use of other tobacco products have been linked to an increased risk of autoimmune diseases.4  

Nutrition is also thought to play a role. Several minerals and vitamins are involved in regulating immune responses; and there are some studies exploring the role specific nutrients and diets may play in immune function, autoimmunity, and patient outcomes. Similarly, physical activity, stress, and other lifestyle factors are also being studied for their potential role.4,8,10,18 

Exposure to certain chemicals, viruses, germs, and other environmental triggers may also increase the risk of immune-mediated diseases—especially in people with genetic susceptibility.4 

Women make up approximately 80% of people living with autoimmune diseases. While the exact cause is still under investigation, researchers believe this may be related to stronger immune responses influenced by hormones.8,19 

Diagnoses of immune-mediated diseases, including autoimmune conditions, are on the rise, and researchers believe several factors contribute4:   

  • More awareness and research in the field of Immunology may support doctors in better recognizing autoimmune disease symptoms
  • Increased environmental exposures to certain chemicals or viral infections (eg, COVID-19) may activate the immune system 
  • Changing lifestyle habits may increase the risk of developing autoimmune diseases 

Immune-mediated diseases affect a large and growing portion of the population.1,4 Novartis is working to understand why, which may lead to better prevention, earlier diagnosis, and more effective treatment. 

How are immune-mediated diseases diagnosed? 

Autoimmune and autoinflammatory diseases are difficult to diagnose because symptoms frequently overlap with other conditions, and diagnosis often requires a combination of clinical assessment, laboratory testing, and other evaluations rather than a single definitive test. Patients may also need to see several doctors and undergo tests for several different conditions before receiving an accurate diagnosis.4,10,20,21

Physicians use several different diagnostic tools when evaluating patients for autoimmune and autoinflammatory diseases, including2,4: 

  • Physical exam and health history review, including whether any biological family members have immune-mediated diseases  
  • Blood tests which look for specific markers or clues the immune system leaves behind after damaging the body or causing specific issues  
  • Imaging tests, including X-rays, magnetic resonance imaging (MRI), computed tomography (CT) scans, and ultrasounds 

Patients often start with a primary care physician (PCP). PCPs play an important role in recognizing early warning signs, ordering initial tests, and referring patients to specialists, like21:  

  • Rheumatologists: Focus on autoimmune diseases (eg, lupus) and conditions affecting the joints, muscles, and connective tissue 
  • Dermatologists: Treat immune-mediated skin conditions (eg, hidradenitis suppurativa, chronic hives) 
  • Allergists/Immunologists: Treat immunodeficiencies (weakened immune system) and allergy-related conditions

The right specialist depends on what type of immune-mediated disease is suspected. Even after a diagnosis, many patients end up working with several specialists to care for their disease and potential complications.  

How do immune-mediated diseases impact patients’ lives? 

Given the diversity of immune-mediated diseases and that some of them can manifest differently in each patient, symptoms vary significantly. However, potential early warning signs include2,4,17: 

  • Persistent fatigue that does not improve with rest 
  • Joint pain, stiffness, or swelling 
  • Muscle weakness 
  • Skin redness, rashes, lesions, or unusual discoloration 
  • Stomach pain or changes in bowel habits 
  • Vision changes 

Many immune-mediated diseases cause symptoms that come and go.2,4 Keeping track of when symptoms occur, what makes them better or worse, and how they affect daily life can help support conversations with your doctor.  

Yes, many of these conditions are chronic, meaning they require ongoing management, and without proper treatment, they may progress and cause life-threatening complications. The biggest risks include organ damage, severe inflammation, and infections.1,4,17  

Early diagnosis and intervention are critical to reducing risks.10

Disease activity refers to how strong a person’s symptoms may be at any given time. Because many autoimmune diseases are chronic, long-lasting conditions, disease activity is rarely constant and tends to fluctuate between two states.4,22,23  

  • Flares: Periods when symptoms become more noticeable or more severe. During a flare, disease activity may increase, causing increased inflammation and damage to healthy tissue  
  • Remission: Periods when symptoms are minimal or absent. Remission is not the same as being disease-free, since the underlying condition is still present 

Monitoring disease activity is important for managing an autoimmune condition and helps guide care decisions.  

Yes, for example, having one autoimmune disease can increase the chance of developing another. In fact, about one in three patients live with more than one autoimmune condition.24  

Our Pipeline

With one of the most robust immunology pipelines, we’re advancing 20+ trials—from small molecules to CAR-T—for patients with limited options.

Learn more

Additional Resources

Products

Clinical Trials

Investigator Initiated Trials

Other Therapeutic Areas

senior patient with healthcare professional

Cardiovascular, renal and metabolic

Transforming how the world tackles cardiovascular disease and delivering new treatments for people with chronic kidney diseases.
smiling patient and two healthcare professionals

Oncology

Combining the power of science and empathy to unravel the inner workings of cancer and develop innovative therapies that restore hope to those with cancer and their loved ones.
nurse and patient exchanging warm moment

Neuroscience

Creating a transformational impact for people living with severe neurological conditions and their caregivers by discovering, developing and delivering innovative medicines that change the course of disease progression.
  1. Xie W-W, Huang J-B, Zhou Y-C, et al. The immunobiology and therapeutic potential of regulatory T cells in autoimmune diseases and allergic diseases. Front Immunol. 2026;16:1709915. doi:10.3389/fimmu.2025.1709915
  2. Autoinflammatory Alliance. Learn Autoinflammatory Syndromes. Accessed April 1, 2022. https://www.nomidalliance.org/learn_intro.php
  3. Williams JP, Meyers JA. Immune-mediated inflammatory disorders (I.M.I.D.s): the economic and clinical costs. Am J Manag Care. 2002;8:S664-S681.
  4. Cleveland Clinic. Autoimmune Diseases. Accessed March 4, 2025. https://my.clevelandclinic.org/health/diseases/21624-autoimmune-diseases
  5. Nikolaikis G, Kaleta KP, Vaiopoulos AG, et al. Phenotypes and pathophysiology of syndromic hidradenitis suppurativa: different faces of the same disease? A systematic review. Dermatology. 2021;237:673-697.doi:10.1159/000509873
  6. Food Allergy Research & Education (FARE). Food Allergy Facts and Statistics for the U.S. Accessed April 2024. https://www.foodallergy.org/sites/default/files/2024-07/FARE%20Food%20Allergy%20Facts%20and%20Statistics_April2024.pdf
  7. American Autoimmune Related Diseases Association (AARDA); National Coalition of Autoimmune Patient Groups (NCAPG). The Cost Burden of Autoimmune Disease: The Latest Front in the War on Healthcare Spending. 2011. Accessed January 21, 2021. https://www.aarda.org (redirects to https://autoimmune.org/)
  8. Goulmamine S, Chew S, Aninye IO. Autoimmune health crisis: An inclusive approach to addressing disparities in women in the United States. Int J Environ Res Public Health. 2024;21(10):1339. doi:10.3390/ijerph21101339
  9. CreakyJoints. How Long Does It Actually Take to Get Diagnosed with an Autoimmune Disease? CreakyJoints website. Accessed June 25, 2026. https://creakyjoints.org/research/getting-diagnosed-with-autoimmune-disease/
  10. Cleveland Clinic. Immune System. Accessed August 20, 2025. https://my.clevelandclinic.org/health/body/21196-immune-system
  11. National Institute of Allergy and Infectious Diseases (NIAID). Immune Cells. Accessed June 25, 2026. https://www.niaid.nih.gov/research/immune-cells
  12. Hampe CS. B Cells in autoimmune diseases. Scientifica (Cairo). 2012;2012:215308. doi:10.6064/2012/215308
  13. Wu D, Xu-Monette ZY, Zhou J, et al. Front Immunol. 2025;16:1613878. doi:10.3389/fimmu.2025.1613878
  14. Justiz Vaillant AA, Jamal Z, Ramphul K. Immunoglobulin. In: StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing; 2022. Accessed August 7, 2022. https://www.ncbi.nlm.nih.gov/books/NBK513460/
  15. Kanagaratham C, El Ansari YS, Lewis OL, Oettgen HC. Front Immunol. 2020;11:603050. doi:10.3389/fimmu.2020.603050
  16. Encyclopaedia Britannica. Immunology. Encyclopaedia Britannica. 2025. Accessed August 10, 2026. https://www.britannica.com/science/immunology
  17. Cleveland Clinic. Complement System. Accessed November 12, 2022. https://my.clevelandclinic.org/health/body/23370-complement-system
  18. Betts JG, Young KA, Wise JA, et al. Chapter 24: Metabolism and Nutrition. In: Anatomy & Physiology 2e. OpenStax; 2022. Accessed September 29, 2026. https://openstax.org/books/anatomy-and-physiology-2e/pages/24-introduction
  19. Desai MK, Brinton RD. Front Endocrinol. 2019;10:265. doi:10.3389/fendo.2019.00265
  20. Global Autoimmune Institute. Misdiagnosed & undiagnosed: expert insights on the autoimmune diagnosis process. Global Autoimmune Institute Website. 2024. Accessed August 25, 2026. https://globalautoimmuneinstitute.org
  21. Global Autoimmune Institute. Autoimmune Disease Specialist Spotlight. Global Autoimmune Institute Website. Accessed June 25, 2026. https://www.autoimmuneinstitute.org/articles/autoimmune-disease-specialist-spotlight/
  22. Global Autoimmune Institute. Outbursts in Autoimmunity: Disease Flare Ups. Global Autoimmune Institute Website. 2025. Accessed August 25, 2026. https://globalautoimmuneinstitute.org
  23. Elkoshi Z. New insights into the phenomenon of remissions and relapses in autoimmune diseases and the puzzle of benign autoantibodies in healthy individuals. Front Immunol. 2025;16:1522356. doi:10.3389/fimmu.2025.1522356
  24. Abend AH, He I, Bahroos N, et al. Estimation of prevalence of autoimmune diseases in the United States using electronic health record data. J Clin Invest. 2025;135(4):e178722. doi:10.1172/JCI178722