Learn More About Lupus Research Studies

What Are Lupus Research Studies?

Lupus is a long-term chronic disease that causes inflammation, joint pain, skin rashes, and tiredness in any body part. It is an autoimmune disease which means our immune system, which normally protects our body from infection and disease, attacks its own tissues. These attacks usually lead to inflammation but can also cause permanent tissue damage in various body parts, such as kidneys, blood cells, the brain, lungs, joints, etc.

There are 4 different types of lupus, and generally, when people talk about it, they mean systemic lupus erythematosus (SLE), the most common form of lupus. Aside from this, the other 3 types include; cutaneous lupus (limited to the skin), drug-induced lupus (a lupus-like disease caused by certain prescription drugs), and neonatal lupus (a rare condition that affects infants of women who have lupus).

Systemic lupus erythematosus is a serious health condition whose symptoms range from mild to life-threatening. Patients with lupus may experience periods of illness (flares) and periods of wellness (remission). Lupus flares can be mild to serious, and they are unpredictable. However, with treatment, many people with lupus can manage the disease.

Despite the advances in technology and research, It is believed that between 10-15 percent of people with lupus will die prematurely due to complications of lupus. Many factors contribute to this statistic, for instance, the cause of lupus is unknown, and thus, it is difficult to diagnose. Since it is an autoimmune disease, its symptoms can match other similar conditions. However, lupus is not contagious and is thought to have developed in response to certain hormones (like estrogen) or environmental triggers.

According to the Lupus Foundation Of America, a majority (63%) of people with lupus surveyed report being incorrectly diagnosed. More than half of those who are reporting incorrect diagnoses (55%) report seeing four or more different healthcare providers for their lupus symptoms before being accurately diagnosed. Thus, the lack of diagnostic tests and limited treatment options make lupus research studies a particular area of interest.

Why Is Lupus Being Studied Through Research Studies?

As stated above, the cause of lupus is unknown; thus, researchers want to learn more about the disease and are looking for what causes it, how it progresses over time, and the genetic factors that might make a person more likely to develop it.

Systemic lupus erythematosus (SLE) is a disease distributed worldwide, which occurs in both genders, and across racial/ethnic and age groups; however, higher rates are observed in adults, women, and non-Caucasians. According to the Lupus Foundation Of America, lupus is two to three times more prevalent among African American, Hispanic/Latina, Asian American, Native American, Alaska Native, Native Hawaiian, and other Pacific Islander women than among White women. Moreover, recent research indicates that lupus affects 1 in 537 young African American women. It is believed that genetic, environmental, socio-demographic, and methodological issues are responsible for these differences and the disease's variable course and outcome.

By the most conservative estimates, lupus affects at least 239,000 Americans. At the same time, recent independent surveys have suggested a prevalence as high as 1.5 million. Fifty years ago, survival was 50 percent after four years. Today, thanks to advances brought about by research on the mechanisms of diseases and aggressive therapy, it is 97 percent at five years and 90 percent at ten years.

Patients with lupus or SLE also experience various symptoms, such as fatigue, skin rashes, fevers, and joint pain or swelling. In some adults, these symptoms occur in periods called flares, which happen every so often or even years apart, while sometimes they go away, called remission. Other symptoms can include sun sensitivity, oral ulcers, arthritis, lung problems, heart problems, kidney problems, seizures, psychosis, and blood cell and immunological abnormalities.

The transformation from a disease with high mortality to a chronic disease means an increased need for therapies to prevent or manage long-term manifestations of the disease.

What Are The Types Of Treatments Available For Lupus?

Lupus can have short-term and long-term effects on an individual’s life and limit physical, mental, and social functioning. Early diagnosis and effective treatments can help reduce the damaging effects of SLE and improve the chance of having better function and quality of life.

Lupus is a chronic disease with no cure; thus, its symptoms can only be managed through long-term treatment and medication. Since lupus affects various organs in the body, a team approach is required. Primarily, SLE treatment consists of immunosuppressive drugs that inhibit the activity of the immune system. The goal of treatment is to prevent permanent organ damage and control symptoms when they occur.

Depending on your health and type, a doctor might recommend a combination of the following medications:

• Hydroxychloroquine: an antimalarial drug that is effective for treating lupus-related arthritis and rashes. It reduces flares by 50 percent and may also help prevent blood clots. It takes around 1 to 3 months to start working.
• Corticosteroids and immune suppressants: they help reduce swelling, tenderness, and pain. These are often recommended for people with serious or life-threatening problems such as kidney inflammation, lung, heart, or central nervous system lupus. This includes high-dose corticosteroids such as prednisone and drugs that suppress the immune system, such as azathioprine, cyclophosphamide, mycophenolate, and methotrexate.
• Biologics: target specific parts of the immune system instead of affecting many areas of the immune system. Belimumab is FDA-approved for treating lupus.
• Monoclonal antibodies: a type of protein developed in a laboratory to find and attach to only one type of substance in the body. There are two types of monoclonal antibodies approved to treat lupus. Benlysta is also approved to treat lupus nephritis in adults and children over 5.

Other medication options include non-steroidal anti-inflammatory drugs, antimalarial drugs, BLyS-specific inhibitors, anticonvulsants for seizures, antibiotics for infections, antihypertensive drugs for high blood pressure, statins for high cholesterol, and drugs for osteoporosis.

Aside from drugs and medications, maintaining a healthy lifestyle is also recommended for managing lupus symptoms. This involves maintaining a healthy weight, introducing a heart-healthy diet in your routine, reducing sun exposure, avoiding smoking, and consulting a doctor for infections.

What Are Some Recent Breakthrough Lupus Research Studies?

There have been several landmark studies involving lupus in recent years. Some of the most notable studies are:

2020: State-of-the-art treatment of systemic lupus erythematosus - this study studied the biologicals aiming to control specific molecular targets anticipated for treating systemic lupus erythematosus (SLE). At present, many biologicals, such as anifrolumab (anti-type I interferon receptor antibody) and ustekinumab (antibody against interleukin 12/23 [p40]), are in clinical trials. Moreover, a phase IIb clinical trial of baricitinib, a low-molecular-weight compound targeting Janus kinase 1/2, in patients with SLE revealed that baricitinib was significantly more effective for relieving arthritis and skin manifestations than placebo and the trial met the primary endpoint.

2020: Immunological pathogenesis and treatment of systemic lupus erythematosus - This review aimed to clarify the immunological pathogenesis and treatment of SLE. The breakdown of self-tolerance is the main pathogenesis of SLE. The innate and adaptive immune networks are interlinked with each other through cytokines, complements, immune complexes, and kinases of the intracellular machinery. Biologic agents like Anifrolumab, Rontalizumab, and sifalimumab that aim to specifically target abnormal immune processes were assessed and may bring new hope to SLE patients.

2020: Lupus treatment with belimumab: a Phase III study extension - This extension study of the Phase III, randomized, placebo-controlled Belimumab International SLE Study (BLISS)-52 and BLISS-76 studies allowed non-US patients with SLE to continue belimumab treatment, to evaluate its long-term safety and tolerability including organ damage accrual. As a result, 738 patients entered the extension study, and 735/738 (99.6%) received one or more doses of belimumab. The annual incidence of AEs, including serious and severe AEs, remained stable or declined over time. Sixty-nine (9.4%) patients experienced an AE resulting in discontinuation of belimumab or withdrawal from the study. Eleven deaths occurred (and two during post-treatment follow-up), including one (cardiogenic shock) considered possibly related to belimumab. Laboratory parameters generally remained stable.

2019: The Jakinibs in systemic lupus erythematosus - This article reviews the preliminary data concerning the efficacy of the JAK inhibitors (Jakinibs) in SLE. Dysregulation of the cytokines is a hallmark of SLE. Targeting the downstream signaling pathways mediated by the JAK-STAT proteins allows simultaneous suppression of multiple cytokines and is an attractive therapeutic option for SLE. Moreover, JAK2/3 inhibition has shown promise in murine lupus nephritis and dermatitis.

Who Are Some Of The Key Opinion Leaders / Researchers / Institutions Conducting Lupus Research Studies?

Lupus Foundation Of America

The Lupus Foundation Of America has made pioneering contributions toward ending the brutal impact of lupus. Their efforts stimulated advances in lupus research that provide insight into the underlying causes of lupus and its progression while creating unprecedented opportunities to expand the future knowledge base. Their research focuses on identifying new drugs for treating and managing different lupus types.

Dr. Dafna Gladman

Dr. Dafna Gladman is a rheumatologist at the Center for Prognosis Studies, Toronto Western Hospital, Toronto, Canada. Dr. Gladman is co-director of the University of Toronto Lupus Clinic and has undertaken numerous and wide-ranging studies of the disease, including genetic analyses, studies of morbidity, and the development of an internationally-recognized activity index for lupus. Dr. Gladman was also a founding member of the Systemic Lupus International Collaborating Clinics (SLICC) group and was its first chair.

Mary K. Crow, MD

Mary K. Crow, M.D., is Physician-in-Chief Emeritus at the Hospital for Special Surgery, Medicine at Weill Cornell Medical College, and Immunology at its Graduate School of Medical Sciences. Dr. Crow is also a Senior Scientist, Co-Director of the Mary Kirkland Center for Lupus Research, and Director of the Autoimmunity and Inflammation Program at the Hospital for Special Surgery's Research Institute. The overall goal of Dr. Crow's research program is to elucidate the underlying mechanisms that account for the initiation and amplification of altered immune function and tissue damage in systemic autoimmune diseases, with a particular focus on the prototype systemic autoimmune diseases, systemic lupus erythematosus (SLE) and rheumatoid arthritis.