15 Jun Lupus Awareness Month: Award Winners Will Improve Diversity in Clinical Trial Landscape
Dr. Maria Bacalao, MD
Department of Internal Medicine
UT Southwestern Medical Center
Dr. Jessica Williams, MD, MPH
Assistant Professor of Medicine
Division of Rheumatology
Emory University School of Medicine
As winners of the The Robert A. Winn Diversity in Clinical Trials Award Program, Drs. Bacalao and Williams discuss the challenges of diagnosing, treating and research into the autoimmune disorder of Lupus.
MedicalResearch.com: Would you briefly explain what is meant by lupus? Are there different types, i.e., SLE, discoid lupus, drug-induced etc.?
Dr. Bacalao: Lupus is a systemic autoimmune condition in which patients make antibodies against their own genetic materials, leading to tissue damage in various organ systems. There are several kinds.
- Systemic lupus erythematosus: a condition in which the immune system affects various organs such as the skin, lungs, kidneys, bone marrow, nervous system.
- Cutaneous Lupus Erythematosus: Lupus that is limited to the skin but does not affect other organs
- Drug induced lupus: drug induced lupus is similar to systemic lupus, but it is a reaction to a particular drug
- Neonatal Lupus: a rare condition in which the antibodies from a mother with lupus affect the fetus, leading to the baby developing transient symptoms of lupus.
Dr. Williams: Lupus is a chronic autoimmune disease that affects approximately 1.5 million people in the United States. In lupus, the immune system develops antibodies against the body’s own tissues, leading to inflammation that can affect multiple organ systems.
There are four major types of lupus including systemic lupus erythematosus (SLE), cutaneous lupus, drug-induced lupus, and neonatal lupus. SLE is the most common type of lupus and can affect any organ system. Cutaneous lupus is limited to the skin and includes discoid lupus, which can lead to scarring. Drug-induced lupus is caused by certain prescription drugs such as hydralazine, a blood pressure medication. Neonatal lupus is rare and may affect infants of women who have lupus.
MedicalResearch.com: How is lupus diagnosed and what are the common clinical presentations?
Dr. Bacalao: The diagnosis of lupus is complex and there is no laboratory test that conclusively diagnoses the condition. Rheumatologists usually use blood tests, physical exam, and X-ray results to diagnose lupus. Rheumatologists look for:
- Rashes in sun-exposed areas of skin (such as a malar or “butterfly” rash)
- Joint tenderness and swelling
- Ulcers in mouth or nose
- Positive antibodies such as the ANA, Smith and DS DNA blood test
- Blood and protein in the urine
- Hair thinning
- Low white blood cell counts
- Symptoms of heart and lung inflammation like chest pain or shortness of breath
- Other symptoms concerning of Lupus like fatigue and unexplained fever
- Unexplained neurological symptoms like seizures, confusion, strokes
Dr. Williams: Lupus is diagnosed through a combination of historical and present symptoms, physical examination findings (such as rashes or joint inflammation), laboratory tests (including autoantibodies), and imaging tests (such as a chest x-ray). There is no single test that can diagnose lupus. Common symptoms of lupus include fatigue, fevers, rashes (especially a butterfly rash on the face or a rash after sun exposure), pain or swelling in the joints, hair loss, sores in the mouth or nose, and chest pain when taking a deep breath. Lupus may also present with low blood counts, kidney disease, or central nervous system disease.
MedicalResearch.com: Does the clinical presentation and course differ among racial/ethnic/gender groups?
Dr. Bacalao: Black Lupus Patients are over twice more likely to develop kidney disease and over 3-5 times more likely to develop end stage renal disease than non-Hispanic White patients. This has not changed in a decade.
- Asian patients have the highest lupus nephritis prevalence (50-75%)
- Black patients are also diagnosed on average 14 years earlier than White patients
- Indigenous patients had a life expectancy of 50 years, vs 64 years for white patients
Dr. Williams: Lupus is more common in women of childbearing age (90% of cases) and non-white patients (two-thirds of cases). Non-white patients and males have more severe disease and worse outcomes.
MedicalResearch.com: Is there a familial predisposition?
Dr. Williams: Yes. Lupus is more common in patients who have a family history of lupus or another autoimmune disease. If a twin develops lupus, there is a 30% chance that their identical twin will also develop lupus and a 5-10% chance that their fraternal twin will develop lupus.
MedicalResearch.com: Are there public health disparities that limit access to health care for black women, particularly those of limited financial means?
Dr. Bacalao: Yes, there are factors that lead to decreased access to healthcare for Black women and other women of Color. Institutional racism, such as food deserts, lack of societal neighborhood investment, also represent significant psychosocial stressors for many BIPOC patients with Lupus. Neighborhood poverty was also linked with increased damage accrual and mortality, which improved when patients exited poverty. All of these factors cause decreased access to healthcare.
Dr. Williams: Yes, the lack of universal access to healthcare in the United States disproportionately impacts Black women, who are more likely to be of lower socioeconomic status and thus uninsured or underinsured.
MedicalResearch.com: Is there adequate representation of black women in research studies?
Dr. Bacalao: The belimumab clinical trial participants were only 14 percent African American and 20 percent Latino. However, the majority of Latino participants were from Latin America (around 80%). In the general population of patients with Lupus, 40% are African American, 38% Non-Hispanic White, 15% Latino, 4% Asian.
Dr. Williams: Black patients are significantly underrepresented in lupus clinical trials. For example, Black patients comprise 43% of prevalent cases of lupus but only 14% of lupus clinical trial participants.
MedicalResearch.com: Is there hesitancy to participate in clinical trials among some individuals and ethnic groups?
Dr. Bacalao: Yes, there is some hesitancy from minority groups but, when given the chance, participation among African Americans and Latinos is actually significant.
Dr. Williams: Yes. Due to historical injustices in medical research such as the Tuskegee Syphilis Study as well as ongoing structural racism and bias in the United States healthcare system, some non-white patients are hesitant to participate in clinical research due to fear of experiencing harm.
MedicalResearch.com: What is the mission of the DCTCDP?
Dr. Bacalao: The Robert A. Winn Career Development Award (Winn CDA) is a 2-year program designed to support the career development of early-stage investigator (as defined by NIH) physicians underrepresented in medicine, and physicians who have a demonstrated commitment to increasing diversity in clinical research, to become independent clinical trial investigators who are engaged in advancing health equity through their research and mentoring.
Dr. Williams: The mission of the DCTCDP is to increase diversity in cancer, cardiovascular, and immunologic clinical trials to achieve equitable representation, ensure that all patients have access to innovative treatments, and confirm that new treatments are safe in all groups. The DCTCDP also aims to train 250 early-career clinical trialists to conduct trials with a focus on community engagement and health equity.
MedicalResearch.com: How do you hope to increase diversity in clinical studies and improve access to health care for underrepresented communities?
Dr. Bacalao: I am currently working on an educational curriculum to help increase diversity in clinical trials.
Dr. Williams: I am currently enrolling patients in lupus clinical trials at Grady Memorial Hospital in Atlanta, Georgia, which is a safety-net hospital that serves >700 predominantly Black patients with lupus. Many of the patients at our site are uninsured or underinsured, and the availability of clinical trials significantly enhances the treatment options for the patient population that I serve. I am also studying clinical trial perceptions and barriers among the Georgians Organized Against Lupus (GOAL) Cohort, a population-based cohort of >1100 predominantly Black patients with validated lupus. These findings will be used to propose interventions to increase Black patient participation in lupus clinical trials.
Dr. Williams: I would like to thank the DCTCDP for providing me with the necessary training and support to become a leader in equitable lupus clinical trials. I am also grateful for my wonderful patients that teach me so much every day, and I hope that one day soon we will have a cure for lupus!
Background on Female American Physicians in The Robert A. Winn Diversity in Clinical Trials Award Program
- Dr. Maria Bacalao: Dr. Bacalao is a physician who was born and raised in Venezuela and came to the U.S. at 13 years old. Through the DCTCDP program, she hopes her clinical research will help to develop new therapeutic modalities for systemic lupus erythematosus (SLE). Dr. Bacalao has shared that it is particularly difficult to treat lupus since it mostly affects women and women of color and current treatments/trials do not necessarily take this into account. Dr. Bacalao hopes to change misconceptions around clinical trials and help address barriers, including education and communication. Additionally, Maria is part of a nonprofit called Literacy of Chiefs, which helps empower and reduce the language barrier immigrants face.
- Dr. Jessica Williams: Being Afro-Latin, Dr. Jessica finds a social justice element in her clinical research surrounding lupus, which is more prevalent in women and severe in patients of color. Currently, her trials through the DCTCDP program consist of two components – a Phase II study of a monoclonal antibody and an annual survey on patient perceptions of clinical trials through the GOAL coalition. Additionally, she is working on the best way to set up a clinical trial at her site and later create a protocol for other under-resourced areas to do the same.
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