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The Lupus Foundation of America (LFA) announced today it has been awarded a new grant from the Office of Minority Health (OMH) at the U.S. Department of Health and Human Services to address the substantial disparities in lupus clinical trial participation. The grant will build upon the LFA’s commitment to reducing health disparities, improving care and ensuring an arsenal of safe and effective treatments for all people living with lupus.

Clinical trials with a diverse array of participants are essential for the development of new and effective lupus therapies, but racial and ethnic minority populations have been and continue to be underrepresented in lupus clinical trials. A review of the years 1997-2017 found that Blacks/African Americans made up 43% of lupus cases nationally, yet represent only 14% of participants in lupus clinical trials. Participation of Blacks/African Americans and other racial and ethnic minority groups in lupus clinical trials is imperative so that new treatments address their medical needs.

“The record is clear that more needs to be done to confront existing disparities in lupus clinical trial participation and help ensure that new lupus therapies are safe and effective for all those impacted by the disease,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America. “The Lupus Foundation of America continues to be committed to tackling this challenging goal and will reach racial and ethnic minority groups through a strategic approach led by trained clinicians and patients, who know first-hand the barriers and obstacles that for too long have limited minority participation in trials.”

With support from the OMH grant, the LFA has launched a new program called Improving Minority Participation and Awareness in Clinical Trials (IMPACT+). Focused on Black/African American women who are disproportionately impacted by lupus, IMPACT+ involves a two-pronged strategy to educate healthcare providers, specifically, rheumatology nurses, and people with lupus about participation in clinical trials, barriers to clinical trial enrollment and best approaches to support racial and ethnic minority participation in trials. A complex and chronic autoimmune disease, lupus impacts an estimated 1.5 million Americans and there is no cure. Black/African American women are two to three times more likely to develop the disease.

Because nurses and advanced practice providers play a critical role in guiding and educating their patients, facilitating relationship-building between patients and providers, and fostering patient trust, IMPACT+ includes a robust training component for rheumatology nurses across the nation in partnership with the Rheumatology Nurses Society. Participants will be trained using the evidence-based Lupus Conversations Program (LCP), developed by researchers at Northwestern University Feinberg School of Medicine and Brigham and Women’s Hospital, and tailored to reach people with lupus, with a focus on Blacks/African Americans. The program includes four modules, an Introduction to Clinical Trials; Barriers, Facilitators, and Mediators in Clinical Trials Enrollment; and Clinical Trials and Racism.

IMPACT+ will also directly reach people with lupus through peer-to-peer education led by people with lupus who serve as volunteer members of the LFA’s Lupus Research Action Network (LRAN). Members of this network will be trained using the LCP, which is also based in part on the Centers for Disease Control’s Popular Opinion Leader model. The training of rheumatology nurses and people with lupus will be conducted in collaboration with physician advisors from Northwestern University and other experts from the lupus and health disparities fields.

During the IMPACT+ program, the LFA will also assess whether a clinical trial education component can be added to a newly established lupus patient navigator program to expand the educational reach of IMPACT+.

Launched in September 2021, IMPACT+ builds upon the LFA’s original IMPACT program developed in 2016 with support from the OMH. The LFA has championed efforts to break down barriers that have limited participation in clinical trials. More than a decade ago, the LFA and lupus advocates worked with Congress to help establish the OMH National Lupus Training, Outreach & Clinical Trial Program. Since that time, Congress has provided more than $20 million in funding to support minority participation in lupus clinical trials.

According to a new study from the United Kingdom, people with lupus report feeling better when they’re making purposeful food choices. The majority of survey respondents (79%) undertaking a dietary change reported benefitting from their new eating pattern. Dietary changes varied from increasing vegetable intake to reducing intake of processed food, sugar, gluten, dairy or carbohydrates. Based on respondents’ reports, dietary changes involving more vegetable consumption, but fewer processed foods and animal products may be of greatest benefit for reducing the severity of lupus symptoms.

Researchers collected data based on an anonymous online survey, which asked people about their experiences regarding their lupus symptoms and their diets. Of the 420 survey respondents who reported their lupus diagnosis, more than half (61%) said they deliberately eat or avoid certain foods to help control symptoms. 

The most commonly reported dietary changes were:

• Increased vegetable intake (62%)
• Reduced or no consumption of
  • Processed foods (50%)
  • Sugar (45%)
  • Alcohol (38%)
  • Gluten (36%)
  • Dairy (35%)

Some respondents also reported following low-carbohydrate, vegetarian or vegan eating patterns. 

Additionally, respondents reported improvements in their symptoms after making changes to their eating habits, with many citing reduced muscle/joint pain (49%), improved mood (43%), less fatigue (39%), better sleep (27%) and improved rashes/skin lesions (27%). 

Interestingly, vegetarian eating patterns (which exclude meat, but include dairy and eggs) provided the most self-reported benefits (93%), while vegan diets (which exclude all animal-based foods) provided the lowest, but still substantial, proportion of positive responses (63%).

Previous studies have found that people with lupus are interested in using diet to treat fatigue, heart disease and other symptoms. However, to date, much about the relationship between diet and lupus remains uncertain. While more research is needed, these findings suggest that dietary changes may help in the management of lupus symptoms. Learn more about diet and nutrition with lupus.

Read this study
 

Updated antibody research by Lupus Foundation of America Gary S. Gilkeson Career Development Awardee May Choi identifies subgroups of lupus patients with different outcomes based on long-term autoantibody data with the aid of artificial intelligence. An autoantibody is a type of protein produced when the body’s immune system is attacking itself, promoting inflammation and tissue damage. Antibody blood tests are used to help clinicians diagnose the disease. 

A group of 805 people newly diagnosed with lupus were examined. Their demographic, clinical and blood was analyzed for five years.

The analysis revealed four autoantibody profiles of lupus outcomes:

1. Cluster 1 – Identified by the biomarkers anti-Sm and anti-RNP – typically youngest at disease onset and of Asian or African ancestry. At year 5, this group had the highest disease activity and most likely to be on immunosuppressive therapy.
2. Cluster 2 – Low frequency of anti-dsDNA and high anti-DFS70 – typically oldest at disease onset. At year 5, this group had the lowest disease activity and least likely to have kidney disease and to be on immunosuppressive medications.
3. Cluster 3 – High frequency of antiphospholipid antibodies – typically of European ancestry, elevated body mass index. At year 5, most likely to have kidney disease and neuropsychiatric involvement that included strokes and seizures.
4. Cluster 4 – High frequency of anti-SSA/Ro60, anti-SSB/La, anti-Ro52/TIM21, anti-ribosomal P, anti-dsDNA anti-histone – At year 5, exhibited low complements (proteins that protect the body against infections).

“Better lupus disease identification and prediction of disease outcome can help clinicians implement a more personalized approach to effectively monitor, evaluate, and treat patients.” Says Dr. May Choi lead study author and Gary S. Gilkeson Career Development Awardee with the Lupus Foundation of America.

Learn more about Dr. Choi and her research efforts. 

Read this study

Environmental risk factors, from exposure to sunlight to commonplace toxins and chemicals, are known to have some link to lupus, though much about how the environment triggers or influences the disease remains unclear. Now, new research adds to the evidence that air pollution may have a real impact on childhood-onset lupus by worsening inflammation.

While short-term, localized inflammation is beneficial, helping wounds to heal and protecting the body against infection, it can be damaging when it occurs in healthy tissue or lasts too long. In children and adults with lupus, the disease is characterized by inflammation of multiple organs or organ systems in the body.

In the latest study, researchers assessed real-time exposure to air pollutants and measured markers of inflammation in the blood samples of those with childhood-onset lupus. The air pollutants studied included fine particles (tiny droplets in the air that can travel deeply into the respiratory tract) and nitrogen dioxide (an air pollutant that forms when fossil fuels such as coal, oil, gas or diesel are burned at high temperatures). Researchers found that exposure to the fine particles – though not nitrogen dioxide – was associated with increases in several different markers of inflammation.

These findings continue to show that one’s physical environment can play a role in lupus activity, and more research is needed to fully understand how exposure to air pollutants and other toxins or chemicals affect the disease. Learn more about understanding lupus environmental triggers.

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Today, clinical trial results were announced on the long-term effectiveness and safety of Lupkynis™ (voclosporin) as a treatment for adults with lupus nephritis (LN, lupus-related kidney disease). The study showed that the drug continued to be safe and well tolerated after up to three years of treatment. Over that time, the therapy also effectively maintained significant reductions in proteinuria, excessively high levels of protein in the urine indicating impaired kidney function. 

Lupkynis was approved by the U.S. Food and Drug Administration (FDA) in January 2021, making it the first FDA-approved oral medicine for the treatment of adults with active LN. The latest results reinforce it as a safe and important treatment option for people living with this disease.

Aurinia Pharmaceuticals Inc., the maker of Lupkynis, also announced the launch of a new study, ENLIGHT-LN, a U.S.-based study of adult patients with LN treated with Lupkynis. The research will capture further long-term data and help track changes within the study population over time. Additional details will be provided in 2022.

Continue to follow the Lupus Foundation of America for late-breaking lupus treatment news, and learn more about Lupkynis. 

Read the Aurinia Pharmaceuticals Inc., press release

The Lupus Foundation of America (LFA) announced today the  recipients of its most prestigious annual awards, naming Richard A. Furie, MD, Northwell Health as this year’s Evelyn V. Hess Award recipient and Melissa Cunningham, MD, PhD, The Medical University of South Carolina (MUSC) as the Mary Betty Stevens Young Investigator Prize award winner.  

Honoring Dr. Furie for Significant Impact in Advancing the Field of Lupus Research 

The Evelyn V. Hess Award was established in 2006 and is given annually to recognize the exceptional contributions of a clinical or basic researcher whose body of work has advanced the understanding of the science of lupus treatment.

Dr. Furie, Chief of the Division of Rheumatology at Northwell Health, Professor of Medicine at the Zucker School of Medicine, and the Marilyn and Barry Rubenstein Chair in Rheumatology, has dedicated his career to developing more effective and safer therapies for people with lupus. He directs The Program in Novel Therapeutics, the Health System’s clinical research program in musculoskeletal disease. As a clinical trialist with an expertise in the design and implementation of clinical trials, much of his clinical research efforts has focused on anti-rheumatic drug development. 

As a Professor in the Institute of Molecular Medicine at the Feinstein Institutes for Medical Research, the science arm of Northwell Health, Dr. Furie has authored numerous studies of novel, innovative therapies including belimumab and, very recently, anifrolumab. He also directs the Northwell Health’s Systemic Lupus Erythematosus and Autoimmune Disease Treatment Center, which has become internationally recognized for its role in the development of new therapies for SLE. Recognized in the New York metropolitan area as a senior rheumatologist, Dr. Furie has served as an advisor for the LFA. For over twenty years he has served on many committees of the American College of Rheumatology and was named a Master of the College in 2018.

“I am pleasantly surprised by this recognition and truly honored to receive the Evelyn V. Hess Award from the Lupus Foundation of America,” said Dr. Furie. “Although the outlook for our patients has greatly improved since the 1950s, significant unmet needs have been present ever since. I am grateful to have contributed to improving the lives of our patients with lupus by addressing many of those unmet needs. Nevertheless, the successes we are now witnessing today, reflect the perseverance and dedication of the entire lupus community, which includes patients, clinicians, investigators, and industry. Our efforts will continue to pave the way for innovation.” 

Honoring Dr. Cunningham’s Exceptional Contributions to the Lupus Research Community 

Established in 2009, the annual Mary Betty Stevens Young Investigator Prize recognizes the remarkable accomplishments of an investigator in the early stages of their lupus career and memorializes Dr. Stevens’ outstanding contributions to lupus research throughout her career.

Dr. Cunningham, Associate Professor of Medicine at MUSC, has a great interest in women’s health issues, is committed to addressing disparities in health, and has focused much of her research career on why lupus is more prevalent in women. Dr. Cunningham’s work has focused on the role of nuclear hormone receptors, particularly the estrogen receptor, which has variants and isoforms that can change the way estrogen acts in different tissues. By advancing the understanding of estrogen receptor biology in immune cells, researchers may be able to harness that knowledge to develop targeted therapeutics, such as next generation selective estrogen receptor modulators (SERMs) that may treat lupus and other female-biased autoimmune diseases, without impacting reproductive tissues. 

“It is incredibly humbling to receive the Mary Betty Stevens Young Investigator Prize,” said Dr. Cunningham. “I have heard such amazing things about Dr. Stevens’ work in the field and her academic enthusiasm. She inspired many students to enter the field of rheumatology and to dedicate their careers to the study of lupus.  I will continue to work as hard as possible to advance lupus research, improve lupus patient care, and teach the next generation of rheumatologists in order to live up to the honor of this award.” 

Learn more about the Evelyn V. Hess Award,  Mary Betty Stevens Young Investigator Prize and our 2021 recipients. 
 

In a new study from Greece, people with systemic rheumatic diseases, such as lupus, who received the COVID-19 vaccine experience better outcomes than unvaccinated people with similar disease.

Researchers examined a group of 195 people who contracted the virus, comprised of 147 who were unvaccinated and 48 who received at least one vaccine dose.

Differences in terms of COVID-19 outcomes were evident. Those who were unvaccinated (27.9%) required oxygen supplementation compared to one dose (14.6%) and fully vaccinated (10.3%) people. No vaccinated people required invasive ventilation versus 2.7% of unvaccinated individuals. Additionally, 29.3% of unvaccinated people required hospitalization, while only 21% of partially and 10.3% of fully vaccinated people needed hospital-based care. Six unvaccinated people died and there were no deaths among vaccinated people.

The LFA remains committed to providing resources and support regarding the COVID-19 pandemic. Learn about up-to-date health information on the virus and people with lupus.

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Findings from a new study of more than 1,300 people with lupus show that several barriers to care can impact a lupus diagnosis. The study, conducted by the Lupus Foundation of America in partnership with Exagen Inc. (NASDAQ: XGN) was presented recently at the 2021 Lupus 21st Century Conference.

Respondents faced many healthcare challenges from the time they first saw a doctor for their symptoms. Healthcare-related challenges associated with delayed diagnosis included: 

• Overall, more than half (51%) reported long wait times before seeing a specialist; those with delayed diagnosis (5 or more years) reported this problem in higher numbers (58%) than those who were diagnosed in less than a year (39%).
• Almost a third (31%) of all respondents reported that out-of-pocket costs were too high; those with a delayed diagnosis also reported this in higher numbers (36%) than those diagnosed within a year (23%). 
• Overall, 30% of all respondents noted that there were not enough doctors nearby to treat lupus; 32% with a delayed diagnosis reported this while 25% of those diagnosed in less than a year did the same. 

Other barriers associated with delayed lupus diagnosis and care included insurance not covering the costs of needed services and long wait times to receive an appointment with primary care providers.

“People with lupus need access to the care they need to receive an accurate diagnosis and improve health outcomes,” shared Stevan W. Gibson, President & CEO, Lupus Foundation of America. “Our study underlines the barriers that are faced by patients seeking critical medical care from health care providers for symptoms that could be lupus and shows the importance in working with the medical community to further practitioner education of lupus, availability of specialists such as rheumatologists, and working toward solutions to reduce out-of-pocket healthcare costs.”

The study also found that many respondents reported they were misdiagnosed, including with anxiety (32%), depression (30%), or fibromyalgia (23%), before their lupus diagnosis. Almost 22% were told nothing was wrong with them.

“Lupus can be difficult to diagnosis due to its diverse symptoms and impact on each individual. However, there is a lot we can do to help ensure an accurate lupus diagnosis and access to care,” added Donald Thomas, MD, author of The Lupus Encyclopedia. “This study helps further identify key barriers to lupus diagnosis and care, which is important to better understand how to overcome these barriers. We need to grow the specialty of rheumatology by mentoring young doctors to attract them to the field, continue to educate healthcare providers on identifying and diagnosing lupus patients at earlier stages of their illness, and ensure access to programs that help alleviate healthcare costs and access barriers for people with lupus.”

Learn more about the study, including its limitations, in the fact sheet, and check out an infographic highlighting key findings.
 

Update November 23, 2021: New Podcast

You can listen to the latest podcast featuring Dr. Jill Buyon, one of Lupus Science & Medicine’s Editors-in-Chief, who talks about highlights of ACR Convergence 2021, which was held virtually from November 3-9.

Listen to Podcast 

This year’s ACR Convergence 2021 (ACR21), the world’s premier annual rheumatology meeting of the American College of Rheumatology, offered an exciting flurry of cutting-edge lupus research discoveries, from treatment news to disease management updates. Lupus experts from around the globe, including health care professionals, drug developers and patient advocates convened from November 3 – 9 to share and discuss the latest findings in lupus research. 

Several studies funded by the Lupus Foundation of America (LFA) were presented at the meeting, and our Inside Lupus Research team covered the conference. Read on for this year’s research highlights. 

Treatment News

Encouraging advancements on several new and investigational drugs were shared at the meeting:

• BIIB059 – Phase 2 study results revealed more promising news for this antibody treatment. The drug was associated with improved joint use in those with lupus-related arthritis. Nearly half (48.2%) of trial participants using the drug saw positive joint response over those taking the placebo treatment. 
• Iberdomide – A phase 2b study found the drug to be safe and well tolerated in people with systemic lupus erythematosus (SLE), with sustained clinical benefits up to week 52 of use.
• Anifrolumab – After receiving approval by the U.S. Food and Drug Administration to treat adults with moderate to severe SLE, study results presented at ACR21 further underscore the therapy as an effective treatment for clinically distinct subgroups of SLE. 
• Barticitnib – This new investigational drug shows early promise as a treatment for SLE, targeting B-cell activity. B-cells are responsible for creating antibodies, including autoantibodies, and may play a role in the development and progression of autoimmune diseases like lupus. 

This year’s annual Great Debate at ACR21 centered around potential first-line treatments for lupus nephritis (LN, lupus-related kidney disease): belimumab (Benlysta®) versus voclosporin (Lupkynis™). The question of which treatment to add first to standard therapy was a contested topic of discussion, with strong clinical evidence supporting the safety and effectiveness of both drugs. Ultimately, the debating researchers concluded there is use for both therapies in managing the diverse patient population living with LN.

In other important treatment news, low doses of hydroxychloroquine, used to reduce lupus disease activity and flares, was associated with increased risk of flares in a new study. Balancing the drug’s benefits with the risk of toxicity at higher doses is challenging but essential in order to discover optimal dosage. 

Another study found that 10% of people with lupus were long-term users of opioids compared to just 1% of the comparison group. Long-term opioid use is rarely indicated for management of chronic pain, due to a lack of effectiveness and risk for developing drug dependency and co-occurring medical problems. Risk factors for long-term opioid use were duration of lupus disease and having a co-occurring mood disorder or fibromyalgia. Identifying alternative pain management therapies will continue to be a priority in lupus treatment research and patient care.

Looking ahead to future drug research, data presented at ACR21 suggests that the COVID-19 pandemic opened opportunities for the benefits of using telemedicine (TM) in clinical care. According to new survey data shared, the vast majority (more than 75%) of people with lupus report satisfaction with TM, and nearly all (92%) believe their physicians can address their concerns via TM. Meanwhile, clinical trials during the COVID-19 pandemic experienced significant delays with only 39% of trials able to continue as intended. Further data suggests that the future will require more adaptable clinical trial designs that are flexible to individual needs in order to enhance drug response rate and participant retention. 

Continue to follow the LFA for the latest lupus treatment discoveries.

Exciting Research from the Lupus Foundation of America

At the LFA, everything we do is focused on improving the quality of life for all people affected by lupus, including through awareness, education, care services and research efforts led and supported by our organization. For ACR21, we shared important program evaluation findings on SELF (Strategies to Embrace Living with Lupus Fearlessly), a new online program developed under a cooperative agreement with the U.S. Centers for Disease Control and Prevention, that’s designed to offer personalized support for lupus warriors looking to build their arsenal of self-management skills. 

Our abstract presented at ACR21 assessed SELF’s performance in a program evaluation pilot and revealed key barriers to enrollment and retention that have since led to strategic program changes aimed at improving the sign-up and onboarding process. Findings from the SELF program evaluation also underscored the importance of developing and disseminating effective self-management education – only 1 in 5 program participants at baseline had mastered the majority of skills needed to manage lupus. The updated SELF program will be launched and made widely available in early 2022.

Additionally, Dr. Jane Salmon, Collette Kean Research Professor at Hospital for Special Surgery, presented results of LFA-funded research to develop an algorithm to predict adverse pregnancy outcomes (APO) in high-risk pregnancies in patients with antiphospholipid syndrome (APS). Her study explored the performance of novel and increasingly popular machine learning (ML) approaches for predicting APO, which affects nearly 20% of pregnancies in women with lupus. 

And, lead investigator, Dr. Gary S. Gilkeson of the Medical University of South Carolina (MUSC) presented two abstracts on findings from an LFA-funded Phase II Mesenchymal Stromal Cell (MSC) trial. His findings suggest that the use of MSCs in the treatment of lupus presents minimal safety concerns. His research also shows that there is a significant amount of variation in subtypes of immune-system cells known as B-cells within the stromal cells of ethnically and geographically diverse subjects with refractory lupus (lupus that is resistant to treatment). Further studies in this area could reveal a connection between specific B-cell subtypes and distinct forms of lupus or help predict individuals’ responses to treatment based on their personal B-cell profile.  

Finally, through the LFA’s partnership with the Childhood Arthritis and Rheumatology Research Alliance (CARRA), we helped fund a study to better understand the practices and preferences of North American pediatricians treating children with LN. The study revealed that, while they’re generally prescribing lower doses of the immunosuppressive drug cyclophosphamide than they were a decade ago, many physicians remain largely unfamiliar with the European protocol, which recommends lower doses of the drug compared to the high-dose cyclophosphamide protocol from the National Institutes of Health (NIH). 

Health Disparities in Lupus

Scientific evidence continues to reveal striking health disparities within the lupus community. New data presented at the meeting show that Black and Hispanic lupus warriors have more severe COVID-19 outcomes, such as hospitalization, need for mechanical ventilation, and death, compared to other races and ethnicities. 

And, two new studies suggest that, while lupus care and outcomes may be improving overall, disparities along racial and ethnic lines still persist. First, research presented by Joyce C. Chang, MD, a 2018 LFA Gary S. Gilkeson Career Development Award winner, showed that hospitalized Black children with lupus are significantly more likely to experience kidney failure, or require dialysis or kidney transplant than hospitalized white children with lupus, despite the fact that these serious outcomes have decreased overall since 2006. 

Furthermore, new research shows that while the rate of hospitalizations for lupus flares has declined over the last 20 years overall, a disproportionate number of those hospitalized are Black. The latest findings urgently highlight the need for more strategically targeted efforts to improve access to care, treatment and disease management education in these communities. 

The Lupus Foundation of America is proud to be a part of the collective, global fight against lupus, developing tools and resources to help today’s lupus warriors overcome the challenges they face – from managing the disease to addressing healthcare disparities – while working to find new treatments and ultimately a cure. Continue to follow Inside Lupus Research for breaking news and important updates and see you at #ACR22!

New research associates an imbalance of quinolinic acid relative to kynurenic acid with poor cognitive performance in people with lupus. Quinolinic acid and kynurenic acid are byproducts of one of the body’s cellular energy pathways. The disruption of this pathway can create an imbalance of quinolinic acid relative to kynurenic acid. This imbalance can potentially damage neurons, leading to cognitive dysfunction. People with lupus exhibited elevated quinolinic acid relative to kynurenic acid compared to healthy people.

Researchers examined a group of people, comprised of 74 who were healthy and 74 who had lupus. They measured blood levels of substances produced in the cellular energy pathway, including quinolinic and kynurenic acid. Each participant was also given a series of cognitive tests along with assessments of pain and mood.

Those with lupus and elevated quinolinic acid relative to kynurenic acid performed worse on the majority of cognitive tests, and had higher depression scores, than healthy people. Elevated quinolinic acid relative to kynurenic acid was associated with poor cognitive performance in people with lupus.

“Cognitive dysfunction is common in lupus patients and potentially devastating, yet therapies are lacking. We report a novel finding that an imbalance of quinolinic acid relative to kynurenic acid associated with poor cognitive performance in lupus. These results suggest a potential therapeutic target that warrants further study,” says Dr. Erik Anderson, a Gary S. Gilkeson Career Development Awardee with the Lupus Foundation of America and primary investigator of the study.

The discovery of an association between an imbalance of quinolinic acid relative to kynurenic acid and poor cognitive performance will help guide further exploration in this area. Continued study may lead to new areas to target for lupus therapy.

Learn more about coping with the cognitive symptoms of lupus. The Lupus Foundation of America supported Dr. Anderson’s lupus research through its Gary S. Gilkeson Career Development Award. Click here to learn more about the Gary S. Gilkeson Career Development Award and here to learn more about Dr. Anderson’s work.

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