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.
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.”
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.
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.”
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.
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.
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.
“Two people are better off than one, for they can help each other succeed. If one person falls, the other can reach out and help. But someone who falls alone is in real trouble. Likewise, two people lying close together can keep each other warm. But how can one be warm alone? A person standing alone can be attacked and defeated, but two can stand back-to-back and conquer. Three are even better, for a triple-braided cord is not easily broken.”
What is lupus community?
I am not a scholar from the NIH, but I would define lupus community as a group of people doing their best to embrace vulnerability and be open and transparent about the physical, emotional, and spiritual peaks and valleys of lupus. A lupus community should be a space to support and encourage each lupus warrior and meet them where they are. To go before, walk beside, and provide a shoulder to lean on. All the while, learning, loving, and growing…together.
If you live with lupus or another chronic illness, you may start to become aware of who you want your close “community” to be. You may start to see a shift in who you gravitate towards, who you reach out to, and who you let your guard down with.
This blog is meant to explore the benefits and obstacles of this process, and delve into why it is so important to find your “community” if you have lupus.
Whether it be a support group, a religious ceremony, a music concert, or football game, experiences of collective assembly affect us. Coming together allows us an opportunity to feel connected to something bigger than ourselves; it is an opportunity to feel joy, meaning, connection, and peace.
Community Resources
Finding community may present as a challenge in these COVID-19 times. Thankfully, there are many online resources to provide you with connection if you are sheltering in place due to the pandemic.
Here are some that I find helpful:
LupusConnect™: is an online lupus community where individuals with lupus and their loved ones can engage with others like them to share experiences, find emotional support and discuss practical insights for coping with the daily challenges of the disease. It’s an easy-to-use, online platform that encourages its community members to ask questions, reply to posts, and read about others’ experiences in a safe and comforting community.
Hospital Special Surgery: LupusLine® is a free national telephone peer counseling service focusing on one-to-one support for people with lupus and their families. LANtern® (Lupus Asian Network) is a free national support and education program for Asian-Americans with lupus and their families. SLE Workshop is a monthly education and support group for people with lupus, along with their family and friends. Charla de Lupus (Lupus Chat)® is a free national peer health education and support program for Spanish-speaking communities with lupus. Teen and Parent Lupus Chat Groups are monthly in-person chat groups for teens with lupus and their parents.
More Than Lupus: MTL offers a monthly In-Person Support Group that lends to an environment of acceptance, and community. We meet the third Saturday of the month, every month. The “Lupus Live” Facebook semi-weekly support chats are an amazing way to foster connections with others in the lupus community from the comfort of your own home or office. Facebook @morethanlupus
The normal American grocery list is often filled with items that contain corn syrup, bad fats, artificial ingredients, and additives. This is dangerous and unhealthy for anyone if these items are consumed regularly. However, if you have lupus or another lupus overlap illness, a grocery list packed with these types of items can be especially dangerous.
Disclaimer: If you have certain forms of kidney disease, kidney stones, diabetes, and high blood pressure, please consult your doctor before you change your dietary habits.
Foods rich in Omega-3 Fatty Acids
Certain fats have been proven to be beneficial in lowering cholesterol and levels of inflammation. Omega-3 Fatty Acids have been shown to lower lupus flares and nephritis (kidney lupus). Considering cardiovascular disease is the number 1 cause of death in SLE, consuming items that lower bad cholesterol and improve your heart health is a must!
For your grocery list:
Cold-water fish (salmon, mackerel, tuna, sardines, herring)
Nuts and seeds (flaxseed, walnuts, chia seeds)
Plant oils (flaxseed oil, olive oil)
Fortified foods (yogurt, eggs)
Tofu
Foods High In Vitamin D
Most people with SLE are deficient in vitamin D. Low levels of vitamin D are associated with more severe disease activity and even antiphospholipid syndrome. Vitamin D (which is really a hormone, not a vitamin) is essential for immune function and is important to keep at a healthy level.
For your grocery list:
Oily fish (herring, swordfish)
Mushrooms
Egg yolks
Fortified foods (cow’s milk, orange juice, various breakfast cereals)
High Antioxidant Foods
According to the USDA, antioxidants remove free radicals from the body which can run rampant and actually damage cells, causing serious illness and even cancers.
For your grocery list:
Berries
Leafy Greens
Beans
Turmeric
Dark Chocolate
Pecans
Low-Fat Foods
Typical American diets are full of high amounts of bad fats. This can lead to increased risk of developing heart disease, diabetes, and strokes. Eating healthy low fat foods is imperative in lowering the risk of developing cardiovascular disease and other health complications.
For your grocery list:
Low-fat yogurt
Low-fat kefir
Lean protein (turkey, chicken, lean white fish)
Healthy Carbohydrates
Unfortunately, many of the carbohydrate foods we eat are made from grains that have been stripped of the nutritious bran and germ. Research links a high intake of refined grain foods with higher levels of inflammatory markers in the body. Always read labels (look for items that say 100% whole grain, or whole wheat) and stick to healthier carbohydrate choices!
For your grocery list:
Quinoa
Brown rice
Barley
Rye
Steel-cut oats
100% whole grain organic wheat bread
Colorful produce
Colorful fruits and vegetables contain valuable plant compounds that may help counter inflammation. Aim for at least five servings each day and the more colorful the better!
For your grocery list:
Spinach
Collard greens
Kale
Avocados
Blueberries
Strawberries
Oranges, lemons, and limes!
Calcium-rich products
Steroids and other lupus medications can decrease the absorption of calcium. You need calcium for your bone health, to maintain strong teeth. The body also needs calcium for muscles to move and for nerves to carry messages between the brain and other body parts.
For your grocery list:
Low-fat cheese
Low-fat yogurt
Low-fat milk
Sardines
Dark leafy greens like spinach, kale, turnips, and collard greens
Broccoli
Fortified cereals such as Total, Raisin Bran, Corn Flakes (They have a lot of calcium in one serving.)
Fortified orange juice
Soybeans
Spices:
Garlic (some say to stay away, but not enough medical evidence to support)
In a nutshell, self-care is any activity that we incorporate into our daily lives that creates balance and fulfills our mental, emotional, and physical needs.
As simple as it seems, it can be very difficult to execute. Why? Though appropriate self-care has been linked to overall improved mood and reduced anxiety, it can be incredibly challenging to find the right balance for you, and for those who are around you. Additionally, it seems even more arduous to overcome the fictitious guilt that taking care of yourself isn’t actually “selfish.”
What Doesn’t Self-Care Mean?
“I pushed myself. I gave of myself. I gave and gave and gave, until I no longer knew who I really was. I was beginning to think I didn’t really exist at all. Any space I took up was only to assess and service someone else’s needs. But, what were my needs? I didn’t seem to know…” – said every person with lupus…ever.
“Self-care is never a selfish act—it is simply good stewardship of the only gift I have, the gift I was put on earth to offer to others.”-Parker Palmer
Knowing what self-care isn’t is even more important than knowing what it is. Self-care does not equate to selfishness. Self-care isn’t vanity, self-righteousness, or narcissism. It isn’t overindulgence either. It is the acknowledgment that if you don’t take care of yourself, you will not be able to take care of others. It is understanding what we need in order to be a healthy functioning human being and take care of ourselves as a whole – so we have the energy, enthusiasm, and empathy to give to those around us.
Here are the basics of self-care:
Make a list of things that bring you joy, peace, and centering. It might be taking a walk, a bath, or listening to a daily meditation or guided prayer lesson. Over time try to incorporate the forms of self-care that work best for you into a consistent routine. Get into a rhythm of setting time for appropriate and necessary self-care.
Add your self-care activities to your calendar, be vocal about them with family and friends, and be intentional with seeking out opportunities to enhance your self-care routines. Self-care is something that you have to actively plan, it is not going to just happen on its own.
Be mindful of why you are choosing to participate in self-care when you are doing it. You might need to repeat a mantra to yourself like this, “I need to do this for myself because my body is worthy of being taken care of.” Take a mental inventory of what you choose to do, how it feels, and what you feel like after.
