Vitamin D and Fish Oil Supplements for Prevention of Autoimmune Diseases, Like Lupus

New research finds Vitamin D supplementation for five years taken with, or without, fish oil (Omega 3 fatty acid) may help reduce autoimmune disease, such as lupus.

In the study, led by Dr. Karen Costenbader, MD, MPH, Lupus Foundation of America Medical-Scientific Advisory Council Chair, 25,871 adults were divided into two groups. One group was given Vitamin D and some received a placebo. The second group was given fish oil and some received a placebo. Both groups were monitored just over five years.

Autoimmune disease was reduced by 22% in those who took the increased levels of Vitamin D with or without fish oil. And those that only took fish oil supplements saw disease decline of 15%.

More research is needed to better understand the effects of dietary supplements on autoimmune disease, like lupus. Consult your physician before making any changes to your nutrition and diet. Learn about diet and nutrition with lupus.

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Lilly Discontinues Development of Olumiant® for Lupus

Eli Lilly and Company and their partner Incyte announced they discontinued development of Olumiant® (baricitinib) as a treatment for lupus. The company announced its decision after reviewing data from two large phase-3 clinical trials (SLE-BRAVE 1 and SLE-BRAVE 2) of Olumiant involving more than 1,000 adults with active lupus.

While the first phase-3 trial of Olumiant reached its primary endpoint of demonstrating a statistically significant reduction in lupus disease activity, the follow-up trial did not. Neither trial achieved key secondary endpoints, as well. The company is working with clinical investigators to wind down a long-term extension trial involving participants who successfully completed the earlier phase-3 trials.

Olumiant is an oral medication that inhibits the activity of one or more of the Janus kinase (JAK) family of enzymes involved in interactions among immune cell proteins. It is approved in the US and Europe for treating rheumatoid arthritis in adults with moderately to severely active rheumatoid arthritis who have failed to respond to other treatments. Lilly is also conducting trials of Olumiant for other immune-related conditions and as a potential COVID-19 therapy.

Despite this disappointing decision, there remains excellent momentum to develop new therapies for lupus. Two new medications received FDA approval in 2021 for use in lupus and lupus nephritis, while another previously approved lupus therapy received expanded authorization for treating lupus nephritis. There is a robust pipeline of potential lupus treatments. Learn more about how you can become involved in research and help propel the development of new and more effective therapies.

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Molecular Discoveries in Kidney Biopsies in People with Lupus Nephritis

New research finds people with class III, IV and V lupus nephritis (LN) or kidney disease share 52 gene expressions and molecular pathways. There are six classes within the LN classification system and treatment is driven by disease classification.

Using NanoString technology, investigators studied immune and information genes in kidney biopsy tissue samples of people with LN class III, IV and V. Gene analysis revealed 52 common gene expressions and pathways. Additionally, further analysis using the same technology revealed presence of biomarkers found in inflammatory cells (type 1 interferon, complement and MHC II molecules). Their presence was most common in class IV LN. Class IV biopsy samples also exhibited increased cellular activity of the protein NF-kB which is involved in immune and inflammatory processes in the body.

Insights into the molecular pathways and inflammatory molecules of kidneys using NanoString technology can lead to better understanding of kidney disease and more targeted treatments for those living with LN. Learn about lupus nephritis.

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In Pregnant Women with Lupus, Low Blood Levels of Hydroxychloroquine Linked to Preterm Birth

New research demonstrates how important it is for women with lupus to continue taking their hydroxychloroquine (HCQ) as prescribed during pregnancy and suggests that higher doses for pregnant women may be warranted. First, the study found that HCQ behaves differently in the body during pregnancy, causing its concentrations in the blood stream to drop more quickly than in non-pregnant users. Additionally, persistently low blood concentrations of HCQ were associated with significantly higher risk of preterm birth.

Researchers followed 56 pregnant women with lupus from their first trimester to their post-partum doctor’s visits and observed how HCQ levels in the bloodstream compared to the levels that would be expected at their given dosages. They found about one in four (25.2%) women had significantly lower-than-expected blood levels of HCQ at some point between their first trimester and post-partum appointment. And, nearly one in five (19.7%) had chronically low HCQ concentrations consistently throughout their pregnancy.

Two-thirds of the women with low average HCQ blood levels had preterm births. Women who delivered their babies early were more likely to have low HCQ concentrations, regardless of race, kidney disease status, and their use of other medications (azathioprine and prednisone). Disease activity was also found to be higher in those with low HCQ concentrations.

A healthy pregnancy is possible for women with lupus, and HCQ (known commercially as Plaquenil®) is safe to continue taking if you become pregnant. Learn more about lupus and pregnancy.

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Lupus Foundation of America Awarded $500,000 Grant to Increase Participation of Minority Participants in U.S. Lupus Clinical Trials

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.

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People with Lupus Report Improved Symptoms with Dietary Changes

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.

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Researchers Identify Four Lupus Subgroups Associated with Lupus Outcomes using Long-term Autoantibody Data and Artificial Intelligence

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. 

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Air Pollution Shown to Affect Inflammation in Those with Childhood-Onset Lupus

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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New Drug LUPKYNIS Shows Long-Term Benefits for People with Lupus Nephritis

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. 

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Lupus Researchers Receive Prestigious Awards for Distinguished Contributions to the Field

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.  

Side-by-side pictures of the 2021 Hess-Stevens awardees, Melissa Cunningham and Richard Furie.

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. 
 

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