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Lupus is a prototypical, chronic autoimmune disorder. Understanding its many complexities is the key to allowing us to better understand a host of other autoimmune diseases and powering many advances in the field of immunology. In the face of this global pandemic, that research has never been more critical. What we know today about lupus is aiding researchers in identifying characteristics of COVID-19. It’s also encouraging that some lupus therapies and rheumatoid arthritis treatments are part of a consideration set for researchers moving forward. Continuing our pursuit to fully understand lupus helps assist all researchers in their pursuit to better understand the immune response to viral invaders like COVID-19.

LRA Leading Lupus/COVID-19 Research

Our Scientific Advisory Board members have been our guide, sharing the similarities they see between combatting autoimmunity to fighting a similar over-zealous immune system reacting to the coronavirus. Following is how the organization has responded aggressively to the COVID-19 crisis for our community based on the science.

January 14, 2020

Dear Friends,

Happy New Year! On behalf of all of us at the Lupus Research Alliance (LRA), thank you so much for your kindness and generosity in 2020 and prior years.

2021 starts off with some exciting milestones for the lupus community including a new treatment for lupus nephritis. But  Recently, our Trustees approved a $3 million project to explore the use of these vaccines specifically for people with lupus. This is a significant expenditure for LRA, but because many of the COVID-19 vaccines under development utilize brand new technology, assessing how the new vaccine platforms might impact people with lupus is very important and timely.

The reason these new vaccines have been developed, tested, and deployed so rapidly is because they produce immunity very differently from traditional vaccines. Older vaccines use dead or severely attenuated (weakened) viruses to provide active immunity. Fortunately, these new vaccine technologies became readily available just as the COVID-19 crisis hit. The critical question for us is, which new vaccine will be most appropriate for lupus patients?

To address this question, the LRA recently convened a meeting attended by experts in vaccinology, immunology, and rheumatology as well as representatives from the LRA Research Committee, the National Institutes of Health (NIH), and the American College of Rheumatology. While our expert advisors felt that all of the vaccines would probably be safe and effective for those with lupus, the absence of data made it impossible to be 100 percent certain. Some vaccines may prove more appropriate for people with lupus than others. However, we will only know with in-depth study. It is for precisely this reason that LRA will be committing so much time, funding, and effort to provide answers to people with lupus.

Many of the new vaccines use the spike protein to stimulate the immune system. Spike protein decorates the surface of all coronaviruses including SARS-CoV-2. Think of spike protein as a key which unlocks a portal called the ACE2 receptor on the surface of human cells and allows genetic material from the virus to penetrate the cell. Once inside, the genetic material of the virus hijacks the machinery of the cell to produce copies of the virus; that is what makes you sick.

Many companies developing these new vaccines use just the spike protein to stimulate the immune system to remember how to fight if faced with the actual virus in the future. The Pfizer and Moderna vaccines use the blueprint within messenger RNA (mRNA) to instruct cells to manufacture spike protein. Once the cells are taught by mRNA to produce spike protein, the cells of inoculated people produce enough of it for the immune system to remember and recognize it as an invader and neutralize the virus, preventing the person from becoming ill.

The AstraZeneca and Johnson and Johnson (Janssen) vaccines use a different approach to achieve the same ends. Their vaccines fuse the genetic instructions for producing spike protein to a harmless adenovirus that can invade cells but doesn’t cause disease in humans. Like a long-haul trucker dropping off his cargo, the adenovirus drops off these genetic instructions which teach cells to make spike protein. As with the mRNA vaccines, the spike protein inspires the immune system to memorize how to destroy the SARS-CoV-2 virus on sight.

The third new vaccine platform that Novavax, and Sanofi with GSK are developing works by directly injecting synthetic spike protein. While this type of vaccine may elicit a less robust immune response than the others, the developers get around this by pairing their vaccines with a chemical called an adjuvant. Adjuvants are substances that incite the immune system to be hypervigilant and may inspire long-lasting immune response.

Unfortunately, no one knows how these technologies may impact lupus. Some experts speculate that the mRNA vaccines might induce production of interferons which are already elevated in many lupus patients, making us wonder if that could cause a flare. The protein vaccines are paired with adjuvants to boost the immune response — which may or may not be an issue for people with lupus. The best guess is that none of this will turn out to be a problem, but it is important to find out for sure. Our new project will not provide answers in time for patients to determine which vaccine might be best for them. Patients will need to make decisions in consultation with their rheumatologists.

So, why evaluate these new vaccine platforms? First, much like the flu, SARS-CoV-2 may turn out to be endemic — meaning they would be permanently found in human populations. If this occurs and if the durability of vaccine protection turns out to be relatively short, it may be necessary to repeat the vaccinations periodically. Secondly, these new vaccine platforms will likely be used for other vaccines in the future. In the fullness of time, we should be able to advise people with lupus which forms of the vaccine are most appropriate for them, especially if patients need to be re-vaccinated year after year.

We are asking the NIH and industry partners as well as our lupus community to join us in this important endeavor, and we’ll keep you posted on our progress.

Meanwhile, if you haven’t seen it yet, I encourage you to watch our Vaccines and Lupus: What to Know Amid COVID-19 video series where I discuss the role of vaccines, the new COVID-19 vaccine technologies and in the latest Episode 3, what we’re doing to evaluate the new technologies in our lupus population. I am also happy to answer your questions about any of this.

With warm regards,

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Kenneth M. Farber
President & CEO
Lupus Research Alliance

LRA’s President and CEO Kenneth Farber taped this video series to explain what vaccines do, how the new COVID-19 vaccine technologies work, and what the LRA is doing to address questions on the safety of these new vaccines for people with lupus.

Episode 1: How do Vaccines Work in General
Episode 2: What are the New Vaccine Technologies Being Used to Fight COVID-19?
Episode 3: What is LRA Doing to Evaluate New Vaccine Technologies in People with Lupus

LRA Survey  Shows Two Thirds of People with Lupus Would Take COVID-19 Vaccine

As coronavirus vaccines are being developed and tested, the Lupus Research Alliance convened a group of experts in vaccine development and lupus care, along with two women with lupus. They talked about special considerations for people with weakened immune systems such as people with lupus.

Next step was to gain insights from those with lupus and those who support them with a survey of 703 people with lupus and 63 of their family members and friends – to best understand the specific questions and concerns about a potential COVID-19 vaccine for our community.  Two thirds of people with lupus said they would take the vaccine. Click here to learn the full results. Click here for Q&A about Vaccines Amid COVID-19

The LRA developed this Question/Answer backgrounder to provide information of interest to our lupus community as the COVID-19 vaccines roll out.

Diving deep on research on behalf of the lupus community during this crisis, the LRA and our affiliate Lupus Therapeutics discussed with a panel of experts the impact and burden of COVID-19 on people with lupus.

Click here for Video Recording

The LRA is among the sponsors of the COVID-19 Global Rheumatology Alliance, a grassroots group formed March 2020 to unite rheumatologists and patients with rheumatic diseases worldwide to respond to the global pandemic.

Led by the American College of Rheumatology, the group created and published important data from a secure global registry for healthcare providers to share their experience treating people with rheumatologic conditions such as lupus who develop COVID-19.

Published results include a study showing that population, racial/ethnic minorities with rheumatic disease and COVID‐19 had increased odds of hospitalization and ventilatory support. Another study recommended exploring therapies that inhibit cytokines to prevent the  development of COVID-19-Cytokine Storm Syndrome observed in many patients.

Publications of the Global Rheumatology Alliance’s research findings can be found here.

 

The LRA’s April 2, 2020 live webcast addressed the most frequently asked questions doctors were hearing from people with lupus, put the hydroxychloroquine shortage into perspective, and highlighted LRA actions on behalf of the community. Hear from lupus experts Drs. Daniel Wallace, Cedars-Sinai Medical Center and Mary Crow, Hospital for Special Surgery along with LRA President/CEO Kenneth Farber on COVID-19 for people with lupus that you won’t want to miss.

Click here for Video Recording

The LRA advocated with government, academic centers, and industry to address the shortage of hydroxychloroquine. Learn More

Subsequently, studies showed a lack of effectiveness of hydroxychloroquine for COVID-19, and this problem then largely abated.

Seeing the need to tamp down an over-active immune system, in April 2020, many pharmaceutical companies began applying their expertise in rheumatic treatments for lupus and other rheumatic diseases to test potential treatments for COVID-19. At that time, reserving the supply of a drug people with lupus rely on, hydroxychloroquine, was a major focus as well as testing other potential treatments for COVID-19.

By the end of 2020, two therapeutics and two vaccines have been giving Emergency Use Authorization by the U.S. Food and Drug Adminstration.  The company Lilly has been testing its existing drug baricitinib (called Olumiant®) for the treatment of COVID-19 because it may prevent cellular immune activation and inflammation. Baricitinib is approved by the Food and Drug Administration (FDA) to treat moderate to severe rheumatoid arthritis.

On November 19, 2020, the FDA issued an Emergency Use Authorization (EUA) for the use of baricitinib in combination with remdesivir in hospitalized adults and children aged ≥2 years with COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Remdesivir was approved by the FDA under the brand name Veklury®) to treat adults and pediatric patients at least 12 years old and weighing at least 40 kilograms with COVID-19 who need hospitalization.

The Pfizer-BioNTech and Moderna COVID-19 vaccines received Emergency Use Authorization and distribution is underway.

Previous announcements about potential treatments for COVID-19:

 

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