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Lupus Therapies Continue to Evolve

Elizabeth Savage


It can be a difficult disease to diagnose and a difficult disease to treat. It’s called lupus, and as many as 24,000 people in the United States are diagnosed with the disease each year.

May is National Lupus Awareness month, a time to think about lupus and the challenges it presents patients, researchers and health care professionals alike. Scientists today are working on many fronts to understand the genetic underpinnings of the disease and to develop new and more targeted therapies to treat it.

What is Lupus?

Lupus is a disease that can damage many parts of the body, including the joints, skin, kidneys, heart, lungs, blood vessels and brain. It is an autoimmune disease—an illness that occurs when the body mistakenly detects its own tissue as foreign and attacks itself, and can be fatal in some severe cases. While people of all races can have the disease, African American women have a three-times higher number of new cases than white, non-Hispanic women. African American women tend to develop the disease at a younger age than white, non-Hispanic women and to develop more serious and life-threatening complications. It is also more common in women of Hispanic, Asian and Native American descent.

The underlying cause of lupus is not fully known, and there are many types of the disease. The most common form, called systemic lupus erythematosus, commonly causes mouth sores, rash, fatigue, joint pain and swelling, as well as affecting the kidneys.

Lupus also is a chronic disease. “With treatment, the disease may quiet down, but it also may relapse eventually. Although it may be controlled with medications, once you get it, you will always have it,” explains Sarah Yim, M.D., a rheumatologist at the Food and Drug Administration (FDA). A person with lupus will have good periods and bad periods, she says, and symptoms can range from mild or moderate to severe.

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Who is Affected?

Estimates vary on the number of lupus sufferers in the United States, ranging from approximately 300,000 to 1.5 million people. According to the American College of Rheumatology, ten times more women than men have lupus, and the disease often starts between the ages of 15 and 44.

What makes lupus so hard to diagnose? A lot of people can be called lupus sufferers but can all have different things wrong with their immune systems, Yim says. And many of the symptoms that can occur in someone with lupus are non-specific and can also occur in other diseases, making it hard to nail down the diagnosis.

Jonca Bull, M.D., director of FDA’s Office of Minority Health, says there is still an enormous need for better therapeutics, and that scientists may be on the cusp of more refined therapies that bring symptoms under control and bring about remission of the diseases that are associated with susceptibility to lupus or play a role in its development. FDA’s Office of Women’s Health has funded several studies related to lupus and other autoimmune diseases in recent years.

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Targeting Therapies

Treatment of lupus depends on the part of the body being affected by the disease, and how serious the problem. FDA approved the first drug to treat lupus, aspirin, in 1948 and later approved corticosteroids, such as prednisone, which suppress the immune system and reduce inflammation. In 1955, the agency approved the antimalarial drug Plaquenil (hydroxychloroquine) which helps to relieve some lupus symptoms such as fatigue, rashes, joint pain or mouth sores.

Part of what makes lupus research such a challenge is that the precise problem with the immune system is so different among patients, Yim says. New research is trying to zero in on what the best targets might be.

“Technologies have been developed in recent years that can make our medicines more targeted to address the specific molecule or molecules in the immune system that may be causing the problem,” Yim says. “Older medicines tend to suppress the whole immune system, which works, but it’s a little bit like shooting a fly with a cannonball, and can be associated with many undesirable side effects.”

FDA approved Benlysta—the first targeted therapy for lupus—in 2011. Benlysta is delivered directly into a vein. It is designed to target a protein called B-lymphocyte stimulator, which may reduce the impact of abnormal cells thought to be a factor in the development of lupus.

Yim says that Benlysta doesn’t work for everyone, and not enough research has been done yet to know if it will work in people with very severe lupus. But it works well for lupus patients with skin and joint involvement, she says.

Advances in the understanding and treatment of lupus over the last several decades have resulted in people with the disease living longer.

Despite these advances, however, there remain many people with lupus who need additional treatment options. FDA remains committed to working with researchers and drug developers to help make new treatments a reality.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Published: May 27, 2014

Reviewed: April 22, 2016

Click here for Original Article

Lupus Biomarkers Advancing to Detect Disease at Earlier Stages

Elizabeth Savage

In a recent review, researchers from the Department of Biomedical Engineering of the University of Houston discussed promising advances in noninvasive biomarker detection in patients with lupus, a disease whose diagnosis has typically been confirmed through a very invasive renal biopsy. The review was titled “Protein Arrays for Biomarker Discovery in Lupus” and published in the journal Proteomics Clinical Applications.

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Lupus: Can Gut Microbes Make a Difference?

Elizabeth Savage

Systemic lupus erythematous (SLE) results from a mistaken response of the body’s immune system against healthy tissue affecting several organs such as skin, kidneys and brain. The underlying causes of SLE remain unknown although several evidences point towards an important role of gut microbes, also known as gut microbiota. Researchers at Virginia Tech have recently discussed the contribution of diet and gut microbes to SLE occurrence and pathogenesis in a publication entitled “SLE: Another Autoimmune Disorder influenced by Microbes and Diet?” published in the journalFrontiers in Immunology.

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Pfizer Patient Assistance program

Elizabeth Savage

Big news yesterday regarding Pfizer Patient Assistance program, Pfizer RxPathways. I wanted to make sure that you were aware of the event any of your patients need assistance with their Pfizer medications. Here is the press release:


In response to the ongoing challenges patients face in paying their out-of-pocket costs for their prescription medicines, Pfizer announced today that it will immediately double the allowable income level for its patient assistance program, so that even more patients in need could be eligible to receive their Pfizer medicines for free. With this change, more than 40 medicines offered for free through the program will now be available to eligible patients earning up to 4 times the Federal Poverty Level (FPL) adjusted for family size ($47,080 for a single person; $97,000 for a family of four).


Through its Pfizer RxPathways program, Pfizer offers patients, including those with health insurance and those without, a range of individual services to help them gain access to Pfizer medicines. In the last five years alone (2010-2014), Pfizer has helped nearly 2.5 million uninsured and underinsured patients get access to more than 30 million Pfizer prescriptions, making it the most comprehensive program of its kind.


Pfizer has been helping patients gain access to the Pfizer medicines they need for more than 25 years. Through Pfizer RxPathways, Pfizer can also help connect patients to other assistance services the company offers if they are not eligible to receive their medicines for free. These programs include:


·         Savings ranging from 35% to 50% off the retail price on Pfizer medicines for uninsured patients regardless of income

·         Medicine access counseling to help patients get connected to the appropriate Pfizer assistance program

·         Insurance counseling for select Pfizer medicines to help patients understand the coverage offered through their insurance plans

·         Co-pay cards for those with private/commercial insurance and information on alternate sources of help, like independent co-pay foundations

·         Referrals to other industry resources that may help if it is discovered a patient is not taking a Pfizer medicine

·         Patients, health care providers and patient advocates can visit to learn more about Pfizer’s programs, including eligibility criteria and how to apply, and to download applications or program brochures.


About Pfizer RxPathways

Pfizer RxPathways is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™.

Temple University scientists make breakthrough in lupus research

Elizabeth Savage


By Emily Rolen, Temple University July 23, 2015 9:38 am


In a press release issued on July 6, 2015, researchers at Temple University School of Medicine (TUSM) announced a breakthrough in the study of systemic lupus erythematosus, an autoimmune disease which causes the immune system to attack DNA and RNA molecules.

According to the Lupus Foundation of America, approximately 1.5 million Americans and at least five million people worldwide have a form of lupus.

The discovery, headed by researchers Çagla Tükel and Stefania Gallucci, found that biofilm — or bacterial communities in the body — may provoke the onset of lupus.

“Basically biofilms are these bacterial communities,” says Tükel, an assistant professor of microbiology and immunology at TUSM. “And when these communities are formed, they are very resistant to treatment. And actually what we found is happening with these biofilms is there is this protein called an amyloid protein. We think there could be a link between biofilm associated diseases and amyloid associated diseases.”

The protein of interest is an amyloid called curli, which Tükel says is currently being treated with antibodies.

“We are thinking maybe the flares in lupus could be associated with the spikes in the curli antibodies and maybe this could be a biomarker for the disease,” Tükel says. “Another thing is the mechanism – how acceleration of lupus is caused in a patient.”

Symptoms vary from patient to patient because any organ in the body could be attacked, although symptoms are often very flu-like. This makes lupus difficult to diagnose, Tükel says.

“Our study is suggesting that underlying infections may actually trigger the disease,” says Galluci, the associate chair of microbiology and immunology and an associate professor in microbiology and immunology at TUSM. “It’s important to go and study ways to better diagnose these underlying infections and treat them.”

Biofilm infections are extremely common in humans, Tükel says. Ear infections and urinary tract infections are just two examples of these kinds of infections.

“Understanding how the biofilms affect flares could lead to a different treatment approach,” Gallucci said in a press release from the Temple School of Medicine. “Now, they give immune suppressive drugs. Maybe you want to do something else, like treat the underlying infection.”

Other researchers are studying the importance of infection in autoimmunity, but this group of researchers is the first to study bacterial biofilms products and lupus, Gallucci says.

Their research was published in the current issue of Immunity, a monthly medical journal of recent articles and reviews in the immunology field.

Their next step, Tükel says, is to hopefully start looking at patients.

Jennifer Mikelonis, 40, of Pittsburgh, Pennsylvania was officially diagnosed with lupus in 2010. Mikelonis says between 2008 and the time she was diagnosed she suffered from endless health concerns, including moderative fibrosis of her liver, a legion on her thyroid, anemia, clotting issues, joint pain and renal and cardiac issues.

“There was a lot of stuff that kind of just sort of waterfalled from the time that I had the bloodwork and somehow it was all intertwined,” Mikelonis says. “I had four surgeries within a 6 month time frame that were all related to my lupus.”

Mikelonis says that while she may look healthy on the outside, fighting the disease is a daily battle.

“You never know what the next day will hold,” she says.

In regards to the new research, Mikelonis says she is willing to try anything. As a mother of three with a strain of lupus that is not hereditary, she says she is willing to hold off the disease for as long as she can, without making it worse.

“It’s a debilitating disease,” she says. “It’s sad how it will definitely deteriorate your life. I went to working 55 hours a week and mother of three to a point where there were days when I couldn’t even get out of my bed. It’s worth any try at all to try and help and prevent this disease.”

The research at TUSM was supported by the National Institutes of Health, the National Institutes of Allergy and Infectious Diseases, the Fox Chase Cancer Center-Temple University Nodal grant, the Lupus Research Institute Innovation Research Grant, the Lupus Foundation’s Goldie Simon Preceptorship Award and the National Institute of Arthritis and Musculoskeletal Skin Diseases.

Emily Rolen is a student at Temple University and a summer 2015 USA TODAY Collegiate Correspondent.

Emily Rolenhealthlupusnewsresearchtemple universityTemple University School of MedicineUSA TODAY CollegeNews



Elizabeth Savage

Lower-than-Standard Dose of Prednisone

Lower-than-Standard Dose of Prednisone Found to be Just as Effective with Fewer Side Effects

A small study in Spain is raising hopes that Lupus Nephritis patients can be treated with a dosage of the corticosteroid Prednisone that is less than half the current standard and still be just as effective with few or no side effects.

Although Prednisone is a key drug in the treatment of lupus, the steroid often causes severe side effects from bone loss to cardiovascular disease. The Lupus Research Institute reports:

LN is typically treated with a combination of immunosuppressants and high-dose prednisone (50-60 mg a day). But the cost of remission over time at that dose is often bone loss, osteonecrosis, cataracts, and cardiovascular disease.

However, researchers at the BioCruces Health Research Institute in Spain report that half or even less than half that amount of prednisone produced complete or partial remission in a majority of patients in as quickly as six months, with few or no side effects.

The new regimen, which they call the "Cruces Protocol," consists of starting doses of 15-30 mg/day given with pulses of methyl-prednisolone, hydroxychloroquine, and cyclophosphamide, rapidly tapering the prednisone to a maintenance dose of 2.5-5 mg/day within 16 weeks, and maintaining azathioprine and/or mycophenolate mofetil for up to two years.

You may read more about the study here. While this study is a bright ray of hope, LFSC would like to remind readers that we provide these updates for information purposes only. If you would like to seek a change to your prescription regimen or dosage, please consult your rheumatologist or treating physician.

Powerful 3-Drug Combination Seen as Effective Against Lupus Nephritis

Elizabeth Savage

One of the most common - and most severe - lupus related complications is kidney infection, known in the medical community as lupus nephritis. Nephritis sometimes affects kidney functions so severely that patients need kidney transplants. According to the National Institutes of Health, up to 60% of lupus patients eventually develop nephritis.

But a new study has given new hope to nephritis sufferers. A 3-drug combination given to patients in the study produced starkly better results than a common single-drug treatment.

In a trial of more than 300 Chinese patients with the condition, known as lupus nephritis, those who were given a trio of powerful drugs were more likely to see a complete remission. After six months, 46 percent were in full remission, versus 26 percent of patients given an intravenous drug called cyclophosphamide. [...]

In the new study .. [Researchers] randomly assigned patients with lupus nephritis to one of two groups: One received monthly infusions of cyclophosphamide, plus oral steroid medication to ease their kidney inflammation; the other received oral steroids, along with two immune-suppressing medications -- MMF and tacrolimus.

After six months, 46 percent of patients on the drug trio were in complete remission, and 84 percent had at least a partial response -- meaning their kidney function had improved, according to the study.

In contrast, just under 26 percent of patients on cyclophosphamide were in complete remission. And 63 percent had at least a partial response, the researchers found.

Study authors cautioned that while the results are optimistic, further research remains to be done to confirm the effectiveness of the treatment among non-Chinese ethnic groups, among other things.


You may read more about this here.