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Long Island Researcher`s Clinical Trial Targets Lupus Pain

Dr. Cynthia Aranow, a medical investigator at the Feinstein Institute for Medical Research has been working closely with Dr. Kevin Tracey of the Feinstein Institute on a possible major breakthrough in lupus pain research. Dr. Aranow, is a long-time board member of the Lupus Alliance of LIQ and a staunch supporter of the LALIQ`s programs and research efforts.

The LALIQ is very excited about this new lupus research here in our own community. These wonderful advancements will help those struggling with the debilitating disease of lupus on Long Island as well as worldwide. The LALIQ is proud to work with the Feinstein Institute; donating to this critical research as part of our mission to serve Long Island and Queens.

The Feinstein Institute collaborates with the LALIQ throughout the year by supporting our educational programs, symposiums and sponsoring our events, like our legacy Walk-Along for Lupus, now in its 24th year. We look forward to working with them on important lupus research advances today and in the future.

We congratulate Dr. Kevin Tracey and Dr. Cynthia Aranow on their fine work in the field of lupus research.


Dr. Kevin Tracey of The Feinstein Institute for Medical Research in Manhasset, shown in his lab on July 7, 2016, holds a device that delivers neurostimulatory impulses and can be used to treat rheumatoid arthritis. This year his team will conduct a clinical trial to research whether the approach alleviates the pain caused by lupus.

A team of Long Island doctors is embarking on a clinical trial this year that will ask a compelling question: Can a tiny bioelectronic implant banish pain caused by lupus, a debilitating, inflammatory disorder that largely affects women?

Dr. Cynthia Aranow, a medical investigator at the Feinstein Institute for Medical Research, disclosed the upcoming trial during a recent round table discussion at the Manhasset facility.

Using an implanted device, “we will be stimulating lupus patients who have musculoskeletal pain,” said Aranow, who works in the institute’s Center for Autoimmune and Musculoskeletal Disorders. The implant will be connected to a key nerve that runs through the neck — the vagus — and will deliver minuscule doses of electricity at programmed intervals.

Doctors have not decided on the trial’s start date. But they are certain that when it comes to treatment of complex inflammatory disorders, it is time to rethink the need for drugs.

The lupus-focused research is the latest test based on groundbreaking discoveries by Dr. Kevin Tracey, the institute’s president and pioneer of a paradigm-shifting field of treatment: bioelectronic medicine.

Tracey posits that treatment with minute pulses of electricity can control pain and eliminate the need for pharmaceuticals. An investigation of patients with rheumatoid arthritis has confirmed his theory.

Gov. Andrew M. Cuomo’s administration is so convinced that Tracey and his Feinstein team are on a breakthrough track that it pledged $50 million to the institute last year to support bioelectronic research.

“After 18 years, the time for this idea has finally arrived,” Tracey said in a recent interview.

General Electric, which has a medical electronics division, is in talks with him and his Feinstein colleagues on potential projects, Tracey confirmed, as are several other corporations whose names he would not disclose.

Pharmaceutical giant GlaxoSmithKline in August 2013 announced its investment in SetPoint Medical, a California company co-founded by Tracey that develops implantable neurostimulating devices. Tracey also has lured bright minds in science and engineering to Feinstein, including Chad Bouton, who was on the Ohio team that created a brain implant enabling a paralyzed man to use his thoughts to move his fingers and play a guitar.

The lupus trial marks the first U.S. clinical investigation of bioelectronic medicine for an inflammatory disease.

Lupus, is an incurable autoimmune condition caused when a patient’s immune system becomes a turncoat, launching an inflammatory attack. A characteristic “butterfly rash” often develops on patients’ faces. Excruciating muscle and joint pain are a hallmark of the disorder, as are attacks on internal organs and blood vessels. Some patients require a kidney transplant.

Women develop lupus at a 9-to-1 ratio compared with men and usually are diagnosed between the ages of 15 and 45, although the disorder can occur in childhood or late in life. Lupus afflicts about 1.5 million people nationwide.

“It affects a population at a very productive time in their lives,” Aranow said, referring to the majority of patients. However, she said, “I’ve seen it in babies and I have diagnosed it in an 82-year-old.”

For reasons not understood, African-Americans, Latinos and Asians are more likely to be affected by lupus than Caucasians, but the condition is widely diagnosed worldwide in all people and in both women and men.

The upcoming trial will address only patients’ muscle and bone pain, Aranow said. Click here to read the entire article in Newsday.

New York Lupus Advocates Celebrate Legislative Victory

The Lupus Agencies of New York State (LANYS) recently announced another victory after Gov. Andrew Cuomo signed into the law the Lupus Education and Outreach Bill.

The new legislation will bring essential lupus education to the public and to health professionals. The bill was passed unanimously in June by the New York State Senate and the state Assembly.

Advocates have visited the State Capital in Albany each May (New York State Lupus Awareness Month) for the past eight years to increase public awareness of lupus and to gather support for improving education programs, diagnostic tests and making treatments more effective, with the ultimate goal of finding a cure for the disease.

The Lupus Education Outreach Bill creates a statewide program within the Department of Health (DOH) to increase public understanding of the causes and consequences of lupus. The bill provides for an education program with a special emphasis on minority populations and at-risk communities.

“An education and outreach program created by the NYS DOH will help to put lupus on the radar of patients, family members and healthcare providers, which will ultimately lessen the physical, emotional and economic impact for those affected,” state Sen. Diane Savino said in a press release. “I commend the governor for signing it into law and applaud Kathleen Arntsen and the many passionate lupus advocates for their tireless efforts in getting this bill passed, and thank Assemblywoman Crystal Peoples-Stokes for sponsoring this important legislation with me.”

The bill also establishes an advisory council of individuals with lupus, advocates, and clinicians who will collaborate with the Department of Health on the program.

“As a rheumatologist it is difficult to diagnose and frustrating to treat an individual with a heterogeneous and unpredictable disease such as lupus,” said Max Hamburger, MD, president of the New York State Rheumatology Society.

“Having a statewide education program that promotes public and health provider awareness will result in earlier diagnosis and treatment which are vital components in diminishing the physical impact of lupus,” he said, thanking Cuomo for making the bill a law “to improve the health of New Yorkers.”

LANYS is a group of organizations dedicated to improving the lives of people living with lupus and their loved ones by providing education, support and outreach services, and also promoting collaborative awareness, advocacy and research programs.

The group includes the Lupus and Allied Diseases Association, Lupus Alliance of Long Island/Queens, Lupus Alliance of Upstate New York, Lupus Foundation of America, Lupus Research Alliance, and Lupus Friends and Family Foundation.


Source: Lupus News Today

The Lupus Alliance of Long Island/Queens Hails a Huge Lupus Advocacy Victory With the Passing of the 21st Century Cures Act

The Lupus Alliance of Long Island/Queens Hails a Huge Lupus Advocacy Victory With the Passing of the 21st Century Cures Act

Legislation will bring essential lupus education to the public and health professionals

The Lupus Alliance of Long Island/Queens, the only lupus agency located on Long Island that is dedicated to helping those who live with lupus in Nassau, Suffolk and Queens, announces a major advocacy victory with the U.S. House of Representatives passing the bipartisan House Amendment 392-39. 392-39 updated the 21st Century Cures Act, intended to spur the development of new medical treatments in many disease areas including lupus.

Over the past 8 years, the LALIQ volunteer advocates both in person and through email campaigns have worked hard to have their voice heard by our local representatives. Over these 8 years our advocates urged our officials to understand the need for better lupus education, awareness and diagnostic tests.

The LALIQ and all of those we serve and represent greatly appreciate that the Bill, with the Amendment, addresses specific requests that our lupus advocates voiced the need for. The Bill will:

  • Streamlining and improving the FDA’s review of life-saving drugs for patients
  • Modernizing clinical trials and removing regulatory uncertainty for the development of new medical apps
  • Supporting and investing in the next generation of Scientists
  • Provides $4.8 billion over 10 years to the National Institutes of Health
  • $500 million to the Food and Drug Administration (FDA) over 10 years to move drugs and medical devices to patients more quickly

We thank the authors of this bill for perseverance in championing this important legislation: Fred Upton (R-MI), Diana DeGette (D-CO), Frank Pallone, Jr. (D-NJ), Joe Pitts (R-PA) and Gene Green (D-TX).


Xencor Highlights Potential Lupus Therapy Now in Phase 2 Testing

During the recent Analyst Day event in New York, Xencor highlighted its lead candidate to treat systemic lupus erythematosus (SLE), now in Phase 2 clinical testing, and other potential treatments advancing in development.

“We believe our flexible bispecific oncology platform has substantial potential. Our programs are built on a novel XmAb Fc domain, which allows for the rapid creation of drug candidates that maintain important full-length antibody properties, without the manufacturing and commercialization challenges that have historically blocked the viability of bispecific antibodies,” Bassil Dahiyat, PhD, president and chief executive officer of Xencor, said in a press release.

The company is also collaborating with Novartis to develop two lead bispecific oncology programs, XmAb14045 and XmAb13676, to treat neuroendocrine tumors and multiple cancers, respectively. Xencor will maintain commercialization rights for both candidates in the U.S.

“We are also pleased to report on the continued advancement of our pipeline of wholly-owned programs. We remain on track to … announce initial data from our ongoing Phase 2 trials of XmAb5871 in IgG4-Related Disease (IgG4-RD) and systemic lupus erythematosus (SLE) in 2017 and 2018, respectively,” Dahiyat said.

Currently, nine candidates engineered with Xencor’s XmAb technology are in clinical development, including XmAb5871, a first-in-class monoclonal antibody (i.e., antibodies that are made by identical immune cells and are able to recognize and attach to specific proteins). In this case, XmAb5871 specifically targets CD19, a protein linked to SLE pathogenesis.

The primary goal of the Phase 2 lupus clinical trial (NCT02725515), which is currently recruiting adult SLE patients at more than a dozen sites across the U.S., is to evaluate the ability of XmAb5871 to maintain improvements in SLE disease activity realized by a brief intramuscular injection of a disease-suppressing steroid therapy.

Initial data is expected in the first half of 2017, and the trial is set to conclude in December 2018. More information is available through this link.

Scientists at The Scripps Research Institute identified key mechanisms contributing to the generation of autoimmune B-cells that attack the body’s own tissues in diseases like systemic lupus eurythematosus. In a cluster of microRNA (miRNA) molecules, the research team found one factor with exaggerated presence that allows faulty cells to sneak past quality control checkpoints.

Source: Lupus News Today


Mouse Study Points Way to Shut Down Harmful Immune Response in Lupus

Molecules that scavenge debris from dying cells appear to halt the cycle of chronic inflammation in lupus, while also enhancing the body’s ability to combat flu, according to Duke Health studies in mice.

The molecules, called polymers, have commonly been used in gene-transfer experiments because they bind to the nucleic acid in DNA and RNA. When deployed directly in mice with lupus or an acute flu infection, the polymers home in on the DNA and RNA refuse from dying cells, halting the damaging immune attack.

“This debris left by dead cells can mistakenly signal to the body that there is an infection that warrants immune action, triggering the innate immune system,” said Bruce A. Sullenger, Ph.D., director of the Duke Translational Research Institute. Sullenger is senior author of a study published online this week in the Proceedings of the National Academy of Sciences.

“By selectively targeting the source of the immune activation rather than shutting off the innate immune system downstream, these nucleic acid scavengers are able to limit pathological inflammation without compromising one’s ability to fight a viral infection,” Sullenger said.

Pathological inflammation, a major cause of illness and death around the world, is a hallmark of autoimmune diseases, including lupus and diabetes, as well as chronic conditions such as heart disease and some cancers. It also fuels the organ failure associated with severe infectious diseases such as Ebola or even flu.

Current therapies to treat pathological inflammation generally focus on quieting the overactive immune response, but in suppressing the immune system, patients are vulnerable to severe infections arising from other sources.

Intrigued by the ability of certain polymers to mop up DNA and RNA for gene transfer, Sullenger and colleagues tested the idea that these chemical compounds might also be effective targeting such nucleic acids as they arise in cell death.

“Essentially what you have in an autoimmune disease is a vicious cycle,” said lead author Eda K. Holl, Ph.D., assistant professor in Duke’s Department of Surgery. “Our goal was to break this cycle at its onset. What we saw in animals with lupus when we used these compounds was a dramatic reduction in inflammation, which gave the body a chance to heal.”

Sullenger and Holl said the approach was further tested to see if it compromised the mice’s ability to fight outside infections. When they exposed the treated mice to the influenza virus, the animals recovered from the illness even better than healthy mice infected with flu that had not undergone the treatment.

“This approach has the potential to treat a wide range of inflammatory conditions —from lupus to diabetes to even obesity,” Sullenger said.

He said the research team is continuing studies in animal models and working to start a company to develop and commercialize the scavenger approach.

Source: Medical Xpress

Temple University Scientists Make Breakthrough in Lupus Research

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.

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.

Source: Emily Rolen, Temple University.

Disease Activity in Pediatric Lupus Nephritis May Possibly Be Monitored with Urine Biomarkers

Researchers have discovered a potential new noninvasive measurement for the management of lupus nephritis in pediatric and young adult patients that may help not only keep track of disease progression but also monitor therapeutic responses.

The study, “Development of a Novel Renal Activity Index of Lupus Nephritis in Children and Young Adults,” was published in the journal Arthritis Care and Research.

Researchers sought to further investigate the possibility of using biomarkers (measures of physiological activity including red blood cell counts, cholesterol levels, and protein concentrations) from patients’ urine in an effort to manage, in a noninvasive manner, the progression of lupus nephritis. There is a rich amount of research literature on the possibility, but unfortunately a successful metric has not been discovered.

 The team analyzed laboratory tests and 16 urine biomarkers of 47 children with lupus nephritis who underwent a kidney biopsy. The analysis was conducted using two standard renal activity indexes, NIH-AI and tubulointerstitial activity index (TIAI) as a reference.

After analysis, researchers concluded that there were six urine biomarkers excreted by patients with lupus nephritis predicted disease activity:

  • monocyte chemotactic protein 1
  • hemopexin
  • neutrophil
  • gelatinase-associated lipocalin ceruloplasmin
  • adiponectin
  • kidney injury molecule 1

The detection accuracy was between 71 percent and 85 percent with lupus nephritis damage minimally influenced by what the researchers classify as the renal activity index for lupus (RAIL) accuracy.

These results suggest that renal activity and specific urine biomarkers could potentially be a metric for measuring lupus nephritis, and specifically this index will be able to give clinical markers for the monitoring of the degree of inflammation in lupus nephritis patients.

“If confirmed in ongoing experiments, the RAIL will allow for more effective and personalized monitoring of lupus nephritis and its therapy,” the authors wrote. “The availability of standardized clinical platforms for the combined measurement of the urinary biomarkers will enable the testing of this hypothesis in the near future.

“Future research will need to confirm the most appropriate cutoff scores for the RAIL and also investigate how the combinatorial RAIL urine biomarkers can be used to noninvasively predict response to therapy,” they added.

Source: Lupus News Today

Autoantibodies Could Help Treat Lupus, Other Autoimmune Diseases

Autoantibodies that naturally occur in patients with an ultra-rare type of autoimmune disorder called autoimmune polyendocrine syndrome type 1 (APS1 or APECED), could help fight lupus and other diseases.

The study, “AIRE-Deficient Patients Harbor Unique High-Affinity Disease-Ameliorating Autoantibodies,” was conducted by scientists at ImmunoQure AG, a German biotechnology company, in collaboration with a group of academic researchers and clinicians. Results were published in the journal Cell.

“This is very significant because antibodies make up one of the largest sectors of the pharmaceutical market, and one of the great quests in the pharmaceutical industry is to be able to routinely generate antibodies against human proteins implicated in diseases,” Adrian Hayday, co-founder of ImmunoQure and professor of immunology at King’s College, London, said in a press release.

Researchers showed that each APS1 patient has antibodies targeting 100 proteins on average. Each patient has a different set of antibodies, so a group of 80 patients has antibodies targeting almost one fifth of all the proteins in the human body.

Although the autoantibodies should pose a severe risk for autoimmune diseases such as type 1 diabetes, multiple sclerosis, rheumatoid arthritis, and lupus, they actually exhibit disease improving properties. The autoantibodies target cytokines and type I interferons, which are cell signaling molecules involved in inflammation.

The researchers showed it is possible to transfer patients’ autoantibodies to pre-clinical models of different diseases, making them perfect candidates to be potential therapeutic agents. Because they are patient-derived and natural, and because they recognize a large number of epitopes, they can potentially make safe, effective and highly defined drugs.

“Rather than committing immense resources and expense to drug discovery, which is at best a very uncertain path, the findings suggest a route to drug recovery, in which naturally arising highly efficacious autoantibodies can be isolated from patients whose clinical information guides us as to the diseases most likely to benefit from drugs derived from those antibodies,” Hayday said.

ImmunoQure is hoping to use the autoantibodies as building blocks to engineer new immunotherapeutics for treating many autoimmune diseases including lupus.

APS1 is an ultra-rare disease caused by mutations in the autoimmune regulator gene AIRE. This results in the body’s inability to detect and destroy naive T-cells that recognize self-proteins. As a result, the auto-reactive T-cells trigger B-cells to develop and generate highly matured self-reactive antibodies.

Source: Lupus News Today

Targeting B Cells in Lupus: Efforts Persist Atacicept Lowered Flares in Post-Hoc Analysis

Atacicept may yet have a role in the treatment of systemic lupus erythematosus, with post-hoc analyses of a phase II/III study showing benefits among patients with high levels of two B-cell biomarkers, researchers reported.

Among patients with high levels of the B-cell stimulating factor known as BLyS and the proliferation-inducing ligand referred to as APRIL, the flare rate over 52 weeks was 32% among those receiving 150-mg subcutaneous atacicept once weekly compared with 50% of those receiving the drug in doses of 75 mg and 75.7% of those given placebo, according to Caroline Gordon, MD, of the University of Birmingham in England, and colleagues.

In addition, time to flare was longer in the high-biomarker group given the 150-mg dose, at 365 days, compared with 275 days in the 75-mg group and 85 days in the placebo group, the researchers reported online in Arthritis & Rheumatology.

“Atacicept is a recombinant fusion protein containing the extracellular, ligand-binding portion of the receptor transmembrane activator and calcium-modulating cyclophilin ligand-interactor and a modified Fc portion of human immunoglobulin (Ig)G,” they explained.

It inhibits BLyS, as does belimumab (Benlysta), but also APRIL, which might increase efficacy because inhibiting APRIL could also target long-lasting plasma cells involved in autoantibody production in lupus, they suggested.

The multicenter study initially enrolled 461 patients with active disease who were autoantibody positive, but before completion two patients in the 150-mg arm died of infections, so that arm was terminated. In the 75-mg group, there were no differences compared with placebo in flare rate (OR 1.15, 95% CI 0.73 to 1.80, P=0.543). However, a preliminary analysis suggested potential flare prevention with the higher dose.

Therefore, with the ongoing unmet need for additional targeted therapies in lupus and the recognition that B cells play an important role in the disease, the study investigators sought to evaluate efficacy and safety outcomes according to biomarkers and drug exposure among patients in the 150-mg dose group who had been randomized more than 52 weeks before termination. These patients would have completed the study if they had no other reason for stopping the treatment, avoiding potential confounding by the termination of that arm of the study.

This potential completer population included 246 patients, with 81 in the 150-mg group, 84 in the 75-mg group, and 81 in the placebo group.

Mean BLyS levels were 1.9 ng/mL in all groups, while mean APRIL levels were 2.2, 2.3, and 2.4 ng/mL in the 150-mg, 75-mg, and placebo groups, respectively.

The investigators divided the patients into subgroups according to levels of BLyS and APRIL. Subgroup 1 included patients whose baseline levels were 1.6 ng/mL or higher for BLyS and 2.2 ng/mL or higher for APRIL (high BLyS/high APRIL), subgroup 2 was high BLyS/low APRIL, and subgroup 3 was low BLyS only.

In subgroup 1, both atacicept groups had lower rates of flare than the placebo group, but the reduction was greater in the higher-dose group. In subgroup 2, only the 150-mg group had a lower flare rate, at 48%, compared with 84.2% in the 75-mg group and 62.5% in the placebo group. No significant reduction in flare rate was seen in subgroup 3, with rates of 48.4%, 51.7%, and 39.3% in the 150-mg, 75-mg, and placebo groups, respectively.

The researchers also looked at treatment responses and other biomarkers such as IgG, IgM, and naive B cells and plasma cells, which were stratified into quartiles, and found that flares were reduced in patients with the greatest reduction in all these markers. They also noted that flare rates were lower among patients with higher serum trough levels of the drug.

The association between treatment response and immunoglobulins and B cells needs further explication, but may relate to a reduction in autoantibody production or errant B cell activity.

No “notable difference” was seen in rates of infection or serious infection in any of the BLyS/APRIL subgroups, the investigators reported. More serious infections occurred in patients with the lowest levels of IgM, but the numbers were small, with five being seen in the top quartile of IgM reduction and none in the lowest quartile.

The two patients who died had IgG levels within the normal range, and their IgM levels remained above 0.34 g/L, while the normal range is 0.4 to 2.3 g/L. They also had “relatively low mean and maximum trough levels of atacicept,” according to the investigators.

“Infections and fatalities in clinical trials must be taken very seriously, and extrapolating from a trial that was ended prematurely has significant limitations, as do all post-hoc analyses,” commented Amit Saxena, MD, of NYU Langone Medical Center in New York City, who was not involved in the study.

“However, the lack of association between atacicept exposure and death allows for the possibility that the drug’s safety profile may be reasonable, which is being studied in a new phase IIb trial. With recent studies showing lack of efficacy with epratuzumab, tabalumab, and atacicept, the question has been raised of how significantly B cell depletion associates with clinical response in SLE,” he told MedPage Today.

“However, subgroup and post-hoc analyses like the one reported here have identified certain patients that respond to these treatments, including those with more active disease and those with elevations in certain biomarkers. Given the way cancer therapeutics are personalized to specific patients, it would seem prudent for the next phase of treatment strategy in lupus to be a similar method of choosing medications based on baseline levels of markers such as B lymphocyte stimulators, interferon, or cytokines,” Saxena said.

Source: Medpage Today

$335K Grant Supports Chronic Disease Management for Lupus

A $335,000 grant from the HHS Office of Minority Health will help the American College of Rheumatology (ACR) strengthen its chronic disease management programs for patients with lupus, the organization announced this week.

The Lupus Initiative, a national educational program intended to improve quality of life and outcomes for patients with the autoimmune disease, has received funding from the Office of the Minority Health (OMH) for seven years in a row.

In 2015, ACR received $500,000 from the OMH to develop a model that reduces barriers to diagnosis, treatment, and ongoing management needs for minority patients who may have trouble accessing necessary care.

“The model allows for primary care providers to treat a person with lupus on their own, or co-manage with a geographically-distant rheumatologist, until an appropriate referral can be made. Additionally, we focus on increasing the awareness of the people in these ‘silent spaces’ about lupus’ signs and symptoms,” said Sheryl McCalla, JD, TLI Project Director and ACR Senior Director, Collaborative Initiatives.

The ACR has made a particular effort to improve lupus-related educational materials and provider education in rural and underserved regions of Southwest Georgia and the Pacific Northwest, where a shortage of rheumatologists means that many patients face long wait times or difficult journeys to access care.

“Lupus can be a debilitating, chronic illnesses but it could be managed if resources were available,” said Sam Lim, MD, MPH, Associate Professor of Medicine and Epidemiology at Emory University and a nationally recognized lupus expert. “TLI will establish an evidence-based model that other organizations, communities, and agencies can replicate to deliver provider education and access to care for patients in need.”

The ongoing project includes collaborations with community organizations and local healthcare providers, including the Emory University School of Medicine, Southwest Georgia Area Health Education Center, Cascades East Area Health Education Center, Let’s Talk Diversity Coalition, Inc., and St. Charles Rheumatology Clinic.

“This model is the first of its kind to establish a method to penetrate the most difficult to reach, but most affected populations – communities in rural and micropolitan areas of the U.S. where there is a shortage of rheumatologists,” said Lim.

“The TLI evidence-based model can be replicated by other organizations, communities, and agencies to deliver provider education and access to care for patients in need.”

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