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      Winter vaccinations!   11/03/2016

      It is very important for people with chronic diseases, such as SLE,and for those people taking corticosteroids and immunosuppressants, including chemotherapy drugs, should go to their doctor to be immunised against flu. Flu is not a bad cold! It can be dangerous. Apart from the annual flu jab, ask your doctor about the pneumovax vaccine which will help prevent serious problems with the lungs. Those with asthma should also ask about the various kinds of vaccines available. Finally, Herpes Zoster infections can lead to the risk of strokes in certain populations which include, rheumatoid arthritis and SLE. There is a new post with information, along with a video. Be well! Ros
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      Blogs!   03/27/2017

      All registered Members can write their own Blog here! Just click on Blog and select a title!
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      Registration and Validation   06/03/2017

      Thank you for your Registration! Validation is not automatic and will depend on time zone differences!It ought to be no more than 24 hours. If you do not hear within 24 hours, send me a message using the Contact Us! This is to try and prevent spammers, bots etc! When you Sign Up,  Please use the following to complete the Date of Birth entry: nn-nn-nnnn where n=number. Thus, if your birthday is 5th May 1968, enter: 05-05-1968. Use the “-“ separator and not the “/“. Thank you and hope the LuPUS MB is useful to you!  
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      GHIC   09/08/2017

      I am excited to announce that LUpus Patients Understanding & Support (LUPUS) is linking with The Graham Hughes International Charity (GHIC). This means I will be posting articles from Professor Hughes here. About 25% of those with SLE also have Hughes Syndrome. As more research is being done, its findings are extremely important for those who have this condition. Like SLE, diagnosis can take a very long time.

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  1. Managing Infections for Lupus Patients - Highlights from Dr. Curran's Presentation On August 9, 2012, the LSI hosted an educational teleconference “Managing and Preventing Infections for Lupus Patients” presented by Dr. James Curran. The event included a presentation by Dr. Curran followed by Q&A from the callers. The article below is based on information obtained from the teleconference. The entire transcript will be available online in the next few weeks. The second leading cause of death in SLE is infection – making managing and preventing infections a top priority for lupus patients. Lupus patients are at greater risk for many reasons; most are on immunosuppressive therapy at one point or another, pathogen exposure at office visits and lupus itself causes a dysfunction of the normal immune response to name a few. Treatments may also contribute to the high infection rate. The new biologic medications (rituximab, orencia and Benlysta) can increase the risk of infection. Corticosteroids, including prednisone, increase the risk of infection. The higher the dose of corticosteroids you’re on, the longer you’re on the dose, the greater the risk of infection. The incidence of infections in lupus patients – especially life-threatening infections – appears to be highest in the first five years of the disease. One reason for this might be that in the first five years, patients are undergoing treatment that is modifying their immune response. Infections lupus patients should be mindful of include bacterial, viral and fungal. Some common threats to lupus are pneumococcal pneumonia or streptococcus pneumonia, Haemophilus influenza and staphylococcus aureus. Lupus patients have a predilection towards salmonella which in lupus patients frequently causes osteomyelitis or bone infections. Shingles is more common in lupus patients than the general public. Yeast infections are also common in lupus patients. Other non-hospitalized infections include respiratory tract infection, sinusitis, urinary tract infections and skin infections. Usually with aggressive treatment and early diagnosis, these infections do not require hospitalization. What can you do to protect yourself again getting an infection? First, non-live vaccines are recommended. That would include the flu shot (NOT the flu vaccine administered through the nasal passages), Pneumococcal vaccine every 5-10 years, a Bordetella pertussis booster, Hepatitis B (for healthcare workers) and meningococcal to name a few. If you are on a biologic, be aware that the biologic medicine may impair the normal response to a vaccine. If you have lupus, you should be vaccinated before you use any biologic and before taking major immunosuppressant medications. Plaquenil, hydroxychloroquine, decreases the risk of infections. A 2009 study showed that individuals on Plaquenil are 16 times less likely to get a major infection when taking the drug – regardless of whether or not corticosteroids are also taken. So, patients on corticosteroids and Plaquenil had fewer infections than patients on steroids alone. Other things you can do to manage infections are to be sure to get treated with antibiotics if you are sick. Be sure to use bactericidal drugs – drugs that kill the bacteria instead of freeze it. Lupus patient’s immune system needs to kill the bacteria. In conclusion, remember vaccinations are very important – avoid live viruses. Plaquenil reduces risk of infection. Limit your exposure to infection.
  2. Lupus Survival Much Improved, But Plateaued September 25, 2017 | Lupus By Gregory M. Weiss, M.D. Survival rates for patients with systemic lupus erythematosus have plateaued since the middle of the 1990s after a period of major improvement starting in the 1950s. It has been thought that survival in systemic lupus erythematosus has continued to improve over the years, with reports of survival in adults increasing from 50% in the 1950s to more than 95% in the 1990s. Data with regard to survival trends in low- and middle-income countries and at 10- and 15-year periods are limited, so Maria Tektonidou and fellow researchers in Greece sought to describe mortality trends for children and adults with systemic lupus erythematosus and presented their findings in a recent Annals of the Rheumatic Diseases article. The study The authors performed a systematic review of the literature, looking at children and adults with systemic lupus erythematosus. Ultimately included in the final analysis were 171 studies; 125 looked at adult survival rates, 51 at pediatric survival, and 5 at both. Results • Studies in high-income countries showed a steady increase in survival from the middle of the 1950s to 1990. Survival rates have remained stable since then. • Five-year survival in high-income countries is greater than 95% in both adults and children who have systemic lupus erythematosus. • Five- and 10 year survival was lower for children than adults in low- to middle-income countries. Adults • Survival in adults with systemic lupus erythematosus has not continued to improve through the 2000s. • From 2008 to 2016, survival rates for adults with systemic lupus erythematosus in high-income countries at 5, 10, and 15 years were 0.95, 0.89, and 0.82, respectively (95% confidence intervals [CIs], 0.94-0.96, 0.88-0.90, and 0.81-0.83, respectively). • From 2008 to 2016, survival rates for adults with systemic lupus erythematosus in low- to middle-income countries at 5, 10, and 15 years were 0.92, 0.85, and 0.79, respectively (95% CIs, 0.91-0.93, 0.84-0.87, and 0.78-0.81, respectively). Children • From 2008 to 2016, survival rates for children with systemic lupus erythematosus in high-income countries at 5 and 10 years were 0.99 and 0.97, respectively (95% CIs, 0.98-1.0 and 0.96-0.98, respectively). • From 1980 to 2000, survival rates for children with systemic lupus erythematosus in low- to middle-income countries at 5 and 10 years were 0.85 and 0.79, respectively (95% CIs, 0.83-0.88 and 0.76-0.82, respectively). • Listing of systemic lupus erythematosus as the cause of death in all cohorts decreased over time. Implications for physicians • Although survival in adults and children with systemic lupus erythematosus both in high-income and in low/middle-income countries has improved dramatically since the 1950s, further gains have not been realized in the 2000s. • A decreased frequency of deaths attributed to systemic lupus erythematosus may be the result of new immunosuppressive drugs and combination therapies. • No increase in death resulting from cardiovascular events or cancer was seen in adults with systemic lupus erythematosus. • The authors suggested that strides need to be made in determining why survival rates are lower in children than in adults in low- and middle-income countries. http://www.rheumatologynetwork.com/lupus/lupus-survival-much-improved-plateaued?GUID=&rememberme=1&ts=26092017
  3. Jewish New Year fruit may hold seeds of hope for brain disease sufferers Israeli neurologist, nanotech expert make pomegranate oil capsules that send antioxidants where they can have the most effect By SHOSHANNA SOLOMON September 18, 2017, 4:36 pm Pomegranates at the Mahane Yehuda market in Jerusalem on August 25, 2016. (Nati Shohat/Flash90) As Jewish families across the world reach for the pomegranate that they customarily eat on Rosh Hashanah, they may not realize that the fruit, with its juicy red seeds and crown-like crest, could hold a key to graceful aging. King Solomon is said to have designed his crown based on that of the pomegranate, and the image of the fruit often appears on ancient coins of Judea. The pomegranate is said to have 613 seeds, which correspond with the 613 Jewish precepts or commandments set out by the Torah regulating the Jewish way of life. For this reason, and because it represents fruitfulness, knowledge, learning and wisdom, and is seasonal in Israel, it customarily appears on Jewish New Year dinner tables. The association of the pomegranate with knowledge, learning and wisdom may not be far from the truth. Pomegranate seed oil (PSO) contains high concentrations of punicic acid, or omega 5 as it is also called, which is believed to be one of the most powerful antioxidants in nature. “Oxidation of proteins and lipids play an important role in aging and neuro degeneration in the brain in general,” said Prof. Ruth Gabizon, a researcher of degenerative brain diseases at the Neurology Department of Hadassah University Hospital in Jerusalem. “Brain cells die over time, from when we are teenagers, and they are not replaced.” Prof. Ruth Gabizon, a researcher of degenerative brain diseases at the Neurology Department of Hadassah University Hospital in Jerusalem (Courtesy) Common daily activities, such as digesting food and breathing, create free radicals that result in oxidation and damage to human cells, in particular to brain cells. Unlike blood or skin cells, brain cells do not get replaced by new ones. So free radicals are harmful to our health and end up impairing our thinking, memory, orientation and alertness, among others. Degenerative brain disease and brain atrophy are typical of debilitating illnesses such as Alzheimer’s, Parkinson’s, and Creutzfeldt-Jakob disease in which brain cells are destroyed, followed by rapid functional and behavioral deterioration and eventual death. The number of people worldwide living with dementia, for example, is expected to almost double every 20 years, reaching 75 million in 2010 and 131.5 million in 20150, according to Alzheimers’ Disease International. Fighting fire with food Aging and brain degeneration are a natural and unavoidable process, explained Gabizon, but they can be accelerated or slowed down depending on our lifestyles. Antioxidants are known for their ability to protect against the destruction of brain and body cells. They can be found in foods such as cranberries, blueberries, beans, artichokes, pecans and foods containing Vitamin E. GranaGard is a food supplement that contains pomegranate seed oil (Courtesy Efrat Eshel) “If we are able to control the levels of free radicals, maybe our cells will work better and live longer,” Gabizon said. “Our approach is that even if we cannot cure the severely affected patients with diseases such as Alzheimer’s, since they are diagnosed at a stage when large numbers of brain cells are already dead, perhaps we can delay the disease’s advance at early stages or even prevent disease outbreak in healthy people at risk of developing neurodegeneration, which is actually most of us. “This, by extending the life span of brain cells, and improving their functioning even under dire conditions in which the body is filled with ‘biological garbage’ like the destructive oxidizing free radicals.” Antioxidants, as they are present in many vegetables and fruits, may in principle protect against the destruction of brain and body cells. And this is the case for pomegranate seed oil. Unfortunately, antioxidants that we consume through food and supplements do not always have the desired impact because they are consumed in too low of a concentration or broken down in the digestive system, and thus never make it to the brain or other cells. The challenge, said Gabizon, is to make sure the pomegranate oil that we eat, which generally is filtered out by the liver, gets to the parts of our body which can benefit from it. So Gabizon teamed up with Prof. Shlomo Magdassi — an expert in the field of nanotechnology from the Casali Institute for Applied Chemistry at the Hebrew University of Jerusalem — and together devised a way to break down the oil into tiny particles that can slip through the liver undetected and make their way to the brain. The product they have developed, called GranaGard, has a high concentration of antioxidants that have a good chance of reaching the brain. Prof. Shlomo Magdassi of the Institute of Chemistry at the Faculty of Science, February 02, 2012. (Nati Shohat/Flash90) A study of GranaGard performed by Gabizon and Magdassi found that consumption by lab mice with multiple sclerosis delayed the spread of the disease and considerably reduced its intensity. An additional experiment with lab mice who suffered from Creutzfeldt-Jakob showed that the use of GranaGard “considerably delayed the spread of the disease and lowered the intensity of the accompanying degenerative-dementing processes,” Gabizon said. The two studies were published in the international Journal of Nanomedicine in November 2015 and in the International Journal of Nanomedicine in 2014. Gabizon and Magdassi patented the product and formed the firm Granalix Biotechnologies Ltd. They are now hoping to undertake clinical trials to test the effect of their formulation in humans with Creutzfeldt-Jakob, Alzheimer’s and multiple sclerosis, Gabizon said. GranaGard is already on sale as a dietary supplement at www.granalix.com and is being used by patients with degenerative brain diseases, their family members and others, Gabizon said. The recommended dose is two capsules with breakfast. Seeds of hope M is a Jerusalem-based 50-year old medical professional who was diagnosed a year and a half ago with brain atrophy. He has been using GranaGard for a year and three months, after a friend recommended the supplement and after he met with Gabizon to find out more about it. “One of the ways to deal with atrophy is via fighting free radicals,” M said, preferring not to make his identity known. Since his diagnosis, he has started an antioxidant diet, which includes taking GranaGard and his regular medications along with exercise. Since his diagnosis, he said, there has been no deterioration in his condition. He would “absolutely” recommend taking the supplement, M said. “I cannot substantially say this (GranaGard) absolutely benefited me, but I have incorporated it as an important piece of my regime. The end result is that I am still functioning.” Prof. Tamir Ben-Hur, the chairman of the Department of Neurology at the Hadassah Medical Center, knows the supplement and also knows Gabizon, but has no stake in the firm or the technology, he said. “Oxidation is one of the important mechanisms of tissue injury in many diseases, including neurodegenerative diseases like Alzheimer’s,” he said in a phone interview. “To use antioxidants to stall the process has been around for a while but efforts have generally failed, because either the anti-oxidants were too weak or the active ingredient did not reach the brain.” The concept behind GranaGard is not new, he said, but the way it is used makes it more powerful than other antioxidants available, such as Vitamin E. Products that consumers find in health stores – either creams or products to be taken orally — are sometimes inconsistent in their dosages and don’t get effectively absorbed. “These capsules help the formulation surpass the liver, and this is the true advantage of this product versus other products in the stores.” “There is no clinical proof that GranaGard can slow down Alzheimer’s, and I hope a clinical trial will prove that. But there is good biological research data that it is well absorbed by the gut, reaches the brain and has an antioxidant effect on the brain. We believe it may work with humans but we need to prove it,” he said. Elderly men play backgammon at a country club in northern Tel Aviv, illustrative (Tomer Neuberg/Flash90) “I would certainly recommend it to people who are aging and prone to degenerative diseases,” he added. “When you have a pre-Alzheimer’s condition there is nothing to prevent the disease from developing and nothing to stop it. There is no clinical proof of efficacy, but I suggest people take it, because there is good biological rationale, and good data in animals, so why not?” Gabizon is cautious about raising hopes of patients who are suffering from these debilitating afflictions. At the moment, the only product her company has on the market is an over-the-counter food supplement. Most likely, to actually defeat these illnesses, a cocktail of various compounds will have to be developed, she said. But each step forward is a victory, she added. Their component has shown a way antioxidants can be broken down to go undetected by the liver and has shown a “definite effect” on the pathology of mice. “We have not yet proven the formulation’s effect on the human brain,” she said, “But the effect on mice has been proven and we hope to show the same effect with humans during the clinical trials. Even if we don’t find a cure for these diseases, if we are able to delay the degeneration process by a few years, we have done our job.” https://www.timesofisrael.com/jewish-new-year-fruit-may-hold-key-to-graceful-ageing/?utm_source=dlvr.it&utm_medium=twitter
  4. Women with Lupus Overwhelmingly Have Healthy Pregnancies By Whitney L. Jackson In contradiction to long-standing beliefs, a healthy pregnancy is possible for women who have lupus, says Jill Buyon, M.D., a rheumatologist and lupus specialist from New York University School of Medicine. “Patients with lupus have been under the impression that pregnancy would be a very dangerous thing for them. From the mother’s perspective, the concerns are: Will the mother sustain a lupus flare? For mothers who have once had kidney involvement: How safe is it to get pregnant? Will there be adverse pregnancy outcomes? Will the baby be very small? Will the baby be born so early that it needs to be in the hospital for a long time. And, of course, the scary question is: Will my baby die? These are the outcomes we look at from the perspective of counseling and what we wanted to learn from this study,” she said. Dr. Buyon recently published research in the Annals of Internal Medicine showing that women with relatively inactive lupus without serious flares experienced a normal pregnancy with a positive outcome. Study participants were women, ages 18-to-45, enrolled in the Predictors of Pregnancy Outcome: Biomarker in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE) Trial. The investigation was multi-center, multi-racial and multi-ethnic. Out of the 385 women followed during the study, 81 percent experienced no adverse events. Overall, 9 percent of pregnancies resulted in premature birth, 4 percent experienced pregnancy loss during the second or third trimester, 1 percent encountered infant death due to pregnancy complications, and 10 percent had very low birth weight. Throughout the study, investigators identified four factors that appeared to increase a woman's likelihood for a negative outcome — high blood pressure during pregnancy, more active lupus during gestation, low platelet count, and a positive lupus anticoagulant test during the first trimester. “The patients who tended to be more sick at the outset, tended to be those who might have an adverse pregnancy outcome. The highest risk factor is the presence of something called a lupus anticoagulant. The presence of this abnormal blood test is very important and one that absolutely all doctors should test for,” Dr. Buyon said. In addition, race and ethnicity — black, Hispanic and Asian — contributed to poor outcomes and was in and of itself, a risk factor. Dr. Buyon said she doubts it is due to socioeconomic factors because the patients were treated by similar doctors in tertiary care centers. She suspects it may be due to genetics, which needs to be explored. Although the findings point to the possibility of healthy pregnancies for this population, Dr. Buyon cautioned women who have high protein levels in urine due to uncontrolled kidney disease could still face significant problems with pregnancy. These women are typically advised to postpone pregnancy until their kidney disease improves. Ten to 15 percent of patients had a moderate flare requiring minimal medication changes, but less than 5 percent of patients had a flare that required high dose steroids or hospitalization. About one in five patients had a renal flare. “The other optimistic perspective was that 225 patients never had kidney disease, but many of them had anti DNA antibodies which is an antibody we worry about in developing renal disease. Only four people developed de novo renal disease. For people who had previous kidney disease ... but were in complete remission, they too had very few renal flares. I think this is very encouraging news for women with past renal disease who really are so worried that maybe they’ll never have a healthy pregnancy, that simply is not true (14:01),” Dr. Buyon said. The hope, she said, is that these findings can be used to inform discussions between doctors and their patients with lupus who are also interested in pursuing pregnancy. Dr. Buyon discusses the study, its findings and implications in the following video with Rheumatology Network. REFERENCES Jill P. Buyon, MD; Mimi Y. Kim, ScD; Marta M. Guerra, MS, et al. "Predictors of Pregnancy Outcomes in Patients With Lupus: A Cohort Study," Annals of Internal Medicine, Aug. 4, 2015. DOI: 10.7326/M14-2235 http://www.rheumatologynetwork.com/lupus/women-lupus-overwhelmingly-have-healthy-pregnancies?GUID=&rememberme=1&ts=12092017
  5. Selena Gomez

    Selena Gomez reveals kidney transplant, best friend was donor FROM THE TOPICENTERTAINMENT 14/09/17 Selena Gomez has revealed that she had a kidney transplant operation this summer linked to her lupus. In an Instagram post, the singer says that her friend Francia Raisa donated an organ to her and says she wanted to explain why fans hadn't heard much from her despite having new music out. "So I found out I needed to get a kidney transplant due to my Lupus and was recovering," she writes. "It was what I needed to do for my overall health." Image captionSelena Gomez has also posted photos of her scar from the kidney transplant operation Selena Gomez also thanked her friend, The Secret Life of the American Teenager actress Francia Raisa, in her Instagram post. Morerelated stories Selena Gomez: Social media isn't real life When celebrities go out in disguise Selena Gomez had lupus but what is it? "There aren't words to describe how I can possibly thank my beautiful friend Francia Raisa," she writes. "She gave me the ultimate gift and sacrifice by donating her kidney to me. I am incredibly blessed. I love you so much sis." Image captionSelena Gomez helped her friend Francia Raisa out in 2014 at the Annual Unlikely Heroes awards in LA, which she was hosting Selena Gomez released the first single from her new untitled album, It Ain't Me featuring Kygo, in March. Since then Bad Liar and Fetish have come out but she hasn't been out promoting the tracks because of her operation. Her first public appearance after recovering from the surgery was in New York with boyfriend The Weeknd last Friday night. She also took time off social media last year to deal with panic attacks, anxiety and depression. The 25-year-old says her ongoing mental health problems are a side-effect of her lupus diagnosis last year. Image captionSelena Gomez appeared in Radio 1's Live Lounge in 2015 to promote her album, Revival Lupus affects the body's immune system. The symptoms of the disease include extreme tiredness, rashes (especially on the face, wrists and hands), joint pain and swelling. In her post, she says not enough is known about the condition. "Lupus continues to be very misunderstood but progress is being made." Find us on Instagram at BBCNewsbeat and follow us on Snapchat, search for bbc_newsbeat http://www.bbc.co.uk/newsbeat/article/41268256/selena-gomez-reveals-kidney-transplant-best-friend-was-donor
  6. 6 of the Best Apps for Chronic Illness Management JULY 17, 2017 BY WENDY HENDERSON IN SOCIAL CLIPS. Click Here to receive Lupus News via e-mail Managing a chronic illness can be difficult. There are many different medications to take (often at different times), appointments to remember, symptoms to keep track of, and lots of information to absorb. Thankfully, living in a digital age means that there are numerous mobile apps that can help you manage your chronic illness. We’ve put together a list of some of the best mobile apps for managing your chronic illness: Medisafe is an app that helps patients manage medications. It helps with dosage and reminds you when you need to take your meds, increasing adherence rates. The information can also be shared with your healthcare team and pharmacy. Pain Diary works for anyone with a chronic illness. It allows patients to chart and score pain as well as record and track other symptoms of the disease such as fatigue and mood swings. This app also has a feature where patients can connect with others living with the same chronic illness and swap best practices. ZocDoc is a handy app if you’ve recently been diagnosed with a chronic illness, since one of the first things you’ll need to do is find a doctor to treat you. ZocDoc allows you to search for local specialist doctors who are approved by your insurance company. The app will even tell you when the doctor is available to see you. MORE: Nine important facts about lupus you may not know. My Medical Info is an app that stores all your relevant health history and insurance details. This makes filling out those endless forms a little less challenging, since you won’t have to rely on your memory for all the details. The app will also allow you to program in doctors’ appointments and all the medications you’re taking. Fooducate helps you keep track of your diet and make healthy choices. Eating well is an integral part of managing any chronic illness and this app will help you to eat the right foods and get you to a healthy body weight. You can program in how many calories you want to consume a day and then add in the food choices you make, the app will work out the nutritional values of everything you eat and tell you how many calories you’ve consumed. It also works in conjunction with many fitness apps to add in details of any physical activities and calories burned. Sleep Cycle helps you get the best out of your sleep. The app analyzes how much sleep and the quality of sleep you get each night and you can also have the alarm set to wake you when you’re in your lightest sleep, leaving you feeling less groggy and more refreshed each day. MORE: Nine tips to help you live better with lupus. Lupus News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. https://lupusnewstoday.com/2017/07/17/6-best-apps-chronic-illness-management/?utm_source=LUP+NEws+E-mail+List --
  7. Benlysta Formulation for Lupus Gets FDA Nod August 01, 2017 | Lupus By Rheumatology Network Staff A new subcutaneous formulation of Benlysta (belimumab) has received FDA approval for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, GSK announced. This is the first subcutaneous self-injection treatment option for patients with SLE, according to GSK. Patients will be able to administer the medicine as a once-weekly injection of 200 mg, from a single-dose prefilled syringe or a single-dose autoinjector, after receiving training from their health care provider. This is the second formulation of Benlysta to be granted FDA approval for SLE, GSK noted. The intravenous formulation, approved in 2011, is administered to patients as a weight-based dose of 10 mg/kg, via a 1-hour infusion in a hospital or clinic setting every 4 weeks (after an initial loading phase given on days 0, 14, and 28). “Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms,” said Vlad Hogenhuis, GSK’s Senior Vice President, Head of Specialty Care. “Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta. The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions.” The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE. The study measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care versus those receiving placebo plus standard of care (assessed by the SLE Responder Index). The Benlysta subcutaneous formulation will be available in specialty pharmacies in the United States in late August. Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017.
  8. GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus Issued: London, UK GSK receives FDA approval for a new self-injectable formulation of Benlysta (belimumab) for systemic lupus erythematosus GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody‑positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus (SLE) is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. The approval marks the first subcutaneous self-injection treatment option for patients with SLE. After training from their health care provider, patients will be able to administer the medicine as a once weekly injection of 200mg, from either a single-dose prefilled syringe or from a single-dose autoinjector. This is the second formulation of Benlysta to be granted approval for SLE, adding to the existing intravenous (IV) formulation, approved in 2011, which is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinic setting every four weeks (following an initial loading phase given on days 0, 14 and 28). Vlad Hogenhuis, Senior Vice President, Head of Specialty Care, GSK said, “We are delighted with today’s decision. Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms. Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta. The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions.” The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, which measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus). Benlysta subcutaneous formulation will be available in specialty pharmacies in the US in late August. Further regulatory submissions for the subcutaneous formulation of Benlysta are under review or planned in other countries during the course of 2017. About Benlysta (belimumab) Benlysta is currently the only medicine specifically developed and approved for SLE. Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. Benlysta does not bind B cells directly. By binding BLyS, Benlysta inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. Benlysta is indicated in the US for the treatment of adult patients with active, autoantibody‑positive, systemic lupus erythematosus (SLE) who are receiving standard therapy: Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations. Full US prescribing information including Medication Guide will be available in the near future at: gsksource.com. In the meantime, you may request a copy through GSK Communications. Benlysta is licensed in the European Union as an add-on therapy in adult patients with active autoantibody-positive SLE, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. Benlysta subcutaneous formulation is currently not approved in the European Union. For the EU Summary of Product Characteristics for Benlysta, please visit www.ema.europa.eu About systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE) is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. Approximately 170,000-200,000 Americans live with SLE. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. Important Safety Information for belimumab Please consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab). BENLYSTA (belimumab): CONTRAINDICATION BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab. WARNINGS AND PRECAUTIONS MORTALITY There were more deaths reported with BENLYSTA than with placebo during the controlled period of the intravenous clinical trials. Out of 2,133 patients in 3 clinical trials, a total of 14 deaths occurred during the placebo-controlled, double-blind treatment periods: 3/675 (0.4%), 5/673 (0.7%), 0/111 (0%), and 6/674 (0.9%) deaths in the groups receiving placebo, BENLYSTA 1 mg/kg, BENLYSTA 4 mg/kg, and BENLYSTA 10 mg/kg, respectively. Etiologies included infection, cardiovascular disease, and suicide. In the controlled clinical trial of BENLYSTA administered subcutaneously (N = 836), a total of 5 deaths occurred during the placebo-controlled, double-blind treatment period (0.7% [2/280] of patients receiving placebo and 0.5% [3/556] of patients receiving BENLYSTA). Infection was the most common cause of death. SERIOUS INFECTIONS Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Caution should be exercised when considering use in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA in patients who develop a new infection while receiving BENLYSTA and monitor these patients closely. In controlled clinical trials of BENLYSTA administered intravenously, serious infections occurred in 6.0% and 5.2% of patients receiving BENLYSTA and placebo, respectively. The most frequent serious infections included pneumonia, urinary tract infection, cellulitis, and bronchitis. Infections leading to discontinuation of treatment occurred in 0.7% and 1.0% of patients receiving BENLYSTA and placebo, respectively. Infections resulting in death occurred in 0.3% (4/1,458) and 0.1% (1/675) of patients receiving BENLYSTA and placebo, respectively. In the controlled trials of BENLYSTA administered subcutaneously (N = 836), serious infections occurred in 4.1% and 5.4% of patients receiving BENLYSTA and placebo, respectively. Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. Consider the diagnosis of PML in any patient presenting with new-onset or deteriorating neurological signs and symptoms and consult with a neurologist or other appropriate specialist as clinically indicated. In patients with confirmed PML, consider stopping immunosuppressant therapy, including BENLYSTA. HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema have been reported and typically occurred up to a week following the most recent infusion. Hypersensitivity, including serious reactions, has occurred in patients who have previously tolerated infusions of BENLYSTA. Limited data suggest that patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. In the controlled clinical trials of BENLYSTA administered intravenously, hypersensitivity reactions occurring on the day of the infusion were reported in 13% (191/1,458) and 11% (76/675) of patients receiving BENLYSTA and placebo, respectively. Anaphylaxis was observed in 0.6% (9/1,458) and 0.4% (3/675) of patients receiving BENLYSTA and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. Some patients (13%) received premedication, which may have mitigated or masked a hypersensitivity response. There is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions. Healthcare providers should be aware of the risk of hypersensitivity reactions and be prepared to manage anaphylaxis. In the event of a serious hypersensitivity reaction, discontinue BENLYSTA immediately and administer appropriate medical therapy. Patients should be monitored during and for an appropriate period of time after the intravenous administration of BENLYSTA. Patients receiving BENLYSTA should be informed of the signs and symptoms of an acute hypersensitivity reaction, and be instructed to seek immediate medical care should a reaction occur. In the controlled trial of BENLYSTA administered subcutaneously (N = 836), the incidence and severity of systemic hypersensitivity reactions were similar to those observed in the intravenous clinical trials. INFUSION REACTIONS In the controlled clinical trials, infusion reactions occurring on the day of the infusion were reported in 17% (251/1,458) and 15% (99/675) of patients receiving BENLYSTA and placebo, respectively. Serious infusion reactions (excluding hypersensitivity reactions) were reported in 0.5% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Serious infusion reactions included bradycardia, myalgia, headache, rash, urticaria, and hypotension. The most common infusion reactions occurring in ≥3% of patients receiving BENLYSTA were headache, nausea, and skin reactions. Some patients (13%) received premedication, which may have mitigated or masked an infusion reaction; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions. BENLYSTA should be administered by healthcare providers prepared to manage infusion reactions. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely. DEPRESSION In controlled clinical trials of BENLYSTA administered intravenously, serious psychiatric events were reported in 0.8% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Serious depression was reported in 0.4% and 0.1% of patients receiving BENLYSTA and placebo, respectively. Two suicides were reported in patients receiving BENLYSTA. In the controlled trial of BENLYSTA administered subcutaneously, serious psychiatric events were reported in 0.2% of patients receiving BENLYSTA and in no patients receiving placebo. It is unknown if treatment with BENLYSTA is associated with increased risk for these events. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes. MALIGNANCY The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk for the development of malignancies. IMMUNIZATION Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations. USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with these therapies. ADVERSE REACTIONS Intravenous administration Adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies, were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 1%. Subcutaneous administration The safety profile observed for BENLYSTA administered subcutaneously was consistent with the known safety profile of BENLYSTA administered intravenously, with the exception of local injection site reactions, which occurred in 6.1% and 2.5% of patients receiving BENLYSTA and placebo, respectively. OTHER IMPORTANT INFORMATION FOR BENLYSTA USE IN SPECIFIC POPULATIONS Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment. Lactation: There is no information available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BENLYSTA and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition. Black/African American Patients: In controlled clinical trials of BENLYSTA administered intravenously, SLE Responder Index-4 (SRI-4) response rates were lower for black/African American patients receiving BENLYSTA relative to black/African American patients receiving placebo. In the controlled trial of BENLYSTA administered subcutaneously, SRI-4 response was slightly higher for black/African American patients receiving BENLYSTA relative to black/African American patients receiving placebo, but the treatment difference was not as great as that observed in the overall population. Use with caution in black/African American patients. Populations not studied Benlysta has not been studied in the following patient groups, and is not recommended in patients with: ∙ severe active central nervous system lupus ∙ severe active lupus nephritis ∙ HIV ∙ a history of, or current, hepatitis B or C ∙ hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) ∙ a history of major organ transplant or hematopoietic stem /cell /marrow transplant or renal transplant.
  9. Researchers identify new genetic markers in patients with lupus Langefeld CD, et al. Nat Commun. 2017;doi:10.1038/ncomms16021. July 21, 2017 Among patients with lupus, researchers have identified new genetic markers that predispose patients to the disease, according to a recently published study. “This study is the largest multi-ethnic lupus genetics study to date and allowed us to identify many new genetic markers, some of which are specific to individual ethnic groups and others that are shared across ethnicities,” Carl Langefeld, PhD, lead author of the study and professor of biostatistical sciences at Wake Forest School of Medicine, said in a press release. “With this information, we can begin to better understand the differences in the rates and severity of disease across ethnic groups.” Researchers assessed 27,574 participants. They identified 58 distinct non-human leukocyte antigen regions in the Europeans, nine in the Africans and 16 in the Hispanic Americans. All of these included 24 new lupus regions. “In addition, we observed that many of the genetic markers associated with lupus are shared across numerous autoimmune diseases, and those that are not shared may allow us to understand why a person develops lupus instead of another autoimmune disease,” Langefeld said. “These results will help us identify the biological pathways that pharmaceutical companies may target, and ultimately, develop personalized medicine for the treatment of lupus.” Reference: www.wakehealth.edu/News-Releases/2017/Large_Multiethnic_Study_Identifies_Many_New_Genetic_Markers_for_Lupus.htm Large Multi-ethnic Study Identifies Many New Genetic Markers for Lupus WINSTON-SALEM, N.C. – July 17, 2017 – Scientists from an international consortium have identified a large number of new genetic markers that predispose individuals to lupus. The study is published in the July 17 issue of the journal Nature Communications and was led by researchers at Wake Forest Baptist Medical Center, Oklahoma Medical Research Foundation, King’s College of London and Genentech Inc. Autoimmune diseases strike one in 15 Americans, are among the top 10 causes of death in women and cost an estimated $100 billion a year in medical care. In autoimmune diseases, the body attacks itself. Systemic lupus erythematosus, the form of lupus studied here, is the most common type of lupus and is a prototypical autoimmune disease. Lupus strikes women nine times more often than men and its onset is most common during childbearing age. Also, African-American and Hispanic women are two to three times more likely to develop lupus and tend to have more severe cases than Caucasian women. At present, there is no cure for lupus, which can affect many parts of the body, including joints, skin, kidney, heart, lungs, blood vessels and brain, according to the Lupus Research Alliance. “This study is the largest multi-ethnic lupus genetics study to date and allowed us to identify many new genetic markers, some of which are specific to individual ethnic groups and others that are shared across ethnicities,” said Carl Langefeld, Ph.D., lead author of the study and professor of biostatistical sciences at Wake Forest School of Medicine, a part of Wake Forest Baptist. “With this information, we can begin to better understand the differences in the rates and severity of disease across ethnic groups. “In addition, we observed that many of the genetic markers associated with lupus are shared across numerous autoimmune diseases, and those that are not shared may allow us to understand why a person develops lupus instead of another autoimmune disease. These results will help us identify the biological pathways that pharmaceutical companies may target, and ultimately, develop personalized medicine for the treatment of lupus.” This study analyzed genetic data from 27,574 individuals of European, African American and Hispanic ancestry using the Immunochip, a genotyping technology designed specifically for autoimmune diseases. The researchers identified 58 regions of the genome in Caucasians, nine in African Americans and 16 in Hispanics. These regions appear independent of the well-known Human Leukocyte Antigen (HLA) associations, also studied in depth here. An important observation was that nearly 50 percent of these regions had multiple genetic variants that predispose someone to lupus, Langefeld said. Another key finding was that as the number of genetic risk variants (alleles) a person has increases, the risk for lupus increases more than expected if the variants were working independently. These observations led the authors to propose a “cumulative hits hypothesis for autoimmune disease”. In future research, the team hopes to better understand how these genetic variants influence the risk of lupus, identify any possible drug targets and determine if any environmental factors, such as infections, can trigger the development of the disease in someone who has a genetic susceptibility. They emphasize that it is important to increase the number of understudied populations, such as African-American and Hispanic, to better understand the genetic causes of health disparities in lupus and the unique risks in all ethnic groups. “We are delighted to see the work we funded on the ImmunoChip come to fruition and congratulate Dr. Langefeld along with his colleagues on this tremendous success," said Kenneth M. Farber, CEO and President, Lupus Research Alliance. "This study is among the few to concentrate heavily on non-Caucasian populations for a significantly broader evaluation, while utilizing the most current and comprehensive information about human DNA.” Key support for the study was provided by the Lupus Research Alliance and the National Institutes of Health. Additional corresponding authors are: Patrick M. Gaffney, M.D., Oklahoma Medical Research Foundation; Robert R. Graham, Ph.D., Genentech, Inc.; and Timothy J. Vyse, M.D., Ph.D., King’s College London. Media Relations Contacts: Marguerite Beck: marbeck@wakehealth.edu,336-716-2415
  10. Large Multi-ethnic Study Identifies Many New Genetic Markers for Lupus http://www.wakehealth.edu/News-Releases/2017/Large_Multiethnic_Study_Identifies_Many_New_Genetic_Markers_for_Lupus.htm WINSTON-SALEM, N.C. – July 17, 2017 – Scientists from an international consortium have identified a large number of new genetic markers that predispose individuals to lupus. The study is published in the July 17 issue of the journal Nature Communications and was led by researchers at Wake Forest Baptist Medical Center, Oklahoma Medical Research Foundation, King’s College of London and Genentech Inc. Autoimmune diseases strike one in 15 Americans, are among the top 10 causes of death in women and cost an estimated $100 billion a year in medical care. In autoimmune diseases, the body attacks itself. Systemic lupus erythematosus, the form of lupus studied here, is the most common type of lupus and is a prototypical autoimmune disease. Lupus strikes women nine times more often than men and its onset is most common during childbearing age. Also, African-American and Hispanic women are two to three times more likely to develop lupus and tend to have more severe cases than Caucasian women. At present, there is no cure for lupus, which can affect many parts of the body, including joints, skin, kidney, heart, lungs, blood vessels and brain, according to the Lupus Research Alliance. “This study is the largest multi-ethnic lupus genetics study to date and allowed us to identify many new genetic markers, some of which are specific to individual ethnic groups and others that are shared across ethnicities,” said Carl Langefeld, Ph.D., lead author of the study and professor of biostatistical sciences at Wake Forest School of Medicine, a part of Wake Forest Baptist. “With this information, we can begin to better understand the differences in the rates and severity of disease across ethnic groups. “In addition, we observed that many of the genetic markers associated with lupus are shared across numerous autoimmune diseases, and those that are not shared may allow us to understand why a person develops lupus instead of another autoimmune disease. These results will help us identify the biological pathways that pharmaceutical companies may target, and ultimately, develop personalized medicine for the treatment of lupus.” This study analyzed genetic data from 27,574 individuals of European, African American and Hispanic ancestry using the Immunochip, a genotyping technology designed specifically for autoimmune diseases. The researchers identified 58 regions of the genome in Caucasians, nine in African Americans and 16 in Hispanics. These regions appear independent of the well-known Human Leukocyte Antigen (HLA) associations, also studied in depth here. An important observation was that nearly 50 percent of these regions had multiple genetic variants that predispose someone to lupus, Langefeld said. Another key finding was that as the number of genetic risk variants (alleles) a person has increases, the risk for lupus increases more than expected if the variants were working independently. These observations led the authors to propose a “cumulative hits hypothesis for autoimmune disease”. In future research, the team hopes to better understand how these genetic variants influence the risk of lupus, identify any possible drug targets and determine if any environmental factors, such as infections, can trigger the development of the disease in someone who has a genetic susceptibility. They emphasize that it is important to increase the number of understudied populations, such as African-American and Hispanic, to better understand the genetic causes of health disparities in lupus and the unique risks in all ethnic groups. “We are delighted to see the work we funded on the ImmunoChip come to fruition and congratulate Dr. Langefeld along with his colleagues on this tremendous success," said Kenneth M. Farber, CEO and President, Lupus Research Alliance. "This study is among the few to concentrate heavily on non-Caucasian populations for a significantly broader evaluation, while utilizing the most current and comprehensive information about human DNA.” Key support for the study was provided by the Lupus Research Alliance and the National Institutes of Health. Additional corresponding authors are: Patrick M. Gaffney, M.D., Oklahoma Medical Research Foundation; Robert R. Graham, Ph.D., Genentech, Inc.; and Timothy J. Vyse, M.D., Ph.D., King’s College London. Media Relations Contacts: Marguerite Beck: marbeck@wakehealth.edu,336-716-2415
  11. Cumulative hydroxychloroquine and aspirin may prevent cardiovascular events in patients with SLE https://www.healio.com/rheumatology/lupus/news/online/{f8a80a3a-3122-457d-ae5e-b2f34606cc5d}/cumulative-hydroxychloroquine-and-aspirin-may-prevent-cardiovascular-events-in-patients-with-sle?utm_source=selligent&utm_medium=email&utm_campaign=rheumatology news&m_bt=1879111151405 Fasano S. Et al. J Rheumatol. 2017;doi:https://doi.org/10.3899/jrheum.161351. July 14, 2017 In patients with lupus, ongoing use of hydroxychloroquine plus low-dose aspirin may be associated with increased effectiveness in the primary prevention of cardiovascular events, according to recently published findings. Researchers identified 189 patients from a database of the Rheumatology Unit of the Second University of Naples. The study group included 175 women and the overall mean age at baseline was 31 years. Patients had a diagnosis of systemic lupus erythematosus (SLE) upon admission, and had never experienced a cardiovascular event (CVE). Patients were seen for follow-up every 3 months to 6 months, depending upon their clinical condition. Investigators documented any CVE that occurred during the intervening time and information about the use of aspirin (ASA) and cumulative dosages of hydroxychloroquine (c-HCQ). Researchers used Kaplan-Meier analysis to determine the cumulative dosage that yielded a lower rate of CVE. Cox regression analysis was used to determine factors linked to an initial CVE. They found 10 patients experienced the following non-lethal thrombotic events: stroke, one patient; transient ischemic attack, five patients; and acute myocardial infarction, four patients. The mean time to the first CVE was 5 years. Four (2.1%) patients died during the course of the study; none of these deaths were related to CV complications. Kaplan-Meier analysis demonstrated a significant disparity in CVE-free rates among the four patient subgroups. There was no difference in CVE-free rate between the 135 patients treated with ASA plus HCA and the 28 patients treated with aspirin monotherapy. A lower rate of CVEs was reported in the c-HCQ patients. A higher CVE-free rate was documented in the 85 patients on an ASA-HCA regimen who had arrived at a cHCQ dosage greater than 600 g than in the 28 patients who were treated with ASA monotherapy or the 51 patients treated with ASA/cHCQ at a dosage less than 600g. There were no differences in traditional CV risk factors and those specific to SLE among the patient groups, nor were there differences between medications (statins, high-dose steroids). Multivariate analysis revealed that cumulative treatment with hydroxychloroquine, when added to ASA, was thromboprotective. High blood pressure and antiphospholipid antibody positivity were identified as predictive of an initial CVE. Serena Fasano “Systemic lupus erythematosus is associated with an increased risk of cardiovascular disease. This study was performed to investigate the role of aspirin and distinct hydroxychloroquine cumulative dosages and treatment durations,” researcher Serena Fasano told Healio/Rheumatology. “We found that aspirin and antimalarials, when administered for more than 5 years at a cumulative dosage greater than 600 g, may reduce the CVE risk in SLE patients.” – by Jennifer Byrne Disclosure: The researchers report no relevant disclosures.
  12. Speakers: Lupus remains challenging disease July 6, 2017 Healio Rheumatology recently interviewed Richard Furie, MD, from Hofstra Northwell School of Medicine, Lars Rönnblom, MD, from Uppsala University in Sweden, and Peggy K. Crow, MD, from Hospital for Special Surgery, about the future of lupus during the Interferon Summit. “We need better drugs,” Furie said. “There is a major need for safer and more efficacious therapies. The typical patient who gets this disease is a young woman and it can be devastating.” SEE ALSO Furie discusses advances in SLE treatment Through the Cracks: Niche Patient Population Battles... Elusive Target: A Rundown of the Drug Pipeline for Systemic... Richard Furie To illustrate the need for better therapies, Furie discussed the progression of treatments for the disease. “We have come a long way with treatments,” he said. “If you go back before steroids were developed, the mortality was high. It was probably 50% at 7 years, but steroids were introduced and they have been a major advance. Then, after that, it was the immunosuppressives; but, until we get rid of all mortality and morbidity, we need new drugs.” To derive better therapies for a disease, there needs to be better disease classification. Rönnblom talked about the current classification of lupus patients and how to treat the underlying cause vs. a cluster of symptoms. “We classify patients with an auto[body] or antibody profile,” Rönnblom said. “In lupus, we classify them according to organ manifestation, but also when they have this interferon signature. My guess is that we will see more pathways coming up. Much of this data will be generated by the clinical trials, of course, who responds and who does not respond.” Lars Rönnblom Crow said better understanding about the molecular pathway and underlying mechanisms of the disease can lead to better therapy. “My own speculation is that we will probably end up with combination therapies and maybe combinations will allow us to use lower doses, each of one or two or three therapies to avoid toxicity. For example, we might want to target this type 1 interferon pathway that I believe is active in a sustained way throughout the disease, but may be more important in some stages than others,” she said. Peggy K. Crow “To have a more effective therapeutic activity, we might also want to target activated T cells or B cell differentiation. My guess is that we, as a community, will end up trying different combinations and some of the selection of those might be informed by the molecular pathways that an individual shows to be activated or abnormal.” – by Will A. Offit Disclosures: The researchers report no relevant financial disclosures. https://www.healio.com/rheumatology/lupus/news/online/{0b28f725-2f50-4168-b619-abd1de8a4266}/speakers-lupus-remains-challenging-disease?utm_source=selligent&utm_medium=email&utm_campaign=rheumatology news&m_bt=1879111151405
  13. Glucocorticoids Use and Organ Damage in Lupus http://www.rheumatologynetwork.com/lupus/glucocorticoids-use-and-organ-damage-lupus Glucocorticoids exposure is strongly associated with the accrual of irreversible organ damage in systemic lupus erythematosus patients, independent of disease activity, researchers report. “Our findings suggest that only extremely low doses of glucocorticoid can be considered free of association with damage accrual in patients with SLE,” write researchers in the Nov. 22 issue of Lupus Science and Medicine Glucocorticoids are a mainstay treatment in both acute and chronic systemic lupus erythematosus. Previous studies have demonstrated that damage accrual is associated with cumulative disease activity. However, more recent studies suggest that damage accrual may also be associated with systemic lupus erythematosus treatment. Approximately 60 percent of systemic lupus erythematosus patients experience permanent organ damage within seven years of being diagnosed with the disease. Given that glucocorticoids are often used in the context of high disease activity, it has been challenging for researchers to tease out the independent effect of systemic lupus erythematosus treatment on damage accrual. This was an observational study of 162 systemic lupus erythematosus patients — 75 percent of whom received glucocorticoids. The patients were observed for two to 4.7 years by Diane Apostolopoulos, M.D., of Monash University in Australia, and colleagues. They measured damage accrual finding that glucocorticoid patients were 42 percent more likely to have significantly more damage as compared to patients who were not prescribed glucocorticoids (42% vs 15%, p<0.01). The observational nature of the study was one of the limitations of the study, yet, it is noteworthy, the researchers wrote. “Given the limitations of observational studies in the face of confounding by indication, our findings suggest the urgent need for a randomized study comparing the effect on damage accrual of usual care with that of a strategy that stringently limits glucocorticoid dosing,” Dr. Apostolopoulos and colleagues wrote. In an editorial that was published online April 7 in Lupus Science and Medicine, Maarten Boers, M.D., of VU University Medical Center in the Netherlands, conveys concerns of the medical community misinterpreting observational studies by limiting applications of a potentially life-saving treatment. “The truth of the matter is that trials on glucocorticoid beneficial and adverse effects are not being done, and that observational studies (invariably only focusing on glucocorticoid adverse effects, both related and unrelated to the disease) are hopelessly and irretrievably confounded by indication,” wrote Boers. “In brief, patients with the most severe disease are preferentially treated with glucocorticoids, and this leads to the associations found in observational studies, regardless of the beneficial effects of glucocorticoids.” The study Glucocorticoid use is associated with harm in both domains of the (Systemic Lupus International Collaborating Clinics Damage Index (SDI) traditionally associated with glucocorticoid-induced harm (cataracts, osteoporotic fracture, avascular necrosis, diabetes mellitus) and the residual SDI domains not previously associated with glucocorticoid-induced harm. Even lower doses of glucocorticoid are associated with damage accrual in SLE. The threshold identified was a time-adjusted mean prednisolone of 4.4 mg per day. Cumulative prednisolone exposure was associated with overall damage accrual after controlling for ethnicity and disease activity and was significant at time-adjusted mean doses above 4.42 mg prednisolone per day. A dose-response relationship between cumulative prednisolone use and irreversible organ damage accrual was observed, with increasing odds ratios with each ascending quartile. Compared to patients in the lowest quartile, patients in the highest quartile of cumulative prednisolone had adjusted odds ratio of 13.46, 95 percent CI (3.59 to 50.4), p<0.01 for damage accrual. Of the demographic factors evaluated, only ethnicity was associated with damage accrual. Asian patients had reduced odds of damage accrual compared with Caucasians (adjusted OR=0.22, 95% CI (0.09 to 0.53), p<0.01). “Our findings further emphasize the need for new, more effective treatments for SLE that minimize or eliminate the need for glucocorticoids,” wrote Apostolopoulos and team. DISCLOSURES This research was supported by a grant from Eli Lilly. REFERENCES Apostolopoulos D, Kandane-Rathnayake R, Raghunath S, et al. “Independent association of glucocorticoids with damage accrual in SLE,” Lupus Science and Medicine. Published online November 22, 2016. DOI: 10.1136/lupus-2016-000157. Boers M. “Observational studies on glucocorticoids are harmful!” Lupus Science and Medicine. Published online April 7, 2017. DOI: 10.1136/lupus-2017-000219
  14. Neonatal Lupus May Not Require Steroid Treatment News | June 30, 2017 | Lupus By Whitney L. Jackson One in 50 pregnant women with systemic lupus erythematosus (SLE) are at risk for having a child with neonatal lupus erythematosus (NLE), according to Dr. Jill Buyon, a rheumatologist with New York University School of Medicine. Although neonatal lupus is rare and is most often benign, when it is not, it can be life-threatening for at-risk newborns. Awareness is important, she said. “Though we think of it as being rare, the recurrence rate is about 18 percent. This is a significant portion of people,” Dr. Buyon said. The first signs of disease often occur during the first few weeks of birth as nonscarring and non-atrophic skin lesions that resemble subacute cutaneous lupus erythematosus. More serious abnormalities effect the cardiovascular system, but can also effect the hematological, hepatobiliary, central nervous and pulmonary systems (1). One of the most controversial issues associated with neonatal lupus is whether the use of fluorinated steroids during pregnancy can protect the fetus from worsening heart block, which is associated with NLE. Dr. Buyon’s research shows that it does not. Neonatal lupus Neonatal lupus occurs when a mother with active or asymptomatic lupus or other autoimmune disease passes autoantibodies against Ro/SSA, La/SSB and U1-ribonucleoprotein (U1-RNP), through the placenta to the fetus. It is rare and one estimate shows only a 1-2 percent risk of having a child with NLE, regardless of whether the mother is symptomatic (1). Dexamethasone or fluorinated steroids have been standard treatments to prevent heart block in NLE. “The idea behind this is that maybe heart block is caused by inflammation and maybe we could stop the inflammation in the beginning, during or even after the initial insult. The question is whether this would change the ultimate prognosis for the fetus,” she said. A 2015 retrospective chart review by Dr. Buyon and colleagues published in the Annals of Rheumatic Diseases addressed whether daily doses of fluorinated steroids effectively treated isolated heart block in utero to prevent the progression of disease beyond the atrioventricular (AV) node. They found that fluorinated steroids did not significantly prevent the development of disease beyond the AV node, reduce mortality or delay or prevent the need for a pacemaker (2). It is believed inflammation plays a significant role in the development and worsening of heart block, making steroids an attractive treatment option. However, evidence doesn't support the use of these steroids to prevent worsening disease or death from this condition. The results, she said, should alleviate worries from providers and expectant mothers who have concerns about using steroids, such as dexamethasone, during pregnancy. There has been a concern about the effect of steroids crossing the placenta into the fetal circulation system. Additionally, steroid use can cause complications in the mother, such as increased risk of infection, as well as other problems in the fetus, including low-birth weight and the loss of amniotic fluids. The 20-year retrospective study analyzed treatment and outcomes for enrollees in the Research Registry for Neonatal Lupus. Only women with diagnosed cases of anti-SSA/Ro-associated cardiac neonatal lupus, meaning their fetus had second- or third-degree heart block, were included. Heart block scars the atrioventricular node, the structure responsible for heart rate. Children born with permanent heart block require pacemaker implantation, and approximately 20 percent die. Although there is some disagreement with Canadian research that supports the use of fluorinated steroids when second- or third-degree heart block is present, recently published French investigations verify her team's findings, she said. Previous studies over the last 20 years have shown that the most challenging aspect in heart block is that once it’s reached a third-degree level, it is generally immutable and by then, steroids cannot reverse the course of disease. “There is a vulnerable period to the development of heart block which is usually about 16 – 26 weeks, with the most heightened time around 19-20 weeks. Once the heart block has happened it’s not common to develop worsening injury because the vulnerable period begins to pass. Admittedly, our colleagues in Canada don’t agree and they almost always subject the mother to steroids for the rest of the pregnancy. And because that carries risk, we felt this study was important,” she said. Now, with this study, Dr. Buyon hopes that physicians will reconsider steroid therapy in these cases. “I appreciate that a mother wants to do all she can to save her baby, but there are also health considerations for her part and on part of the fetus. The idea of taking a steroid that will cross into the fetal circulation can be very anxiety provoking both for the patient and physician. This is the study that was needed to help in pregnancy counseling,” she said. Dr. Buyon discusses the structure, findings and importance of this work with Rheumatology Network in this video. http://www.rheumatologynetwork.com/lupus/neonatal-lupus-may-not-require-steroid-treatment REFERENCES 1. Kam Lun Hon and Alexander K. C. Leung. "Neonatal Lupus Erythematosus." Autoimmune Dis. 2012; 2012: 301274. Published online 2012 Sep 2. DOI: 10.1155/2012/301274 2. Izmirly PM, Saxena A, Sahl SK, et al. “Assessment of fluorinated steroids to avert progression and mortality in anti-SSA/Ro-associated cardiac injury limited to the fetal conduction system.” the Annals of Rheumatic Diseases. Published Online First: 01 December 2015. DOI: 10.1136/annrheumdis-2015-208311
  15. Women with Lupus Overwhelmingly Have Healthy Pregnancies News | June 30, 2017 | Lupus By Whitney L. Jackson In contradiction to long-standing beliefs, a healthy pregnancy is possible for women who have lupus, says Jill Buyon, M.D., a rheumatologist and lupus specialist from New York University School of Medicine. “Patients with lupus have been under the impression that pregnancy would be a very dangerous thing for them. From the mother’s perspective, the concerns are: Will the mother sustain a lupus flare? For mothers who have once had kidney involvement: How safe is it to get pregnant? Will there be adverse pregnancy outcomes? Will the baby be very small? Will the baby be born so early that it needs to be in the hospital for a long time. And, of course, the scary question is: Will my baby die? These are the outcomes we look at from the perspective of counseling and what we wanted to learn from this study,” she said. Dr. Buyon recently published research in the Annals of Internal Medicine showing that women with relatively inactive lupus without serious flares experienced a normal pregnancy with a positive outcome. Study participants were women, ages 18-to-45, enrolled in the Predictors of Pregnancy Outcome: Biomarker in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus (PROMISSE) Trial. The investigation was multi-center, multi-racial and multi-ethnic. Out of the 385 women followed during the study, 81 percent experienced no adverse events. Overall, 9 percent of pregnancies resulted in premature birth, 4 percent experienced pregnancy loss during the second or third trimester, 1 percent encountered infant death due to pregnancy complications, and 10 percent had very low birth weight. Throughout the study, investigators identified four factors that appeared to increase a woman's likelihood for a negative outcome — high blood pressure during pregnancy, more active lupus during gestation, low platelet count, and a positive lupus anticoagulant test during the first trimester. “The patients who tended to be more sick at the outset, tended to be those who might have an adverse pregnancy outcome. The highest risk factor is the presence of something called a lupus anticoagulant. The presence of this abnormal blood test is very important and one that absolutely all doctors should test for,” Dr. Buyon said. In addition, race and ethnicity — black, Hispanic and Asian — contributed to poor outcomes and was in and of itself, a risk factor. Dr. Buyon said she doubts it is due to socioeconomic factors because the patients were treated by similar doctors in tertiary care centers. She suspects it may be due to genetics, which needs to be explored. Although the findings point to the possibility of healthy pregnancies for this population, Dr. Buyon cautioned women who have high protein levels in urine due to uncontrolled kidney disease could still face significant problems with pregnancy. These women are typically advised to postpone pregnancy until their kidney disease improves. Ten to 15 percent of patients had a moderate flare requiring minimal medication changes, but less than 5 percent of patients had a flare that required high dose steroids or hospitalization. About one in five patients had a renal flare. “The other optimistic perspective was that 225 patients never had kidney disease, but many of them had anti DNA antibodies which is an antibody we worry about in developing renal disease. Only four people developed de novo renal disease. For people who had previous kidney disease ... but were in complete remission, they too had very few renal flares. I think this is very encouraging news for women with past renal disease who really are so worried that maybe they’ll never have a healthy pregnancy, that simply is not true (14:01),” Dr. Buyon said. The hope, she said, is that these findings can be used to inform discussions between doctors and their patients with lupus who are also interested in pursuing pregnancy. Dr. Buyon discusses the study, its findings and implications in the following video with Rheumatology Network. http://www.rheumatologynetwork.com/lupus/women-lupus-overwhelmingly-have-healthy-pregnancies REFERENCES Jill P. Buyon, MD; Mimi Y. Kim, ScD; Marta M. Guerra, MS, et al. "Predictors of Pregnancy Outcomes in Patients With Lupus: A Cohort Study," Annals of Internal Medicine, Aug. 4, 2015. DOI: 10.7326/M14-2235
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