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Found 56 results

  1. Take the Right Shots for Lupus! August 15, 2019 While August is when we savor the last weeks of summer, it is also the time to look ahead and prepare for fall. In recognition of National Immunization Month, our Chief Scientific Officer Dr. Teodora Staeva provides background on vaccines and relays government recommendations for which are safe for people with lupus. “Vaccines help to develop immunity, in other words protect against disease, by imitating an infection,” notes Dr. Staeva. “Most vaccines contain small amounts of the germs (or parts of them) that cause disease but are either killed or weakened. The vaccine prompts the immune system to produce T cells and antibodies against these germs, and thus allows the body to learn how to fight these microbes in the future. However, several rounds of vaccination are often required to achieve optimal protection.” Currently there are four main types of vaccines. Live-attenuated vaccines use the weakened (attenuated) form of the virus so that it does not cause serious illness in individuals with healthy immune systems. Vaccines with live viruses are generally NOT recommended for people with lupus. Inactivated vaccines are made by killing the germ while making the vaccine. These are considered safe and effective for people with lupus. Subunit or purified antigen vaccines use only specific pieces of the germ. Thus, they give a very robust immune response targeted to key portions of the microbe. Generally, these vaccines can be used widely, including on people with weakened immune systems. Toxoid vaccines use a toxin (harmful product) made by the germ that causes a disease. They create immunity to the parts of the germ that cause a disease instead of the germ itself. That means the immune response is targeted to the toxin instead of the whole germ. “People with lupus are at greater risk for infections due to immunosuppression, so vaccines are very important,” noted Dr. Staeva. “But speak to your doctor before getting any vaccine to determine which are right for you and when.” _________________________________________________________________________ Recommendations from the U.S. Department of Health & Human Services (HHS), Office of Women’s Health: People with lupus typically can get the following vaccines that do not contain live viruses: The flu shot (not nasal spray which contains a live form of the flu virus) Pneumonia vaccine Human papillomavirus (HPV) vaccine Tetanus, diphtheria, and acellular pertussis (Td/Tdap) vaccine Vaccines with live viruses that may not be safe for people with lupus, include: Nasal spray vaccine for the flu Varicella (chickenpox) vaccine Herpes Zoster (Shingles) vaccine Measles, Mumps, Rubella (MMR) vaccine Live typhoid vaccine (oral) Sources: U.S. Department of Health & Human Services, Office of Women’s Health https://www.lupusresearch.org/take-the-right-shots-for-lupus/
  2. Entry Requirements for Lupus Nephritis Clinical Trials Exclude Majority of Patients in UK Registry, Study Says JULY 10, 2019 BY IQRA MUMAL IN NEWS. Click Here to receive Lupus News via e-mail How clinical trials into lupus nephritis define their requirements for patient eligibility are too strict, leaving many people with active and severe disease ineligible for participation, according to a study that looked at six lupus trials and how well their “inclusion and exclusion criteria” matched patients in a large U.K. registry. Its researchers reported that a majority of registry patients, 50.6%, would not have been enrolled under published entry requirements. These findings were presented at the recent 2019 European Congress of Rheumatology(EULAR 2019), in a poster titled “How Well Do Clinical Trials Represent Real World Lupus Nephritis Patients?” Lupus nephritis (inflammation of the kidneys) can be a serious complication of systemic lupus erythematosus (SLE). The standard of care for lupus nephritis is treatment using glucocorticoids or conventional immunosuppressants. Rituxan (rituximab), an antibody that dampens some immune cells, has been used off-label to treat some with lupus nephritis, but has not shown efficacy across several clinical trials. Finding better treatments for these people requires clinical studies that determine safety and effectiveness. But stringent requirements for trial participation, often done to ensure patient homogeneity in the group studied, can result in criteria that does not accurately reflect real-world patients, the study notes. Researchers set out to evaluate clinical trial criteria for lupus nephritis by determining how closely they reflected a general population. They reviewed six recently published clinical trials involving these patients. Then they compared inclusion and exclusion criteria common across the trials to patients with active lupus nephritis in a U.K.-wide database of SLE patients called the BILAG-Biologics Register (BILAG-BR). Inclusion criteria define the characteristics that potential participants must have to be in a study, while exclusion criteria define those that disqualify from participation. The registry showed 259 people with active lupus nephritis, corresponding to 28.9% of its population. Among them, 230 had been treated with Rituxan, while the 29 others were given standard of care. Analysis showed that 70 people (30.4%) in the Rituxan group and 10 (34.5%) in the standard-of-care group that would not meet all inclusion criteria common to the six trials. The requirement that patients most often missed was not having a urine protein/creatinine ratio below 100 mg/mmol. This would exclude people with more severe kidney impairment. A majority, 118 patients or 51.3%, in the Rituxan group and six patients (20.7%) in standard-of-care also met one or more common exclusion criteria for the trials. Most often, the excluding criteria was active disease in the central nervous system and low levels of antibodies implying an immune system disorder (hypogammaglobulinaemia). Overall, more than half of registry patients (50.6%) with active lupus nephritis would not satisfy all inclusion and exclusion criteria, and likely be ineligible for clinical trial entry, the study found. Among patients deemed ineligible, those in the Rituxan group were younger (mean age, 36) compared to those given standard of care (mean age, 49). Most were also minorities (non-Caucasian) and female. “In a large national cohort of active LN [lupus nephritis] we found that 50.6% of patients would not be eligible for clinical trial entry using published entry criteria,” the researchers wrote. “This poses significant implications on the study of LN treatment in patients with more severe disease. When designing clinical trials, the stringency of eligibility criteria should be reviewed in order to provide greater representation of the target disease population,” they concluded. https://lupusnewstoday.com/2019/07/10/entry-criteria-for-lupus-nephritis-trials-exclude-majority-patients-in-uk-registry-study-finds/?utm_source=LUP+NEws+E-mail+List&utm_campaign=4dbb72aad6-RSS_WEEKLY_EMAIL_CAMPAIGN_US&utm_medium=email&utm_term=0_50dac6e56f-4dbb72aad6-71887989
  3. Understanding the Role of Polyautoimmunity in Rheumatic Diseases (©Zerbor,Shutterstock.com) Linda Peckel July 16, 2019 Rheumatology, Autoimmune Diseases, Modern Medicine News, News, Rheumatoid Arthritis An estimated 5 percent of the world’s population is diagnosed with one of a group of heterogeneous autoimmune rheumatic diseases (ARDs) including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjogren’s syndrome (SS). Not only do these diseases share mechanisms and risk factors, they are often comorbid conditions recognized as polyautoimmune (PolyA) manifestations of the same underlying dysfunction. Patients with SLE are frequently positive for anti-rheumatoid factor (RF) and less often for anti-citrullinated protein antibodies associated with RA, although less than 10% are diagnosed with concomitant SLE/RA, known as rhupus. Another 10% of SLE patients are recognized to have antiphospholipid syndrome (APS) although up to 54% have been shown to carry antibodies. Other PolyA’s may include SLE/hypothyroidism, RA/autoimmune thyroid disease (AITD), and concomitant symptoms of SS with SLE, AITD, or systemic sclerosis (SSc). According to studies by Gonzalez and colleagues (the most recent of which is published in the Journal of Autoimmunity)1 , 2 patterns of PolyA have emerged: 1) Overt PolyA, which reflects more than one well-defined ARD in a single patient, and 2) Latent PolyA, in which underlying patterns of autoantibodies are identified that do not correspond to the main diagnosis, and may be predictive of 1 or more additional ARDs. The authors conducted a cross-sectional cluster analysis of patients with the most common ARDs for antibody and cytokine patterns in a cohort of 187 individuals with diagnoses of SLE, RA, SSc, and SS (n = 70, 51, 35, and 31). They found that the frequency of PolyA did not differ across all 4 ARDs, although SLE and SS were associated with a younger age of onset. Rheumatoid factor and CCP3 were identified in 84.3% and76.5% of patients with RA, who also had the highest levels of Interleukin (IL)-6, interferon (IFN)-α, and IL-12/23p40 cytokines. Antinuclear antibodies (ANAs) were most prevalent in patients with SSc (97% positive) and SLE patients (71.4%), with distinctive patterns of additional antibodies and cytokines to each disease. The study revealed six main PolyA clusters involving the 4 ARDs that may provide biomarkers useful for diagnosis of current disease as well as prediction of other ARDs over time. The authors suggested that particular attention should be paid to latent PolyA, and to the strong association of IL-12/23p40 to 3 of the 6 cluster groups. REFERENCE 1. Molano-González N, Rojas M, Monsalve DM. "Cluster analysis of autoimmune rheumatic diseases based on autoantibodies. New insights for polyautoimmunity." J Autoimmun 2019;98:24-32. https://www.rheumatologynetwork.com/rheumatology/understanding-role-polyautoimmunity-rheumatic-diseases?rememberme=1&elq_mid=7781&elq_cid=1830808&GUID=9D824BFE-EF27-47A3-BAE0-900DC34C90C7
  4. Fatigue in Patients with Lupus is Real Fatigue in patients with systemic lupus erythematosus (SLE) has been linked to anti-NR2 antibodies, which responds to treatment with belimumab, a study shows. (©ArtemidaPsy,Shutterstock.com) Whitney J. Palmer June 24, 2019 Lupus, Rheumatology, Women's Health Patients with systemic lupus erythematosus (SLE) who have higher levels of antibodies to the receptor in the brain associated with memory and learning also experience more severe levels of fatigue, new research shows. The results, published in a recent issue of Annals of Rheumat ic Diseases, identifies a link between fatigue—one of the most challenging symptoms patients with systemic lupus erythematosus face—and the presence of anti-NR2, a brain-reacting antibody. “The presence of anti-NR2 antibodies in patients with lupus with fatigue is a helpful diagnostic tool and may offer a major approach in the therapeutic management of this important disabling symptom in patients with lupus,” said Andreas Schwarting, M.D., a rheumatologist, immunologist, and medical director at the University Medical Center of the Johannesburg-Gutenberg University Mainz in Germany. Elevated levels of anti-NR2 have been reported in 25 percent to 38 percent of patients with lupus, they said, so these findings could affect a substantial number of patients. To determine the impact of these autoantibodies, researchers analyzed blood samples from 426 patients with lupus. They also assessed fatigue severity using a self-reporting questionnaire. The findings found that patients with higher anti-NR2 levels experienced the more significant impacts of fatigue, including motoric and cognitive fatigue. Researchers found no correlation between anti-NR2 levels and renal function, erythrocyte sedimentation rate, or C-reactive protein. Study results also showed belimumab effectively relieved fatigue. Patients receiving belimumab for six months to 36 months saw a significant decline in their levels of anti-NR2 antibodies, as well as a clinically significant drop in their fatigue scores. Overall, investigators said, the findings could directly impact patient care. “The results of our study offer a sustained clinical advantage: to add an objective measurement of fatigue in lupus patients to a subjective questionnaire,” they said. “Anti-NMDAR antibodies should be identified routinely for patients with lupus suffering from fatigue.” REFERENCE Schwarting A, Mockel T, Lutgendorf F, et al. "Fatigue in SLE: diagnostic and pathogenic impact of anti-N-methyl-D-aspartate receptor (NMDAR) autoantibodies." Annals of Rheumatic Diseases(2019), doi: 10.1136/annrheumdis-2019-215098. https://www.rheumatologynetwork.com/lupus/fatigue-patients-lupus-real?rememberme=1&elq_mid=7437&elq_cid=1830808&GUID=9D824BFE-EF27-47A3-BAE0-900DC34C90C7
  5. Fracture Risk is High in Lupus Patients with systemic lupus erythematosus (SLE) are at an increased risk for fractures, new research shows. The risk is particularly high among patients with lupus nephritis. (©PollapatChirawongShutterstock.com) Whitney J. Palmer June 24, 2019 Lupus, Joint/Bone Health, News, Rheumatology Patients with systemic lupus erythematosus (SLE) are at an increased risk for fractures, new research shows. The risk is particularly high among patients with lupus nephritis. In a study published in a recent issue of Arthritis & Rheumatology, investigators foiund that patients with lupus nephritis were far more likely to break a bone than patients who do not have lupus. “Patients with lupus nephritis may be at particularly high risk of fracture due to secondary or tertiary hyperparathyroidism and vitamin D deficiency,” said study author Sara Tedeschi, M.D., MPH, a rheumatology fellow at Brigham and Women’s Hospital. To assess fracture risk, researchers examined medical records for 47,709 lupus patients, including 9,449 patients who also had lupus nephritis. They identified pelvic, wrist, hip, and humeral fractures and compared these records to those of 190,836 patients without lupus. According to results, all lupus patients had a two-fold higher risk for any fracture compared to patients without lupus. Lupus nephritis patients have a three-fold risk over non-lupus patients and a 1.6-fold increase over lupus patients. However, findings did indicate that African American patients with lupus experienced a lower fracture risk than other study participants. When examining risk for specific types of fractures, investigators found lupus patients were at high risk for hip and pelvic fracture compared to patients without lupus. The risk was also elevated, though not as much, for humerus and wrist fractures. Researchers also discovered younger lupus patients had a 2.3-times higher fracture risk than younger patients who didn’t have lupus. Lupus patients over age 50 had a two-fold fracture risk increase. Less than half of patients with lupus received glucocorticoid treatment, indicating use of this medication was only responsible for some increased fracture risk. Ultimately, investigators said, these results reinforce the importance of identifying high-risk patients who have lupus and lupus nephritis to monitor them and provide for fracture prevention. REFERENCE Tedeschi S, Kim S, Guan H, Grossman J, Costenbader K. "Comparative Fracture Risks Among United States Medicaid Enrollees With and Those Without Systemic Lupus Erythematosus." Arthritis & Rheumatology (2019), doi: 10.1002/art.40818 https://www.rheumatologynetwork.com/lupus/fracture-risk-high-lupus?rememberme=1&elq_mid=7437&elq_cid=1830808&GUID=9D824BFE-EF27-47A3-BAE0-900DC34C90C7
  6. Treatment with Tofacitinib Helps Relieve Arthritis and Rash Symptoms in Lupus Patients, Study Shows lupusnewstoday.com/2019/05/31/tofacitinib-relieve-arthritis-skin-rash-symptoms-sle/ Ana PenaMay 31, 2019 Tofacitinib tablets, a medicine approved to treat rheumatoid and psoriatic arthritis, may work for lessening signs and symptoms of arthritis and skin rash in people with systemic lupus erythematosus (SLE), a small study has found. These findings were reported in the letter “Successful treatment of arthritis and rash with tofacitinib in systemic lupus erythematosus: the experience from a single centre” that was published in the journal Annals of Rheumatic Diseases. Tofacitinib is marketed by Pfizer with the brand name Xeljanz for treating rheumatoid and psoriatic arthritis in adults who have failed treatment with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). The medicine also has been approved to help manage inflammation in adults with ulcerative colitis, another chronic inflammatory condition. It blocks the activity of certain janus kinases (JAK) enzymes, which are critical for the activity of the immune system. By targeting JAKs, tofacitinib inhibits the activity of several signaling molecules, including interferons and interleukins known to have a role in SLE development and progression. Clinical data collected from rheumatoid arthritis patients indicates that tofacitinib can act quickly to reduce inflammation, as corticosteroids do, but without the side effects of steroids. Tofacitinib has been used off-label to treat SLE in some patients, but there is still very little data about the effectiveness and safety of this treatment for lupus. That’s why a group of researchers at the Peking Union Medical College Hospital in China evaluated tofacitinib’s effectiveness in a group of 10 lupus patients seen at the center. Nine women and one man received 5 mg of tofacitinib two times a day, and were followed by the team for at least four weeks and up to one year. At each follow-up visit, patients were monitored for disease activity with laboratory tests, such as measurement of anti-dsDNA antibodies and complement C3 levels, and by using scoring systems commonly used in clinics — SLE Disease Activity Index-2000 (SLEDAI-2K) and physician’s global assessment (PGA). Within one year, tofacitinib yielded a quick resolution of arthritis in all four patients who had such symptoms, and promoted significant relief in skin rash in six of nine participants. All those patients who experienced improvements achieved clinical remission of arthritis or skin rash. Tofacitinib’s effectiveness for rash, however, was more uncertain. In two patients, the medicine improved symptoms only partially or not at all. And another patient even experienced a flare during the follow-up period. Despite the rapid benefit seen for disease activity, SLE blood markers remained unchanged during the study. This agrees with prior tests reported for a different JAK inhibitor, baricitinib (sold in the U.S as Olumiant), in lupus patients and animal models. Two patients experienced treatment-related adverse events. One had herpes varicella zoster (shingles) and the other had alopecia (spot baldness). Both continued on tofacitinib, but their dosage was tapered and they ended up achieving disease remission. Based on these findings the team believes that “tofacitinib can rapidly improve the symptoms and signs of arthritis and partially improve skin rash in patients with SLE, sparing steroid to reach [clinical remission].” In view of the small number of patients studied and the variable periods of follow-up for each of them, researchers stress that more studies are needed to confirm tofacitinib’s effectiveness and define its specific indication in patients with SLE.
  7. Gene Changes Key to Successful Pregnancy in Lupus April 29, 2019 Pregnant women with lupus are more likely to suffer complications than those who don’t. Lupus Research Alliance Scientific Advisory Board members Dr. Virginia Pascual, Professor at Weill Cornell Medicine; and Dr. Jane Salmon, Collette Kean Research Professor at Hospital for Special Surgery, and their colleagues asked if testing the blood, of pregnant women with lupus, using advanced technologies could identify, early in pregnancy, lupus patients at high risk for complications. Their new paper in the Journal of Experimental Medicine shows that during uncomplicated pregnancy in both healthy and lupus women some genes that incite the immune system become less active. These changes may make the immune system less aggressive and reduce the odds that it will attack the fetus. However, women with lupus who had pregnancy complications, including preeclampsia, did not show the desirable decrease in these immune signatures. Doctors came up with the term “lupus” because they thought the disease’s skin inflammation looked liked a wolf’s bite. The study “supports the idea that in some cases, pregnancy can ‘tame the wolf.’” Drs. Timothy Niewold and Shilpi Mehta-Lee wrote in a commentary on the paper. They note that the findings may enable doctors to identify patients with lupus who are susceptible to pregnancy complications and need careful monitoring To the immune system, a fetus developing in the womb resembles a foreign invader. Normally during pregnancy, the mother’s immune system develops what researchers call tolerance and avoids attacking the fetus. But when patients with lupus become pregnant, their immune system may be less likely to develop tolerance to the fetus, leading to complications such as preeclampsia, premature birth, and even death of the fetus. In the new study, Dr. Pascual and colleagues compared 92 pregnant women with lupus to 43 pregnant women who didn’t have the disease. The researchers obtained blood samples from the women during and shortly after their pregnancies. To detect the earliest changes associated with pregnancy onset, the scientists also analyzed blood from patients undergoing assisted reproductive technology. The researchers evaluated the patients’ immune system by measuring the activity of different genes that help determine how strongly it responds to potential threats. For a subset of these study participants, the investigators also examined the types of cells that are producing the specific immune responses. Early in pregnancy, the activity of key genes decreased in women who didn’t have lupus, probably increasing their tolerance to the developing baby. The researchers saw similar changes in women with lupus who had successful pregnancies. However, the immune system of women with lupus who went on to develop complications was not turned down. Their immune system might be more likely to attack the fetus or prevent its proper development. This inability to turn down the immune activity appears to be a risk factor for adverse pregnancy outcomes in lupus. Testing for these changes in gene activity might pinpoint patients with lupus who are more likely to develop pregnancy complications and who needs careful monitoring and specific therapeutic intervention to improve the outcome. https://www.lupusresearch.org/gene-changes-key-to-successful-pregnancy-in-lupus/
  8. APRIL 2019 11 April 2019 by Professor Graham R V Hughes MD FRCP Easter comes late this year. Frenetic Brexit politics – the Westminster establishment fighting to overturn the ‘popular vote’. So sad. Last week I gave a lecture at an ‘immuno-therapy’ meeting in Madrid. Three hundred attendees, including representatives of the Spanish patients’ APS Society. The atmosphere was fantastic. So many doctors (and patients’) wanting to learn more about our syndrome. Talking about ‘learning more’, we now have a date for our own Patients’ Meeting – Friday, 13th September 2019. (For details of the programme and admission, please visit our website: www.ghic.world). This year we are opening up the meeting to include topics on Sjogren’s and lupus, as well as antiphospholipid syndrome. I will also send this blog, as well as details or our annual Patients’ Meeting, to our colleagues in Spain. Patient of the Month “I still feel tired all the time”. Mrs J.S. aged 55, was referred by her G.P. complaining of a variety of symptoms, including aches and pains, headaches, constipation, pins and needles and mental sluggishness. Above all else, she felt constantly fatigued. Despite this very full set of symptoms, the diagnosis remained uncertain. The pins and needles in both hands were put down to carpal tunnel syndrome. But there was little else to find. In view of the frequent headaches, Mrs J.S. was referred to a neurologist who arranged for further tests, including a brain MRI (which showed two small ‘dot’ lesions – reported as probably not significant. To her credit, the neurologist considered lupus and arranged lupus blood tests among the more routine ones. The tests came back showing a normal blood count. However, the ESR (the guide to inflammation) came back ‘borderline positive’ at 35 (normal under 20). The tests for lupus were essentially negative (anti-DNA negative, ANA ‘weak’ (1 in 80). What is the diagnosis (1)? The penny dropped. Could this be thyroid? Bilateral carpal tunnel syndrome is certainly seen in ‘low thyroid’, and significantly Mrs J.S. had a sister with ‘Hashimotos thyroiditis’ – and underactive thyroid with auto-immune features. As with all her other tests the thyroid blood tests were ‘borderline’. Nevertheless, the fatigue, the constipation, the aches and pains, could all be down to ‘low thyroid’. Following a *‘kerbside consult’, with her endocrinology colleague, she instituted thyroxine treatment. Within 2 months the pins and needles were gone and the mental sluggishness, as well as the constipation, were improving. BUT – the aches and pains and the fatigue remained – as bad as ever. What is the diagnosis (2)? It turned out that Mrs J.S. had suffered a series of miscarriages in her early 20’s and she and her husband remained childless. Could the problems – especially the frequent headaches – be due to Hughes Syndrome? Sure enough the antiphospholipid antibody (aPL) tests were strongly positive – not even ‘borderline’. She was started on clopidogrel (‘Plavix’) – an anti-clotting drug similar to aspirin (Mrs J.S. had previously tried aspirin but found it caused indigestion. Result? An almost immediate lessening of the headaches. And, if anything, a further improvement in her memory problems. BUT: no improvement in the fatigue or the aches and pains. What is the diagnosis (3)? Mrs J.S. was referred to a lupus clinic. Again, the results were similar (‘borderline’ ANA and negative anti-DNA). The lupus clinic doctor had seen this before – possible ‘Sjogren’s syndrome’. And, sure enough, the Shirmer’s test – a simple ‘blotting paper’ eye test was completely dry – a useful and very inexpensive screening test for the dry eyes of Sjogren’s Syndrome. Low dose hydroxychloroquine (Plaquenil) (one a day) was started. Three months later at follow-up clinic, ‘fatigue gone. Aches gone. Back to normal life”. What is this patient teaching us? I often talk of ‘The Big Three’ diseases – Lupus, Sjogren’s and Hughes Syndrome, which can overlap clinically However, the world of auto-immune diseases in which I practice includes another ‘big three’, which frequently go together : Hughes Syndrome, Sjogren’s Syndrome and low thyroid (often, specifically, Hashimoto’s thyroiditis) – three ‘named’ syndromes. Clearly, to miss one or even two of the triad would be an ‘under-treatment’. The three conditions can have similar features. And fortunately, potentially very successful treatment – thyroid, aspirin (or Plavix) and hydroxychloroquine. I call the combination of aspirin and hydroxychloroquine (derived from quinine) my ‘two trees’ – treatment –willow and cinchona. Perhaps the biggest lesson from this patient is that there may be more than one diagnosis causing the problems. PROFESSOR GRAHAM R V HUGHES MD FRCP Head of The London Lupus Centre London Bridge Hospital http://www.ghic.world/blog/april-2019
  9. An Increased Risk of Dementia Possible in Lupus Stephanie Pappas Jul 13, 2016 Neuropsychiatric symptoms have long been known to affect some patients with systemic lupus erythematosus. But now, emerging evidence suggests that lupus patients may be at increased risk of dementia, as well. A retrospective study published in April in the journal Arthritis Care and Research used the Taiwan Longitudinal Health Insurance Database 2005, a random sampling of the 99.9 percent of Taiwanese citizens covered by the country's national health insurance, to compare dementia rates in people with systemic lupus erythematosus to age- and sex-matched patients without the autoimmune disease. The analysis revealed a doubled rate of dementia in SLE patients. There were 357 cases per 100,00 person-years in the lupus cohort, compared with 180 cases per 100,000 person-years in the non-SLE cohort. {Crude hazard ratio 1.92, 95 percent CI, 1.14−3.23, P< 0.001.) Dementia is a condition of gradual decline, while neuropsychiatric SLE usually manifests early in the diagnosis, wrote study author Dr. Yu-Ru Lin of Taipei Medical Hospital and colleagues. Antiphospholipid antibodies might put patients at risk of micro-stroke, they hypothesized. Alternatively, anatomical changes in the brain attributable to the disease or corticosteroid treatments may contribute to cognitive decline. Rheumatology Network spoke with Dr. Yehuda Shoenfeld, an autoimmunity researcher at Tel Aviv University in Israel, for a deeper look at the dementia-lupus connection. Though not involved with the Taiwanese study, Dr. Shoenfeld has conducted research on lupus autoantibodies and has written about neuropsychiatric lupus in the clinic. He provided his perspective on the need to better understand how lupus might affect the brain. RN: Obviously, neurologic symptoms are well-known in systemic lupus erythematosus. What is the difference between central nervous system lupus and dementia? Shoenfeld: There are neurological, physical findings and also X-ray findings in which you see defects in neurological functions, mainly nerves which can be motor or sensory or so forth. It can be represented by conversions. It can be represented by paralysis. It can be presented as paresthesia, which means it feels like ants are going on your body. So it's more in the domain of physical examination. Dementia is more that you lose your capacity for cognition, memory or so forth. You cannot detect it by X-rays, but you can detect it by talking to the patient and listening to him and you can see that he's not finding himself, I would say, in space. So this is a big difference. What is new about this study by Lin and colleagues? So far we knew that CNS lupus is quite common, 20 percent of the patients can suffer from that. There are many manifestations of CNS lupus from paralysis to conversion, from deafness to blindness, from paresthesia to pains and so forth. Dementia up until now was not part of the story of lupus - neither in regular lupus nor in CNS lupus. We did have psychotic attack in CNS lupus, which could be completely resolved upon proper therapy, for instance with corticosteroids or immunosuppressive drugs. Suddenly, there is dementia. Now, I want to remind you that lupus is a disease of young females, so it's not elderly females with dementia at this age. So the people who published the paper came with the idea that in those patients with CNS lupus, you can find, eventually, more dementia, which is a new revelation, not known so far. With my colleague, Professor Howard Amital [of Sheba Medical Center], an expert on Big Data — we asked the computer to cross the word dementia with SLE in a health database, but we did something else in this respect. We compared it to two other autoimmune diseases. I have to say that, to my great surprise, we have found also that patients with SLE have a threefold increase in dementia. We were not able so far to segregate it to the different factor that we would like to, but we found also with rheumatoid, there was an increase. There was no increase, for instance, in Behcet's syndrome. So most probably, these results are correct, and they should raise a red light. We will analyze our results and we will publish it very soon. But I think it's interesting, even though I had not believed this when I had received the paper from you. What kind of mechanisms might explain why there could be this link? When you have an organic damage to the brain, being autoimmune in nature, being the position of autoantibodies, being the position of other factors it causes chronic damage to the brain and eventually, there is some kind expression that above this threshold it can cause the psychological defects which are expressed as dementia. It's like accumulating damage. Given what is known right now, what is the message for practicing rheumatologists? Before we do anything with patients, we should confirm the results and indeed analyze what could be the mechanism and then eventually work on this to see how we could prevent this. Maybe, for instance, a very quick recovery should be installed whenever there are any signs of CNS lupus. We have to see if, indeed, it's limited only to patients with CNS lupus. There is a lot to analyze now, to learn, to study and to draw conclusions for the future. References: Lin Y-R, Chou L-C, Chen H-C, Liou T-H, Huang S-W, Lin H-W. "Increased risk of dementia in patients with systemic lupus erythematosus: A nationwide population-based cohort study." Arthritis Care & Research. 2016. doi:10.1002/acr.22914. Kivity S, Agmon-Levin N, Zandman-Goddard G, Chapman J, Shoenfeld Y. "Neuropsychiatric lupus: a mosaic of clinical presentations." BMC Medicine BMC Med. 2015;13(1):43. doi:10.1186/s12916-015-0269-8. https://www.rheumatologynetwork.com/lupus/increased-risk-dementia-possible-lupus
  10. SLE Patients at Higher Risk for Some Blood Cancers, Study Says FEBRUARY 18, 2019 BY JOANA CARVALHO IN NEWS. Click Here to receive Lupus News via e-mail Systemic lupus erythematosus (SLE) patients have a higher risk for certain cancers — including cervical, thyroid, ovarian, and oral cancer, as well as lymphoma, multiple myeloma, and leukemia — than the general population, emphasizing the importance of cancer screening programs as part of SLE management. The findings of the study, “Systemic lupus erythematosus is a risk factor for cancer: a nationwide population-based study in Korea,” were published in Lupus. SLE, the most prevalent form of lupus, is a chronic autoimmune disease characterized by behavioral and psychological symptoms including pain, fatigue, depression, and impaired cognition. Previous studies have suggested that SLE patients are more likely to be affected by certain types of cancers, including non-Hodgkin’s lymphoma, lung, liver, and vaginal cancer. “However, some studies have found a decreased risk of some hormone-sensitive cancers, such as breast, ovarian, and endometrial cancer, in SLE patients. However, whether patients with SLE have increased or decreased risk of breast cancer remains unclear,” the researchers said. In this study, investigators set out to characterize the relationship between SLE and cancer in the entire Korean population. The nationwide, retrospective, cohort study involved 21,016 SLE patients and 105,080 age- and sex-matched controls without SLE. The cohort was selected from the Korean National Health Insurance Service (NHIS) database between 2008 and 2014. Over a follow-up period of seven years, 763 (3.36%) SLE patients and 2,667 (2.54%) controls developed cancer. The incidence risk of cancer was higher in SLE patients compared to controls (6.427 vs 4.466). Incidence risk refers to the chance of a disease happening over a defined period of time. After accounting for age and sex, SLE patients showed a 44% higher risk of developing cancer. No differences in cancer risk were found between female and male SLE patients. SLE patients at higher risk for cancer were younger (under 40) and male, being 12 and 29 times more likely of developing lymphoma than control subjects. Looking at different cancer types, researchers found that SLE patients were more likely to develop cervical, thryoid, ovarian, and oral cancer, as well as lymphoma, leukemia, and multiple myeloma than controls. On the other hand, no significant differences in the risk of stomach, colorectal, liver, pancreatic, lung, breast, prostate, biliary, laryngeal, renal, bladder, nerve, and skin cancer were found between SLE patients and controls. While the mechanisms leading to increased risk of cancer in SLE patients are yet to be fully understood, the findings highlight the need for cancer screening programs among this patient population. “In conclusion, SLE is an independent risk factor for malignancy, especially cervical, thyroid, ovarian, oral … as well as lymphoma, multiple myeloma, and leukemia. The importance of cancer screening programs should be emphasized in SLE patients,” the scientists concluded. https://lupusnewstoday.com/2019/02/18/sle-patients-may-be-at-higher-risk-of-developing-certain-types-of-cancer/?utm_source=LUP+NEws+E-mail+List&amp;utm_campaign=1e70fc3e85-RSS_WEEKLY_EMAIL_CAMPAIGN_US&amp;utm_medium=email&amp;utm_term=0_50dac6e56f-1e70fc3e85-71887989
  11. Congratulations and Many Thanks to Lady Gaga! To the entire world, Lady Gaga is a winner. But to the lupus community she’s a hero. Last night at the 2019 Grammy’s, she won an award for Best Pop Solo in honor of her aunt Joanne who lost her battle with lupus at 19. Afterwards she tweeted: Lady Gaga has shared the song’s significance on social media. “I have carried a deep grief in my heart over my family’s tragedy. The loss of Joanne affected my father so deeply that it affected me. When he cried, I cried. When he was angry, I was angry. When he was hurt, I hurt. Today I transform this grief to hope and healing. After 10 years with you I still get nervous before the Grammys, but I know I have an angel with me.” Hear about lupus research from Lady Gaga's dad And watch this video to hear directly from Lady Gaga’s dad, Joe Germanotta, about why he has honoured his sister by actively supporting the Lupus Research Alliance. As a member of our Board of Directors, Joe believes that the research funded by the Lupus Research Alliance is where hope begins. Where our funded research discoveries are breaking through to deliver better treatments and a cure!
  12. Lupus: 3 Things to Know Mark L. Fuerst Dec 3, 2018 Lupus Three new studies in systemic lupus erythematosus (SLE) reveal that a gut bacterium may be linked to autoimmune diseases, including SLE; pregnancy complications in women with lupus have decreased over the past 2 decades; and physical or emotional abuse in childhood raises the risk of lupus.1-3Scroll through the slides for the latest findings and their clinical implications. http://www.rheumatologynetwork.com/lupus/lupus-3-things-know
  13. Environmental Factors Tied to Lupus Gregory M. Weiss, M.D. Tuesday, December 5, 2017 Lupus Key points • Ultraviolet light may cause flare-ups in systemic lupus erythematosus (SLE). • The chemicals found in cigarette smoke can worsen the symptoms of SLE. • Estrogen analogues such as oral contraceptives and bisphenol A (BPA), a substance used to make plastic bottles, may increase the risk of SLE. Background SLE affects women and African Americans disproportionately. Dr. Gaurav Gulati at the University of Cincinnati in Ohio points out that even though we have treatments for lupus, a complete understanding of its etiology and progression is lacking. Although genetics clearly plays a role in SLE, it appears that environmental factors may act as triggers in those who are susceptible. Dr. Gulati conducted a review of the literature related to SLE and environmental versus genetic factors; he presented his findings recently in Seminars in Arthritis and Rheumatism. The study A systematic review was conducted that looked at over 100 studies focused on SLE. The results • A triad of factors was found in one study that linked a patient’s genetics, how the patient’s DNA changes over time, and exposure to environmental factors to the development and course of SLE. • Twin studies reveal only a 24% concordance of SLE in identical siblings; this points to a conclusion that a combination of genetic predisposition and environmental factors is involved in the development of lupus. • Heavy metals and other trace elements may be triggers for SLE; uranium, lead, and cadmium are linked to autoimmunity. • Elements such as mercury, nickel, and gold have been implicated in delayed hypersensitivity and inflammation, and a higher rate of lupus has been noted among dental workers. • An increase in SLE has been found in women who take oral contraceptives and in those exposed to xenoestrogens such as BPA, a chemical found in plastics. Implications for physicians • Physicians and particularly rheumatologists who treat patients with SLE should vigorously encourage positive lifestyle modifications such as smoking cessation and avoidance of direct sunlight. • Patients with SLE should be advised to always wear sunscreen. • Rheumatologists should provide regular surveillance to their patients with SLE as changes in disease activity and treatment are warranted. References: Gulati G, Brunner HI. Environmental triggers in systemic lupus erythematosus. Semin Arthritis Rheum. 2017 Oct 5. pii: S0049-0172(17)30469-9. doi: 10.1016/j.semarthrit.2017.10.001. [Epub ahead of print]
  14. Sex Differences in Lupus Mortality Mariah Zebrowski Leach, JD, MS Monday, December 4, 2017 A comprehensive US population-based study identified an average 22-year and 12-year deficit in life expectancy among females and males with systemic lupus erythematosus (SLE), respectively, compared with the general population. Background In the United States, SLE is a source of significantly decreased life expectancy. While marked differences have been observed between the sexes in terms of the incidence, prevalence, and clinical manifestations of SLE, this area is still poorly understood. Falasinnu and colleagues1 at Stanford School of Medicine identified sex-based differences in the causes of death among SLE decedents in the United States and recognized clinically relevant comorbidities that may warrant careful consideration in patients’ clinical management. The study This study examined SLE-related deaths using the 2014 National Center for Health Statistics multiple cause of death (MCOD) database, a population-based electronic medical recording of all death certificates issued in the United States. The analysis considered not only the number of death certificates listing SLE as the underlying cause of death, but also those listing SLE in general. Demographic information considered included age, race/ethnicity, sex, educational attainment, foreign-born status, marital status, and pregnancy status. SLE decedents were compared with non-SLE decedents in the general population belonging to the same age group. The findings In 2014, there were 2,660,497 deaths in the United States, of which 2036 (0.1%) listed SLE among the causes of death. Approximately 86.2% of SLE deaths occurred among females, with a median age at death of 59 years and the highest proportion of deaths occurring between 45 and 64 years of age. In comparison, the overall median age at death for females in the general population was 81 years, and the majority of deaths occurred among females over 65 years of age. Black females experienced the greatest burden of SLE mortality. Approximately 32% of all female SLE decedents were black, compared with only 11% of non–SLE-related deaths in the general population. Female decedents with SLE had a slightly higher proportion of foreign-born individuals than the general population, but there were no other significant demographic differences. The most frequently listed comorbidities among female decedents with SLE were septicemia (4.32%) and hypertension (3.04%). Among male decedents with SLE, the median age at death was 61 years, compared with 73 years in the general population. Of male decedents with SLE, 23.5% were black, compared with only 12% in the general population. The age-standardized mortality was highest among American Indian males. There were no other demographic differences related to SLE among male decedents. The most frequently listed comorbidities among male decedents with SLE were heart disease (3.70%) and diabetes mellitus with complications (3.61%). Implications for physicians and future research This study offers an opportunity to better describe the association between SLE and related comorbidities in the context of mortality, although the MCOD data have a number of limitations. Inaccuracy on death certificates can lead to the underestimation of the SLE mortality burden, and researchers were unable to differentiate between causes of death that were related to the natural age process, disease activity, and drug therapy. Still, the MCOD data provide a comprehensive understanding of the population-based burden of SLE mortality. While female SLE patients tend to have more frequent disease exacerbations, male patients appear to have significantly greater multisystemic damage accrual and disease severity. Greater disease severity among male SLE patients may be related to under diagnosis due to selective attention given to females by physicians during clinical decision-making. This potential for gender bias needs to be carefully considered. Racial minorities generally have a disproportionately higher burden of mortality. The scope and degree of these differences in SLE are particularly pronounced, with mortality rates among black females nearly four times as high as those in white females. “Our findings reinforce the urgent need for interventions that reduce morbidity and mortality in patients with SLE to improve health outcomes and ultimately reduce health disparities,” the researchers write. They note that novel translational research programs are currently underway to attempt to address these disparities. Clinically relevant comorbidities also need to be considered more carefully in the course of patients’ clinical management and the natural history of SLE. This study revealed future targets for the investigation of sex-based differences and directions for epidemiological research. “A comprehensive understanding of causes of death and the related comorbidities can improve clinical diagnostic and therapeutic strategies, impact survival outcomes in patients living with SLE, and enhance population-based disease surveillance estimates,” the researchers conclude. References: 1. Falasinnu T, Chaichian Y, Simard JF. Impact of sex on systemic lupus erythematosus-related causes of premature mortality in the United States. J Womens Health (Larchmt). 2017;26:1214-1221. doi: 10.1089/jwh.2017.6334.
  15. Treatment Target Shows Promise in Systemic Lupus Erythematosus Mariah Zebrowski Leach, JD, MS Monday, December 4, 2017 The lupus low disease activity state (LLDAS) is a promising treatment target in systemic lupus erythematosus (SLE), according to new research. Background Successfully applied in rheumatoid arthritis as well as in non-rheumatic conditions, a treat-to-target approach aims to improve disease outcomes through the achievement of a pre-specified goal. An international task force suggested such a strategy for the treatment of SLE.1 They recommended that the treatment target should be remission or—when that is unachievable—the lowest possible disease activity. LLDAS is a composite definition of minimal acceptable disease activity proposed by the Asia-Pacific Lupus Collaboration (APLC). LLDAS is based on the following criteria: 1. SLE Disease Activity Index 2000 (SLEDAI-2K) ≤ 4, with no activity in major organ systems 2. No new lupus disease activity compared with the previous assessment 3. Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (PGA) ≤ 1 4. Current prednisolone (or equivalent) dose ≤ 7.5 mg daily 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents To be considered a valid treatment target, LLDAS should be protective against damage accrual in the early SLE stages. Piga and colleagues2 at the University Clinic and AOU of Cagliari in Italy sought to determine the frequency of LLDAS achievement and its association with early damage accrual in a homogenous cohort of Caucasian patients with SLE prospectively assessed during the first 18 months of treatment after diagnosis. The study This study primarily aimed to assess the frequency of LLDAS achievement and its association with early damage, with a secondary aim to identify the main reasons for failure to achieve LLDAS. The study cohort consisted of 107 patients from the Cagliari (Italy) SLE cohort between January 2006 and December 2016. To assess LLDAS as a goal for initial treatment, the primary study endpoint was set at 6 months, with 18 months considered an appropriate time to evaluate the effect of maintenance treatment and early damage accrual. At each visit, disease activity was assessed using the SLEDAI-2K score and the PGA. At 18 months, damage accrual was assessed by the SDI and the possible attribution to corticosteroids was done according to a previous definition. Average daily dose of prednisolone (or equivalent) and ongoing use and new prescription of medications were assessed at every visit. The findings At the 6-month point, LLDAS had been achieved by 47 patients (43.9%). At 18 months, 48 patients (44.9%) were in LLDAS; 33 of them had achieved LLDAS at 6 months and were still in this condition and 15 had reached LLDAS for the first time. Of the 59 patients who were not in LLDAS at 18 months, 45 had never been in LLDAS and 14 had been in LLDAS at 6 months but no longer were at 18 months. Thus, despite a seemingly overall stable LLDAS rate, these results demonstrate the dynamic nature of this condition. On univariate analysis, the following factors were significantly associated with failure to achieve LLDAS at 6 months: renal involvement, higher SLEDAI-2K score, positive (> 10 UL/mL) anti-dsDNA antibodies, lower serum C3 and C4 values, and higher prednisolone dose and immunosuppressant drug use. On multivariate analysis, renal involvement and C4 levels were confirmed to be associated with failure to achieve LLDAS. Implications for physicians The limitations of this study are the relatively small sample size, which may have hampered study results, and the retrospective design, which prevented researchers from testing LLDAS criterion validity by comparing it with other treatment targets such as the SLE Responder Index. Nevertheless, by enrolling consecutively diagnosed patients at the time of treatment initiation and following them prospectively, the researchers were able to provide novel data on LLDAS as a potential treatment target. In this study, the most frequent reason for failure to achieve LLDAS 6 months after therapy initiation was daily prednisolone dosage > 7.5 mg. Damage was definitely attributable to steroid use in 40% of cases in this cohort. However, supported by this data and literature evidence on damage development, the researchers consider 7.5 mg/d an acceptable cutoff to define low disease activity during initial treatment. Still, they recommend a lower cutoff should be targeted to minimize risk of steroid-related damage during maintenance therapy in patients with SLE. In this cohort, patients with renal involvement and serological disorders had the lowest remission rate, and renal involvement at baseline was the most important factor associated with failure to achieve LLDAS. “LLDAS is a promising treatment target in SLE, being attainable and negatively associated with damage accrual in the early stages of the disease,” the researchers write. “However, it seems to poorly fit with the heterogeneity of clinical presentation in patients with SLE, mostly in those with renal involvement,” they conclude. References: 1. van Vollenhoven R, Voskuyl A, Bertsias G, et al. Treat-to-target in systemic lupus erythematosus: recommendations from an international task force. Ann Rheum Dis. 2014;73:958-967. 2. Piga M, Floris A, Cappellazzo G, et al. Failure to achieve lupus low disease activity state (LLDAS) six months after diagnosis is associated with early damage accrual in Caucasian patients with systemic lupus erythematosus. Arthritis Res Ther. 2017;19:247. doi: 10.1186/s13075-017-1451-5.
  16. Poverty Stacks the Deck Against Patients With Lupus Gregory M. Weiss, M.D. Tuesday, November 28, 2017 Lupus Poor patients with systemic lupus erythematosus (SLE) who receive Medicaid are less likely to adhere to their treatment regimen than are patients who live in more affluent areas. Adherence to SLE therapy may also be lower in areas with large African American populations and limited access to health care professionals. In addition, Medicaid patients are less likely to take hydroxychloroquine for lupus if they live in areas with fewer hospitals, high African American populations, and low provider numbers. SLE strikes women with greater frequency than men and is more than twice as common in the African American population. Dr. Candace Feldman and colleagues at Harvard Medical School note that compliance with hydroxychloroquine therapy in lupus patients is poor at baseline. “Studies in other chronic diseases demonstrate that where individuals live has a significant effect on their health-related behaviors and on disease control and outcomes,” said Dr. Feldman. It was this premise that led the authors to look into how location and resources contribute to adherence to treatment in SLE. They presented their findings at the recent American College of Rheumatologyannual meeting in San Diego, California. The study Utilizing the Medicaid database, new users of hydroxychloroquine were identified and adherence was measured over a 12-month period. The study included 10,268 subjects with SLE who were new users of hydroxychloroquine. The results • Only 15% of subjects remained adherent to hydroxychloroquine therapy based on taking the drug on 80% or more of days covered. • Zip codes with higher percentages of African American residents had lower odds of adherence. • Adherence was highest in counties with more hospitals and lowest in areas with low numbers of health care professionals. • Living in areas with higher numbers of African Americans and fewer hospitals and health care professionals independently predicted low adherence to hydroxychloroquine therapy. Implications for physicians • Low adherence to hydroxychloroquine therapy in SLE is widespread among Medicaid recipients. • Patients with SLE in predominantly low-income, African American communities are at higher risk for non-compliance to hydroxychloroquine therapy. • Lack of access to health care providers and hospitals reduces the likelihood that patients with lupus will adhere to therapy. • Physicians should make every effort to identify barriers to care and treatment adherence, especially in low-income patients with lupus who live in isolated communities with large minority populations. References: American College of Rheumatology Press Release. “Diversity Rate and Poor Access to Health Professionals May Influence Lupus Therapy Adherence.” November 4, 2017. ACR/ARHP Annual Meeting. San Diego, California.
  17. An evidence-based approach to pre-pregnancy counselling for patients with systemic lupus Y K Onno Teng Edwin O W Bredewold Ton J Rabelink Tom W J HuizingaH C Jeroen Eikenboom Maarten Limper Ruth D E Fritsch-StorkKitty W M Bloemenkamp Marieke Sueters Rheumatology, kex374, https://doi.org/10.1093/rheumatology/kex374 Published: 20 November 2017 Abstract Patients with SLE are often young females of childbearing age and a pregnancy wish in this patient group is common. However, SLE patients are at high risk for adverse pregnancy outcomes that require adequate guidance. It is widely acknowledged that pre-pregnancy counselling is the pivotal first step in the management of SLE patients with a wish to become pregnant. Next, management of these patients is usually multidisciplinary and often requires specific expertise from the different physicians involved. Very recently a EULAR recommendation was published emphasizing the need for adequate preconception counselling and risk stratification. Therefore the present review specifically addresses the issue of pre-pregnancy counselling for SLE patients with an evidence-based approach. The review summarizes data retrieved from recently published, high-quality cohort studies that have contributed to a better understanding and estimation of pregnancy-related risks for SLE patients. The present review categorizes risks from a patient-oriented point of view, that is, the influence of pregnancy on SLE, of SLE on pregnancy, of SLE on the foetus/neonate and of SLE-related medication. Lastly, pre-pregnancy counselling of SLE patients with additional secondary APS is reviewed. Collectively these data can guide clinicians to formulate appropriate preventive strategies and patient-tailored monitoring plans during pre-pregnancy counselling of SLE patients. https://academic.oup.com/rheumatology/advance-article-abstract/doi/10.1093/rheumatology/kex374/4641853?redirectedFrom=fulltext
  18. 21 November, 2017 SAN DIEGO — At the American College of Rheumatology Annual Meeting, Joan Merrill, MD, spoke about a study that she said is further demonstration that atacicept should continue being developed as a potential treatment for lupus. According to Merrill, the results also suggest that measurements of low-disease activity may represent not just clinically meaningful endpoints, but may also “work as endpoints in clinical trials to discriminate drug from placebo.” https://www.healio.com/rheumatology/lupus/news/online/{1b289264-6a9b-47a3-86c6-9b0eb8a3980f}/video-atacicept-is-a-potential-exciting-treatment-for-lupus?utm_source=selligent&utm_medium=email&utm_campaign=rheumatology news&m_bt=1879111151405
  19. Obesity linked to worse outcomes of pain, fatigue, depression in women with lupus November 13, 2017 SAN DIEGO — Among women with systemic lupus erythematosus, obesity appears to be independently linked to worse patient-reported outcomes, suggesting that weight loss may improve outcomes for this population, according to findings presented at the American College of Rheumatology Annual Meeting. “The research that I am presenting at this conference was inspired by previous work that showed that patients with lupus experienced big deferments in patient-reported outcomes, or PROs,” Sarah L. Patterson, MD, a fellow in rheumatology at the University of California, San Francisco, and an author of the study, said in her presentation. “It's also been noted that these deferments in PROs are not fully explained by the severity of their lupus disease or by sociodemographic factors such as poverty. So, we therefore wanted to know whether body composition and, specifically, excess adipose tissue contributes to the worse health-related quality of life and greater symptom burden that we see in this particular patient population.” In the study, Patterson and colleagues identified a sample of 148 patients with SLE (65% white, 14% Asian and 13% African-American; mean age, 48 ± 12.3 years) from the Arthritis Body Composition and Disability (ABCD) study. Eligible participants were women aged at least 18 years who had a diagnosis of SLE that could be corroborated by medical record review. The researchers calculated BMI and fat mass index (FMI). FMI measures total fat mass adjusted for height and was evaluated in the study using whole dual-energy X-ray absorptiometry. Obesity was defined using two designations: FMI of at least 13 kg/m2 and BMI of at least 30 kg/m2. The following four validated patient-reported outcomes were included as dependent variables: disease activity via Systemic Lupus Activity Questionnaire, depressive symptoms via Center for Epidemiologic Studies Depression Scale, pain assessed by SF-36 pain subscale and fatigue measured by SF-36 vitality subscale. Multivariable linear regression was used to analyze correlations of obesity with patient-reported outcomes , adjusted for possible confounding factor (age, race, education, income, smoking status, disease duration, disease damage and prednisone use). Adjusted means for each outcome were then calculated based on the multivariable regression. Of the patients in the sample, 17% had poverty-level income; 86% had education beyond high school; the mean duration of disease was 16 ± 9 years; and 45% were being treated with glucocorticoids. Based on the FMI definition of obesity, 32% of patients met the criteria for obesity, whereas 30% were deemed obese by the BMI definition. The multivariate regression model found that FMI-defined obesity was correlated with worse scores on each patient-reported outcome (greater disease activity, higher levels of depression, more pain and more fatigue). In the analyses that used the traditional BMI of at least 30 kg/m2 criteria, the same correlations were seen between obesity and each of the patient-reported outcomes. “These findings have important clinical implications. The PROs that we measured, particularly pain and fatigue, are known to have profound effects on quality of life, and remain a major area of unmet need in people with lupus,” Patterson said. “In other words, there are many patients with lupus who are treated with aggressive immunomodulatory therapy and these symptoms of pain and fatigue persist. The relationship that we observed between excess fat and worse outcomes really underscores the need for lifestyle interventions for lupus patients who are overweight.” – by Jennifer Byrne Reference: Patterson SL, et al. Abstract #2263. Presented at: American College of Rheumatology Annual Meeting; Nov. 4-8, 2017; San Diego. Disclosures: The authors report no relevant financial disclosures. https://www.healio.com/rheumatology/lupus/news/online/{88b88835-9c84-4880-a058-1e4d1d926aa6}/obesity-linked-to-worse-outcomes-of-pain-fatigue-depression-in-women-with-lupus?utm_source=selligent&utm_medium=email&utm_campaign=rheumatology news&m_bt=1879111151405
  20. 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
  21. 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
  22. 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
  23. 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 --
  24. 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.
  25. 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
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