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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
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
Furie discusses SLE pathogenesis April 27, 2016 CHICAGO — At the American College of Rheumatology State-of-the-Art Clinical Symposium, Richard A. Furie, MD, compared the number of “wins” in research into treatments for systemic lupus erythematosus to a losing season for a baseball team. “But, we have had some highlights,” Furie, an investigator at The Feinstein Institute for Medical Research and chief of the Division of Rheumatology at Northwell Health, said. “I think the introduction of mycophenolate mofetil has been great. It has now become pretty much the standard of care for patients with lupus nephritis.” Furie presented a review of data that showed an improvement in response rates with mycophenolate mofetil compared with cyclophosphamide or azathioprine in studies that re-randomized patients to different treatments after showing a response to the first-line treatment. The approval of belimumab was important for patients with systemic lupus erythematosus (SLE), but Furie added resurgence in the use of hydroxychloroquine has improved survival and is effective for many SLE patients with rash or arthritis. In addition, the medication reduces lipid levels and promotes strong bones. “The dogma is now that every lupus patient should be on hydroxychloroquine,” Furie said. However, he argued, “We are not doing a good job if you look at data.” Response rates to new treatments, which include background therapy with corticosteroids, are often 50% or lower, according to Furie. “We are down in the single digits for the abatacept studies,” Furie said. “So we have major unmet needs. I think the biggest need is for lupus nephritis. For those with severe renal disease, we need better drugs. We need safer drugs. We need more efficacious drugs.” Organ damage prevention is key, he said, whether the damage is related to disease progression or side effects of the medication. The pathogenesis of SLE, according to Furie, “starts with a genetically susceptive host, and there has to be an environmental trigger.” For some patients, the environmental trigger may be the sun, according to Furie, which can cause apoptosis of skin cells, the release of RNA and DNA, and activation of toll-like receptor-9 and RNA toll-like receptor-7. “The consequence of toll-like receptor signaling is the elaboration of a variety of cytokines, chief of which is interferon-alpha,” he said. The activation of T cells is a function of the adaptive immune cells involved in SLE, and interactions between B cells and T cells may be responsible for disease activity, according to Furie, and these have been, and will continue to be, targets for treatments of SLE. Reference: Furie RA. Recent advances in SLE treatment. Presented at: American College of Rheumatology State-of-the-Art Clinical Symposium; April 9-10, 2016; Chicago. Disclosures: Furie reports relationships with Pfizer, Amgen, Anthera, Biogenldec, BMS, BoehringerIngelheim, Celgene, Dynavax, Eli Lilly, Exagen, Genetech/Roche, GlaxoSmithKline, Medimmune, Novartis, Pfizer, Mallinckrodt Pharmaceuticals, Sanofi, Takeda, UCB, Abbvie, Alnylam, Biogenldec, BMS, BoehringerIngelheim , Celgene, Chugai, Eli Lilly, Estrela (Janssen), Exagen, Genetech/Roche, GlaxoSmithKline, Medimmune, Pfizer, Onyx, Mallinckrodt Pharmaceuticals, Regeneron, Sanofi, Takeda, UCB, Lupus Foundation of America, Lupus Alliance of America, SLE Foundation, Alliance for Lupus Research and The Lupus Academy.