Author Interviews, Autism, Genetic Research, Nature, Pediatrics / 10.12.2019

MedicalResearch.com Interview with: Dr. Stephen Scherer, PhD, FRSC Senior Scientist, Genetics & Genome Biology Director, The Centre for Applied Genomics SickKids Hospital Toronto MedicalResearch.com: What is the background for this study? Response: One of the most common questions we get from parents with a child with autism is, "what is the likelihood of having a second or third child with autism, and what is the chance others in our family will have kids with autism?". To help provide answers to these questions, we started the infant (or baby) siblings study ten years ago. Families having an older sibling with a diagnosis of autism were invited to enroll their next born for assessment and following to see if they also developed autism, and what the likelihood of that happening was. Biological samples like blood, and DNA from blood, were also collected and tested.  (more…)
Accidents & Violence, Author Interviews, ENT, JAMA / 09.12.2019

MedicalResearch.com Interview with: Roman Povolotskiy MD Candidate '20 Rutgers University New Jersey Medical School MedicalResearch.com: What is the background for this study? Response: The idea for the study came from seeing a few patients with stories of their injuries related to cellphones. Aside from the now ubiquitous texting while driving, we also had patients who were dropping cellphones on their faces while texting in bed. We wanted to see how many head and neck injuries are related to these devices that we can’t seem to take out hands or eyes off of. The main findings were that the incidence of cell phone related injuries has seen a dramatic rise in the recent decade, starting around the time that smart phones really started to take off. We also found that this problem is most prevalent in the adolescent and young adult age groups. (more…)
Author Interviews, Biomarkers, Hematology, Transplantation / 09.12.2019

MedicalResearch.com Interview with: Hrishikesh Srinagesh MD The Tisch Cancer Institute at Mount Sinai MedicalResearch.com: What is the background for this study? Response: Graft-versus-host disease (GVHD) is the leading cause of non-relapse mortality (NRM) after allogeneic hematopoietic cell transplantation (HCT). Acute GVHD occurs in approximately 50% of HCT patients and targets the skin, liver, and gastrointestinal tract primarily. The change in clinical symptoms (e.g. reduction in volume of diarrhea) is used as the primary endpoint in most trials of acute GVHD treatment, but more accurate metrics are needed to predict long-term survival. Over the past decade, the Mount Sinai Acute GVHD International Consortium (MAGIC) has studied two biomarkers important in GVHD pathogenesis: suppressor of tumorigenesis 2 (ST2) and regenerating islet-derived 3 alpha (REG3). These proteins are shed into the bloodstream when the gastrointestinal tract is damaged during GVHD, the most lethal form of acute GVHD. The concentrations of ST2 and REG3 can be used generate an individual’s estimated probability of 6 month NRM known as the MAGIC Algorithm Probability (MAP). Our study evaluated whether the MAP measured at the start of GVHD treatment and four weeks later could predict long-term survival and we compared the MAP to clinical response after four weeks, the gold standard of response.  (more…)
Author Interviews, Brigham & Women's - Harvard, Global Health, JAMA, Pediatrics, Vaccine Studies / 09.12.2019

MedicalResearch.com Interview with: Emily Parker Hyle, M.D. Assistant Professor of Medicine Massachusetts General Hospital MedicalResearch.com: What is the background for this study? Response: We found that many children who were planning to travel internationally were eligible for MMR vaccination prior to departure but often did not receive it - especially if they were aged 6 months to 6 years. That is because most children do not routinely receive their first dose of MMR till 12-15 months of age and their second dose of MMR till 4-6 years of age. However, ACIP recommendations are different for children who are traveling internationally. The risk of being infected with measles is much higher outside of the US, so it is recommended that children older than 1 year have had 2 MMR vaccinations and that children 6-12 months receive 1 MMR vaccination prior to travel. MMR vaccination is a safe and effective way to greatly reduce the risk of measles infection.  (more…)
Author Interviews, Hematology, Lymphoma / 07.12.2019

MedicalResearch.com Interview with: Constantine Tam, M.D. Hematologist and Disease Group Lead Low Grade Lymphoma and CLL at Peter MacCallum Cancer Centre Victoria, Australia, and Lead study investigator of CAPTIVATE MedicalResearch.com: What is the background for this study? Response: The Phase 2 CAPTIVATE (PCYC-1142) clinical trial evaluated 164 patients younger than 70 years (median age of 58 years) with previously untreated CLL/SLL. Patients were planned to receive ibrutinib for 3 cycles, followed by 12 cycles of ibrutinib and venetoclax in combination. Ninety percent of patients was able to complete the planned therapy. MRD status was evaluated in PB after 6, 9, and 12 cycles and in BM after 12 cycles of the combination. (more…)
Author Interviews, Cancer Research, Lymphoma / 06.12.2019

MedicalResearch.com Interview with: Dr. Matthew S. Davids MD MSC Associate Director of the Dana-Farber CLL Center Attending physician Lymphoma Program, Division of Hematologic Malignancies Dana-Farber   Dr. Jennifer Crombie MD Instructor in Medicine Harvard Medical School    MedicalResearch.com: What is the background for this study? Response: New data from our investigator-sponsored Phase 1 study exploring duvelisib in combination with venetoclax will be presented at ASH on December 7. In relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), duvelisib plus venetoclax demonstrated promising clinical activity, a manageable tolerability profile, and identified a recommended Phase 2 dosing (RP2D) regimen.  (more…)
Author Interviews, Breast Cancer, Mammograms / 06.12.2019

MedicalResearch.com Interview with: Sarah Moorman, MD Department of Radiology Michigan Medicine   MedicalResearch.com: What is the background for this study? Response: Professional societies and government agencies have variable recommendations regarding how often women should get a screening mammogram. Breast cancer screening may be recommended annually or biennially. These differing recommendations lead to confusion for both referring physicians and patients. The goal of our study was to better understand differences between annual and biennial screening. We reviewed clinical outcomes of women undergoing annual or biennial mammographic screening to determine if there is an advantage to annual screening. (more…)
Accidents & Violence, Author Interviews, Cannabis / 05.12.2019

MedicalResearch.com Interview with: Nathan J. Connealy Doctoral student John Jay College of Criminal Justice CUNY MedicalResearch.com: What is the background for this study? Response: The background, or what prompted this study, is that research on this topic is pertinent right now as more states continue down a path towards legalization. A large share of the research base and public debate centers around the potential adverse effects of marijuana accessibility, consumer-based concerns, and health specific outcomes associated with usage. This research instead focuses on a lesser explored question related to the potential for the physical dispensary locations to impact crime levels, which is also an important consideration when assessing the impact of recreational marijuana legalization. (more…)
Author Interviews, OBGYNE, Opiods / 05.12.2019

MedicalResearch.com Interview with: Dr. Rupa Radhakrishnan, MD Assistant professor of Radiology and Imaging Sciences Indiana University School of Medicine MedicalResearch.com: What is the background for this study? Response: Opioid use in pregnancy is a major public health crisis. Opioids adversely impact maternal, fetal and infant health. Infants who were exposed to opioids in the womb, can have withdrawal symptoms soon after birth, and are also at risk for poor long term neurodevelopment outcomes. Our group studied the changes in brain function in infants exposed to opioids in the womb, to understand how opioids affect the developing brain. We used resting state functional MRI to study these infants.  (more…)
Annals Internal Medicine, Author Interviews, Health Care Systems, Hepatitis - Liver Disease, UC Davis / 04.12.2019

MedicalResearch.com Interview with: Barbara J Turner MD, MSED, MA, MACP Senior Advisor, Gehr Family Center for Health Systems Science Professor of Clinical Medicine Keck School of Medicine, USC  MedicalResearch.com: What is the background for this study? Response: Chronic hepatitis C (HCV) infection affects millions of persons in the United States but especially minorities and persons from low income communities. Current national guidelines recommend testing all baby boomers (born 1945 – 65) for HCV with the aim of ultimately curing those with chronic HCV infection with a short course of highly effective medication.  However implementation of these guidelines faces many hurdles in “safety net” practices serving vulnerable populations. (more…)
Author Interviews, Infections, OBGYNE / 04.12.2019

MedicalResearch.com Interview with: Giovanni Piedimonte, MD, FAAP, FCCP Vice President for Research Institutional Official Professor of Pediatrics Tulane University MedicalResearch.com: What is the background for this study? Response: We have been testing the hypothesis that, when a pregnant woman catches a common cold with a virus called respiratory syncytial virus (RSV), viral particles can spread from the mother’s respiratory tract to the unborn child via the placenta. Preliminary data in animal models suggest that this is possible, and might cause changes in lung growth predisposing the offspring to develop asthma after birth. Recently, also human data have supported this theory. However, an essential step to conclusively demonstrate vertical transmission of respiratory viruses was the confirmation that human placentas can be infected and allow the transmission of such germs, which is the main finding of this study. (more…)
Author Interviews, Gender Differences, OBGYNE / 03.12.2019

MedicalResearch.com Interview with: Dr. Amanda N. Sferruzzi-Perri University Lecturer in Physiology Royal Society Dorothy Hodgkin Research Fellow & Lister Institute Fellow University of Cambridge MedicalResearch.com: What is the background for this study? Response: Having a pregnancy in advanced age (35 years or older) is often associated with a series of risks and complications for both the mother and her baby. These include preeclampsia (raised blood pressure in the mother during pregnancy), gestational diabetes (diabetes in the mother that develops onset in pregnancy), stillbirth and fetal growth restriction. There is also evidence from work in experimental animals that offspring from mothers who have entered pregnancy at an older age, are at heightened risk of heart problems and high blood pressure as young adults and particularly so, if they are male rather than female. We wondered whether these sex-related differences may derive from the way in which the male and female fetuses were supported within the womb, in an aged mother during pregnancy. (more…)
Author Interviews, Biomarkers, Prostate Cancer / 02.12.2019

MedicalResearch.com Interview with: Dr Jeremy Clark University of East Anglia Norwich Medical School MedicalResearch.com: What is the background for this study? Response: Earlier this year we published our pilot study which showed how useful we have found urine to be for diagnosing prostate cancer and predicting which cancers will get bigger and nastier up to 5 years later (Connell et al 2019). – Our PUR (Prostate Urine Risk) signatures separated men with low-risk cancer into two groups one of which had 8-times the rate of future development of aggressive cancer that the other. There is nothing in clinical use at present that can do this. The new development is our At-Home Urine collection system which means that we can now send out a urine collection kit to a man at home, he fills up a small pot with his first wee of the day and posts it back to us for PUR analysis. This makes the whole system so much less stressful for the patient. The idea behind it is as follows: the prostate lays just below the bladder, it is a secretory organ and these secretions carry cells and molecules from all over the prostate to the urethra which then get flushed out of the body on urination. If a cancer is present then tiny bits of the tumour are also carried with the secretions and we can detect these in the urine. As the prostate is constantly secreting the levels of biomarkers in the urethra will build up with time. Collecting from the first wee of the day means that overnight secretions can be collected which makes the analysis more sensitive and more robust. (more…)
Author Interviews, Education, JAMA, Race/Ethnic Diversity, Social Issues / 02.12.2019

MedicalResearch.com Interview with: Lynn Blewett, PhD Mayo Professor, Division of Health Policy and Management Director, State Health Access Data Assistance Center (SHADAC) University of Minnesota MedicalResearch.com: What is the background for this study? Response: We used a new set of questions about patient's perspectives of cultural competence of their providers that was added to the National Health Interview Survey and accessed through the Minnesota Population Center IPUMS Health Surveys.   MedicalResearch.com: What should readers take away from your report? Response: Most patients (97%) report being treated with respect by their providers. BUT we also found important disparities.  Black or Hispanic (vs White), uninsured (vs insured), and low income (vs >200% FPL) individuals reported being treated with respect less often, viewed a shared culture as more important, and saw providers who shared culture less often. (more…)
AHA Journals, Author Interviews, Gender Differences, Stroke / 30.11.2019

MedicalResearch.com Interview with: Cheryl Carcel MD Research Fellow, Stroke & Women's Health Program Conjoint Senior Lecturer, Faculty of Medicine, UNSW Sydney Associate Lecturer, Sydney Medical School, The University of Sydney The George Institute for Global Health | Australia MedicalResearch.com: What is the background for this study? Response: This study builds on previous findings of differences in the presentation, treatment and outcome for women and men who experience stroke. For this analysis, we pooled five large international, multicenter, randomized controlled trials that included the following: the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT-1 and -2 studies), the alteplase-dose arm of the Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED), the Head Position in Acute Stroke Trial (HeadPoST), and the Scandinavian Candesartan Acute Stroke Trial (SCAST). (more…)
Author Interviews, Depression, JAMA / 30.11.2019

MedicalResearch.com Interview with: Karina Pereira-Lima, PhD Department of Psychiatry, University of Michigan Medical School, Ann Arbor Department of Psychiatry, Federal University of São Paulo, São Paulo, Brazil MedicalResearch.com: What is the background for this study? Response: Questions regarding the magnitude and direction of the associations between physician depressive symptoms and medical errors remain open in recent literature. By pooling data from 11 studies involving 21,517 physicians, we were able to verify that depressive symptoms among physicians were associated with increased risk of reporting medical errors (RR, 1.95; 95% CI, 1.63 – 2.33). (more…)
Author Interviews, Education, ENT, Hearing Loss, JAMA, Pediatrics / 30.11.2019

MedicalResearch.com Interview with: Dr. Carlijn M. P. le Clercq, MD Speech and Language Pathology, Pediatrics, Otolaryngology Erasmus MC, Rotterdam MedicalResearch.com: What is the background for this study? Response: Recently, more reports have been publishes about the prevalence of slight to mild hearing loss among children in the general population. These studies showed that slight hearing loss is common, also within our population-based cohort in the Netherlands. Slight hearing loss is often scored as “not relevant”. We wanted to examine if we could find associations of hearing thresholds in children with performance scores in everyday life. (more…)
Aging, Author Interviews, JAMA, Opiods / 27.11.2019

MedicalResearch.com Interview with: Yong-Fang Kuo, PhD Professor and Director, Office of Biostatistics Don W. and Frances Powell Professor in Aging Research Mukaila Raji, MD, MS, FACP Professor & Director Edgar Gnitzinger Distinguished Professorship in Aging Preventive Medicine and Population Health UTMB Health MedicalResearch.com: What is the background for this study? Response: Medicare beneficiaries who qualified because of disability constitute a growing population of patients hospitalized for opioid/heroin overdose. Although the CDC regularly generates reports of opioid overdose deaths by demographics and states, studies on policy actionable predictors of overdose mortality (e.g., clusters of medical and psychiatric conditions, types of disabling conditions) are lacking in this population.  (more…)
Author Interviews, JAMA, Opiods / 27.11.2019

MedicalResearch.com Interview with: Steven H. Woolf, MD, MPH Director Emeritus and Senior Advisor, Center on Society and Health Professor, Department of Family Medicine and Population Health C. Kenneth and Dianne Wright Distinguished Chair in Population Health and Health Equity Virginia Commonwealth University School of Medicine Richmond, Virginia 23298-0212 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Life expectancy in the US has decreased for three years in a row, the first time this has occurred in this country since the Spanish flu epidemic a century ago. Meanwhile, life expectancy in other countries continues to climb. Our study found that the trend is being driven by an increase in death rates among working-age adults (ages 25-64 years), which began as early as the 1990s. The increase has involved deaths from drug overdoses—a major contributor—but also from alcoholism, suicides, and a long list of organ diseases. We found increases in 35 causes of death. We analyzed the trends across the 50 states and discovered that the trend is concentrated in certain regions, especially the Industrial Midwest (Rust Belt) and Appalachia, whereas other regions like the Pacific states were least affected. Increases in midlife mortality in four Ohio Valley states (Ohio, Pennsylvania, Indiana and Kentucky) accounted for one third of the excess deaths between 2010 and 2017. (more…)
Author Interviews, JAMA / 27.11.2019

MedicalResearch.com Interview with: James S. Goodwin, M.D. George and Cynthia Mitchell Distinguished Chair in Geriatric Medicine University of Texas Medical Branch Galveston, TX  77555-0177James S. Goodwin, M.D. George and Cynthia Mitchell Distinguished Chair in Geriatric Medicine University of Texas Medical Branch Galveston, TX  77555-0177 MedicalResearch.com: What is the background for this study? Response: Full time hospital doctors, called hospitalists, now provide the medical care for most patients hospitalized in the US. Depending on the hospital and also the hospitalist group, the working schedules of hospitalists can have vary greatly. For example, some might work 8 AM to 5PM for seven days followed by seven days off. Others might work 24 hours on and 72 hours off. Depending on the schedule of the hospitalists proving care, a patient  might have one or two or three or more different doctors proving care during their stay. Some patients see a new doctor each day. Our goal was to see if patients who received care from hospitalists who tended to work several days in a row did better than those who were cared for many different hospitalists with intermittent schedules. (more…)
Author Interviews, JAMA, Neurology, Ophthalmology, Pain Research / 27.11.2019

MedicalResearch.com Interview with: Priv.-Doz. Dr. med. Christoph Schankin Consultant Head University Headache Clinic Department of Neurology Inselspital, Bern University Hospital University of Bern MedicalResearch.com: What is the background for this study? Response: Visual snow syndrome is a debilitating disorder with a continuous TV snow-like visual disturbance that persists over years. Patients have additional visual problems, such as severe afterimages, floaters or photophobia. The syndrome is associated with migraine and migraine aura, but the interaction between the two remains unclear. (more…)
Abbvie, Author Interviews, Rheumatology / 27.11.2019

MedicalResearch.com Interview with: Aileen Lorenzo Pangan MD Executive Medical Director AbbVie MedicalResearch.com: What is the background for this study? Response: Our ongoing commitment to advancing the standard of care for patients with rheumatic diseases is illustrated by our growing portfolio and the thirty-eight abstracts we presented at this year's ACR/ARP Annual Meeting, including results from five studies of RINVOQ in rheumatoid arthritis (RA) and primary results from our study in ankylosing spondylitis (AS). (more…)
Aging, Dermatology, JAMA / 26.11.2019

MedicalResearch.com Interview with: Christian Sell, PhD Associate Professor of Biochemistry and Molecular Biology Drexel University College of Medicine MedicalResearch.com: What is the background for this study? Response: In terms of background, the drug rapamycin targets a pathway that scientists know is critical for growth and development but is also a key regulator of lifespan in many model organisms such as worms, flies, and mice. This pathway is known as the mTOR pathway. Rapamycin is already in use clinically, it is given to people who have received organ transplants to prevent rejection and is also in trials to treat some forms of cancer, at very high doses. Many studies in mice have shown that rapamycin delays aging and prevents age-related disorders such as the decline in heart function and cognitive function. Based on this work, there is a strong expectation that these results will translate into humans, but no studies have been done due to concerns regarding potential side effects of rapamycin when the drug is given orally to prevent rejection. Our previous studies have shown that a very low dose of rapamcyin can reduce the aging of human cells and improve cell growth, while the high does used for organ transplant patients actually block cell growth.  We decided to test the impact of low dose rapamycin on aging in the skin because we could treat people safely. Previous studies have shown that the drug does not get into the blood stream when high doses were given topically to people with a rare genetic disorder, so we knew that the low doses used in our study would not get into the bloodstream and would be safe for the patients. (more…)
Author Interviews, Blood Pressure - Hypertension, JAMA / 26.11.2019

MedicalResearch.com Interview with: Brian S. Alper, MD, MSPH, FAAFP, FAMIA Board Certifications: Family Medicine, Clinical Informatics Founder of DynaMed Vice President of Innovations and Evidence-Based Medicine Development EBSCO Health  MedicalResearch.com: What is the background for this study? Response: We often use clinical practice guidelines as a “source of truth” for decision support for healthcare professionals and even as a standard of care for medical legal considerations.  However our experience evaluating guidelines for clinical reference support finds they are often inconsistent.  We picked one of the most common conditions managed in healthcare (ie hypertension, or high blood pressure) and sought out the top clinical practice guidelines that guide care around the world.   We systematically evaluated these guidelines against 70 specific recommendations to see how often the guidelines agreed or disagreed. (more…)
Author Interviews, Cancer Research, Genetic Research, Pharmaceutical Companies / 26.11.2019

MedicalResearch.com Interview with: Ambry GeneticsRachid Karam, MD PhD Director, Ambry Translational Genomics Lab Ambry Genetics MedicalResearch.com: What is the background for this study? Response: Standard DNA testing for hereditary cancer risk excludes large portions of DNA, thereby missing some mutations. In addition, DNA testing can produce inconclusive results and fail to determine that an error in our DNA increases cancer risk. These limitations impact patients and their families because doctors may not have the information needed to recommend appropriate preventive, early detection, or therapeutic steps. Additionally, relatives may not be referred for genetic testing and obtain the care they would otherwise have gotten if they had learned they had mutations. The study looked at how the addition of RNA genetic testing to standard DNA testing for hereditary cancer risk was able to increase diagnostic yield. The study looked at the first 2,500 patients that received Ambry Genetics +RNAinsight™, paired RNA and DNA genetic testing for hereditary cancer risk. The data from this study showed that the addition of RNA genetic testing to DNA testing (1) identified new mutations that would have been missed with DNA testing alone, and (2) clarified inconclusive results as disease-causing. (more…)
Author Interviews, JAMA, Osteoporosis / 26.11.2019

MedicalResearch.com Interview with: Pamela L. Lutsey, PhD Associate Professor Division of Epidemiology and Community Health University of Minnesota School of Public Health Minneapolis MedicalResearch.com: What is the background for this study? Response: Warfarin is prescribed to atrial fibrillation (AF) patients for the prevention of cardioembolic complications. However, whether it adversely impacts bone health is controversial. With the availability of alternate direct oral anticoagulant (DOAC) options, it is now possible to evaluate the comparative safety of warfarin in relation to fracture risk. (more…)
Author Interviews, Brigham & Women's - Harvard, Colon Cancer, JAMA, Omega-3 Fatty Acids / 26.11.2019

MedicalResearch.com Interview with: MINGYANG SONG, MD, ScD Assistant Professor, Epidemiology Harvard T.H. Chan School Of Public Health Assistant Professor of Medicine Clinical and Translational Epidemiology Unit Massachusetts General Hospital MedicalResearch.com: What is the background for this study? Response: Increasing data indicate that high intake of omega-3 fatty acid may reduce the risk of colorectal cancer. Since effects of nutritional factors on risk of cancer, a slow-developing disease, typically emerge only after several years, it is useful to study the effect of preventive agents on cancer precursors such as colorectal polyps. Colorectal polyps are small growths on the lining of the colon or rectum. Most polyps are harmless, but some can become cancerous. (more…)
Author Interviews, Brigham & Women's - Harvard, Cannabis, JAMA, Pediatrics / 26.11.2019

MedicalResearch.com Interview with: Bertha K. Madras PhD Director, Laboratory of Addiction Neurobiology Psychobiologist, Substance Use Disorders Division, Basic Neuroscience Division Professor of Psychobiology, Department of Psychiatry Harvard Medical School MedicalResearch.com: What is the background for this study? Parent use of marijuana is rising, and I wondered whether this could be associated with offspring use of specific substances and across several substances
  • Several fathers have confided in me that they used marijuana to bond with their sons. They became horrified after witnessing their sons progress to using other drugs, especially heroin.
  • In general, living with a parent using substances or having substance use disorders is an explicit risk for use of substances among young offspring. Yet, few studies have directly examined whether parental marijuana use elevates the risk for opioid misuse among adolescent and young adults living with parents.  Most importantly and to the best of our knowledge, none of the existing research  simultaneously explored frequency of  parental marijuana use and whether it related to adolescent and young adult offspring’s marijuana, tobacco, alcohol use, and opioid misuse.
(more…)
Author Interviews, Ophthalmology, Thyroid Disease / 26.11.2019

MedicalResearch.com Interview with: Raymond S. Douglas, MD, PhD Ophthalmology Cedars-Sinai, Los Angeles MedicalResearch.com: What is the background for this study? Response: The data presented at the American College of Rheumatology (ACR) annual meeting on November 11, 2019 are integrated, pooled efficacy data from the Phase 2 and Phase 3 clinical trials of teprotumumab for the treatment of active thyroid eye disease (TED) compared to placebo. The results support prior analyses of significant reductions in inflammation, proptosis (eye bulging) and diplopia (double vision), as well as improvements in quality of life (QoL). This presentation of the pooled analyses builds on the individual positive results of the Phase 2 and Phase 3 clinical studies.  (more…)
Author Interviews, Rheumatology / 22.11.2019

MedicalResearch.com Interview with: Professor Jianmin Fang, Ph.D. Founder, CEO & CSO RemeGen MedicalResearch.com: What is the background for this study? Response: Systemic lupus erythematosus (SLE), known more commonly as lupus, is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissue. SLE can affect tissues like the skin, joints, kidneys, brain and other organs, resulting in a wide variety of signs and symptoms. With limited treatment options for lupus and the significant unmet medical needs in the treatment of autoimmune diseases, the Phase 2b study evaluated the efficacy and safety of subcutaneous RC18 (telitacicept), a potential new medicine for the treatment of systemic lupus erythematosus (SLE) versus a placebo in combination with standard therapy in patients with SLE at 48 weeks. (more…)