Author Interviews, COVID -19 Coronavirus, JAMA / 10.08.2020

MedicalResearch.com Interview with: Karina W. Davidson, PhD, MA Senior Vice President of Research, Northwell Health Director, Center for Personalized Health, Feinstein Institutes for Medical Research Dean of Academic Affairs & Professor, Feinstein Institutes for Medical Research Donald and Barbara Zucker Professor in Health Outcomes, Department of Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell MedicalResearch.com: What is the background for this study? What are the main findings? Response: New York was epicenter for COVID-19 at the height of the pandemic, and Northwell Health, the largest health system in New York, did everything in its power to care for our sick community members but also care for and protect our frontline health care providers (HCPs) and 72,000 employees. We were fortunate enough to have not run out of PPE – from masks to gowns. Through our employee health team we were able to offer free antibody screenings and through the Northwell Health Research Consortium and the Feinstein Institutes for Medical Research we looked to use the data collected from our consented employees to determine the prevalence of antibodies. We designed the study to not only identify the presence of antibodies but also key factors like demographics, in what capacity our providers worked on the frontlines and if they suspected infection. Our data helped identify the best practices Northwell Health – from PPE to care procedures - and others nationwide would need to do to keep our frontline workers safe. Key takeaways from the research show that from April 20 to June 23, of the final consented sample of health care providers (40,329), 13 percent (5,523) tested positive for antibodies. The positive sample pool included 28.4 percent (11,468) nurses and 9.3 percent (3,746) physicians. (more…)
AstraZeneca, Author Interviews, Rheumatology / 11.06.2020

MedicalResearch.com Interview with: Richard Alan Furie, MD Professor, Center for Autoimmune, Musculoskeletal and Hematopoietic Diseases Feinstein Institutes for Medical Research Chief, Division of Rheumatology, Northwell Health Professor of Medicine, Donald and Barbara Zucker School of Medicine Hofstra/Northwell MedicalResearch.com: What is the background for this study? Response: It has been known for decades that type I interferons play a role in SLE pathogenesis, and therefore the burning question has been whether inhibitors of these pro-inflammatory cytokines would reduce SLE disease activity and could be used as a therapeutic.  There are several strategies for inhibiting the type I interferon pathway, but a conventional approach is to create an antibody against the target protein. The first few clinical trials in SLE evaluated monoclonal antibodies to alpha interferon.  Results were modest at best.  Since this approach only inhibited one (alpha) of five type I interferon subtypes, there were still four subtypes unaffected that could provoke inflammation.  A rather crucial piece of information is that all five subtypes bind to the same receptor.  Therefore, if the receptor is blocked as opposed to a single cytokine, the entire type I interferon family of proteins would be prevented from binding the receptor. This was accomplished with anifrolumab. The phase 2 study in SLE (known as MUSE), which yielded very robust results, was reported several years ago.  It served as a foundation for the phase 3 program, which consisted of two pivotal studies known as TULIP-1 and TULIP-2. Both studies were reported at the 2019 American College of Rheumatology meeting in November, 2019.  Although TULIP-1 did not achieve the primary endpoint, several secondary endpoints were met.  TULIP-2 was successful.  Between all three studies, approximately 1000 patients were enrolled.  Taking advantage of these large numbers, additional analyses of the combined datasets afforded our ability to answer questions about the effects of anifrolumab that were not previously addressed with greater power. In the narrative that accompanied my presentation, I stated “In lupus, disease activity begets damage, and damage begets more damage.  The long-term sequelae of heightened disease activity, better known as flare, are significant.  Regardless of how flare is defined or measured, a major goal is to prevent flare. It is quite justified to think a drug that reduces lupus disease activity should also prevent flares. Well, the proof is in the pudding. In this analysis, we evaluated the effects of anifrolumab on flares.  Recall that anifrolumab targets the type I interferon receptor, blocking all 5 type I subtypes.  The phase 2 MUSE study yielded robust results as did the phase 3 TULIP-2 study.  While, the phase 3 TULIP-1 study did not achieve its primary endpoint, many secondary endpoints showed benefit. In this study, we focused on flare, and examined TULIP-1 and 2 individually as well as pooled data from both studies.”  (more…)
AstraZeneca, Author Interviews, Kidney Disease, Mineral Metabolism / 08.07.2019

MedicalResearch.com Interview with: Steven Fishbane MD Chief, Division of Kidney Disease and Hypertension Vice President, Northwell Health for Network Dialysis Services, Northwell Health Professor of Medicine Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York  MedicalResearch.com: What is the background for this study? Response: Patients on hemodialysis have a great frequency of hyperkalemia. The hemodialysis treatment removes some potassium but not enough to get rid of this problem. Available medications to bind potassium have not been tested among these patients. The purpose of the study was to see if sodium zirconium cyclosilicate could be used as a potassium binder to reduce the risk of hyperkalemia in patients on a hemodialysis. (more…)