Author Interviews, Biogen, NEJM, Rheumatology / 15.09.2022

MedicalResearch.com Interview with: Nathalie Franchimont, M.D., Ph.D. Senior Vice President, Head of Multiple Sclerosis and Immunology Head of the Multiple Sclerosis and Immunology Development Unit Biogen MedicalResearch.com: What is the background for this study? What are the main findings? Response: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that affects multiple organ systems. Rash and arthritis are among the most frequent manifestations of the disease and severe organ damage can also occur especially when organs like the kidney are affected. Litifilimab (known as BIIB059) is a monoclonal antibody being studied for the potential treatment of SLE and cutaneous lupus erythematosus (CLE). The Phase 2 LILAC study evaluated litifilimab versus placebo in two parts: Part A in participants who have SLE with active joint and skin manifestations; and Part B in participants with active CLE, including chronic and subacute subtypes, with or without other organ involvement. Results from the SLE portion of the study (Part A) show litifilimab met the study’s primary endpoint by significantly reducing total active joint count compared to placebo. Total active joint count was defined as the total number of tender or swollen joints. Litifilimab was generally well tolerated, with most reported adverse events (AEs) rated as mild or moderate. Note, this Phase 2 trial was not powered to assess secondary endpoints. Based on these positive Phase 2 results, Biogen is currently enrolling participants into the Phase 3 TOPAZ-1 and TOPAZ-2 studies, which will evaluate the efficacy and safety of litifilimab in participants with active SLE worldwide. Part B results from LILAC were published separately in NEJM on July 28, 2022 and expand the body of evidence supporting litifilimab as a potential first-in-class therapy for cutaneous lupus erythematosus in addition to SLE. (more…)
Aging, Author Interviews, Dental Research, Geriatrics, NYU / 23.01.2022

MedicalResearch.com Interview with: Bei Wu, PhD Dean's Professor in Global Health Vice Dean for Research Rory Meyers College of Nursing Affiliated Professor, College of Dentistry Co-Director, NYU Aging Incubator New York University New York, NY 10010 MedicalResearch.com:  What is the background for this study?    Response: Social isolation and loneliness are global public health concerns. Social isolation is the lack of social contacts and having few people to have regular interactions; while loneliness is the distressing feeling of being alone or separated. Approximately 24% of community-dwelling older adults aged 65 and above are considered to be socially isolated in the United States, and 43% adults aged over 60 years old report feeling lonely. Increasing evidence suggests that social isolation and loneliness are risk factors for older adults’ health outcomes, such as depression, comorbidities, cognitive impairment and dementia, and premature mortality. However, one key limitation in the literature is that only a few studies have examined the impact of social isolation and loneliness on oral health. (more…)
Author Interviews, Diabetes, NEJM, Pediatrics, Technology / 20.01.2022

MedicalResearch.com Interview with: Dr Julia Ware (née Fuchs) Clinical Research Associate Wellcome-MRC Institute of Metabolic Science-Metabolic Research Laboratories and Medical Research Council Metabolic Diseases Unit, University of Cambridge Addenbrooke’s Hospital, Cambridge MedicalResearch.com: What is the background for this study? Response: Management of type 1 diabetes is challenging in very young children, due to their high variability of insulin requirements and unpredictable eating and activity patterns. As a result, many young children do not meet the recommended glycemic targets, or only maintain recommended glycemic control with extensive caregiver input. This in turn leads to high management burden and reduced quality of life for the whole family. While the increasing use of continuous glucose-monitoring devices and insulin-pump therapy has led to reductions in the incidence of severe hypoglycaemia and diabetic ketoacidosis, and has been accompanied by modest improvements in glycemic control, the burden of management has remained high. Hybrid closed-loop systems (also called an artificial pancreas), in which an algorithm automatically adjusts insulin delivery on the basis of real-time sensor glucose levels, may address ongoing challenges in this age group. However, to date hybrid closed-loop studies involving very young children have been small and of short duration and the efficacy and safety of longer term use of a closed-loop system, as compared with standard therapy, was unclear.   To address this knowledge gap, we compared 16-week use of the Cambridge closed-loop algorithm with sensor-augmented pump therapy in children aged 1 to 7 years with type 1 diabetes in a multi-national randomised crossover study. (more…)
Author Interviews, Pediatrics / 10.01.2019

MedicalResearch.com Interview with: PHILIPPE P. HUJOEL PhD, DDS, MSD, MS Professor, Oral Health Sciences Adjunct Professor, Epidemiology Adjunct Professor, Periodontics Dental Public Health Sciences, School of Dentistry University of Washington MedicalResearch.com: What is the background for this study? Response: In 2012, an economist, Kevin Denny, identified an association between breastfeeding and handedness.  The newly published study attempted to refute this association in a larger population, and with more control for potential confounding variables. (more…)