Author Interviews, Dermatology, Eli Lilly, Immunotherapy / 18.05.2023

MedicalResearch.com Interview with: Lotus Mallbris, MD PhD Dermatologist andSenior Vice President Global Immunology Development and Medical Affairs  Lilly   MedicalResearch.com: What is the background for this study?  Would you briefly describe what is meant by atopic dermatitis and types treated in this study? Response: First, this study specifically evaluated lebrikizumab, a novel, investigational, monoclonal antibody that selectively binds to interleukin 13 (IL-13) with high-affinity and high potency. Inflammation due to over-activation of the IL-13 pathway plays a central role in the pathogenesis of moderate-to-severe atopic dermatitis, commonly called eczema. This secondary analysis focused on patients treated with lebrikizumab from the 16-week induction periods of the ADvocate 1 and ADvocate 2 studies and the ADhere study. In the trials, we assessed the presence or absence of face or hand dermatitis in patients with moderate-to-severe atopic dermatitis. If present at baseline, at 16 weeks, clinicians assessed the change from baseline on a scale of cleared, improved, no change, or worsened. Only patients with face and hand dermatitis were evaluated as part of the analysis. (more…)
Author Interviews, Gastrointestinal Disease, Immunotherapy / 17.05.2023

MedicalResearch.com Interview with: Marla Dubinsky, M.D. Professor of Pediatrics and Medicine Co-director of the Susan and Leonard Feinstein IBD Clinical Center Chief of the Division of Pediatric Gastroenterology and Nutrition Icahn School of Medicine at Mount Sinai     MedicalResearch.com: What is the background for this study? How does MIRIKIZUMAB differ from other medications for UC? Response: This is a phase 2 study to assess the PK (pharamcokinetics), safety and efficacy of mirikizumab in pediatric ulcerative colitis (UC). Mirikizumab is a humanized monoclonal antibody that specifically binds to the p19 subunit of interleukin-23, a key inflammatory mediator in inflammatory bowel disease. (more…)
Author Interviews, Diabetes, Kidney Disease / 08.06.2022

MedicalResearch.com Interview with: prof. dr. H.J. (Hiddo) Lambers Heerspink Clinical Pharmacologist Department Clinical Pharmacy and Pharmacology University Medical Center Groningen Groningen  MedicalResearch.com:  What is the background for this study?    Response: Tirzepatide is a novel GIP-GLP1 receptor agonist recently FDA approved for the treatment of type 2 diabetes. The SURPASS_4 trial demonstrated that in patients with type 2 diabetes at high cardiovascular risk tirzepatide compared to insulin glargine markedly reduces Hba1c and body weight. About 1 out of 3 patients with type 2 diabetes and CV disease has kidney disease and these patients are at high risk of kidney failure. The aim of this study was to assess whether tirzepatide could slow CKD progression in high risk individuals with type 2 diabetes participating in the SURPASS 4 trial.  (more…)
Alzheimer's - Dementia, Author Interviews, Eli Lilly, NEJM / 16.03.2021

MedicalResearch.com Interview with: Stephen Salloway, M.D., M.S. Director of Neurology and the Memory and Aging Program, Butler Hospital Martin M. Zucker Professor of Psychiatry and Human Behavior Professor of Neurology, Alpert Medical School of Brown University Providence, RI 02906  MedicalResearch.com: What is the background for this study? Response: This 78 week phase 2 study tested donanemab in patients with early Alzheimer’s disease. Donanemab is a an anti-amyloid monoclonal antibody that targets the N3 pyroglutamate epitope.  MedicalResearch.com: What are the main findings? Response: The drug produced a substantial lowering of amyloid plaques and showed a slowing in cognitive decline. Key innovations included using PET scans to ensure all patients were amyloid positive and had a moderate level of tau build-up and switching from drug to placebo once the amyloid level was below the expected cut-off for Alzheimer’s disease. There were no new safety signals. The main side-effect was amyloid-related imaging abnormalities (ARIA) that have been seen with other anti-amyloid treatments. ARIA is managed with regular safety MRI scans.  Donanemab is now being tested in a larger phase 3 trial that could lead to regulatory approval. (more…)