Author Interviews, Dermatology, Eli Lilly, NEJM / 26.03.2023

MedicalResearch.com Interview with: Jonathan Silverberg, MD, PHD, MPH Professor Director of Clinical Research Director of Patch Testing George Washington University School of Medicine and Health Sciences Washington, DC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Lebrikizumab was previously shown to be safe and effective as a treatment for moderate-severe atopic dermatitis in a phase 2 study. These Phase 3 randomized placebo-controlled trials are the largest studies to date of lebrikizumab in AD. They showed that lebrikizumab was safe and highly effective for the treatment of moderate-severe atopic dermatitis. These studies will hopefully support the approval of lebrikizumab in the United States later this year. (more…)
Author Interviews, Gastrointestinal Disease / 17.03.2023

MedicalResearch.com Interview with: Richard E. Moses, D.O., J.D. Gastroenterologist, Associate Vice President, Mirikizumab Indication Lead Global Medical Affairs, Eli Lilly and Company MedicalResearch.com: What is the background for this study? Would you briefly describe how mirikizumab works in UC?  Response: First, this study specifically evaluated mirikizumab, a humanized IgG4 monoclonal antibody that selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of UC. Regulatory decisions for mirikizumab as a potential treatment for adults with moderately to severely active UC in the U.S., E.U and other countries around the world are expected in 2023. If approved, mirikizumab has the potential to be the only UC treatment that selectively targets the p19 subunit of IL-23. Gastroenterologists today benefit from having data from a range of endpoints, which can help them determine appropriate treatment options depending on their specific patients' needs and symptoms. In addition to clinical response and clinical remission – which are often used to determine the effectiveness of a treatment – we can also use combined endpoints like histologic-endoscopic mucosal improvement (which gauges remission and treatment effectiveness), histologic-endoscopic mucosal remission (the reduction of underlying inflammation visible endoscopically) and inflammatory biomarkers faecal calprotectin (fCal) and C-reactive protein (CRP) to inform our treatment strategies. This analysis focused on patients treated with mirikizumab from the induction study who received intravenous mirikizumab every 4 weeks until Week 12 (LUCENT-1), and patients who responded to mirikizumab during 12-week induction period who were re-randomized for the maintenance period, receiving subcutaneous mirikizumab every four weeks up to Week 40 (LUCENT-2) for 52 weeks of continuous treatment. This study explored the relationship between achieving histologic-endoscopic mucosal improvement (HEMI), histologic-endoscopic mucosal remission (HEMR) and improvement of biomarkers fCal and CRP levels at Weeks 12 and 52. (more…)
AACR, Author Interviews, Cancer Research, MD Anderson / 12.04.2021

MedicalResearch.com Interview with: Vivek Subbiah, MD Department of Investigational Cancer Therapeutics Division of Cancer Medicine The University of Texas MD Anderson Cancer Center MedicalResearch.com: What is the background for this study? Response: RET fusions occur predominantly in 2% of lung cancers and 10-20% of thyroid cancers, and in low frequency in an increasing number of diverse cancers, including pancreatic cancer, salivary gland cancer, and colorectal cancer. The therapeutic relevance of RET fusions occurring outside of lung and thyroid cancers has not been well established.. (more…)