Author Interviews, Gastrointestinal Disease / 17.03.2023 Interview with: Richard E. Moses, D.O., J.D. Gastroenterologist, Associate Vice President, Mirikizumab Indication Lead Global Medical Affairs, Eli Lilly and Company 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…)
Author Interviews, Gastrointestinal Disease, HIV, Inflammation / 15.12.2016 Interview with: Prof. Jamal Tazi Director, Institute for Molecular Genetics CNRS and University of Montpellier and Executive Committee Member ABIVAX What is the background for this study? Response: Its long been established that people with HIV, even those treated successfully with antiretroviral treatment, exhibit significantly higher levels of chronic inflammation than HIV-negative people. The causes of this inflammation are many – ongoing viral replication, often in the so-called viral reservoirs, leaky gut syndrome, concomitant viral infections (eg CMV, hepatitis etc). (more…)