Author Interviews, Eli Lilly, Gastrointestinal Disease / 03.11.2023

MedicalResearch.com Interview with: Lotus Mallbris, M.D., Ph.D., Senior Vice President of Immunology Development Eli Lilly MedicalResearch.com: Would you briefly describe the condition of Crohn's disease and who is most susceptible to this disease? Response: Crohn's disease is a form of inflammatory bowel disease (IBD) that can cause systemic inflammation manifested as abdominal pain, diarrhea, fever and weight loss. It can lead to intestinal obstruction, fibrosis and other complications. Approximately 900,000 patients in the U.S. and 1 million patients in Europe are currently suffering from Crohn’s disease, and 70% of those have moderate to severe disease. Although the majority of patients are started on conventional therapy such as corticosteroids and immunomodulators, many will unfortunately progress to having moderate to severe disease. Furthermore, current therapies to treat Crohn’s disease often fail to achieve remission for a majority of patients, and of the patients who do achieve remission, a substantial proportion lose it within the first year. (more…)
Author Interviews, Eli Lilly, Gastrointestinal Disease, NEJM / 02.11.2023

MedicalResearch.com Interview with: Marla C. Dubinsky, MD Professor of Pediatrics and Medicine Icahn School of Medicine at Mount Sinai Co- director, Susan and Leonard Feinstein IBD Clinical Center Mount Sinai Health System MedicalResearch.com: What is the background for this study? Would you briefly describe the condition of UC? Response: Lucent 1 and Lucent 2 were the induction and maintenance registration trials studying the efficacy and safety of mirikizumab in patients 18 years and older with moderate to severely active ulcerative colitis. Mirikizumab is a monoclonal antibody targeting the p19 subunit of IL23. Lucent-3 is the open label extension arm for those meeting inclusion criteria after completing Lucent 2. This study evaluated the long term efficacy and safety of mirikizumab in patients with ulcerative colitis who completed a total of 104 weeks of active mirikizumab treatment. Ulcerative colitis is a chronic incurable inflammatory condition of colon. Common symptoms include diarrhea, blood in the stool, abdominal cramping and bowel urgency. Bowel urgency is one of the most burdensome symptoms that a patient with you could experience. (more…)
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, 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…)
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…)
Author Interviews, Dermatology, Eli Lilly / 16.02.2019

MedicalResearch.com Interview with: Lotus Mallbris, MD PhD Dermatologist and Vice President, Head of Global Immunology Drug Development Platform Team Leader at Lilly MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by atopic dermatitis? How common is this condition?  Response:The BREEZE-AD1 and BREEZE-AD2 clinical trials are multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies to evaluate the efficacy and safety of baricitinib monotherapy in adult patients with moderate to severe atopic dermatitis. These are two of five studies that will be part of the placebo-controlled data program intended to support global registrations. Atopic dermatitis, a serious form of eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body. It affects approximately 1-3 percent of adults worldwide. (more…)
Author Interviews, Dermatology, Eli Lilly / 25.09.2018

MedicalResearch.com Interview with: Lotus Mallbris, M.D., Ph.D., Vice president, Immunology Development Lilly Bio-Medicines  MedicalResearch.com: What is the background for this study? What are the main findings? Response: By exploring creative clinical approaches and patient-centric pathways to more thoroughly address the key aspects of treating these complex conditions, Lilly is bringing innovation forward in hopes of reducing the burden of dermatologic disease for people around the world. The results of the IXORA-S study suggest that Taltz may provide significantly greater clearance of nail psoriasis than ustekinumab. This is significant because nail lesions are a common feature of psoriasis. It’s often associated with discomfort, which can lead to functional impairment and distress, further supporting the importance of complete clearance.   (more…)
Author Interviews, Eli Lilly, Lancet, Pharmacology, Rheumatology, UCLA / 26.07.2018

MedicalResearch.com Interview with: Daniel J. Wallace M.D., FACP, MACR Associate Director, Rheumatology Fellowship Program Board of Governors, Cedars-Sinai Medical Center Professor of Medicine, Cedars-Sinai Medical Center David Geffen School of Medicine Center at UCLA In affiliation with Attune Health Beverly Hills, Ca 90211 MedicalResearch.com: What is the background for this study? What are the main findings?   Response: This is the first positive study of systemic lupus erythematosus (SLE) using baricitinib,  a small oral molecule that blocks the JAK system. The human kinome consists of 500 genes and helps regulate cell surface receptor interaction. While agents that inhibit certain pathways are approved for rheumatoid arthritis and certain malignancies, this is the first study of its kind in SLE. (more…)
Author Interviews, Dermatology, Eli Lilly, Sexual Health / 07.03.2018

MedicalResearch.com Interview with: Dr. Jennifer Cather MD Medical Director at Modern Dermatology and Modern Research Associate Dallas, Texas  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Genital psoriasis can be an uncomfortable and burdensome condition that many people living with moderate-to-severe plaque psoriasis experience. Due to the significant impact, Lilly conducted a 12-week Phase 3b clinical trial with patients with moderate-to-severe genital psoriasis treated with ixekizumab, which found that patients had a greater decrease in the impact of their condition on sexual activity compared to placebo as early as one week. Specifically, trial patients were randomized to receive ixekizumab (80 mg every two weeks, following a 160-mg starting dose) or placebo and researchers measured pre-specified patient-reported outcomes, including the Genital Psoriasis Sexual Impact Scale (GPSIS), which is composed of the Sexual Activity Avoidance (Avoidance) and Impact of Sexual Activity on Genital Psoriasis Symptoms (Impact) subscales. Patient-reported outcomes were also measured by the Sexual Frequency Questionnaire (SFQ) item 2, evaluating the impact of genital psoriasis on the frequency of sexual activity, and the Dermatology Life Quality Index (DLQI) item 9, evaluating the impact of skin symptoms on sexual difficulties. At 12 weeks, patients reported the following outcomes:
  • DLQI Item 9 0/1: 92.0 percent of patients treated with ixekizumab compared to 56.8 percent of patients treated with placebo reported no (0) or little (1) sexual difficulties caused by skin symptoms.
  • SFQ Item 2 0/1:  78.4 percent of patients treated with ixekizumab compared to 21.4 percent of patients treated with placebo (reported the frequency of sexual activity was either never (0) or rarely (1) limited by genital psoriasis.
  • GPSIS-Avoidance 1/2:  76.7 percent of patients treated with ixekizumab compared to 25.7 percent of patients treated with placebo reported never (1) or rarely (2) avoiding sexual activity due to genital psoriasis.
  • GPSIS-Impact 1/2:  85.7 percent of patients treated with ixekizumab compared to 52.9 percent of patients treated with placebo reported worsening of genital psoriasis symptoms during or after sexual activity was very low/none at all (1) or low (2). 
(more…)
Author Interviews, Cancer Research, Eli Lilly, Lung Cancer / 20.10.2017

MedicalResearch.com Interview with: Martin Reck, MD, PhD Head of the Department of Thoracic Oncology Head of the Clinical Trial Department Department of Thoracic Oncology at the Lung Clinic Grosshansdorf  MedicalResearch.com: What is the background for this study? What are the main findings? Response: There is an urgent medical need to improve outcomes in pretreated patients with advanced non-small cell lung cancer (NSCLC), in particular those with fast progressing tumors. The Phase 3 REVEL study, which included patients with nonsquamous and squamous forms of NSCLC, demonstrated improved overall survival (OS), progression‐free survival (PFS), and objective response rate (ORR) – independent of histology. This analysis confirmed efficacy - with improvement of ORR, PFS and OS - in poor prognosis patients with fast progressing tumors (after 9, 12 or 18 weeks) without additional toxicity or impact on Quality of Life compared to the intent-to-treat (ITT) population results of REVEL. (more…)
AstraZeneca, Author Interviews, Boehringer Ingelheim, Diabetes, Eli Lilly, J&J-Janssen, Merck, Pharmacology / 18.10.2017

MedicalResearch.com Interview with: Melanie J Davies CBE MB ChB MD FRCP FRCGP Professor of Diabetes Medicine NIHR Senior Investigator Emeritus Diabetes Research Centre Leicester Diabetes Centre – Bloom University of Leicester MedicalResearch.com: What is the background for this study? What are the main findings? Response:  This was the first study to test the effectiveness of an oral GLP-1 in patients with type 2 diabetes. The main findings were that compared to both placebo and a GLP-1, Semaglutide, delivered by sub-cutaneous injection weekly, the oral therapy delivered once a day produced better results than placebo and similar results to injectable GLP-1 with regard to reductions in HbA1c and weight loss. (more…)
AstraZeneca, Author Interviews, Eli Lilly, Merck / 07.09.2017

MedicalResearch.com Interview with: Dragana Radovanovic, MD  Head of AMIS Plus Data Center Hirschengraben Zürich MedicalResearch.com: What is the background for this study? What are the main findings? Response: What we know so far? When a woman suffers a heart attack she is older, has consequently more cardiovascular risk factors such as hypertension, has more comorbidities, is less likely to receive the same therapies and more likely to die in hospital. Furthermore, we know from many hospital statistics and administrative data bases that in-hospital mortality of acute myocardial infarction patients has been on the decrease from 1970 to the early 2000’s. We then wanted to know what the situation looks like in Switzerland and therefore analyzed in-hospital mortality over the last 20 years with regard to gender, age and therapies. For this study we used the data of the nationwide AMIS Plus registry (Acute Myocardial Infarction in Switzerland) which exists since 1997 and continuously prospectively collects clinical data of patients hospitalized with acute myocardial infarction. We have found that during the last 20 years (from 1997 to the end of 2016) in-hospital mortality of patients with acute myocardial infarction in Switzerland has halved. Although in-hospital mortality was consistently higher in women, overall age-adjusted mortality has decreased more prominently in women compared to men. Especially in patients aged below 60 years a significant decrease in in-hospital mortality was observed in women but not in men. (more…)
AstraZeneca, Author Interviews, Boehringer Ingelheim, Diabetes, Eli Lilly, J&J-Janssen, Lipids, Merck / 19.06.2017

MedicalResearch.com Interview with: Lawrence Leiter, M.D. MDCM, FRCPC, FACP FACE, FAHA Chair of the ODYSSEY DM Steering Committee and Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute St. Michael’s Hospital University of Toronto, Canada MedicalResearch.com: What is the background for this study? What are the main findings? Response: The ODYSSEY DM-INSULIN trial was a randomized, double-blind, placebo-controlled, multicenter study that evaluated alirocumab (Praluent) in 517 patients with insulin treated type 1 and type 2 diabetes with high cardiovascular (CV) risk and hypercholesterolemia despite maximally tolerated dose (MTD) statins. The primary endpoint was percent change in calculated LDL-C from baseline to week 24. Alirocumab 75 mg every two weeks was added to MTD statins, with the dose increased at week 12 to 150 mg every two weeks if the LDL-C at week 8 was greater than or equal to 70 mg/dL. In fact, only about 20% of the alirocumab treated participants required the higher dose. Results of the type 2 diabetes study population (n=441) showed that the addition of alirocumab to MTD statin therapy, reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was -49 percent (p<0.0001). Treatment with alirocumab also improved the overall lipid profile. Furthermore, no new safety issues were identified. There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Additionally, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk. (more…)
AstraZeneca, Author Interviews, Autism, Boehringer Ingelheim, Depression, Eli Lilly, J&J-Janssen, JAMA, Merck, OBGYNE / 17.04.2017

MedicalResearch.com Interview with: Florence Gressier MD PhD Insermk Department of psychiatry CHU de Bicêtrem Le Kremlin Bicêtre France MedicalResearch.com: What is the background for this study? What are the main findings? Response: Results from recent studies have suggested an increased risk for Autism Spectrum Disorders (ASDs) in children exposed to antidepressants in utero. We performed a systematic review of and a meta-analysis of published studies to assess the association between ASDs and fetal exposure to antidepressants during pregnancy for each trimester of pregnancy and preconception. Our systematic review and meta-analysis suggests a significant association between increased ASD risk and maternal use of antidepressants during pregnancy; however, it appears to be more consistent during the preconception period than during each trimester. In addition, the association was weaker when controlled for past maternal mental illness. Maternal psychiatric disorders in treatment before pregnancy rather than antenatal exposure to antidepressants could have a major role in the risk for Autism Spectrum Disorders. (more…)
Author Interviews, Boehringer Ingelheim, Dermatology, Eli Lilly, Immunotherapy, J&J-Janssen, Merck / 30.03.2017

MedicalResearch.com Eric Hughes Global Development Franchise Head Immunology & Dermatology Novartis MedicalResearch.com: What is the background for this study? What are the main findings? Response: Psoriasis is a chronic immune-mediated inflammatory disease that negatively impacts patients’ quality of life (QOL); therefore QOL outcomes are increasingly recognized as an important measure of efficacy in psoriasis, complementing traditional measures of severity such as the Psoriasis Area and Severity Index (PASI). Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin-17A (IL-17A), exhibits significant efficacy in the treatment of moderate-to-severe psoriasis, ankylosing spondylitis and psoriatic arthritis, demonstrating a rapid onset of action and a favorable safety profile. Biologic therapies for psoriasis have previously been associated with a fall-off in efficacy over time; accordingly, extended follow-up is required to adequately evaluate novel therapeutic strategies like IL-17A inhibition. Recently, results from the extension of the SCULPTURE secukinumab trial showed that high responses initially achieved with secukinumab at year 1 in the SCULPTURE study were sustained over time up to 3 years with no new or unexpected safety concerns. In this analysis, we examined whether the sustained efficacy observed in SCULPTURE up to 3 years was translated into sustained effect of secukinumab on patient’s QOL measured by the Dermatology Life Quality Index (DLQI) questionnaire. SCULPTURE, a multi-center extension study, was conducted with subjects who completed 52 weeks of treatment. Subjects were randomized into two maintenance dosing regimens; a fixed-interval schedule of secukinumab 300 mg every 4 weeks (Fixed interval dosing regimen (FI) cohort), and secukinumab retreatment-as-needed (Retreatment as needed (RAN) cohort), in which subjects received placebo until start of relapse, at which time secukinumab 300 mg every 4 weeks was re-initiated. The analysis using as-observed data showed that at Year 3, improvements in the total score on DLQI was well sustained in both FI and RAN cohorts. Approximately two-thirds of the subjects in the FI cohort reported no impact of skin disease on QOL (corresponding to a score of 0 or 1 on DLQI). The proportion of patients in the RAN cohort reporting no impact of the disease on their QOL was well sustained through 3 years but remained consistently lower than those observed in the FI cohort. The results for each subscale of the DLQI questionnaire were consistent with those with DLQI total score i.e. showing high and sustained proportions of patients reporting no impact of the disease on different domains of health-related QOL in the two secukinumab cohorts with greater effect in the FI cohort compared to the RAN cohort. (more…)