NOV-11 / Novartis - LARVOL DELTA

"Tweeting from the Bench: Twitter and the Physician-Scientist Benefits and Challenges [Nov 11, 2020] @JessicaLittleMD @romeerizwan Current Hematologic Malignancy Reports https://t.co/M1hHiSa44w PDF: https://t.co/npoH3GhrSy #socialoncology HT @DrChoueiri" (@mtmdphd)

Hematological Disorders • Hematological Malignancies • Oncology

Community transmission of rotavirus infection in a vaccinated population in Blantyre, Malawi: a prospective household cohort study. (PubMed, Lancet Infect Dis) - "Rotavirus vaccine has the potential to substantially reduce household rotavirus transmission. This finding should be considered in clinical and health economic assessments of vaccine effectiveness."

Clinical • Journal • Allergy • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease

"𝗦𝗲𝗽 𝟮𝟬𝟭𝟵 Tracing confirms ITALY SARSCoV2 antibodies were DETECTED in 111 blood samples taken between September 2019 & March 2020. pub Nov 11, 2020 https://t.co/pveTUtnXdM" (@Neferast)

Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial. (PubMed, Lancet Child Adolesc Health) - P2 | "In this cohort of self-selected South African adolescents at risk of HIV acquisition, PrEP appears safe and tolerable in those who continued use. PrEP use decreased throughout the course of the study as the number of planned study visits declined. Adolescents in southern Africa needs access to PrEP with tailored adherence support and possibly the option for more frequent and flexible visit schedules."

Clinical • Journal • P2 data • Allergy • Dermatology • Gastrointestinal Disorder • Human Immunodeficiency Virus • Immunology • Infectious Disease • Pain • Pediatrics

"COVID-19: The science of how we got here & where we are headed. @Rutherford_UCSF recorded Nov11 on @uctelevision https://t.co/jZAnUAxbjD" (@zlatev101)

Infectious Disease • Novel Coronavirus Disease

"#COVID19WI Nov 11, 2020" (@mtmdphd)

Infectious Disease • Novel Coronavirus Disease

Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study. (PubMed, Lancet Oncol) - P3 | "Surufatinib significantly improves progression-free survival and has an acceptable safety profile in patients with progressive, advanced pancreatic NETs, and could be a potential treatment option in this patient population."

Clinical • Journal • P3 data • Gastrointestinal Disorder • Hypertension • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Renal Disease • Solid Tumor

Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. (PubMed, Lancet Diabetes Endocrinol) - P3 | "Treatment with dapagliflozin resulted in UACR reduction, which might provide renoprotective benefits in individuals with type 1 diabetes and albuminuria. Dedicated prospective studies are needed to confirm these findings as prespecified endpoints."

Clinical • Journal • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Renal Disease • Type 1 Diabetes Mellitus

Performance of CT-based low skeletal muscle index, low mean muscle attenuation, and bioelectric impedance derived low phase angle in the detection of an increased risk of nutrition related mortality. (PubMed, Clin Nutr) - "Determination of phase angle < 5th percentile is a convenient non-invasive and inexpensive bedside method with high sensitivity and a high negative predictive value to detect patients at risk of nutrition related mortality with a performance comparable to CT derived skeletal muscle index or mean muscle attenuation."

Journal • Sarcopenia

"Chaired by @scottdehm @UMNCancer ! @UrologySBUR meeting Nov 11-14 - Society for Basic Urologic Research https://t.co/PBhtgRKleM" (@cancerassassin1)

Oncology • Urology

[VIRTUAL] ProBNP: A decision making tool in the ED for quick admission strategy – an audit of patient records. (EUSEM 2020) - " Between Nov 11, 2019 ­– Dec 12, 2019, 85 patients in Holbæk ED had ProBNP measured... ProBNP seems to be a valuable tool with regards to fast initial assessment of patient admittance strategy"

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure

[VIRTUAL] Prevalence of cirrhotic cardiomyopathy according to the old and new diagnostic criteria (EASL-ILC-I 2020) - "Recently published new multidisciplinary diagnostic criteria of cirrhotic cardiomyopathy(Izzy et al.Hepatology 2019 Nov 11.doi:10.1002/hep.31034) define systolic dysfunction of the left ventricle as ejection fraction(EF)≤ 50% and/or global longitudinal strain(GLS)-22%,while the diastolic dysfunction is diagnosed when three of following conditions are present: average E/e’>14, peak tricuspid regurgitation velocity>2.8 m/s, septal e34 ml/m2... Prevalence of diastolic dysfunction is significantly lower according to the new criteria, while the prevalence of systolic dysfunction was higher. Further follow-up of patients with increased contractility and GLS>-22% is needed(pathological value only in cirrhotic patients)."

Cardiomyopathy • Cardiovascular • Fibrosis • Gastroenterology • Heart Failure • Hepatology • Immunology • Liver Cirrhosis

[VIRTUAL] Factors associated with the presence of cirrhotic cardiomyopathy defined according to the new multidisciplinary diagnostic criteria (EASL-ILC-I 2020) - "Hepatology 2019 Nov 11... According to the new criteria > 60% of the cirrhotic patients were diagnosed with cirrhotic cardiomyopathy. LS assessed by Hitachi SWE and liver steatosis seems to correlate with reduced systolic contractility."

Cardiomyopathy • Cardiovascular • Fibrosis • Gastroenterology • Heart Failure • Hepatology • Immunology • Liver Cirrhosis

Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. (PubMed, Lancet Infect Dis) - P2 | "ChAd3-EBO-Z was immunogenic and well tolerated in children aged 1-17 years. This study provides the first ChAd3-EBO-Z data in a paediatric population. Further development should focus on multivalent approaches including Sudan and Marburg strains, and heterologous prime-boost strategies, for instance using modified vaccinia Ankara-based vaccine to boost the immune response."

Clinical • Journal • P2 data • Hematological Disorders • Infectious Disease • Pain • Pediatrics • Tetanus • Thrombocytopenia

[VIRTUAL] Steroid Refractory Organizing Pneumonia Due to IgG4 Related Lung Disease (ATS-I 2020) - "The patient was started on high dose prednisone, however, his respiratory status continued to deteriorate and he had several hospitalizations due to acute hypoxemic respiratory failure...This case highlights a rare etiology of steroid refractory organizing pneumonia along with successful use of Rituximab in pulmonary IgG-4 related disease...2014 Nov;11(9):1466-75. doi: 10.1513/AnnalsATS.201403-128FR."

Fibrosis • Immunology • Infectious Disease • Musculoskeletal Pain • Myositis • Oncology • Pain • Pancreatitis • Pneumonia • Respiratory Diseases

First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "Pembrolizumab can be safely combined with trastuzumab and chemotherapy and has promising activity in HER2-positive metastatic oesophagogastric cancer. A randomised phase 3 clinical trial assessing the efficacy and safety of pembrolizumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic oesophagogastric cancer is underway."

Clinical • Journal • P2 data • Esophageal Cancer • Gastric Cancer • GastroEsophageal Cancer • Gastrointestinal Cancer • Gene Therapies • Hematological Disorders • Oncology • Pain

Associations between androgens and sexual function in premenopausal women: a cross-sectional study. (PubMed, Lancet Diabetes Endocrinol) - "Associations between androgens and sexual function in premenopausal women are small, and their measurement offers no diagnostic use in this context. Further research to determine whether 11-ketoandrostenedione or 11-ketotestosterone are of clinical significance is warranted."

Clinical • Journal • Observational data • Sexual Disorders

Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial. (PubMed, Lancet Glob Health) - P=N/A | "Passive chlorination at the point of collection could be an effective and scalable strategy in low-income urban settings for reducing child diarrhoea and for achieving global progress towards Sustainable Development Goal 6.1 to attain universal access to safe and affordable drinking water. Targeting a low chlorine residual (<0·5 ppm) in treated water can increase taste acceptability of chlorinated drinking water while still reducing the risk of diarrhoea."

Clinical • Journal

Rheumatoid Arthritis (RA)-Associated Autoantibodies Are Present in the Periodontal Exudate of Patients with and without RA (ACR-ARHP 2018) - "In non-RA patients, RA-associated autoantibodies are present in GCF, and are presumably the result of local formation due to periodontitis. Local production of autoantibodies may contribute to onset of RA. ReferencesHarvey et al."

Clinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Steroid Refractory Organizing Pneumonia Due to IgG4 Related Lung Disease (ATS 2020) - "The patient was started on high dose prednisone, however, his respiratory status continued to deteriorate and he had several hospitalizations due to acute hypoxemic respiratory failure...This case highlights a rare etiology of steroid refractory organizing pneumonia along with successful use of Rituximab in pulmonary IgG-4 related disease.1Campbell SN, Rubio E, Loschner AL...2014 Nov;11(9):1466-75. doi: 10.1513/AnnalsATS.201403-128FR."

CNS Disorders • Fibrosis • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Myositis • Pain • Pancreatitis • Pneumonia • Pulmonary Disease • Respiratory Diseases

Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial. (PubMed, Lancet) - P2/3; "Reinforcement of the abdominal wall with a biological mesh at the time of stoma closure reduced clinically detectable incisional hernia within 24 months of surgery and with an acceptable safety profile. The results of this study support the use of biological mesh in stoma closure site reinforcement to reduce the early formation of incisional hernias."

Clinical • Journal

Hematopoietic stem cell transplantation using single UM171-expanded cord blood: a single-arm, phase 1-2 safety and feasibility study. (PubMed, Lancet Haematol) - P1/2; "Our preliminary findings suggest that UM171 cord blood stem cell expansion is feasible, safe, and allows for the use of small single cords without compromising engraftment. UM171-expanded cord blood might have the potential to overcome the disadvantages of other cord blood transplants while maintaining the benefits of low risk of chronic GVHD and relapse, and warrants further investigation in randomised trials."

Clinical • Journal • P1/2 data

"2/2 #ASHsm MT @VincentRK [Nov 11, 2019] https://t.co/5mGMzj1N0a ...For my picks at @ASH_hematology @ASCO etc meetings check out: #ASH17VR #ASH18VR #ASH19VR #ASCO18VR #ASCO19VR #IMW2019VR #ASH19" (@mtmdphd)

"@ExpressScripts received this letter dated Nov 11 for a ruling for Nov 1 #fda @FDA_Drug_Info" (@No2Greenhaven)

Corbus Pharmaceuticals Updates Data from Lenabasum Open-Label Extension Studies in Systemic Sclerosis and Dermatomyositis at 2019 ACR Annual Meeting (GlobeNewswire, Corbus Pharmaceuticals Holdings, Inc.) - "Corbus Pharmaceuticals Holdings, Inc....today announced continued favorable safety and efficacy outcomes in open-label extensions (OLE) of lenabasum Phase 2 studies in two rare and serious autoimmune diseases: systemic sclerosis (SSc) and dermatomyositis (DM). These data are being presented at the American College of Rheumatology ('ACR') 2019 Annual Meeting being held November 8-13, 2019 in Atlanta, Georgia....Efficacy and safety of lenabasum in SSc is currently being evaluated in the Company’s global RESOLVE-1 Phase 3 study. Enrollment is complete...The Company expects topline data in summer 2020."

Enrollment status • P2 data • P3 data • Trial status