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David A Rubin

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https://www.readbyqxmd.com/read/28197743/the-impact-of-therapeutic-antibodies-on-the-management-of-digestive-diseases-history-current-practice-and-future-directions
#1
EDITORIAL
M Anthony Sofia, David T Rubin
The development of therapeutic antibodies represents a revolutionary change in medical therapy for digestive diseases. Beginning with the initial studies that confirmed the pathogenicity of cytokines in inflammatory bowel disease, the development and application of therapeutic antibodies brought challenges and insights into their potential and optimal use. Infliximab was the first biological drug approved for use in Crohn's disease and ulcerative colitis. The lessons learned from infliximab include the importance of immunogenicity and the influence of pharmacokinetics on disease response and outcomes...
February 14, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28195944/regulatory-advocacy-update-asps-comments-in-response-to-the-fda-draft-guidance-documents-on-human-cell-and-tissue-products
#2
J Peter Rubin, Richard A D'Amico, Ricardo Rodriguez, Sydney R Coleman, Paul Cederna, Scot Glasberg, Michael Neumeister, David H Song, Charles Butler, Keith M Hume
The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).
February 9, 2017: Plastic and Reconstructive Surgery
https://www.readbyqxmd.com/read/28190787/comparison-of-hemodynamic-parameters-in-treatment-na%C3%A3-ve-and-pre-treated-patients-with-pulmonary-arterial-hypertension-in-the-randomized-phase-iii-patent-1-study
#3
Nazzareno Galiè, Friedrich Grimminger, Ekkehard Grünig, Marius M Hoeper, Marc Humbert, Zhi-Cheng Jing, Anne M Keogh, David Langleben, Lewis J Rubin, Arno Fritsch, Neil Davie, Hossein-Ardeschir Ghofrani
BACKGROUND: Detailed hemodynamic data from the phase III PATENT-1 study of riociguat in patients with pulmonary arterial hypertension (PAH) were investigated. METHODS: Patients with PAH who were treatment naïve or pre-treated with endothelin receptor antagonists or non-intravenous prostanoids were randomly assigned to riociguat up to 2.5 mg 3 times a day or placebo. Hemodynamic parameters were assessed at baseline and week 12. RESULTS: Riociguat significantly decreased pulmonary vascular resistance in treatment-naïve (n = 221; least squares [LS] mean difference -266 dyne∙sec∙cm(-5) [95% confidence interval (CI) -357 to -175; p < 0...
December 24, 2016: Journal of Heart and Lung Transplantation
https://www.readbyqxmd.com/read/28176907/a-randomized-trial-of-once-daily-fluticasone-furoate-vilanterol-or-vilanterol-versus-placebo-to-determine-effects-on-arterial-stiffness-in-copd
#4
Surya P Bhatt, Mark T Dransfield, John R Cockcroft, Jie Wang-Jairaj, Dawn A Midwinter, David B Rubin, Catherine A Scott-Wilson, Courtney Crim
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is associated with increased cardiovascular morbidity and mortality. Elevated arterial stiffness, measured by aortic pulse wave velocity (aPWV), is a cardiovascular risk surrogate and is potentially modifiable by inhaled corticosteroid/long-acting beta2-agonist combinations in patients with COPD. MATERIALS AND METHODS: The effects of once-daily inhaled fluticasone furoate/vilanterol (FF/VI) 100/25 µg, VI 25 µg, versus placebo on arterial stiffness in patients with COPD and baseline aPWV ≥11...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28145781/detection-of-adalimumab-and-antibodies-to-adalimumab-using-the-anser%C3%A2-ada-homogeneous-mobility-shift-assay
#5
David T Rubin, Snehal Naik, Venkateswarlu Kondragunta, Tharak Rao, Anjali Jain
OBJECTIVE: In 2013 a novel commercial test was launched (Anser ADA test, Prometheus Laboratories Inc.) for the assay of serum adalimumab (ADL) and antibodies-to-adalimumab (ATA). This study aims to understand clinical practice patterns used with ADL in a real-world cross-sectional population. METHODS: Wilcoxon rank sum test, and linear and logistic regression methods were applied in the statistical analysis to test hypotheses. The study design was observational and uncontrolled...
February 1, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28144619/two-complex-cases-of-hermansky-pudlak-syndrome-highlight-a-potential-biologic-explanation-for-an-associated-crohn-s-disease-phenotype
#6
M Anthony Sofia, Atsushi Sakuraba, David T Rubin
Hermansky-Pudlak syndrome (HPS) is a rare autosomal recessive disorder characterized by oculocutaneous albinism and a lack of dense granules in platelets. HPS types 1 and 4 are associated with a granulomatous enterocolitis that is phenotypically indistinguishable from Crohn's disease. We present two cases of HPS-associated Crohn's disease phenotype in which the patients were refractory to standard medical management. The pathophysiology of HPS is mediated by single-gene defects that alter endosome trafficking, and we hypothesize that this mechanism leads to the observed association with a CD phenotype...
2017: ACG Case Reports Journal
https://www.readbyqxmd.com/read/28130995/investigating-the-separate-and-interactive-associations-of-trauma-and-depression-on-neurocognition-in-urban-dwelling-adults
#7
Aimee James Karstens, Leah H Rubin, Stewart A Shankman, Olusola Ajilore, David J Libon, Anand Kumar, Melissa Lamar
BACKGROUND: Trauma and depression have each been associated with neurocognitive alterations, but their combined effect on neurocognition is unclear. We investigated the separate and interactive associations of trauma and depression on neurocognition in a sample of ethnically diverse urban dwellers, and explored the impact of age on these effects. METHODS: 284 adults aged 30-89 were divided into groups based on their current depression and trauma history. Individuals meeting DSM-IV criteria for depression were considered Depressed (D+) and individuals rated through diagnostic interview as having trauma history were considered positive for Trauma (T+)...
January 16, 2017: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/28129987/comparison-of-adjuvant-gemcitabine-and-capecitabine-with-gemcitabine-monotherapy-in-patients-with-resected-pancreatic-cancer-espac-4-a-multicentre-open-label-randomised-phase-3-trial
#8
John P Neoptolemos, Daniel H Palmer, Paula Ghaneh, Eftychia E Psarelli, Juan W Valle, Christopher M Halloran, Olusola Faluyi, Derek A O'Reilly, David Cunningham, Jonathan Wadsley, Suzanne Darby, Tim Meyer, Roopinder Gillmore, Alan Anthoney, Pehr Lind, Bengt Glimelius, Stephen Falk, Jakob R Izbicki, Gary William Middleton, Sebastian Cummins, Paul J Ross, Harpreet Wasan, Alec McDonald, Tom Crosby, Yuk Ting Ma, Kinnari Patel, David Sherriff, Rubin Soomal, David Borg, Sharmila Sothi, Pascal Hammel, Thilo Hackert, Richard Jackson, Markus W Büchler
BACKGROUND: The ESPAC-3 trial showed that adjuvant gemcitabine is the standard of care based on similar survival to and less toxicity than adjuvant 5-fluorouracil/folinic acid in patients with resected pancreatic cancer. Other clinical trials have shown better survival and tumour response with gemcitabine and capecitabine than with gemcitabine alone in advanced or metastatic pancreatic cancer. We aimed to determine the efficacy and safety of gemcitabine and capecitabine compared with gemcitabine monotherapy for resected pancreatic cancer...
January 24, 2017: Lancet
https://www.readbyqxmd.com/read/28129752/the-english-national-cohort-study-of-flooding-and-health-cross-sectional-analysis-of-mental-health-outcomes-at-year-one
#9
Thomas David Waite, Katerina Chaintarli, Charles R Beck, Angie Bone, Richard Amlôt, Sari Kovats, Mark Reacher, Ben Armstrong, Giovanni Leonardi, G James Rubin, Isabel Oliver
BACKGROUND: In winter 2013/14 there was widespread flooding in England. Previous studies have described an increased prevalence of psychological morbidity six months after flooding. Disruption to essential services may increase morbidity however there have been no studies examining whether those experiencing disruption but not directly flooded are affected. The National Study of Flooding and Health was established in order to investigate the longer-term impact of flooding and related disruptions on mental health and wellbeing...
January 28, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28122568/thermodynamic-considerations-in-renal-separation-processes
#10
Robert H Louw, David M Rubin, David Glasser, Robyn F R Letts, Diane Hildebrandt
BACKGROUND: Urine production in the kidney is generally thought to be an energy-intensive process requiring large amounts of metabolic activity to power active transport mechanisms. This study uses a thermodynamic analysis to evaluate the minimum work requirements for urine production in the human kidney and provide a new perspective on the energy costs of urine production. In this study, black-box models are used to compare the Gibbs energy inflow and outflow of the overall kidney and physiologically-based subsections in the kidney, to calculate the work of separation for urine production...
January 26, 2017: Theoretical Biology & Medical Modelling
https://www.readbyqxmd.com/read/28075132/discovery-of-imidazo-1-2-a-pyridine-ethers-and-squaramides-as-selective-and-potent-inhibitors-of-mycobacterial-adenosine-triphosphate-atp-synthesis
#11
Subramanyam J Tantry, Shankar D Markad, Vikas Shinde, Jyothi Bhat, Gayathri Balakrishnan, Amit K Gupta, Anisha Ambady, Anandkumar Raichurkar, Chaitanyakumar Kedari, Sreevalli Sharma, Naina V Mudugal, Ashwini Narayan, C N Naveen Kumar, Robert Nanduri, Sowmya Bharath, Jitendar Reddy, Vijender Panduga, K R Prabhakar, Karthikeyan Kandaswamy, Ramanatha Saralaya, Parvinder Kaur, Neela Dinesh, Supreeth Guptha, Kirsty Rich, David Murray, Helen Plant, Marian Preston, Helen Ashton, Darren Plant, Jarrod Walsh, Peter Alcock, Kathryn Naylor, Matthew Collier, James Whiteaker, Robert E McLaughlin, Meenakshi Mallya, Manoranjan Panda, Suresh Rudrapatna, Vasanthi Ramachandran, Radha Shandil, Vasan K Sambandamurthy, Khisi Mdluli, Christopher B Cooper, Harvey Rubin, Takahiro Yano, Pravin Iyer, Shridhar Narayanan, Stefan Kavanagh, Kakoli Mukherjee, V Balasubramanian, Vinayak P Hosagrahara, Suresh Solapure, Sudha Ravishankar, Shahul Hameed P
The approval of bedaquiline to treat tuberculosis has validated adenosine triphosphate (ATP) synthase as an attractive target to kill Mycobacterium tuberculosis (Mtb). Herein, we report the discovery of two diverse lead series imidazo[1,2-a]pyridine ethers (IPE) and squaramides (SQA) as inhibitors of mycobacterial ATP synthesis. Through medicinal chemistry exploration, we established a robust structure-activity relationship of these two scaffolds, resulting in nanomolar potencies in an ATP synthesis inhibition assay...
February 3, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28072481/can-contrast-enhanced-sonography-detect-bowel-wall-fibrosis-in-mixed-inflammatory-and-fibrotic-crohn-disease-lesions-in-an-animal-model
#12
Jonathan R Dillman, Jonathan M Rubin, Laura A Johnson, David S Moons, Peter D R Higgins
OBJECTIVES: To determine whether contrast-enhanced sonographic quantitative perfusion parameters can detect bowel wall fibrosis in the setting of mixed inflammatory and fibrotic lesions in a Crohn disease animal model. METHODS: This study was approved by the institutional Committee on the Use and Care of Animals. Multiple (range, 1-5) 2,4,6-trinitrobenzenesulfonic acid-ethanol enemas were used to create intestinal inflammatory lesions with variable fibrosis in female Lewis rats...
January 10, 2017: Journal of Ultrasound in Medicine: Official Journal of the American Institute of Ultrasound in Medicine
https://www.readbyqxmd.com/read/28059768/sox2-promotes-lineage-plasticity-and-antiandrogen-resistance-in-tp53-and-rb1-deficient-prostate-cancer
#13
Ping Mu, Zeda Zhang, Matteo Benelli, Wouter R Karthaus, Elizabeth Hoover, Chi-Chao Chen, John Wongvipat, Sheng-Yu Ku, Dong Gao, Zhen Cao, Neel Shah, Elizabeth J Adams, Wassim Abida, Philip A Watson, Davide Prandi, Chun-Hao Huang, Elisa de Stanchina, Scott W Lowe, Leigh Ellis, Himisha Beltran, Mark A Rubin, David W Goodrich, Francesca Demichelis, Charles L Sawyers
Some cancers evade targeted therapies through a mechanism known as lineage plasticity, whereby tumor cells acquire phenotypic characteristics of a cell lineage whose survival no longer depends on the drug target. We use in vitro and in vivo human prostate cancer models to show that these tumors can develop resistance to the antiandrogen drug enzalutamide by a phenotypic shift from androgen receptor (AR)-dependent luminal epithelial cells to AR-independent basal-like cells. This lineage plasticity is enabled by the loss of TP53 and RB1 function, is mediated by increased expression of the reprogramming transcription factor SOX2, and can be reversed by restoring TP53 and RB1 function or by inhibiting SOX2 expression...
January 6, 2017: Science
https://www.readbyqxmd.com/read/28035201/the-role-of-biosimilars-in-inflammatory-bowel-disease
#14
Sudarshan Paramsothy, Noa Krugliak Cleveland, Nada Zmeter, David T Rubin
Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formulations of conventional medications...
December 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28017585/evaluation-of-the-stromal-vascular-fraction-of-adipose-tissue%C3%A2-as-the-basis-for-a-stem-cell-based-tissue-engineered-vascular-graft
#15
Jeffrey T Krawiec, Han-Tsung Liao, LaiYee Lily Kwan, Antonio D'Amore, Justin S Weinbaum, J Peter Rubin, William R Wagner, David A Vorp
OBJECTIVE: One of the rate-limiting barriers within the field of vascular tissue engineering is the lengthy fabrication time associated with expanding appropriate cell types in culture. One particularly attractive cell type for this purpose is the adipose-derived mesenchymal stem cell (AD-MSC), which is abundant and easily harvested from liposuction procedures. Even this cell type has its drawbacks, however, including the required culture period for expansion, which could pose risks of cellular transformation or contamination...
December 22, 2016: Journal of Vascular Surgery
https://www.readbyqxmd.com/read/28011037/assessment-of-safety-and-efficacy-of-long-term-treatment-with-combination-lumacaftor-and-ivacaftor-therapy-in-patients-with-cystic-fibrosis-homozygous-for-the-f508del-cftr-mutation-progress-a-phase-3-extension-study
#16
Michael W Konstan, Edward F McKone, Richard B Moss, Gautham Marigowda, Simon Tian, David Waltz, Xiaohong Huang, Barry Lubarsky, Jaime Rubin, Stefanie J Millar, David J Pasta, Nicole Mayer-Hamblett, Christopher H Goss, Wayne Morgan, Gregory S Sawicki
BACKGROUND: The 24-week safety and efficacy of lumacaftor/ivacaftor combination therapy was shown in two randomised controlled trials (RCTs)-TRAFFIC and TRANSPORT-in patients with cystic fibrosis who were aged 12 years or older and homozygous for the F508del-CFTR mutation. We aimed to assess the long-term safety and efficacy of extended lumacaftor/ivacaftor therapy in this group of patients in PROGRESS, the long-term extension of TRAFFIC and TRANSPORT. METHODS: PROGRESS was a phase 3, parallel-group, multicentre, 96-week study of patients who completed TRAFFIC or TRANSPORT in 191 sites in 15 countries...
February 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/27997434/the-crohn-s-and-colitis-foundation-of-america-survey-of-inflammatory-bowel-disease-patient-health-care-access
#17
David T Rubin, Lauren D Feld, Sarah R Goeppinger, Joel Margolese, Joel Rosh, Michele Rubin, Sandra Kim, Dylan M Rodriquez, Laura Wingate
BACKGROUND: Despite anecdotal information about unaffordable care for patients with inflammatory bowel disease (IBD), there are no data regarding access to health care resources and expert care for patients with IBD. Our study was designed to assess IBD patients' ability to access and use care, as well as the timeliness, affordability, and financial stressors related to care. METHODS: We modified the Centers for Disease Control National Health Interview Survey for IBD...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/27990445/voriconazole-induced-periostitis-enthesopathy-in-solid-organ-transplant-patients-case-reports
#18
Monica Sircar, Camille Kotton, David Wojciechowski, Kassem Safa, Hannah Gilligan, Eliot Heher, Winfred Williams, Ravi Thadhani, Nina Tolkoff-Rubin
BACKGROUND: Voriconazole is frequently used to treat fungal infections in solid organ transplant patients. Recently, there have been reports suggesting that prolonged voriconazole therapy may lead to periostitis. AIM: Here we present two cases of voriconazole-induced periostitis in solid organ transplant patients. CASE PRESENTATION: Voriconazole was given to two transplant patients-one with a liver transplant and the second with a heart transplant, to treat their fungal infections...
November 2016: Journal of biosciences and medicines
https://www.readbyqxmd.com/read/27981566/patient-perceptions-of-care-as-influenced-by-a-large-institutional-pharmacogenomic-implementation-program
#19
Ryan P McKillip, Brittany A Borden, Paige Galecki, Sandra A Ham, Linda Patrick-Miller, Julianne P Hall, Sheena Hussain, Keith Danahey, Mark Siegler, Matthew J Sorrentino, Yasmin Sacro, Andrew M Davis, David T Rubin, Kristen Lipstreuer, Tamar S Polonsky, Rita Nanda, William R Harper, Jay L Koyner, Deborah L Burnet, Walter M Stadler, Mark J Ratain, David O Meltzer, Peter H O'Donnell
Despite growing clinical use of genomic information, patient perceptions of genomic-based care are poorly understood. We prospectively studied patient-physician pairs who participated in an institutional pharmacogenomic implementation program. Trust/Privacy/Empathy/Medical Decision-Making (MDM)/Personalized Care (PC) dimensions were assessed through patient surveys after clinic visits at which physicians had access to preemptive pharmacogenomic results (Likert scale, 1-minimum/5-maximum; mean [SD]). From 2012-2015, 1,261 surveys were issued to 507 patients, with 792 (62...
December 16, 2016: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27964837/efficacy-of-sitagliptin-for-the-hospital-management-of-general-medicine-and-surgery-patients-with-type-2-diabetes-sita-hospital-a-multicentre-prospective-open-label-non-inferiority-randomised-trial
#20
Francisco J Pasquel, Roma Gianchandani, Daniel J Rubin, Kathleen M Dungan, Isabel Anzola, Patricia C Gomez, Limin Peng, Israel Hodish, Tim Bodnar, David Wesorick, Vijay Balakrishnan, Kwame Osei, Guillermo E Umpierrez
BACKGROUND: The role of incretin-based drugs in the treatment of patients with type 2 diabetes admitted to hospital has not been extensively assessed. In this study, we compared the safety and efficacy of a dipeptidyl peptidase-4 inhibitor (sitagliptin) plus basal insulin with a basal-bolus insulin regimen for the management of patients with type 2 diabetes in general medicine and surgery in hospitals. METHODS: We did a multicentre, prospective, open-label, non-inferiority randomised clinical trial (Sita-Hospital) in five hospitals in the USA, enrolling patients aged 18-80 years with type 2 diabetes and a random blood glucose concentration of 7·8-22·2 mmol/L who were being treated with diet or oral antidiabetic drugs or had a total daily insulin dose of 0·6 units per kg or less, admitted to general medicine and surgery services...
February 2017: Lancet Diabetes & Endocrinology
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