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https://www.readbyqxmd.com/read/29877140/risk-factors-health-care-resource-utilization-and-costs-associated-with-nonadherence-to-antiretrovirals-in-medicaid-insured-patients-with-hiv
#1
Keith Dunn, Marie-Hélène Lafeuille, Xiaolong Jiao, Hela Romdhani, Bruno Emond, Kimberly Woodruff, Jacqueline Pesa, Neeta Tandon, Patrick Lefebvre
BACKGROUND: Adherence to antiretrovirals (ARVs) is critical to achieving durable virologic suppression. OBJECTIVE: To investigate risk factors of poor adherence and the effect of suboptimal adherence on health care resource utilization (HCRU) and costs in Medicaid patients. METHODS: A retrospective longitudinal study was conducted using Medicaid data. Adults (aged ≥ 18 years) with human immunodeficiency virus (HIV)-1 initiating selected ARVs (index date) were identified...
June 7, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29876351/industrializing-autologous-adoptive-immunotherapies-manufacturing-advances-and-challenges
#2
REVIEW
Rohin K Iyer, Paul A Bowles, Howard Kim, Aaron Dulgar-Tulloch
Cell therapy has proven to be a burgeoning field of investigation, evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. Many cell therapies have been shown to be efficacious in humans, such as modified T-cells and natural killer (NK) cells. Adoptive immunotherapy has shown the most promise in recent years, with particular emphasis on autologous cell sources. Chimeric Antigen Receptor (CAR)-based T-cell therapy targeting CD19-expressing B-cell leukemias has shown remarkable efficacy and reproducibility in numerous clinical trials...
2018: Frontiers in Medicine
https://www.readbyqxmd.com/read/29869106/dosing-patterns-and-economic-burden-of-palbociclib-drug-wastage-in-hr-her2-metastatic-breast-cancer
#3
Anand A Dalal, Patrick Gagnon-Sanschagrin, Rebecca Burne, Annie Guérin, Geneviève Gauthier, Tania Small, Polly Niravath
INTRODUCTION: Targeted therapies have revolutionized the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC). However, as for many oncology drugs, the dose of targeted therapies may need to be adjusted over time, leading to drug wastage when a dose modification is needed but the dose cannot be split or saved. This has been shown to be the case for palbociclib and has led to concerns among payers. This study described palbociclib dosing patterns and estimated the economic burden of the drug wastage associated with palbociclib dose modifications in postmenopausal women with HR+/HER2- mBC...
June 4, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29804902/ribociclib-plus-endocrine-therapy-for-premenopausal-women-with-hormone-receptor-positive-advanced-breast-cancer-monaleesa-7-a-randomised-phase-3-trial
#4
Debu Tripathy, Seock-Ah Im, Marco Colleoni, Fabio Franke, Aditya Bardia, Nadia Harbeck, Sara A Hurvitz, Louis Chow, Joohyuk Sohn, Keun Seok Lee, Saul Campos-Gomez, Rafael Villanueva Vazquez, Kyung Hae Jung, K Govind Babu, Paul Wheatley-Price, Michelino De Laurentiis, Young-Hyuck Im, Sherko Kuemmel, Nagi El-Saghir, Mei-Ching Liu, Gary Carlson, Gareth Hughes, Ivan Diaz-Padilla, Caroline Germa, Samit Hirawat, Yen-Shen Lu
BACKGROUND: In MONALEESA-2, ribociclib plus letrozole showed improved progression-free survival compared with letrozole alone as first-line treatment for postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer. MONALEESA-7 aimed to assess the efficacy and safety of ribociclib plus endocrine therapy in premenopausal women with advanced, HR-positive breast cancer. METHODS: This phase 3, randomised, double-blind, placebo-controlled trial was done at 188 centres in 30 countries...
May 24, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29799330/greater-spending-associated-with-improved-survival-for-some-cancers-in-ocm-defined-episodes
#5
James Baumgardner, Ahva Shahabi, Mark Linthicum, Seanna Vine, Christopher Zacker, Darius Lakdawalla
BACKGROUND: Previous research finds significant variation in spending and utilization across regions, with little evidence of differences in outcomes. While such findings have been interpreted as evidence that spending can be reduced without compromising patient outcomes, the link between spending variation and outcomes remains a critical question. OBJECTIVE: To use evidence from geographic variations in spending and an individual-level survival analysis to test whether spending within oncology care episodes is associated with survival, where episodes are defined as in the Center for Medicare and Medicaid Innovation's Oncology Care Model (OCM)...
June 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29799329/cost-effectiveness-of-ribociclib-plus-letrozole-versus-palbociclib-plus-letrozole-and-letrozole-monotherapy-in-the-first-line-treatment-of-postmenopausal-women-with-hr-her2-advanced-or-metastatic-breast-cancer-a-u-s-payer-perspective
#6
Rohit Mistry, Jessica R May, Gaurav Suri, Kate Young, Diana Brixner, Gary Oderda, Joseph Biskupiak, Derek Tang, Subrata Bhattacharyya, Dinesh Mishra, Devarshi Bhattacharyya, Anand A Dalal
BACKGROUND: U.S. regulatory approvals of the cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors ribociclib and palbociclib as add-ons to letrozole greatly enhance the prospects for treating postmenopausal women with hormone receptor-positive (HR+)/human epidermal receptor 2-negative (HER2-) advanced or metastatic breast cancer. Clinical trials have established that the combination of a CDK 4/6 inhibitor with letrozole can significantly improve progression-free survival (PFS) versus letrozole monotherapy and is safe and well tolerated...
June 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29799328/real-world-economic-outcomes-during-time-on-treatment-among-patients-who-initiated-sunitinib-or-pazopanib-as-first-targeted-therapy-for-advanced-renal-cell-carcinoma-a-retrospective-analysis-of-medicare-claims-data
#7
Nicholas J Vogelzang, Sumanta K Pal, Sameer R Ghate, Nanxin Li, Elyse Swallow, Miranda Peeples, Miriam L Zichlin, Mark K Meiselbach, Jose Ricardo Perez, Neeraj Agarwal
BACKGROUND: The median age at renal cell carcinoma (RCC) diagnosis is 64 years. However, few studies have assessed the real-world time on treatment (TOT), health resource utilization (HRU), costs, or treatment compliance associated with targeted therapy use among patients in this age group with RCC. OBJECTIVE: To assess the HRU, costs, and compliance during TOT among Medicare patients aged ≥ 65 years with advanced RCC (aRCC) who initiated first targeted therapy with pazopanib or sunitinib...
June 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29777521/an-early-view-of-real-world-patient-response-to-sacubitril-valsartan-a-retrospective-study-of-patients-with-heart-failure-with-reduced-ejection-fraction
#8
Dana Drzayich Antol, Adrianne Waldman Casebeer, Richard W DeClue, Stephen Stemkowski, Patricia A Russo
INTRODUCTION: Sacubitril/valsartan has been established as an effective treatment for heart failure (HF) with reduced ejection fraction based on clinical trial data; however, little is known about its use or impact in real-world practice. METHODS: This study included data from medical and pharmacy claims and medical records review for patients (n = 200) who initiated sacubitril/valsartan between August 2015 and March 2016 preceding issuance of American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) focused update on new pharmacological therapy for HF (May 2016), which included recommendations for sacubitril/valsartan...
May 17, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29769713/author-correction-discovery-of-a-selective-catalytic-p300-cbp-inhibitor-that-targets-lineage-specific-tumours
#9
Loren M Lasko, Clarissa G Jakob, Rohinton P Edalji, Wei Qiu, Debra Montgomery, Enrico L Digiammarino, T Matt Hansen, Roberto M Risi, Robin Frey, Vlasios Manaves, Bailin Shaw, Mikkel Algire, Paul Hessler, Lloyd T Lam, Tamar Uziel, Emily Faivre, Debra Ferguson, Fritz G Buchanan, Ruth L Martin, Maricel Torrent, Gary G Chiang, Kannan Karukurichi, J William Langston, Brian T Weinert, Chunaram Choudhary, Peter de Vries, Arthur F Kluge, Michael A Patane, John H Van Drie, Ce Wang, David McElligott, Edward A Kesicki, Ronen Marmorstein, Chaohong Sun, Philip A Cole, Saul H Rosenberg, Michael R Michaelides, Albert Lai, Kenneth D Bromberg
In the originally published version of this Letter, the authors Arthur F. Kluge, Michael A. Patane and Ce Wang were inadvertently omitted from the author list. Their affiliations are: I-to-D, Inc., PO Box 6177, Lincoln, Massachusetts 01773, USA (A.F.K.); Mitobridge, Inc. 1030 Massachusetts Avenue, Cambridge, Massachusetts 02139, USA (M.A.P.); and China Novartis Institutes for BioMedical Research, No. 4218 Jinke Road, Zhangjiang Hi-Tech Park, Pudong District, Shanghai 201203, China (C.W.). These authors contributed to the interpretation of results and design of compounds...
May 16, 2018: Nature
https://www.readbyqxmd.com/read/29768981/a-scalable-pipeline-for-high-throughput-flow-cytometry
#10
Aaron C Wilson, Ioannis K Moutsatsos, Gary Yu, Javier J Pineda, Yan Feng, Douglas S Auld
Flow cytometry (FC) provides high-content data for a variety of applications, including phenotypic analysis of cell surface and intracellular markers, characterization of cell supernatant or lysates, and gene expression analysis. Historically, sample preparation, acquisition, and analysis have presented as a bottleneck for running such types of assays at scale. This article will outline the solutions that have been implemented at Novartis which have allowed high-throughput FC to be successfully conducted and analyzed for a variety of cell-based assays...
May 1, 2018: SLAS Discovery
https://www.readbyqxmd.com/read/29768139/canakinumab-for-the-treatment-of-autoinflammatory-recurrent-fever-syndromes
#11
RANDOMIZED CONTROLLED TRIAL
Fabrizio De Benedetti, Marco Gattorno, Jordi Anton, Eldad Ben-Chetrit, Joost Frenkel, Hal M Hoffman, Isabelle Koné-Paut, Helen J Lachmann, Seza Ozen, Anna Simon, Andrew Zeft, Inmaculada Calvo Penades, Michel Moutschen, Pierre Quartier, Ozgur Kasapcopur, Anna Shcherbina, Michael Hofer, Philip J Hashkes, Jeroen Van der Hilst, Ryoki Hara, Segundo Bujan-Rivas, Tamas Constantin, Ahmet Gul, Avi Livneh, Paul Brogan, Marco Cattalini, Laura Obici, Karine Lheritier, Antonio Speziale, Guido Junge
BACKGROUND: Familial Mediterranean fever, mevalonate kinase deficiency (also known as the hyperimmunoglobulinemia D syndrome), and the tumor necrosis factor receptor-associated periodic syndrome (TRAPS) are monogenic autoinflammatory diseases characterized by recurrent fever flares. METHODS: We randomly assigned patients with genetically confirmed colchicine-resistant familial Mediterranean fever, mevalonate kinase deficiency, or TRAPS at the time of a flare to receive 150 mg of canakinumab subcutaneously or placebo every 4 weeks...
May 17, 2018: New England Journal of Medicine
https://www.readbyqxmd.com/read/29728611/tmem173-variants-and-potential-importance-to-human-biology-and-disease
#12
REVIEW
Seema Patel, Lei Jin
TMEM173 gene encodes the protein STING (stimulator of interferon genes), a key player in host defense against pathogens. Mutations in the human TMEM173 gene cause a life-threatening auto-inflammatory disease called SAVI (STING-associated vasculopathy with onset in infancy). Human STING is also a promising therapeutic target for cancers and infectious diseases. Recently, Aduro Biotech and Novartis announced a $250M-plus initiative to develop STING-targeting cancer immunotherapies. Thus, understanding the genetics of the human TMEM173 gene is important for both basic and translational research...
May 1, 2018: Genes and Immunity
https://www.readbyqxmd.com/read/29717691/probability-of-major-depression-diagnostic-classification-using-semi-structured-versus-fully-structured-diagnostic-interviews
#13
Brooke Levis, Andrea Benedetti, Kira E Riehm, Nazanin Saadat, Alexander W Levis, Marleine Azar, Danielle B Rice, Matthew J Chiovitti, Tatiana A Sanchez, Pim Cuijpers, Simon Gilbody, John P A Ioannidis, Lorie A Kloda, Dean McMillan, Scott B Patten, Ian Shrier, Russell J Steele, Roy C Ziegelstein, Dickens H Akena, Bruce Arroll, Liat Ayalon, Hamid R Baradaran, Murray Baron, Anna Beraldi, Charles H Bombardier, Peter Butterworth, Gregory Carter, Marcos H Chagas, Juliana C N Chan, Rushina Cholera, Neerja Chowdhary, Kerrie Clover, Yeates Conwell, Janneke M de Man-van Ginkel, Jaime Delgadillo, Jesse R Fann, Felix H Fischer, Benjamin Fischler, Daniel Fung, Bizu Gelaye, Felicity Goodyear-Smith, Catherine G Greeno, Brian J Hall, John Hambridge, Patricia A Harrison, Ulrich Hegerl, Leanne Hides, Stevan E Hobfoll, Marie Hudson, Thomas Hyphantis, Masatoshi Inagaki, Khalida Ismail, Nathalie Jetté, Mohammad E Khamseh, Kim M Kiely, Femke Lamers, Shen-Ing Liu, Manote Lotrakul, Sonia R Loureiro, Bernd Löwe, Laura Marsh, Anthony McGuire, Sherina Mohd Sidik, Tiago N Munhoz, Kumiko Muramatsu, Flávia L Osório, Vikram Patel, Brian W Pence, Philippe Persoons, Angelo Picardi, Alasdair G Rooney, Iná S Santos, Juwita Shaaban, Abbey Sidebottom, Adam Simning, Lesley Stafford, Sharon Sung, Pei Lin Lynnette Tan, Alyna Turner, Christina M van der Feltz-Cornelis, Henk C van Weert, Paul A Vöhringer, Jennifer White, Mary A Whooley, Kirsty Winkley, Mitsuhiko Yamada, Yuying Zhang, Brett D Thombs
BACKGROUND: Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.AimsTo evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics...
June 2018: British Journal of Psychiatry: the Journal of Mental Science
https://www.readbyqxmd.com/read/29715275/hedgehog-inhibition-mediates-radiation-sensitivity-in-mouse-xenograft-models-of-human-esophageal-adenocarcinoma
#14
Jennifer Teichman, Lorin Dodbiba, Henry Thai, Andrew Fleet, Trevor Morey, Lucy Liu, Madison McGregor, Dangxiao Cheng, Zhuo Chen, Gail Darling, Yonathan Brhane, Yuyao Song, Osvaldo Espin-Garcia, Wei Xu, Hala Girgis, Joerg Schwock, Helen MacKay, Robert Bristow, Laurie Ailles, Geoffrey Liu
BACKGROUND: The Hedgehog (Hh) signaling pathway is active in esophageal adenocarcinoma (EAC). We used a patient-derived murine xenograft (PDX) model of EAC to evaluate tumour response to conventional treatment with radiation/chemoradiation with or without Hh inhibition. Our goal was to determine the potential radioresistance effects of Hh signaling and radiosensitization by Hh inhibitors. METHODS: PDX models were treated with radiation, chemotherapy or combined chemoradiation...
2018: PloS One
https://www.readbyqxmd.com/read/29702733/how-often-do-safety-signals-occur-by-chance-in-first-in-human-trials
#15
Gemma L Clayton, Asher D Schachter, Baldur Magnusson, Yue Li, Laurence Colin
Clinicians working on first-in-human clinical studies need to be able to judge whether safety signals observed on an investigational drug were more likely to have occurred by chance or to have been caused by the drug. We retrospectively reviewed 84 Novartis studies including 1,234 healthy volunteers receiving placebo to determine the expected incidence of changes in commonly measured laboratory parameters and vital signs, in the absence of any active agent. We calculated the frequency of random incidence of safety signals, focusing on the liver, cardiovascular system, kidney, and pancreas...
April 27, 2018: Clinical and Translational Science
https://www.readbyqxmd.com/read/29700499/novartis-grows-its-gene-therapy-ambitions
#16
Asher Mullard
No abstract text is available yet for this article.
April 27, 2018: Nature Reviews. Drug Discovery
https://www.readbyqxmd.com/read/29696567/factors-influencing-the-prescribing-preferences-of-physicians-for-drug-naive-patients-with-type-2-diabetes-mellitus-in-the-real-world-setting-in-japan-insight-from-a-web-survey
#17
Hiroki Murayama, Kota Imai, Masato Odawara
INTRODUCTION: The Japanese guidelines for type 2 diabetes mellitus (T2DM) emphasize individualization of treatment based on patient need and encourage physicians to select an appropriate oral antidiabetes drug (OAD). However, limited evidence is available on the factors influencing the selection by physicians (diabetes specialists and nonspecialists) of the first-line OAD to treat drug-naive patients with T2DM. A survey was designed to explore the treatment factors and patient characteristics that influence physicians when they choose an initial OAD to prescribe to a drug-naive patient with T2DM in a real-world setting in Japan...
June 2018: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/29694286/primary-nonadherence-to-oral-anticoagulants-in-patients-with-atrial-fibrillation-real-world-data-from-a-population-based-cohort
#18
Clara L Rodriguez-Bernal, Salvador Peiró, Isabel Hurtado, Aníbal García-Sempere, Gabriel Sanfélix-Gimeno
BACKGROUND: Primary nonadherence (not filling a first prescription) is an important yet unstudied aspect of adherence to oral anticoagulant (OAC) therapy. OBJECTIVE: To estimate the rates of primary nonadherence to OACs and determine associated factors in real-world practice. METHODS: This population-based retrospective cohort study set in the Valencia region of Spain (about 5 million inhabitants) included all patients with atrial fibrillation who were newly prescribed OACs during 2011-2014 (N = 18,715)...
May 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29694270/higher-incidence-rates-of-comorbidities-in-patients-with-psoriatic-arthritis-compared-with-the-general-population-using-u-s-administrative-claims-data
#19
Jeffrey Kaine, Xue Song, Gilwan Kim, Peter Hur, Jacqueline B Palmer
BACKGROUND: Psoriatic arthritis (PsA) is associated with multiple comorbid conditions, including cardiovascular (CV) comorbidities that impose a considerable burden on patients. Effective management of PsA requires an understanding of comorbidity profiles. OBJECTIVE: To compare the frequency and incidence rates of comorbidities and hospitalizations among newly diagnosed PsA patients and a matched general population without PsA, using large national claims databases in the United States...
April 25, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29687336/clinical-efficacy-and-safety-of-current-interventions-for-choroidal-neovascularization-associated-with-rare-diseases-a-systematic-literature-review
#20
REVIEW
Natalie Bennett, Lokho John, Nishkarsh Likhar, Rumjhum Agrawal, Winfried M Amoaku
INTRODUCTION: The aim of this systematic literature review was to evaluate the efficacy and safety of interventions for the treatment of choroidal neovascularization (CNV) secondary to etiologies other than age-related macular degeneration and pathologic myopia. METHODS: Relevant randomized controlled trials (RCTs) and prospective observational studies were identified by searching MEDLINE, MEDLINE In-Process, EMBASE, and CENTRAL. RESULTS: The search identified 5 RCTs; no relevant observational studies were identified...
May 2018: Advances in Therapy
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