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https://www.readbyqxmd.com/read/29669947/anti-cd19-car-t-cells-with-high-dose-melphalan-and-autologous-stem-cell-transplantation-for-refractory-multiple-myeloma
#1
Alfred L Garfall, Edward A Stadtmauer, Wei-Ting Hwang, Simon F Lacey, Jan Joseph Melenhorst, Maria Krevvata, Martin P Carroll, William H Matsui, Qiuju Wang, Madhav V Dhodapkar, Kavita Dhodapkar, Rituparna Das, Dan T Vogl, Brendan M Weiss, Adam D Cohen, Patricia A Mangan, Emily C Ayers, Selene Nunez-Cruz, Irina Kulikovskaya, Megan M Davis, Anne Lamontagne, Karen Dengel, Naseem Ds Kerr, Regina M Young, Donald L Siegel, Bruce L Levine, Michael C Milone, Marcela V Maus, Carl H June
BACKGROUND: Multiple myeloma is usually fatal due to serial relapses that become progressively refractory to therapy. CD19 is typically absent on the dominant multiple myeloma cell population but may be present on minor subsets with unique myeloma-propagating properties. To target myeloma-propagating cells, we clinically evaluated autologous T cells transduced with a chimeric antigen receptor (CAR) against CD19 (CTL019). METHODS: Subjects received CTL019 following salvage high-dose melphalan and autologous stem cell transplantation (ASCT)...
April 19, 2018: JCI Insight
https://www.readbyqxmd.com/read/29669908/progressive-multifocal-leukoencephalopathy-after-fingolimod-treatment
#2
Joseph R Berger, Bruce A Cree, Benjamin Greenberg, Bernhard Hemmer, Brian J Ward, Victor M Dong, Martin Merschhemke
OBJECTIVE: We describe the characteristics of the 15 patients with fingolimod-associated progressive multifocal leukoencephalopathy (PML) identified from the Novartis data safety base and provide risk estimates for the disorder. METHODS: The Novartis safety database was searched for PML cases with a data lock point of August 31, 2017. PML classification was based on previously published criteria. The risk and incidence were estimated using the 15 patients with confirmed PML and the overall population of patients treated with fingolimod...
April 18, 2018: Neurology
https://www.readbyqxmd.com/read/29661699/effect-of-neprilysin-inhibition-on-renal-function-in-patients-with-type-2-diabetes-and-chronic-heart-failure-who-are-receiving-target-doses-of-inhibitors-of-the-renin-angiotensin-system-a-secondary-analysis-of-the-paradigm-hf-trial
#3
Milton Packer, Brian Claggett, Martin P Lefkowitz, John J V McMurray, Jean L Rouleau, Scott D Solomon, Michael R Zile
BACKGROUND: Neprilysin inhibition has favourable effects on experimental diabetic nephropathy. We sought to assess the effects of neprilysin inhibition on the course of renal function in patients with type 2 diabetes. METHODS: In the randomised, double-blind PARADIGM-HF trial, the effects of sacubitril/valsartan (97 mg/103 mg twice daily) were compared with enalapril (10 mg twice daily) in 8399 patients with mild-to-moderate chronic heart failure and systolic dysfunction...
April 13, 2018: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29628397/enhanced-labile-plasma-iron-and-outcome-in-acute-myeloid-leukaemia-and-myelodysplastic-syndrome-after-allogeneic-haemopoietic-cell-transplantation-allive-a-prospective-multicentre-observational-trial
#4
Martin Wermke, Julia Eckoldt, Katharina S Götze, Stefan A Klein, Gesine Bug, Liesbeth C de Wreede, Michael Kramer, Friedrich Stölzel, Malte von Bonin, Johannes Schetelig, Michael Laniado, Verena Plodeck, Wolf-Karsten Hofmann, Gerhard Ehninger, Martin Bornhäuser, Dominik Wolf, Igor Theurl, Uwe Platzbecker
BACKGROUND: The effect of systemic iron overload on outcomes after allogeneic haemopoietic cell transplantation (HCT) has been a matter of substantial debate. We aimed to investigate the predictive value of both stored (MRI-derived liver iron content) and biologically active iron (enhanced labile plasma iron; eLPI) on post-transplantation outcomes in patients with acute myeloid leukaemia or myelodysplastic syndrome undergoing allogenic HCT. METHODS: The prospective, multicentre, observational, ALLogeneic Iron inVEstigators (ALLIVE) trial recruited patients at five centres in Germany...
April 5, 2018: Lancet Haematology
https://www.readbyqxmd.com/read/29623148/diclofenac-potassium-in-acute-postoperative-pain-and-dysmenorrhoea-results-from-comprehensive-clinical-trial-reports
#5
REVIEW
R Andrew Moore, Sheena Derry
We compared the efficacy of diclofenac potassium in unpublished clinical study reports (CSRs) and published reports to examine publication bias, industry bias, and comprehensiveness. Novartis provided CSRs of randomised double-blind trials of diclofenac potassium involving postoperative patients following third molar extraction (3 trials, n =519), gynaecological surgery (3 trials, n =679), and dysmenorrhoea (2 trials, n =711) conducted in 1988-1990. Searches identified published reports of 6 trials. Information from 599/1909 patients was not published; trials with 846/1909 patients were published in a defunct journal...
2018: Pain Research & Management: the Journal of the Canadian Pain Society
https://www.readbyqxmd.com/read/29605841/secukinumab-versus-adalimumab-for-psoriatic-arthritis-comparative-effectiveness-up-to-48-weeks-using-a-matching-adjusted-indirect-comparison
#6
Peter Nash, Iain B McInnes, Philip J Mease, Howard Thom, Matthias Hunger, Andreas Karabis, Kunal Gandhi, Shephard Mpofu, Steffen M Jugl
INTRODUCTION: Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations. METHODS: Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N = 299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs...
March 31, 2018: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29578852/economic-burden-of-patients-with-inadequate-response-to-targeted-immunomodulators-for-rheumatoid-arthritis
#7
Vibeke Strand, Namita Tundia, Yan Song, Dendy Macaulay, Mahesh Fuldeore
BACKGROUND: Targeted immunomodulators (TIMs), including biologic disease-modifying antirheumatic drugs (DMARDs) and JAK/STAT inhibitors, are effective therapies for rheumatoid arthritis (RA), but some patients fail to respond or lose response over time. This study estimated the real-world prevalence of RA patients with inadequate responses to an initial TIM (nonresponders) in the United States and assessed their direct and indirect economic burden compared with treatment responders. METHODS: Administrative claims data (January 1999-March 2014) from a large private-insurer database were used, which included work-loss data from a subset of reporting companies...
April 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29578848/the-additional-costs-per-month-of-progression-free-survival-and-overall-survival-an-economic-model-comparing-everolimus-with-cabozantinib-nivolumab-and-axitinib-for-second-line-treatment-of-metastatic-renal-cell-carcinoma
#8
Elyse Swallow, Andrew Messali, Sameer Ghate, Evangeline McDonald, Emilie Duchesneau, Jose Ricardo Perez
BACKGROUND: When considering optimal second-line treatments for metastatic renal cell carcinoma (mRCC), clinicians and payers seek to understand the relative clinical benefits and costs of treatment. OBJECTIVE: To use an economic model to compare the additional cost per month of overall survival (OS) and of progression-free survival (PFS) for cabozantinib, nivolumab, and axitinib with everolimus for the second-line treatment of mRCC from a third-party U.S. payer perspective...
April 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29576505/siponimod-versus-placebo-in-secondary-progressive-multiple-sclerosis-expand-a-double-blind-randomised-phase-3-study
#9
Ludwig Kappos, Amit Bar-Or, Bruce A C Cree, Robert J Fox, Gavin Giovannoni, Ralf Gold, Patrick Vermersch, Douglas L Arnold, Sophie Arnould, Tatiana Scherz, Christian Wolf, Erik Wallström, Frank Dahlke
BACKGROUND: No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor1,5 modulator, on disability progression in patients with SPMS. METHODS: This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries...
March 22, 2018: Lancet
https://www.readbyqxmd.com/read/29573941/encorafenib-plus-binimetinib-versus-vemurafenib-or-encorafenib-in-patients-with-braf-mutant-melanoma-columbus-a-multicentre-open-label-randomised-phase-3-trial
#10
Reinhard Dummer, Paolo A Ascierto, Helen J Gogas, Ana Arance, Mario Mandala, Gabriella Liszkay, Claus Garbe, Dirk Schadendorf, Ivana Krajsova, Ralf Gutzmer, Vanna Chiarion-Sileni, Caroline Dutriaux, Jan Willem B de Groot, Naoya Yamazaki, Carmen Loquai, Laure A Moutouh-de Parseval, Michael D Pickard, Victor Sandor, Caroline Robert, Keith T Flaherty
BACKGROUND: Combined BRAF-MEK inhibitor therapy is the standard of care for BRAFV600 -mutant advanced melanoma. We investigated encorafenib, a BRAF inhibitor with unique target-binding properties, alone or in combination with the MEK inhibitor binimetinib, versus vemurafenib in patients with advanced BRAFV600 -mutant melanoma. METHODS: COLUMBUS was conducted as a two-part, randomised, open-label phase 3 study at 162 hospitals in 28 countries. Eligible patients were aged 18 years or older and had histologically confirmed locally advanced (American Joint Committee on Cancer [AJCC] stage IIIB, IIIC, or IV), unresectable or metastatic cutaneous melanoma, or unknown primary melanoma; a BRAFV600E or BRAFV600K mutation; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; and were treatment naive or had progressed on or after previous first-line immunotherapy...
March 21, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29571946/nilotinib-in-locally-advanced-pigmented-villonodular-synovitis-a-multicentre-open-label-single-arm-phase-2-trial
#11
Hans Gelderblom, Claire Cropet, Christine Chevreau, Richard Boyle, Martin Tattersall, Silvia Stacchiotti, Antoine Italiano, Sophie Piperno-Neumann, Axel Le Cesne, Virginia Ferraresi, Nicolas Penel, Florence Duffaud, Philippe Cassier, Maud Toulmonde, Paolo Casali, Sophie Taieb, Séverine Guillemaut, Séverine Metzger, David Pérol, Jean-Yves Blay
BACKGROUND: Pigmented villonodular synovitis (alternatively known as diffuse-type giant cell tumour) is a rare, locally aggressive tumour driven by a specific translocation resulting in the overexpression of colony-stimulating factor 1 (CSF1). CSF1 receptor (CSF1R) inhibitors (ie, tyrosine kinase inhibitors and antibodies) induce a response in patients with pigmented villonodular synovitis. We investigated the safety and efficacy of a CSF1R tyrosine kinase inhibitor, nilotinib, in patients with locally advanced non-resectable pigmented villonodular synovitis...
March 20, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29557701/treatment-patterns-among-patients-with-psoriatic-arthritis-treated-with-a-biologic-in-the-united-states-descriptive-analyses-from-an-administrative-claims-database
#12
Jessica A Walsh, Oluwakayode Adejoro, Benjamin Chastek, Jacqueline B Palmer, Peter Hur
BACKGROUND: In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use. OBJECTIVE: To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor. METHODS: Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database...
March 20, 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29556908/economic-burden-of-hr-her2-metastatic-breast-cancer-among-adult-premenopausal-women
#13
Geneviève Gauthier, Patrick Gagnon-Sanschagrin, Annie Guérin, Rebecca Burne, Tania Small, Polly Niravath, Anand A Dalal
INTRODUCTION: Premenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) have complex treatment needs and may receive sequential combinations of endocrine therapy (ET) or chemotherapy. This study describes healthcare utilization (HRU) and costs among premenopausal women with HR+/HER2- mBC in real-world settings from a payer's perspective. METHODS: In this retrospective cohort study, premenopausal women with HR+/HER2- mBC who received ET or chemotherapy were identified from the Truven Health Analytics MarketScan database (1 January 2006-31 December 2015)...
March 20, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29534939/phase-i-trial-of-the-combination-of-docetaxel-prednisone-and-pasireotide-in-metastatic-castrate-resistant-prostate-cancer
#14
Manish K Thakur, Lance Heilbrun, Kimberlee Dobson, Julie Boerner, Karri Stark, Jing Li, Daryn Smith, Elisabeth Heath, Joseph Fontana, Ulka Vaishampayan
BACKGROUND: Pasireotide (SOM230; Novartis Inc, Basel, Switzerland) is a multitargeted somatostatin receptor analogue likely to treat the neuroendocrine, and docetaxel resistant components within metastatic castrate-resistant prostate cancer (mCRPC). This phase I trial tested the combination of pasireotide, docetaxel, and prednisone in pretreated mCRPC. PATIENTS AND METHODS: Chemotherapy naive mCRPC patients received docetaxel 75 mg/m2 intravenously every 21 days and pasireotide intramuscularly every 28 days at escalating dose levels of 40, 60, and 80 mg...
February 13, 2018: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/29524120/a-beacon-in-the-dark-canakinumab-a-new-therapeutic-perspective-in-chronic-tophaceous-gout
#15
Daniela Marotto, Antonella De Santis, Donatella Chessa, Davide Firinu, Stefano Del Giacco
Gout is the most common form of arthritis in adults. It is often associated with other comorbidities, which contraindicate the use of conventional therapies. The discovery of the role of interleukin-1β (IL-1β) in orchestrating the monosodium urate crystal-induced inflammatory response offered new therapeutic prospects to refractory patients, or to those in whom standard therapies are contraindicated. This paper describes a clinical case of a 65-year-old man with chronic tophaceous gouty arthropathy and subintrant flares, who had comorbidities contraindicating the use of conventional gout therapies-to which he did not respond-who was treated with canakinumab, a monoclonal selective inhibitor of IL-1β...
March 9, 2018: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29518252/interventions-for-autumn-exacerbations-of-asthma-in-children
#16
REVIEW
Katharine C Pike, Melika Akhbari, Dylan Kneale, Katherine M Harris
BACKGROUND: Asthma exacerbations in school-aged children peak in autumn, shortly after children return to school following the summer holiday. This might reflect a combination of risk factors, including poor treatment adherence, increased allergen and viral exposure, and altered immune tolerance. Since this peak is predictable, interventions targeting modifiable risk factors might reduce exacerbation-associated morbidity and strain upon health resources. The peak occurs in September in the Northern Hemisphere and in February in the Southern Hemisphere...
March 8, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29498517/fragment-based-drug-discovery-of-inhibitors-of-phosphopantetheine-adenylyltransferase-from-gram-negative-bacteria
#17
Robert J Moreau, Colin K Skepper, Brent A Appleton, Anke Blechschmidt, Carl J Balibar, Bret M Benton, Joseph E Drumm, Brian Y Feng, Mei Geng, Cindy Li, Mika K Lindvall, Andreas Lingel, Yipin Lu, Mulugeta Mamo, Wosenu Mergo, Valery Polyakov, Thomas M Smith, Kenneth Takeoka, Kyoko Uehara, Lisha Wang, Jun-Rong Wei, Andrew H Weiss, Lili Xie, Wenjian Xu, Qiong Zhang, Javier de Vicente
The discovery and development of new antibiotics capable of curing infections due to multidrug-resistant and pandrug-resistant Gram-negative bacteria is a major challenge with fundamental importance to our global healthcare system. Part of our broad program at Novartis to address this urgent, unmet need includes the search for new agents that inhibit novel bacterial targets. Here we report the discovery and hit-to-lead optimization of new inhibitors of phosphopantetheine adenylyltransferase (PPAT) from Gram-negative bacteria...
March 2, 2018: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/29488151/a-review-of-the-role-of-the-pharmacist-in-heart-failure-transition-of-care
#18
REVIEW
Sarah L Anderson, Joel C Marrs
This article reviews current literature on the role of pharmacists in the transition of care (TOC) for patients with heart failure (HF) and the impact of their contributions on therapeutic and economic outcomes. Optimizing the TOC for patients with HF from the hospital to the community/home is crucial for improving outcomes and decreasing high rates of hospital readmissions, which are associated with increased morbidity, mortality, and costs. A multidisciplinary team approach to the management of patients with HF facilitates the transition from the hospital to the ambulatory care setting, allowing for the consideration of medical, pharmacological, and lifestyle variables that impact the care of individual patients...
February 27, 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29477448/effect-of-lung-deflation-with-indacaterol-plus-glycopyrronium-on-ventricular-filling-in-patients-with-hyperinflation-and-copd-claim-a-double-blind-randomised-crossover-placebo-controlled-single-centre-trial
#19
Jens M Hohlfeld, Jens Vogel-Claussen, Heike Biller, Dominik Berliner, Korbinian Berschneider, Hanns-Christian Tillmann, Simone Hiltl, Johann Bauersachs, Tobias Welte
BACKGROUND: Pulmonary hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with reduced biventricular end-diastolic volumes and increased morbidity and mortality. The combination of a long-acting β agonist (LABA) and a muscarinic antagonist (LAMA) is more effective in reducing hyperinflation than LABA-inhaled corticosteroid combination therapy but whether dual bronchodilation improves cardiac function is unknown. METHODS: We did a double-blind, randomised, two-period crossover, placebo-controlled, single-centre study (CLAIM) at the Fraunhofer Institute of Toxicology and Experimental Medicine (Hannover, Germany), a specialty clinic...
February 21, 2018: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/29462761/a-guide-to-manufacturing-car-t-cell-therapies
#20
REVIEW
Philipp Vormittag, Rebecca Gunn, Sara Ghorashian, Farlan S Veraitch
In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescarta of KITE Pharma, the first CAR T cell therapy products have been approved. Promising clinical outcomes have yet been tempered by the fact that many therapies may be prohibitively expensive to manufacture. The process is not yet defined, far from being standardised and often requires extensive manual handling steps...
February 17, 2018: Current Opinion in Biotechnology
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