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https://www.readbyqxmd.com/read/29339097/safety-and-preliminary-efficacy-of-venetoclax-with-decitabine-or-azacitidine-in-elderly-patients-with-previously-untreated-acute-myeloid-leukaemia-a-non-randomised-open-label-phase-1b-study
#1
Courtney D DiNardo, Keith W Pratz, Anthony Letai, Brian A Jonas, Andrew H Wei, Michael Thirman, Martha Arellano, Mark G Frattini, Hagop Kantarjian, Relja Popovic, Brenda Chyla, Tu Xu, Martin Dunbar, Suresh K Agarwal, Rod Humerickhouse, Mack Mabry, Jalaja Potluri, Marina Konopleva, Daniel A Pollyea
BACKGROUND: Elderly patients (aged ≥65 years) with acute myeloid leukaemia have poor outcomes and no effective standard-of-care therapy exists. Treatment with hypomethylating agents such as azacitidine and decitabine is common, but responses are modest and typically short-lived. The oral anti-apoptotic B-cell lymphoma 2 protein inhibitor, venetoclax, has shown promising single-agent activity in patients with relapsed or refractory acute myeloid leukaemia and preclinical data suggested synergy between hypomethylating agents and venetoclax, which led to this combination phase 1b study...
January 12, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29246803/venetoclax-for-chronic-lymphocytic-leukaemia-progressing-after-ibrutinib-an-interim-analysis-of-a-multicentre-open-label-phase-2-trial
#2
Jeffrey A Jones, Anthony R Mato, William G Wierda, Matthew S Davids, Michael Choi, Bruce D Cheson, Richard R Furman, Nicole Lamanna, Paul M Barr, Lang Zhou, Brenda Chyla, Ahmed Hamed Salem, Maria Verdugo, Rod A Humerickhouse, Jalaja Potluri, Steven Coutre, Jennifer Woyach, John C Byrd
BACKGROUND: Therapy targeting Bruton's tyrosine kinase (BTK) with ibrutinib has transformed the treatment of chronic lymphocytic leukaemia. However, patients who are refractory to or relapse after ibrutinib therapy have poor outcomes. Venetoclax is a selective, orally bioavailable inhibitor of BCL-2 active in previously treated patients with relapsed or refractory chronic lymphocytic leukaemia. In this study, we assessed the activity and safety of venetoclax in patients with chronic lymphocytic leukaemia who are refractory to or relapse during or after ibrutinib therapy...
December 12, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29222670/venetoclax-for-treating-chronic-lymphocytic-leukaemia-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#3
REVIEW
Hema Mistry, Chidozie Nduka, Martin Connock, Jill Colquitt, Theodoros Mantopoulos, Emma Loveman, Renata Walewska, James Mason
Venetoclax is licensed to treat relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL). As part of the Single Technology Appraisal (STA) ID944, the National Institute for Health and Care Excellence (NICE) invited AbbVie, the manufacturer, to submit evidence on the use of venetoclax, within its licensed indication. The Evidence Review Group (ERG), Warwick Evidence, was asked to provide an independent and critical review of the submitted evidence. Evidence came from three single-arm trials in CLL patients with or without 17p deletion [del(17p])/TP53 chromosomal abnormalities...
December 8, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29204858/a-retrospective-analysis-of-corticosteroid-utilization-before-initiation-of-biologic-dmards-among-patients-with-rheumatoid-arthritis-in-the-united-states
#4
Christina A Spivey, Jenny Griffith, Cameron Kaplan, Arnold Postlethwaite, Arijit Ganguli, Junling Wang
INTRODUCTION: Understanding the effects of corticosteroid utilization prior to initiation of biologic disease-modifying antirheumatic drugs (DMARDs) can inform decision-makers on the appropriate use of these medications. This study examined treatment patterns and associated burden of corticosteroid utilization before initiation of biologic DMARDs among rheumatoid arthritis (RA) patients. METHODS: A retrospective analysis was conducted of adult RA patients in the US MarketScan Database (2011-2015)...
December 4, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29183563/a-systematic-review-and-economic-evaluation-of-adalimumab-and-dexamethasone-for-treating-non-infectious-intermediate-uveitis-posterior-uveitis-or-panuveitis-in-adults
#5
Hazel Squires, Edith Poku, Inigo Bermejo, Katy Cooper, John Stevens, Jean Hamilton, Ruth Wong, Alastair Denniston, Ian Pearce, Fahd Quhill
BACKGROUND: Non-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic corticosteroids, immunosuppressants and biological drugs. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of subcutaneous adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) and a dexamethasone intravitreal implant (Ozurdex®; Allergan Ltd, Marlow, UK) in adults with non-infectious intermediate uveitis, posterior uveitis or panuveitis...
November 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29181488/preclinical-and-clinical-development-of-abbv-8e12-a-humanized-anti-tau-antibody-for-treatment-of-alzheimer-s-disease-and-other-tauopathies
#6
T West, Y Hu, P B Verghese, R J Bateman, J B Braunstein, I Fogelman, K Budur, H Florian, N Mendonca, D M Holtzman
Tau neurofibrillary tangles are found in the brains of patients suffering from Alzheimer's disease and other tauopathies. The progressive spreading of tau pathology from one brain region to the next is believed to be caused by extracellular transsynaptic transmission of misfolded tau between neurons. Preclinical studies have shown that antibodies against tau can prevent this transfer of misfolded tau between cells. Thus, antibodies against tau have the potential to stop or slow the progression of tau pathology observed in human tauopathies...
2017: Journal of Prevention of Alzheimer's Disease
https://www.readbyqxmd.com/read/29150912/sustaining-an-efficient-and-effective-cho-cell-line-development-platform-by-incorporation-of-24-deep-well-plate-screening-and-multivariate-analysis
#7
Alessandro Mora, Sheng Sam Zhang, Gerald Carson, Bernard Nabiswa, Patrick Hossler, Seongkyu Yoon
Efficient and effective cell line screening is paramount toward a successful biomanufacturing program. Here we describe the implementation of 24-deep well plate (24-DWP) screening of CHO lines as part of the cell line development platform at AbbVie. Incorporation of this approach accelerated the identification of the best candidate lines for process development. In an effort to quantify and predict process performance comparability, we compared cell culture performance in and in shake flasks, for a panel of Chinese Hamster Ovary cell lines expressing a monoclonal antibody...
November 18, 2017: Biotechnology Progress
https://www.readbyqxmd.com/read/29105621/adalimumab-etanercept-and-ustekinumab-for-treating-plaque-psoriasis-in-children-and-young-people-systematic-review-and-economic-evaluation
#8
Ana Duarte, Teumzghi Mebrahtu, Pedro Saramago Goncalves, Melissa Harden, Ruth Murphy, Stephen Palmer, Nerys Woolacott, Mark Rodgers, Claire Rothery
BACKGROUND: Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA®, AbbVie, Maidenhead, UK), etanercept (Enbrel®, Pfizer, New York, NY, USA) and ustekinumab (STELARA®, Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people...
November 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29104158/moderate-salt-restriction-with-or-without-paricalcitol-in-type-2-diabetes-and-losartan-resistant-macroalbuminuria-proceed-a-randomised-double-blind-placebo-controlled-crossover-trial
#9
Aneliya Parvanova, Matias Trillini, Manuel A Podestà, Ilian Petrov Iliev, Barbara Ruggiero, Manuela Abbate, Annalisa Perna, Francesco Peraro, Olimpia Diadei, Nadia Rubis, Flavio Gaspari, Fabiola Carrara, Nadia Stucchi, Antonio Belviso, Antonio C Bossi, Roberto Trevisan, Giuseppe Remuzzi, Martin de Borst, Piero Ruggenenti
BACKGROUND: Macroalbuminuria predicts renal and cardiovascular events in patients with type 2 diabetes. We aimed to assess the albuminuria-lowering effects of salt restriction, paricalcitol therapy, or both, in this population. METHODS: In this randomised, double-blind, placebo-controlled, crossover trial, we recruited adult patients with type 2 diabetes from six diabetology outpatient clinics in northern Italy, with 24 h albuminuria of more than 300 mg despite 100 mg per day losartan therapy, blood pressure of less than 140/90 mm Hg, serum creatinine concentration of less than 2 mg/dL, stable renal function on stable renin-angiotensin system inhibitor therapy with a fixed dose of losartan, parathyroid hormone concentration of 20 pg/mL to <110 pg/mL, serum calcium concentration of less than 9·5 mg/dL, and serum phosphate concentration of less than 5 mg/dL, who had been more than 80% compliant with placebo treatment during a 1 month placebo run-in...
November 2, 2017: Lancet Diabetes & Endocrinology
https://www.readbyqxmd.com/read/29101714/changes-in-healthcare-spending-after-diagnosis-of-comorbidities-among-endometriosis-patients-a-difference-in-differences-analysis
#10
Andrew J Epstein, Ahmed M Soliman, Matthew Davis, Scott J Johnson, Michael C Snabes, Eric S Surrey
INTRODUCTION: We sought to characterize changes in healthcare spending associated with the onset of 22 endometriosis-related comorbidities. METHODS: Women aged 18-49 years with endometriosis (N = 180,278) were extracted from 2006-2015 de-identified Clinformatics(®) DataMart claims data. For 22 comorbidities, comorbidity patients were identified on the basis of having a first comorbidity diagnosis after their initial endometriosis diagnosis. Controls were identified on the basis of having no comorbidity diagnosis and were matched 1:1 to comorbidity patients on demographics and baseline spending...
November 3, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29096949/effect-of-tight-control-management-on-crohn-s-disease-calm-a-multicentre-randomised-controlled-phase-3-trial
#11
Jean-Frederic Colombel, Remo Panaccione, Peter Bossuyt, Milan Lukas, Filip Baert, Tomas Vaňásek, Ahmet Danalioglu, Gottfried Novacek, Alessandro Armuzzi, Xavier Hébuterne, Simon Travis, Silvio Danese, Walter Reinisch, William J Sandborn, Paul Rutgeerts, Daniel Hommes, Stefan Schreiber, Ezequiel Neimark, Bidan Huang, Qian Zhou, Paloma Mendez, Joel Petersson, Kori Wallace, Anne M Robinson, Roopal B Thakkar, Geert D'Haens
BACKGROUND: Biomarkers of intestinal inflammation, such as faecal calprotectin and C-reactive protein, have been recommended for monitoring patients with Crohn's disease, but whether their use in treatment decisions improves outcomes is unknown. We aimed to compare endoscopic and clinical outcomes in patients with moderate to severe Crohn's disease who were managed with a tight control algorithm, using clinical symptoms and biomarkers, versus patients managed with a clinical management algorithm...
October 31, 2017: Lancet
https://www.readbyqxmd.com/read/29083976/letter-corrected-net-health-benefit-calculations-for-enzalutamide-using-asco-value-framework-guidelines-and-nccn-evidence-blocks
#12
Scott Flanders, Bruce Brown, Marjan Massoudi, Neil Schultz, Krishnan Ramaswamy
This research was funded by Astellas Pharma and Medivation, which was acquired by Pfizer in 2016. Astellas Pharma and Medivation are the co-developers of enzalutamide. Flanders, Brown, Massoudi, and Schultz are employees of Astellas Pharma. Ramaswamy is an employee of Pfizer and holds stock in Johnson & Johnson. Flanders holds stock in Johnson & Johnson, AbbVie, and Abbott Labs.
November 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29063827/subcutaneous-injection-of-adalimumab-trial-compared-with-control-sciatic-a-randomised-controlled-trial-of-adalimumab-injection-compared-with-placebo-for-patients-receiving-physiotherapy-treatment-for-sciatica
#13
Nefyn H Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A Hughes, Eifiona Wood, Nadine E Foster, David A Walsh, Dawn Carnes, Valerie Sparkes, Elaine M Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson
BACKGROUND: Biological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29039055/treatment-patterns-complications-and-health-care-utilization-among-endometriosis-patients-undergoing-a-laparoscopy-or-a-hysterectomy-a-retrospective-claims-analysis
#14
Eric S Surrey, Ahmed M Soliman, Hongbo Yang, Ella Xiaoyan Du, Bowdoin Su
INTRODUCTION: Hysterectomy and laparoscopy are common surgical procedures used for the treatment of endometriosis. This study compares outcomes for women who received either procedure within the first year post initial surgery. METHODS: The study used data from the Truven Health MarketScan claims databases from 2004 to 2013 to identify women aged 18-49 years who received an endometriosis-related laparoscopy or hysterectomy. Patients were excluded if they did not have continuous insurance coverage from 1 year before through 1 year after their endometriosis-related procedure, if they were diagnosed with uterine fibroids prior to or on the date of surgery (i...
October 16, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29035083/multiplicity-adjusted-semiparametric-benefiting-subgroup-identification-in-clinical-trials
#15
Patrick M Schnell, Peter Müller, Qi Tang, Bradley P Carlin
Background A recent focus in the health sciences has been the development of personalized medicine, which includes determining the population for which a given treatment is effective. Due to limited data, identifying the true benefiting population is a challenging task. To tackle this difficulty, the credible subgroups approach provides a pair of bounding subgroups for the true benefiting subgroup, constructed so that one is contained by the benefiting subgroup while the other contains the benefiting subgroup with high probability...
October 1, 2017: Clinical Trials: Journal of the Society for Clinical Trials
https://www.readbyqxmd.com/read/29020583/glecaprevir-and-pibrentasvir-in-patients-with-hcv-and-severe-renal-impairment
#16
MULTICENTER STUDY
Edward Gane, Eric Lawitz, David Pugatch, Georgios Papatheodoridis, Norbert Bräu, Ashley Brown, Stanislas Pol, Vincent Leroy, Marcello Persico, Christophe Moreno, Massimo Colombo, Eric M Yoshida, David R Nelson, Christine Collins, Yang Lei, Matthew Kosloski, Federico J Mensa
BACKGROUND: Chronic hepatitis C virus (HCV) infection is more prevalent among patients who have chronic kidney disease than among those who do not have the disease. Patients with chronic kidney disease who also have HCV infection are at higher risk for progression to end-stage renal disease than those who have chronic kidney disease without HCV infection. Patients with both HCV infection and advanced chronic kidney disease have limited treatment options. METHODS: We conducted a multicenter, open-label, phase 3 trial to evaluate the efficacy and safety of treatment with the combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir for 12 weeks in adults who had HCV genotype 1, 2, 3, 4, 5, or 6 infection and also had compensated liver disease (with or without cirrhosis) with severe renal impairment, dependence on dialysis, or both...
October 12, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28939957/effect-of-hepatitis-c-treatment-with-ombitasvir-paritaprevir-r%C3%A2-%C3%A2-dasabuvir-on-renal-cardiovascular-and-metabolic-extrahepatic-manifestations-a-post-hoc-analysis-of-phase-3-clinical-trials
#17
Darshan A Mehta, Eric Cohen, Mariem Charafeddine, Daniel E Cohen, Yanjun Bao, Yuri Sanchez Gonzalez, Tram T Tran
INTRODUCTION: We analyzed phase 3 trial data of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) ± ribavirin (RBV) in genotype 1 chronic hepatitis C patients to investigate the impact of 3D ± RBV on renal, cardiovascular and metabolic extrahepatic manifestations (EHMs), including persistency 52 weeks post treatment and differential impact by EHM disease severity. METHODS: Estimated glomerular filtration rate (eGFR), fasting triglyceride and fasting glucose values from clinical trials were used to assess renal, cardiovascular and metabolic EHMs, respectively...
September 22, 2017: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/28929412/glecaprevir-pibrentasvir-first-global-approval
#18
Yvette N Lamb
A fixed-dose combination tablet of the hepatitis C virus (HCV) NS3/4A protease inhibitor (PI) glecaprevir and the HCV NS5A inhibitor pibrentasvir [glecaprevir/pibrentasvir; MAVIRET™ (EU); MAVYRET™ (USA)] has been developed by AbbVie. Oral glecaprevir/pibrentasvir 300 mg/120 mg (three 100 mg/40 mg tablets) taken once daily has been approved by the EMA for the treatment of all major genotypes (genotypes 1-6) of chronic HCV infection in adults. It has also been approved by the US FDA for the treatment of adult patients with chronic HCV genotype 1-6 infection without cirrhosis and with compensated cirrhosis, and for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing either an HCV NS5A inhibitor or an NS3/4A PI, but not both...
October 2017: Drugs
https://www.readbyqxmd.com/read/28926247/beyond-the-rule-of-5-lessons-learned-from-abbvie-s-drugs-and-compound-collection
#19
David A DeGoey, Hui-Ju Chen, Philip B Cox, Michael D Wendt
Recently, there has been an increasing focus on the pursuit of targets considered to be less-druggable that offer potential for development of promising new therapeutic agents for the treatment of diseases with large unmet medical need, particularly in the areas of oncology and virology. However, conducting drug discovery campaigns in "beyond Rule of 5" (bRo5) chemical space presents a significant drug design and development challenge to medicinal chemists to achieve acceptable oral pharmacokinetics. Retrospective analysis of past successes and failures in drug discovery bRo5 may shed light on the key principles that contribute to the oral bioavailability of successful bRo5 compounds and improve the efficiency of drug design for future projects...
September 19, 2017: Journal of Medicinal Chemistry
https://www.readbyqxmd.com/read/28881159/patent-trend-and-competitive-analysis-of-cancer-immunotherapy-in-the-united-states
#20
Chia-Lin Pan, Feng-Chi Chen
Immunotherapy has brought high hopes for cancer treatment, and attracted tremendous resources from the biopharmaceutical community. Here we analyze cancer immunotherapy-related patents granted by the United States Patent and Trademark Office in the past decade (2006-2016). A total of 2,229 patents were identified in 13 subfields. The growth of patent number in this field has outpaced the background rate, with cytokine-related therapies, immune checkpoint inhibitors, and natural killer cell therapies growing the most rapidly...
November 2, 2017: Human Vaccines & Immunotherapeutics
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