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Ryan R Witt, John J Rodger, John C Rodger
Lucrin Depot (AbbVie), a 1-month microsphere gonadotrophin-releasing hormone (GnRH) agonist preparation, was investigated as a potential agent to synchronise cycling in the fat-tailed dunnart (Sminthopsis crassicaudata). Forty-eight randomly selected females were treated with 5 or 10mgkg-1 Lucrin Depot (n=24 per dose). Eighteen females per treatment had their reproductive activity scored at 4, 8, 12 and 16 weeks using two ovarian (Graafian follicle and corpus luteum status) and two reproductive tract (uterine and vaginal muscularity and vascularity) parameters that formed a reproductive activity score...
March 2018: Reproduction, Fertility, and Development
John K Marshall, Louis Bessette, Carter Thorne, Neil H Shear, Gerald Lebovic, Sebastien K Gerega, Brad Millson, Driss Oraichi, Tania Gaetano, Sandra Gazel, Martin G Latour, Marie-Claude Laliberté
PURPOSE: Adalimumab (ADA) is a tumor necrosis factor-α inhibitor indicated for use in various immune-mediated inflammatory diseases. Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care's Patient Support Program (PSP), which provides personalized services, including tailored interventions in the form of nurse-provided care coach calls (CCCs), with the goal of improving patients' experiences and outcomes. The primary objective of this study was to evaluate the impact of PSP services, including CCCs and patient characteristics, on persistence with and adherence to ADA for those patients enrolled in the PSP...
March 5, 2018: Clinical Therapeutics
Edouard J Louis, Walter Reinisch, David A Schwartz, Robert Löfberg, Anne M Robinson, Sofie Berg, Anthony W Wang, Jen-Fue Maa, Bidan Huang, Brandee Pappalardo
INTRODUCTION: Extraintestinal manifestations (EIMs) in patients with Crohn's disease (CD) are common and associated with additional morbidity. This study aimed to evaluate the effect of adalimumab therapy on EIM resolution and identify potential predictors of EIM resolution in adult and pediatric patients with moderate to severe CD. METHODS: EIM data were pooled from 11 induction, maintenance, and open-label extension studies of adalimumab. Resolution of EIMs was evaluated at approximately 6 months and 1 year...
March 7, 2018: Advances in Therapy
Sibylle Loibl, Joyce O'Shaughnessy, Michael Untch, William M Sikov, Hope S Rugo, Mark D McKee, Jens Huober, Mehra Golshan, Gunter von Minckwitz, David Maag, Danielle Sullivan, Norman Wolmark, Kristi McIntyre, Jose J Ponce Lorenzo, Otto Metzger Filho, Priya Rastogi, W Fraser Symmans, Xuan Liu, Charles E Geyer
BACKGROUND: Although several randomised trials in patients with triple-negative breast cancer have shown that the addition of carboplatin, with or without poly(ADP-ribose) polymerase (PARP) inhibitors, to neoadjuvant chemotherapy increases the likelihood of achieving a pathological complete response, the use of these therapies in this setting has remained controversial. The BrighTNess trial was designed to assess the addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer...
February 28, 2018: Lancet Oncology
Nienke M Scheltema, Elisabeth E Nibbelke, Juliëtte Pouw, Maarten O Blanken, Maroeska M Rovers, Christiana A Naaktgeboren, Natalie I Mazur, Joanne G Wildenbeest, Cornelis K van der Ent, Louis J Bont
BACKGROUND: Respiratory syncytial virus (RSV) infection is associated with subsequent wheeze and asthma. We previously reported on the causal relationship between prevention of RSV infection during infancy and reduced frequency of subsequent wheeze using a double-blind, randomised, placebo-controlled trial (MAKI). We continued follow-up and analysed the effect of RSV prevention during infancy on asthma and lung function at age 6 years. METHODS: We studied 429 infants born at 32-35 weeks of gestation between 2008-10 who had randomly received either palivizumab for RSV immunoprophylaxis or placebo during the RSV season of their first year of life...
February 27, 2018: Lancet Respiratory Medicine
Jennifer C Samp, Min J Joo, Glen T Schumock, Gregory S Calip, A Simon Pickard, Todd A Lee
BACKGROUND: With increasing health care costs that have outpaced those of other industries, payers of health care are moving from a fee-for-service payment model to one in which reimbursement is tied to outcomes. Chronic obstructive pulmonary disease (COPD) is a disease where this payment model has been implemented by some payers, and COPD exacerbations are a quality metric that is used. Under an outcomes-based payment model, it is important for health systems to be able to identify patients at risk for poor outcomes so that they can target interventions to improve outcomes...
March 2018: Journal of Managed Care & Specialty Pharmacy
Eric A F Simões, Louis Bont, Paolo Manzoni, Brigitte Fauroux, Bosco Paes, Josep Figueras-Aloy, Paul A Checchia, Xavier Carbonell-Estrany
INTRODUCTION: The REGAL (RSV Evidence - A Geographical Archive of the Literature) series has provided a comprehensive review of the published evidence in the field of respiratory syncytial virus (RSV) in Western countries over the last 20 years. This seventh and final publication covers the past, present and future approaches to the prevention and treatment of RSV infection among infants and children. METHODS: A systematic review was undertaken of publications between January 1, 1995 and December 31, 2017 across PubMed, Embase and The Cochrane Library...
February 22, 2018: Infectious Diseases and Therapy
Ahmed M Soliman, Eric Surrey, Machaon Bonafede, James K Nelson, Jane Castelli-Haley
INTRODUCTION: The prevalence of endometriosis and the need for treatment in the USA has led to the need to explore the contemporary cost burden associated with the disease. This retrospective cohort study compared direct and indirect healthcare costs in patients with endometriosis to a control group without endometriosis. METHODS: Women aged 18-49 years with endometriosis (date of initial diagnosis = index date) were identified in the Truven Health MarketScan® Commercial database between 2010 and 2014 and female control patients without endometriosis were matched by age and index year...
February 15, 2018: Advances in Therapy
Rodrigo A Bressan, Geder E M Grohs, Gabriela Matos, Sukhi Shergill
According to the experience of people with schizophrenia, their psychiatrists' attitude towards the outcome of their illness is lacking in hope, which directly affects mutual faith in treatment. Here we discuss the scientific basis of hope and show its instrumental role in optimising the best treatment strategies for schizophrenia. Declaration of interest R.A.B has received honoraria for educational input and non-financial support from Ache; honoraria for educational input from Lundbeck; grants, honoraria for educational input and non-financial support from Janssen; all outside the submitted work...
January 2018: British Journal of Psychiatry: the Journal of Mental Science
Pascale Richetta
Dr. Pascale Richetta is Executive Vice President and Head of the Bone Patient Value Unit at UCB (Brussels, Belgium). She joined UCB in 2016 following over 20 years' experience in the pharma and biotech industry. After completing her MD at the University of Poitiers (France), she spent time as vice president at Abbvie/Abbott and has also held positions at GlaxoSmithKline, Ipsen and Servier. Through the course of her career she acquired impressive commercial experience managing both traditional pharmaceuticals and complex biologics and her knowledge of markets around the world is key to helping UCB prepare for future product launches...
February 2018: Future Science OA
Stefan Zeuzem, Graham R Foster, Stanley Wang, Armen Asatryan, Edward Gane, Jordan J Feld, Tarik Asselah, Marc Bourlière, Peter J Ruane, Heiner Wedemeyer, Stanislas Pol, Robert Flisiak, Fred Poordad, Wan-Long Chuang, Catherine A Stedman, Steven Flamm, Paul Kwo, Gregory J Dore, Gladys Sepulveda-Arzola, Stuart K Roberts, Ruth Soto-Malave, Kelly Kaita, Massimo Puoti, John Vierling, Edward Tam, Hugo E Vargas, Rafi Bruck, Francisco Fuster, Seung-Woon Paik, Franco Felizarta, Jens Kort, Bo Fu, Ran Liu, Teresa I Ng, Tami Pilot-Matias, Chih-Wei Lin, Roger Trinh, Federico J Mensa
BACKGROUND: Glecaprevir and pibrentasvir are direct-acting antiviral agents with pangenotypic activity and a high barrier to resistance. We evaluated the efficacy and safety of 8-week and 12-week courses of treatment with 300 mg of glecaprevir plus 120 mg of pibrentasvir in patients without cirrhosis who had hepatitis C virus (HCV) genotype 1 or 3 infection. METHODS: We conducted two phase 3, randomized, open-label, multicenter trials. Patients with genotype 1 infection were randomly assigned in a 1:1 ratio to receive once-daily glecaprevir-pibrentasvir for either 8 or 12 weeks...
January 25, 2018: New England Journal of Medicine
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
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
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...
April 2018: PharmacoEconomics
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
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
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
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...
January 2018: Biotechnology Progress
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
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
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