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https://www.readbyqxmd.com/read/27883347/-adalimumab-as-induction-therapy-for-crohn-s-disease-one-center-study
#1
Maciej Gonciarz, Aldona Mularczyk, Dawid Szkudłapski, Iwona Piątek, Marek Kopała
: Adalimumab is a subcutaneously administered recombinant fully human monoclonal antibody targeting tumor necrosis factor alpha. It has been approved for use in Poland to treat patients with Crohn's disease under the program of Polish National Health Found since 2010. AIM: The aim of this study was to evaluate the efficacy of adalimumab monotherapy for inducing clinical remission in patients with active Crohn's disease . The primary outcome assessment was the reduction in score to 150 or below on the Crohn's Disease Activity Index (CDAI) at 12 weeks and the secondary one was the reduction in ΔCDAI of at least 100 points...
November 25, 2016: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/27882832/geographic-variation-in-the-quality-and-cost-of-care-for-patients-with-rheumatoid-arthritis
#2
Jason Shafrin, Arijit Ganguli, Yuri Sanchez Gonzalez, Jin Joo Shim, Seth A Seabury
BACKGROUND: There is considerable push to improve value in health care by simultaneously increasing quality while lowering or containing costs. However, for diseases that are best treated with comparatively expensive treatments, such as rheumatoid arthritis (RA), there could be tension between these aims. In this study, we measured geographic variation in quality, access, and cost for patients with RA, a disease with effective but costly specialty treatments. OBJECTIVE: To assess the geographic differences in the quality, access, and cost of care for patients with RA...
December 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27864751/defining-the-risk-and-associated-morbidity-and-mortality-of-severe-respiratory-syncytial-virus-infection-among-infants-with-chronic-lung-disease
#3
REVIEW
Bosco Paes, Brigitte Fauroux, Josep Figueras-Aloy, Louis Bont, Paul A Checchia, Eric A F Simões, Paolo Manzoni, Xavier Carbonell-Estrany
INTRODUCTION: The REGAL (RSV evidence-a geographical archive of the literature) series provide a comprehensive review of the published evidence in the field of respiratory syncytial virus (RSV) in Western countries over the last 20 years. This third publication covers the risk and burden of RSV infection in infants with chronic lung disease (CLD), formerly called bronchopulmonary dysplasia (BPD). METHODS: A systematic review was undertaken of publications between January 1, 1995 and December 31, 2015 across PubMed, Embase, The Cochrane Library, and Clinicaltrials...
November 18, 2016: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/27854054/impact-of-treatment-related-beliefs-on-medication-adherence-in-immune-mediated-inflammatory-diseases-results-of-the-global-align-study
#4
Pierre Michetti, John Weinman, Ulrich Mrowietz, Josef Smolen, Laurent Peyrin-Biroulet, Edouard Louis, Dieter Schremmer, Namita Tundia, Pascal Nurwakagari, Nicole Selenko-Gebauer
INTRODUCTION: Medication adherence is critical in chronic immune-mediated inflammatory diseases (IMIDs) and could be affected by patients' treatment-related beliefs. The objective of this study was to determine beliefs about systemic medications in patients with IMIDs and to explore the association of those beliefs and other factors with adherence. METHODS: This was a multi-country, cross-sectional, self-administered survey study. Included were adults diagnosed with one of six IMIDs receiving conventional systemic medications and/or tumor necrosis factor inhibitors (TNFi)...
November 16, 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27845027/clinical-effectiveness-and-cost-effectiveness-of-use-of-therapeutic-monitoring-of-tumour-necrosis-factor-alpha-tnf-%C3%AE-inhibitors-lisa-tracker%C3%A2-enzyme-linked-immunosorbent-assay-elisa-kits-tnf-%C3%AE-blocker-elisa-kits-and-promonitor%C3%A2-elisa-kits-versus-standard-care
#5
Karoline Freeman, Martin Connock, Peter Auguste, Sian Taylor-Phillips, Hema Mistry, Deepson Shyangdan, Rachel Court, Ramesh Arasaradnam, Paul Sutcliffe, Aileen Clarke
BACKGROUND AND OBJECTIVES: Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER(®) enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor(®) ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn's disease (CD)...
November 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27792008/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-1-humira
#6
Ulrich Storz
This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optiimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics.
October 21, 2016: Human Antibodies
https://www.readbyqxmd.com/read/27747584/economic-evaluation-of-timely-versus-delayed-use-of-tumor-necrosis-factor-inhibitors-for-treatment-of-psoriatic-arthritis-in-the-us
#7
Vibeke Strand, Elaine Husni, Jenny Griffith, Zheng-Yi Zhou, James Signorovitch, Arijit Ganguli
INTRODUCTION: The present study aimed to evaluate clinical outcomes and costs associated with timely versus delayed use of tumor necrosis factor inhibitors (TNFis) among patients with moderately to severely active psoriatic arthritis (PsA) with and without moderate/severe psoriasis (Ps) from a US payer's perspective. METHODS: An economic model evaluated PsA patients initially treated with a TNFi (timely TNFi use) or apremilast (delayed TNFi use). Patients without joint (American College of Rheumatology 20%, [ACR20]) improvement either switched TNFis or initiated one...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27747583/randomized-crossover-comparison-of-injection-site-pain-with-40%C3%A2-mg-0-4-or-0-8%C3%A2-ml-formulations-of-adalimumab-in-patients-with-rheumatoid-arthritis
#8
Peter Nash, Johan Vanhoof, Stephen Hall, Udayasankar Arulmani, Rita Tarzynski-Potempa, Kristina Unnebrink, Andrew N Payne, Alfred Cividino
INTRODUCTION: Adalimumab, an anti-tumor necrosis factor antibody, is currently available in a 40 mg/0.8 mL formulation. The objective of this analysis was to evaluate injection site-related pain, safety, and tolerability of a 40 mg/0.4 mL formulation of adalimumab that had fewer excipients, a smaller volume, and a delivery presentation with a smaller gauge needle, versus the current 40 mg/0.8 mL formulation in patients with rheumatoid arthritis (RA). METHODS: Two identically designed, phase 2, randomized, single-blind, two-period crossover studies were conducted in Belgium and the Czech Republic (Study 1) and Australia, Canada, and Germany (Study 2)...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27747581/network-meta-analysis-and-cost-per-responder-of-tumor-necrosis-factor-%C3%AE-and-interleukin-inhibitors-in-the-treatment-of-active-ankylosing-spondylitis
#9
Keith A Betts, Jenny Griffith, Yan Song, Manish Mittal, Avani Joshi, Eric Q Wu, Arijit Ganguli
INTRODUCTION: Biologic therapies have improved the clinical management of ankylosing spondylitis (AS). Few head-to-head studies have directly compared the efficacy of these agents. This study was conducted to indirectly compare the efficacy of biologic agents for treatment of active AS. METHODS: A targeted literature review was conducted to identify randomized clinical trials for adalimumab, infliximab, golimumab, certolizumab pegol, etanercept, and secukinumab for the treatment of active AS...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27747511/effect-of-methotrexate-plus-adalimumab-on-the-achievement-of-rheumatoid-arthritis-therapeutic-goals-post-hoc-analysis-of-japanese-patients-melody-study
#10
Takao Koike, Masayoshi Harigai, Naoki Ishiguro, Shigeko Inokuma, Syuji Takei, Tsutomu Takeuchi, Hisashi Yamanaka, Yoshinari Takasaki, Tsuneyo Mimori, Katsutoshi Hiramatsu, Shuichi Komatsu, Yoshiya Tanaka
INTRODUCTION: There is insufficient evidence regarding the appropriate dose of methotrexate (MTX) required to achieve specific treatment goals in patients with rheumatoid arthritis (RA) receiving biologic drugs in Japan. The present study aimed to assess the dose-response effect of MTX in combination with adalimumab (ADA) to achieve low disease activity (LDA) and/or remission at 24 weeks in RA patients. METHODS: This analysis used data of the ADA all-case survey in Japan (n = 7740), and 5494 patients who received ADA and MTX were classified into five groups by weighted average MTX dose (>0-<4, 4-<6, 6-<8, 8-< 10, and ≥10 mg/week)...
June 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27696240/d3r-grand-challenge-2015-evaluation-of-protein-ligand-pose-and-affinity-predictions
#11
Symon Gathiaka, Shuai Liu, Michael Chiu, Huanwang Yang, Jeanne A Stuckey, You Na Kang, Jim Delproposto, Ginger Kubish, James B Dunbar, Heather A Carlson, Stephen K Burley, W Patrick Walters, Rommie E Amaro, Victoria A Feher, Michael K Gilson
The Drug Design Data Resource (D3R) ran Grand Challenge 2015 between September 2015 and February 2016. Two targets served as the framework to test community docking and scoring methods: (1) HSP90, donated by AbbVie and the Community Structure Activity Resource (CSAR), and (2) MAP4K4, donated by Genentech. The challenges for both target datasets were conducted in two stages, with the first stage testing pose predictions and the capacity to rank compounds by affinity with minimal structural data; and the second stage testing methods for ranking compounds with knowledge of at least a subset of the ligand-protein poses...
September 30, 2016: Journal of Computer-aided Molecular Design
https://www.readbyqxmd.com/read/27695184/placement-of-the-abbvie-peg-j-tube-for-the-treatment-of-parkinson-s-disease-in-the-interventional-radiology-suite
#12
Mark L Montgomery, Noel K Miner, Michael J Soileau, Douglas K McDonald
The primary treatment for Parkinson's disease is dopaminergic stimulation. Although levodopa has historically been administered orally, maintaining a predictable plasma concentration of the drug is challenging. As a result, enteral administration of carbidopa/levodopa (Duopa) has emerged as a promising tool in the treatment of the disease. This requires placement of an enteric catheter, two of which have been approved by the Food and Drug Administration for delivery of Duopa. The approved tubes are placed using the "peroral" or "pull" technique, a method traditionally requiring endoscopy...
October 2016: Proceedings of the Baylor University Medical Center
https://www.readbyqxmd.com/read/27677319/substituted-indole-mcl-1-inhibitors-a-patent-evaluation-wo2015148854a1
#13
Ting Song, Ziqian Wang, Zhichao Zhang
The myeloid cell leukemia 1 (Mcl-1) protein, an anti-apoptotic member of Bcl-2 family, plays a critical role in the development and maintenance of many cancers and is listed in the 'top ten' pathological factors across the diversity of human cancers. The patent described in this evaluation (WO2015148854A1) claimed substituted indole Mcl-1 inhibitors for the treatment of diseases and conditions (e.g., cancer) characterized by the over-expression or dysregulation of Mcl-1 proteins. A variety of 2-position substituents distinguished indole Mcl-1 inhibitors claimed in this patent from another two patents by AbbVie Inc...
October 4, 2016: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/27664107/a-retrospective-claims-database-study-on-drug-utilization-in-japanese-patients-with-crohn-s-disease-treated-with-adalimumab-or-infliximab
#14
Kaoru Yokoyama, Kiyotaka Yamazaki, Miiko Katafuchi, Sameh Ferchichi
INTRODUCTION: Crohn's disease (CD) is a chronic and progressive disease in which the long-term management is important. This study sought to assess treatment persistence and dose escalation in the maintenance phase with adalimumab (ADA) or infliximab (IFX) in a Japanese real-world setting. METHODS: A retrospective analysis was conducted using the Japan Medical Data Center database. CD patients with either ADA or IFX prescriptions between January 2012 and February 2015 were included...
November 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27637985/ibrutinib-for-patients-with-relapsed-or-refractory-chronic-lymphocytic-leukaemia-with-17p-deletion-resonate-17-a-phase-2-open-label-multicentre-study
#15
Susan O'Brien, Jeffrey A Jones, Steven E Coutre, Anthony R Mato, Peter Hillmen, Constantine Tam, Anders Österborg, Tanya Siddiqi, Michael J Thirman, Richard R Furman, Osman Ilhan, Michael J Keating, Timothy G Call, Jennifer R Brown, Michelle Stevens-Brogan, Yunfeng Li, Fong Clow, Danelle F James, Alvina D Chu, Michael Hallek, Stephan Stilgenbauer
BACKGROUND: The TP53 gene, encoding tumour suppressor protein p53, is located on the short arm of chromosome 17 (17p). Patients with 17p deletion (del17p) chronic lymphocytic leukaemia have poor responses and survival after chemoimmunotherapy. We assessed the activity and safety of ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase, in relapsed or refractory patients with del17p chronic lymphocytic leukaemia or small lymphocytic lymphoma. METHODS: We did a multicentre, international, open-label, single-arm study at 40 sites in the USA, Canada, Europe, Australia, and New Zealand...
October 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27628014/defining-the-risk-and-associated-morbidity-and-mortality-of-severe-respiratory-syncytial-virus-infection-among-preterm-infants-without-chronic-lung-disease-or-congenital-heart-disease
#16
Josep Figueras-Aloy, Paolo Manzoni, Bosco Paes, Eric A F Simões, Louis Bont, Paul A Checchia, Brigitte Fauroux, Xavier Carbonell-Estrany
INTRODUCTION: The REGAL (RSV Evidence-a Geographical Archive of the Literature) series provide a comprehensive review of the published evidence in the field of respiratory syncytial virus (RSV) in Western countries over the last 20 years. This second publication covers the risk and burden of RSV infection in preterm infants born at <37 weeks' gestational age (wGA) without chronic lung disease or congenital heart disease. METHODS: A systematic review was undertaken for articles published between January 1, 1995 and December 31, 2015...
September 14, 2016: Infectious Diseases and Therapy
https://www.readbyqxmd.com/read/27602665/adalimumab-in-patients-with-active-noninfectious-uveitis
#17
RANDOMIZED CONTROLLED TRIAL
Glenn J Jaffe, Andrew D Dick, Antoine P Brézin, Quan Dong Nguyen, Jennifer E Thorne, Philippe Kestelyn, Talin Barisani-Asenbauer, Pablo Franco, Arnd Heiligenhaus, David Scales, David S Chu, Anne Camez, Nisha V Kwatra, Alexandra P Song, Martina Kron, Samir Tari, Eric B Suhler
BACKGROUND: Patients with noninfectious uveitis are at risk for long-term complications of uncontrolled inflammation, as well as for the adverse effects of long-term glucocorticoid therapy. We conducted a trial to assess the efficacy and safety of adalimumab as a glucocorticoid-sparing agent for the treatment of noninfectious uveitis. METHODS: This multinational phase 3 trial involved adults who had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment for 2 or more weeks...
September 8, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27602344/intramuscular-depot-formulations-of-leuprolide-acetate-suppress-testosterone-levels-below-a-20-ng-dl-threshold-a-retrospective-analysis-of-two-phase-iii-studies
#18
Aaron Spitz, Marc Gittelman, Lawrence I Karsh, Sanja Dragnic, Ahmed M Soliman, Aditya Lele, Damian Gruca, Michael Norton
INTRODUCTION: Androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) analogs is a standard treatment for advanced prostate cancer. GnRH analog therapy can reduce testosterone to "castrate" levels, historically defined as <50 ng/dL. With the advent of newer assays, a lower threshold of <20 ng/dL has recently been proposed. We report the results of a retrospective analysis of two Phase III trials of 4- and 6-month depot microsphere formulations of leuprolide acetate (LA), a GnRH agonist that has previously demonstrated efficacy in testosterone suppression to <50 ng/dL in patients on ADT...
2016: Research and Reports in Urology
https://www.readbyqxmd.com/read/27542302/adalimumab-for-prevention-of-uveitic-flare-in-patients-with-inactive-non-infectious-uveitis-controlled-by-corticosteroids-visual-ii-a-multicentre-double-masked-randomised-placebo-controlled-phase-3-trial
#19
RANDOMIZED CONTROLLED TRIAL
Quan Dong Nguyen, Pauline T Merrill, Glenn J Jaffe, Andrew D Dick, Shree Kumar Kurup, John Sheppard, Ariel Schlaen, Carlos Pavesio, Luca Cimino, Joachim Van Calster, Anne A Camez, Nisha V Kwatra, Alexandra P Song, Martina Kron, Samir Tari, Antoine P Brézin
BACKGROUND: Non-infectious uveitis is a potentially sight-threatening ocular disorder caused by chronic inflammation and its complications. Therapeutic success is limited by systemic adverse effects associated with long-term corticosteroid and immunomodulator use if topical medication is not sufficient to control the inflammation. We aimed to assess the efficacy and safety of adalimumab in patients with inactive, non-infectious uveitis controlled by systemic corticosteroids. METHODS: We did this multicentre, double-masked, randomised, placebo-controlled phase 3 trial at 62 study sites in 21 countries in the USA, Canada, Europe, Israel, Australia, and Latin America...
September 17, 2016: Lancet
https://www.readbyqxmd.com/read/27530546/an-oral-nav1-8-blocker-improves-motor-function-in-mice-completely-deficient-of-myelin-protein-p0
#20
Mette R Rosberg, Susana Alvarez, Christian Krarup, Mihai Moldovan
Mice deficient of myelin protein P0 are established models of demyelinating Charcot-Marie-Tooth (CMT) disease. Dysmyelination in these mice is associated with an ectopic expression of the sensory neuron specific sodium channel isoform NaV1.8 on motor axons. We reported that in P0+/-, a model of CMT1B, the membrane dysfunction could be acutely improved by a novel oral NaV1.8 blocker referred to as Compound 31 (C31, Bioorg. Med. Chem. Lett. 2010, 20, 6812; AbbVie Inc.). The aim of this study was to investigate the extent to which C31 treatment could also improve the motor axon function in P0-/-, a CMT model with a much more severe neuropathy...
October 6, 2016: Neuroscience Letters
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