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https://www.readbyqxmd.com/read/29590279/comparison-of-drug-discontinuation-effectiveness-and-safety-between-clinical-trial-eligible-and-ineligible-patients-in-badbir
#1
Kayleigh J Mason, Jonathan N W N Barker, Catherine H Smith, Philip J Hampton, Mark Lunt, Kathleen McElhone, Richard B Warren, Zenas Z N Yiu, Christopher E M Griffiths, A David Burden
Importance: Patients with psoriasis enrolled in clinical trials of biologics may not be representative of the real-world population. There is evidence that patients ineligible for such trials have a greater risk of serious adverse events (SAEs), but the effect on drug discontinuation and effectiveness are unknown. Objective: To determine whether (1) drug discontinuation, (2) effectiveness, and (3) rates of SAEs differ in patients with psoriasis categorized as eligible or ineligible for clinical trials...
March 28, 2018: JAMA Dermatology
https://www.readbyqxmd.com/read/29574229/simple-and-robust-n-glycan-analysis-based-on-improved-2-aminobenzoic-acid-labeling-for-recombinant-therapeutic-glycoproteins
#2
Yeong Ran Jeong, Sun Young Kim, Young Sam Park, Gyun Min Lee
N-glycans of therapeutic glycoproteins are critical quality attributes that should be monitored throughout all stages of biopharmaceutical development. To reduce both the time for sample preparation and the variations in analytical results, we have developed an N-glycan analysis method that includes improved 2-aminobenzoic acid (2-AA) labeling to easily remove deglycosylated proteins. Using this analytical method, 15 major 2-AA labeled N-glycans of Enbrel® were separated into single peaks in hydrophilic interaction chromatography mode and therefore could be quantitated...
March 21, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29518978/structural-biology-of-the-tnf%C3%AE-antagonists-used-in-the-treatment-of-rheumatoid-arthritis
#3
REVIEW
Heejin Lim, Sang Hyung Lee, Hyun Tae Lee, Jee Un Lee, Ji Young Son, Woori Shin, Yong-Seok Heo
The binding of the tumor necrosis factor α (TNFα) to its cognate receptor initiates many immune and inflammatory processes. The drugs, etanercept (Enbrel® ), infliximab (Remicade® ), adalimumab (Humira® ), certolizumab-pegol (Cimzia® ), and golimumab (Simponi® ), are anti-TNFα agents. These drugs block TNFα from interacting with its receptors and have enabled the development of breakthrough therapies for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis...
March 7, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29499461/glycosimilarity-assessment-of-biotherapeutics-1-quantitative-comparison-of-the-n-glycosylation-of-the-innovator-and-a-biosimilar-version-of-etanercept
#4
Beata Borza, Marton Szigeti, Akos Szekrenyes, Laszlo Hajba, Andras Guttman
The carbohydrate moieties on the polypeptide chains in most glycoprotein based biotherapeutics and their biosimilars play essential roles in such major mechanisms of actions as antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, anti-inflammatory functions and serum clearance. In addition, alteration in glycosylation may influence the safety and efficacy of the product. Glycosylation, therefore, is considered as one of the important critical quality attributes of glycoprotein biotherapeutics, and consequently for their biosimilar counterparts...
May 10, 2018: Journal of Pharmaceutical and Biomedical Analysis
https://www.readbyqxmd.com/read/29439320/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-2-enbrel-remicade-cimzia-and-simponi
#5
Ulrich Storz
This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
February 5, 2018: Human Antibodies
https://www.readbyqxmd.com/read/29424120/longitudinal-assessment-of-the-impact-of-multiple-switches-between-a-biosimilar-and-its-reference-product-on-efficacy-parameters
#6
Johanna Mielke, Heike Woehling, Byron Jones
Patients, physicians, and health care providers in Europe have more than 10 years of experience with biosimilars. However, there are still debates if switching between a biosimilar and its reference product influences the efficacy of the treatment. In this paper, we address this uncertainty by developing a formal statistical test that can be used for showing that switching has no negative impact on the efficacy of biosimilars. For that, we first introduce a linear mixed-effects model that is used for defining the null hypothesis (switching influences the efficacy) and the alternative hypothesis (switching has no influence on the efficacy)...
February 8, 2018: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29411222/physicochemical-characterization-glycosylation-pattern-and-biosimilarity-assessment-of-the-fusion-protein-etanercept
#7
Othman Montacir, Houda Montacir, Andreas Springer, Stephan Hinderlich, Fereidoun Mahboudi, Amirhossein Saadati, Maria Kristina Parr
Etanercept is a soluble fusion protein of the tumor necrosis factor receptor (TNFR) extracellular domain, linked to an Fc part of IgG1. It possesses three N- and 13 O-glycosylation sites. Due to its complex structure, an analytical challenge is facing the development and approval of biosimilars. In the current study, physicochemical characterization using state-of-the-art analytics was performed to analyze intact and subunit masses, post-translational modifications (PTMs), higher order structure and potency of Etanercept originator Enbrel® and its biosimilar Altebrel™ (AryoGen Pharmed) in accordance to critical quality attributes of biopharmaceuticals...
February 6, 2018: Protein Journal
https://www.readbyqxmd.com/read/29304271/blau-jabs-syndrome-in-a-tertiary-ophthalmologic-center
#8
Heloisa Nascimento, Jacqueline M Sousa, Délia González Fernández, Gustavo H A Salomão, Elcio H Sato, Cristina Muccioli, Rubens Belfort
In a prospective case series of patients with Blau-Jabs syndrome (BJS) conducted in the Ophthalmology Department/Federal University of Sao Paulo, seven patients with clinical and ophthalmologic manifestations of the disease and a positive genetic test result for the presence of a mutation in the CARD15/NOD2 gene were followed for a minimal period of 1 year. All patients had uveitis, five had nummular corneal subepithelial opacities, and four had multifocal choroiditis. Oral prednisolone was administered to all patients; inflammation was controlled in six patients with at least one immunosuppressive drug...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/29208847/effect-of-etanercept-on-the-success-of-assisted-reproductive-technology-in-patients-with-endometrioma
#9
Göğşen Önalan, Yusuf Aytaç Tohma, Hulusi Bülent Zeyneloğlu
AIMS: To determine the effects of a tumor necrosis factor inhibitor (etanercept) on pregnancy outcomes in patients with endometrioma who were treated with assisted reproductive technology. METHODS: Sixty-eight infertile patients who had endometrioma were included in our retrospective case-control study. We administered etanercept (Enbrel, 50 mg in 1 mL intramuscularly) to 19 patients on the second day of their previous menstrual cycle. All patients were treated with assisted reproductive technology...
November 24, 2017: Gynecologic and Obstetric Investigation
https://www.readbyqxmd.com/read/29105621/adalimumab-etanercept-and-ustekinumab-for-treating-plaque-psoriasis-in-children-and-young-people-systematic-review-and-economic-evaluation
#10
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/29094341/safety-efficacy-and-drug-survival-of-biologics-and-biosimilars-for-moderate-to-severe-plaque-psoriasis
#11
A Egeberg, M B Ottosen, R Gniadecki, S Broesby-Olsen, T N Dam, L E Bryld, M K Rasmussen, L Skov
BACKGROUND: Real-life data on newer biological and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab and ustekinumab) and compare originators with biosimilars (i.e. Enbrel with Benepali, and Remicade with Remsima). METHODS: The DERMBIO registry contains data on all Danish patients with moderate-to-severe plaque psoriasis treated with biologics...
February 2018: British Journal of Dermatology
https://www.readbyqxmd.com/read/29026983/quartz-crystal-microbalance-as-an-assay-to-detect-anti-drug-antibodies-for-the-immunogenicity-assessment-of-therapeutic-biologics
#12
Evan A Dubiel, Tamás Fülöp, Sylvain Vigier, Patrick Vermette
Because of their biological origins, therapeutic biologics can trigger an unwanted deleterious immune response with some patients. The immunogenicity of therapeutic biologics can affect drug efficacy and patient safety by the production of circulating anti-drug antibodies (ADA). In this study, quartz crystal microbalance (QCM) was developed as an assay to detect ADA. Etanercept (Enbrel®) was covalently grafted to dextran-modified QCM surfaces. Rabbits were immunized with etanercept to generate ADA. Results showed the QCM assay could detect purified ADA from rabbits at concentrations as low as 50 ng/mL, within the sensitivity range of ELISA...
December 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/29020515/manufacturing-history-of-etanercept-enbrel-%C3%A2-consistency-of-product-quality-through-major-process-revisions
#13
Brian Hassett, Ena Singh, Ehab Mahgoub, Julie O'Brien, Steven M Vicik, Brian Fitzpatrick
Etanercept (ETN) (Enbrel®) is a soluble protein that binds to, and specifically inhibits, tumor necrosis factor (TNF), a proinflammatory cytokine. ETN is synthesized in Chinese hamster ovary cells by recombinant DNA technology as a fusion protein, with a fully human TNFRII ectodomain linked to the Fc portion of human IgG1. Successful manufacture of biologics, such as ETN, requires sophisticated process and product understanding, as well as meticulous control of operations to maintain product consistency. The objective of this evaluation was to show that the product profile of ETN drug substance (DS) has been consistent over the course of production...
January 2018: MAbs
https://www.readbyqxmd.com/read/29020508/variability-of-intended-copies-for-etanercept-enbrel%C3%A2-data-on-multiple-batches-of-seven-products
#14
Brian Hassett, Morton Scheinberg, Gilberto Castañeda-Hernández, Mengtao Li, Uppuluri R K Rao, Ena Singh, Ehab Mahgoub, Javier Coindreau, Julie O'Brien, Steven M Vicik, Brian Fitzpatrick
Fusion protein and monoclonal antibody-based tumor necrosis factor (TNF) inhibitors represent established treatment options for a range of inflammatory diseases. Regulatory authorities have outlined the structural characterization and clinical assessments necessary to establish biosimilarity of a new biotherapeutic product with the innovator biologic drug. Biologic products that would not meet the minimum World Health Organization's standard for evaluation of similar biotherapeutic products are available in some countries; in some cases relevant data to assess biosimilarity and appropriate regulatory approval pathways are lacking...
January 2018: MAbs
https://www.readbyqxmd.com/read/28976302/certolizumab-pegol-and-secukinumab-for-treating-active-psoriatic-arthritis-following-inadequate-response-to-disease-modifying-antirheumatic-drugs-a-systematic-review-and-economic-evaluation
#15
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA®, Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX®, Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA®, UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28960486/multiple-switches-between-gp2015-an-etanercept-biosimilar-with-originator-product-do-not-impact-efficacy-safety-and-immunogenicity-in-patients-with-chronic-plaque-type-psoriasis-30-week-results-from-the-phase-3-confirmatory-egality-study
#16
S Gerdes, D Thaçi, Cem Griffiths, P Arenberger, J Poetzl, G Wuerth, M Afonso, H Woehling
BACKGROUND: EGALITY was a phase III confirmatory efficacy and safety study conducted in patients with plaque-type psoriasis as a part of totality of evidence gathered during the development of GP2015, an etanercept biosimilar. OBJECTIVE: To demonstrate equivalent efficacy and comparable safety and immunogenicity of GP2015 and the etanercept originator product (ETN, Enbrel(®) ), and evaluate effects of repeated switching between GP2015 and ETN. Results for efficacy, safety and immunogenicity during treatment period (TP) 2 (TP2) are presented pooling the two continued treatment arms (pooled continued) versus the two treatment arms with repeated switches (pooled switched)...
September 28, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28903543/biosimilars-in-rheumatology-a-review-of-the-evidence-and-their-place-in-the-treatment-algorithm
#17
REVIEW
Hendrik Schulze-Koops, Alla Skapenko
Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28790869/etanercept-enbrel-%C3%A2-alternative-storage-at-ambient-temperature
#18
Edel Shannon, Joanne Daffy, Heather Jones, Andrea Paulson, Steven M Vicik
BACKGROUND: Biologic disease-modifying antirheumatic drugs, including tumor necrosis factor inhibitors such as etanercept (Enbrel(®)), have improved outcomes for patients with rheumatic and other inflammatory diseases, with sustained remission being the optimal goal for patients with rheumatoid arthritis. Flexible and convenient treatment options, compatible with modern lifestyle, are important in helping patients maintain treatment and manage their disease. Etanercept drug product (DP) is available in lyophilized powder (Lyo) for solution injection, prefilled syringe, and prefilled pen presentations and is typically stored under refrigerated conditions...
2017: Clinical Pharmacology: Advances and Applications
https://www.readbyqxmd.com/read/28723598/effects-of-tumor-necrosis-factor-blocker-on-salicylate-induced-tinnitus-in-mice
#19
Juen-Haur Hwang, David Chang-Wei Huang, Yin-Chang Lu, Wei-Shiung Yang, Tien-Chen Liu
OBJECTIVE: Neuroinflammation is considered a novel mechanism for acute tinnitus. Here, we investigated the effects of a tumor necrosis factor (TNF) blocker on the gene expression of inflammatory-cytokine in the cochlea in a tinnitus animal model. METHODS: Enbrel® (30 mg/kg, intraperitoneally (i.p.)) were administrated to the mice with the salicylate induced tinnitus for 3 days. Tinnitus score and mRNA expression levels of TNFR1, TNFR2, and N-methyl-d-aspartate receptor subunit 2B (NR2B) and its downstream regulatory element antagonist modulator (DREAM) in the cochlea of mice were measured and compared to the control...
June 1, 2017: International Tinnitus Journal
https://www.readbyqxmd.com/read/28638112/the-structure-function-relationship-of-disulfide-bonds-in-etanercept
#20
William C Lamanna, Robert Ernst Mayer, Alfred Rupprechter, Michael Fuchs, Fabian Higel, Cornelius Fritsch, Cornelia Vogelsang, Andreas Seidl, Hansjoerg Toll, Martin Schiestl, Johann Holzmann
Etanercept is a TNFα receptor Fc fusion protein used for the treatment of rheumatic disease and psoriasis. Physicochemical and functional investigation of process fractions during development of the etanercept biosimilar GP2015 (Erelzi(®)) revealed a correlation between reduced potency and incorrect disulfide bridging between specific cysteines in the receptor domain. This novel structure-function relationship was found to be the molecular basis for reduced potency in recent Enbrel(®) batches, which exhibit higher levels of incorrect disulfide bridging...
June 21, 2017: Scientific Reports
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