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https://www.readbyqxmd.com/read/28790869/etanercept-enbrel-%C3%A2-alternative-storage-at-ambient-temperature
#1
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
#2
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
#3
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
https://www.readbyqxmd.com/read/28590834/comparison-of-the-effects-of-a-pharmaceutical-industry-decision-guide-and-decision-aids-on-patient-choice-to-intensify-therapy-in-rheumatoid-arthritis
#4
Richard W Martin, Ryan D Enck, Donald J Tellinghuisen, Aaron T Eggebeen, James D Birmingham, Andrew J Head
OBJECTIVE: To compare the effects a pharmaceutical industry decision guide and International Patient Decision Aids Standard (IPDAS) compliant patient decision aids (PtDA) on patient medication beliefs and choice to intensify therapy. METHODS: Rheumatoid arthritis (RA) patients, who had never taken etanercept (Enbrel), took part in a mail survey. They were presented with a hypothetical decision scenario where they were asked to consider adding etanercept to their current regimen...
July 2017: Medical Decision Making: An International Journal of the Society for Medical Decision Making
https://www.readbyqxmd.com/read/28551775/lbec0101-a-proposed-etanercept-biosimilar-pharmacokinetics-immunogenicity-and-tolerability-profiles-compared-with-a-reference-biologic-product-in-healthy-male-subjects
#5
Heechan Lee, Hyewon Chung, SeungHwan Lee, Howard Lee, Sung Mo Yang, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: We performed this study to compare the pharmacokinetic (PK), immunogenicity, and tolerability profiles of etanercept between LBEC0101, a proposed biosimilar, and Enbrel(®), the reference biological product. METHODS: A randomized, double-blind, single-dose, two-treatment, two-period, two-sequence, crossover study was conducted in 48 healthy males. In each period, a single dose of LBEC0101 or Enbrel(®) was subcutaneously injected at 25 mg and serial blood samples for PK evaluation were collected up to 648 h post-dose...
May 27, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28530055/-pulmonary-fibrosis-induced-by-anti%C3%B6-tnf-%C3%AE-lpha-treatment
#6
Sharon Baum, Orit Schachter, Aviv Barzilai
INTRODUCTION: TNFα-targeted therapies have emerged as a new class of drugs in the treatment of various inflammatory diseases, including psoriasis. With the increasing use and longer follow-up periods of TNFα targeted therapies, a spectrum of immunological adverse events have been described, ranging from asymptomatic immunological alterations to life-threatening systemic diseases such as pulmonary fibrosis. We present a case of a 66 year old man diagnosed with psoriasis who developed pulmonary fibrosis three years after initiation of Etanercept (Enbrel) for his skin disease...
October 2016: Harefuah
https://www.readbyqxmd.com/read/28431492/anti-drug-antibodies-in-colombian-patients-with-rheumatoid-arthritis-treated-with-enbrel-vs-etanar-preliminary-report
#7
Benjamín Reyes-Beltrán, Gabriela Delgado
The present study was undertaken to detect antibodies against etanercept (ETN) in a group of Colombian patients with rheumatoid arthritis (RA) and being treated with Enbrel(®) vs. Etanar(®). From these patients with RA, clinical and laboratory data were collected and serum taken for anti-drug antibody (ADAb) analysis. Samples from 32 patients (16 who had been treated with Enbrel(®) and 16 with Etanar(®)) were analyzed. Positive sera for ADAb were found in six of the 32 subjects (18.7%); five (31.2%) in the Enbrel(®) group and one (6...
December 2017: Journal of Immunotoxicology
https://www.readbyqxmd.com/read/28417318/patient-and-healthcare-professionals-preference-for-brenzys-vs-enbrel-autoinjector-for-rheumatoid-arthritis-a-randomized-crossover-simulated-use-study
#8
Marc Egeth, Jennifer Soosaar, Peter Nash, Denis Choquette, Ricardo Infante, Dena Rosen Ramey, Sevag Sahakian, Angela Lai, Jin Ju Kim, David Wu
INTRODUCTION: Brenzys was developed as an etanercept biosimilar of Enbrel. The aim of this study was to assess preference and perceived ease of use for the new Brenzys autoinjector compared to the currently available marketed Enbrel MYCLIC autoinjector (Australia) and Enbrel SureClick autoinjector (Canada) for the treatment of rheumatoid arthritis (RA). Because RA affects manual dexterity, ease of use of an autoinjector is a particularly important consideration in developing effective self-delivery of long-term courses of therapy...
May 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28201948/enbrel-and-etanercept-biosimilars-a-tale-of-two-patent-systems
#9
Peter Norman
No abstract text is available yet for this article.
February 16, 2017: Pharmaceutical Patent Analyst
https://www.readbyqxmd.com/read/27999842/reduced-skin-blistering-in-experimental-epidermolysis-bullosa-acquisita-after-anti-tnf-treatment
#10
Misa Hirose, Anika Kasprick, Foteini Beltsiou, Katharina Dieckhoff Schulze, Franziska Sophine Schulze, Unni Kjsrl Samavedam, Jennifer E Hundt, Hendri H Pas, Marcel F Jonkman, Enno Schmidt, Kathrin Kalies, Detlef Zillikens, Ralf J Ludwig, Katja Bieber
Epidermolysis bullosa acquisita (EBA) is a difficult-to-treat subepidermal autoimmune blistering skin disease (AIBD) with circulating and tissue-bound anti-type VII collagen antibodies. Different reports have indicated an increased concentration of tumor necrosis factor alpha (TNF) in the serum and blister fluid of patients with subepidermal AIBDs. Furthermore, successful anti-TNF treatment has been reported for individual patients with AIBDs. Here, we show that in mice, induction of experimental EBA by repeated injections of rabbit-anti mouse type VII collagen antibodies led to increased expression of TNF in skin, as determined by real-time PCR and immunohistochemistry...
December 20, 2016: Molecular Medicine
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#11
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
February 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27869161/therapeutic-targeting-of-necroptosis-by-smac-mimetic-bypasses-apoptosis-resistance-in-acute-myeloid-leukemia-cells
#12
C Safferthal, K Rohde, S Fulda
Resistance to apoptosis, for example due to overexpression of Inhibitor of Apoptosis (IAP) proteins, is associated with poor prognosis in acute myeloid leukemia (AML). Here, we identify that Smac mimetics such as BV6, which antagonizes IAP proteins, elicit necroptosis in AML cells, in which apoptosis is inhibited pharmacologically by caspase inhibitors or genetically by caspase-8 knockdown. Importantly, BV6 triggers necroptosis also in apoptosis-resistant patient-derived AML blasts, underlining the clinical relevance of our findings...
March 2017: Oncogene
https://www.readbyqxmd.com/read/27817152/patient-perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-findings-from-a-patient-survey-in-europe
#13
Kunal Thakur, Anna Biberger, Alexandra Handrich, Mourad Farouk Rezk
INTRODUCTION: Benepali(®) was the first etanercept (Enbrel(®)) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United Kingdom (UK) reported that their patients with rheumatoid arthritis (RA) would prefer the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. To determine whether patients' perceptions were similar to those of the nurses, this survey evaluated patients' perceptions and preferences of the Benepali autoinjector versus the Enbrel MYCLIC autoinjector in the same five European countries...
December 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27787890/the-egality-study-a-confirmatory-randomized-double-blind-study-comparing-the-efficacy-safety-and-immunogenicity-of-gp2015-a-proposed-etanercept-biosimilar-vs-the-originator-product-in-patients-with-moderate-to-severe-chronic-plaque-type-psoriasis
#14
C E M Griffiths, D Thaçi, S Gerdes, P Arenberger, G Pulka, K Kingo, J Weglowska, N Hattebuhr, J Poetzl, H Woehling, G Wuerth, M Afonso
BACKGROUND: GP2015 is a proposed etanercept biosimilar. OBJECTIVES: To demonstrate equivalent efficacy, and comparable safety and immunogenicity of GP2015 and the etanercept originator (ETN, Enbrel(®) ) in patients with moderate-to-severe chronic plaque-type psoriasis. METHODS: In total, 531 eligible patients were randomized 1 : 1 to self-administer GP2015 or ETN twice weekly subcutaneously. Patients with ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 12 were rerandomized to continue the same treatment on a once-weekly dosing schedule or to undergo a sequence of three treatment switches between GP2015 and ETN until week 30...
April 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/27780088/real-time-label-free-detection-and-kinetic-analysis-of-etanercept-protein-a-interactions-using-quartz-crystal-microbalance
#15
Evan A Dubiel, Bruno Martin, Sylvain Vigier, Patrick Vermette
A quartz crystal microbalance (QCM) was constructed to assess if such a biosensor has value as a complementary real-time label-free analysis platform for the biopharmaceutical industry. This was achieved through modifying QCM crystals with a low-fouling carboxymethyl-dextran layer bearing Protein A, and then injecting solutions containing Etanercept (i.e., Enbrel(®)) into the QCM chambers. The kinetics of Enbrel(®) - Protein A interactions was modeled using the Langmuir binding model and Enbrel(®) concentrations between 0...
January 1, 2017: Colloids and Surfaces. B, Biointerfaces
https://www.readbyqxmd.com/read/27747586/erratum-to-perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-a-new-european-union-approved-etanercept-biosimilar-benepali-%C3%A2-versus-etanercept-enbrel-%C3%A2-findings-from-a-nurse-survey-in-europe
#16
https://www.readbyqxmd.com/read/27747519/perceptions-and-preferences-of-two-etanercept-autoinjectors-for-rheumatoid-arthritis-a-new-european-union-approved-etanercept-biosimilar-benepali-%C3%A2-versus-etanercept-enbrel-%C3%A2-findings-from-a-nurse-survey-in-europe
#17
Kunal Thakur, Anna Biberger, Alexandra Handrich, Mourad Farouk Rezk
INTRODUCTION: Enbrel(®) (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali(®): manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The perceptions and preferences of the Benepali autoinjector versus Enbrel MYCLIC autoinjector were evaluated by nurses from Europe...
June 2016: Rheumatology and Therapy
https://www.readbyqxmd.com/read/27709444/the-usage-of-biological-dmards-and-clinical-remission-of-rheumatoid-arthritis-in-china-a-real-world-large-scale-study
#18
MULTICENTER STUDY
Yuan An, Tian Liu, Dongyi He, Lijun Wu, Juan Li, Yi Liu, Liqi Bi, Bin Zhou, Changsong Lin, Lan He, Xiangyuan Liu, Xiaofeng Li, Niansheng Yang, Zhuoli Zhang, Hui Song, Wei Wei, Jing Liu, Yu Bi, Zhanguo Li
The aims of this study are to characterize the biological disease-modifying antirheumatic drug (bDMARD) usage patterns in real-life and examine the remission rate of rheumatoid arthritis (RA) patients receiving bDMARDs in routine clinical practice in China. Consenting RA patients (≥18 years) from 15 teaching hospitals and receiving marketed bDMARDs were included. In total, 802 patients (81.3 % women, 49.0 ± 13.9 years) were included; 89.5 % were receiving a combination of bDMARDs and conventional synthetic DMARDs (csDMARDS), whereas 10...
January 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/27643935/changes-of-microrna-1-15b-and-21-levels-in-irradiated-rat-hearts-after-treatment-with-potentially-radioprotective-drugs
#19
B Kura, C Yin, K Frimmel, J Krizak, L Okruhlicova, R C Kukreja, J Slezak
The aim of this study was to measure expression levels of microRNAs (miRNAs) (miRNA-1, -15b and -21) in the rat myocardium after a single dose of ionizing radiation (6-7 Gy/min, total 25 Gy). The rats were treated with selected drugs (Atorvastatin, acetylsalicylic acid (ASA), Tadalafil, Enbrel) for six weeks after irradiation. MiRNAs levels were measured by RT-qPCR. Irradiation down-regulated miRNA-1 in irradiated hearts. In Tadalafil- and Atorvastatin-treated groups, miRNA-1 expression levels were further decreased compared with irradiated controls...
September 19, 2016: Physiological Research
https://www.readbyqxmd.com/read/27588378/periodontal-conditions-in-juvenile-idiopatic-arthritis
#20
Cinzia Maspero, Lucia Giannini, Vera Carletti, Guido Galbiati, Chiara Prevedello, Giampietro Farronato
BACKGROUND: The possible relationship between periodontitis and Juvenile Idiopathic Arthritis is now mostly unknown but there are common characteristics in both diseases. The purpose of this study is to evaluate Etanercept (Enbrel®) effects on periodontal conditions of children affected by Juvenile Idiopathic Arthritis. METHODS: For this study three group of patients were selected. The first one is represented by Juvenile Idiopathic Arthritis subjects in pharmacologic therapy with Etanercept(Enbrel ®)...
September 2, 2016: Minerva Stomatologica
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