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https://www.readbyqxmd.com/read/28753571/1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol-ameliorates-arthritic-joints-through-reducing-neutrophil-infiltration-mediated-by-il-6-stat3-and-mip-2-activation
#1
Young-Jun Kim, Jae Min Shin, Su-Hyun Shin, Joo Heon Kim, Ki-Young Sohn, Heung-Jae Kim, Jong-Koo Kang, Sun Young Yoon, Jae Wha Kim
The pathogenesis of rheumatoid arthritis (RA) has been implicated neutrophil extracellular traps (NETs) formation which could generate autoantigen. Neutrophil contributes to initiate and maintain the inflammatory process in the joint. In this study, we show that 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (PLAG) decreases neutrophil migration by regulating the activity of STAT3, a regulator of IL-6 and MIP-2 expression. PLAG caused a decrease in IL-6 production in the RAW264.7 macrophage cell line and in rheumatoid arthritis-fibroblast-like synoviocytes via the regulation of STAT3 signaling without affecting NF-κB signaling...
July 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/28735823/comparison-of-remicade-to-curcumin-for-the-treatment-of-crohn-s-disease-a-systematic-review
#2
REVIEW
Allaire Schneider, Ivy Hossain, Julia VanderMolen, Kara Nicol
OBJECTIVE: The aim of this study was to review the literature to assess if there is evidence to support the use of Curcumin as a safe complementary therapy in treating Crohn's Disease (CD) in conjunction with Remicade. DESIGN: Systematic searches were performed by three researchers using electronic databases (ProQuest Medical Library, CINAHL Complete, and PUBMED) to locate and identify articles to meet a predetermined set of inclusion criteria. Specifically full text, peer-reviewed articles published after 2007 were included if they studied human participants 18 years or older...
August 2017: Complementary Therapies in Medicine
https://www.readbyqxmd.com/read/28692448/the-use-of-biosimilars-in-paediatric-inflammatory-bowel-disease
#3
Maria Myrthe Elisabeth Jongsma, Arnold Vulto, Lissy de Ridder
PURPOSE OF REVIEW: After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience in patients with ankylosing spondylitis and rheumatoid arthritis. The extrapolation of CT-P13 to IBD and to paediatric patients raised concerns among paediatric IBD specialists...
July 7, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28667429/long-term-clinical-outcomes-after-switching-from-remicade-%C3%A2-to-biosimilar-ct-p13-in-inflammatory-bowel-disease
#4
Lisa J T Smits, Anna Grelack, Lauranne A A P Derikx, Dirk J de Jong, Aura A J van Esch, Ronald S Boshuizen, Joost P H Drenth, Frank Hoentjen
BACKGROUND: Limited data are available on long-term clinical outcomes regarding the switch from Remicade(®) to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients. AIMS: To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity. METHODS: We performed a single-center prospective observational cohort study following an elective switch from Remicade(®) to CT-P13 in IBD patients. RESULTS: Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up...
June 30, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28640663/glycosylation-profile-and-biological-activity-of-remicade%C3%A2-compared-with-flixabi%C3%A2-and-remsima%C3%A2
#5
Changsoo Lee, Min Jeong, JongAh Joanne Lee, Saebom Seo, Sung Chun Cho, Wei Zhang, Orlando Jaquez
As biosimilars enter the market, comparisons of product quality are needed. Manufacturing differences may lead to differences in critical quality attributes, which affect efficacy. Therefore, critical quality attributes (structure and biological activity) of Remicade® and of 2 biosimilar products (Flixabi®/Renflexis® and Remsima®/Inflectra®) were determined. We assessed binding to tumor necrosis factor in a fluorescence competitive binding assay; potency in a luciferase reporter gene assay; percentages of galactosylated glycan, afucose plus high mannosylated glycans, and charged glycan; FcγRIIIa (CD16) binding (assessed by 3 methods); and antibody-dependent cell-mediated cytotoxicity (ADCC) in the NK92-CD16a cell line and in peripheral blood mononuclear cells (PBMC)...
August 2017: MAbs
https://www.readbyqxmd.com/read/28593609/therapeutic-drug-monitoring-tdm-as-a-tool-in-the-switch-from-infliximab-innovator-to-biosimilar-in-rheumatic-patients-results-of-a-12-month-observational-prospective-cohort-study
#6
E M H Schmitz, S Benoy-De Keuster, A J L Meier, V Scharnhorst, R A M Traksel, M A C Broeren, L J J Derijks
The objective of this study is to apply therapeutic drug monitoring (TDM) as an objective tool to monitor the switch from infliximab innovator (INX) to infliximab biosimilar (INB) in our diverse rheumatic cohort in daily clinical practice. All rheumatic patients on INX treatment (Remicade®) and ≥18 years were switched to INB (Inflectra®) as part of routine care, but in a controlled setting. Patients were monitored by taking blood samples just before the first infusion of INB (T1), and after the second (T2), fourth (T3), and seventh (T4) infusion of INB...
June 7, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28583807/an-orthogonally-protected-cyclotriveratrylene-ctv-as-a-highly-pre-organized-molecular-scaffold-for-subsequent-ligation-of-different-cyclic-peptides-towards-protein-mimics
#7
Ondřej Longin, Helmus van de Langemheen, Rob M J Liskamp
The synthesis of a semi-orthogonally protected CycloTriVeratrilene (CTV) scaffold derivative as well as the sequential introduction of three different peptide loops onto this molecular scaffold via Cu(I)-catalyzed azide alkyne cycloaddition towards a medium-sized protein mimic is described. This approach for the construction of medium-sized protein mimics is illustrated by the synthesis of a paratope mimic of the monoclonal antibody Infliximab (Remicade®) and provides access to a range of highly pre-organized molecular constructs bearing three different peptide segments...
May 18, 2017: Bioorganic & Medicinal Chemistry
https://www.readbyqxmd.com/read/28514405/-stable-high-interleukin-17a-concentration-in-patients-with-ankylosing-spondylitis-treated-with-tumor-necrosis-factor-%C3%AE-inhibitors-during-a-year
#8
I Z Gaydukova, A P Rebrov, A V Aparkina, E V Khondkaryan
AIM: To assess changes in the concentration of interleukin-17A (IL-17A) in patients with ankylosing spondylitis (AS) treated with tumor necrosis factor-α (TNFα) inhibitors during a year. SUBJECTS AND METHODS: Examinations were made in 30 patients (22 (73.3%) men) aged 38.35±9.19 years with AS (modified New-York criteria, BASDAI ≥4.0; AS duration, 11.4±9.6 years) and in 20 healthy individuals (12 (60%) men) aged 40.1±7.7 years) (a control group). All the patients were treated with infliximab (remicade, MSD) 5 mg/kg body weight during a year according to the recommended regimen...
2017: Terapevticheskiĭ Arkhiv
https://www.readbyqxmd.com/read/28497221/evaluation-of-the-cross-reactivity-of-antidrug-antibodies-to-ct-p13-and-infliximab-reference-product-remicade-an-analysis-using-immunoassays-tagged-with-both-agents
#9
Walter Reinisch, Jørgen Jahnsen, Stefan Schreiber, Silvio Danese, Julián Panés, Alejandro Balsa, Won Park, JiSoo Kim, Jee Un Lee, Dae Hyun Yoo
BACKGROUND: During two pivotal clinical trials of the infliximab biosimilar CT-P13 (PLANETAS and PLANETRA), antidrug antibodies (ADAs) and neutralising antibodies (NAbs) were detected in the sera of patients treated with CT-P13 and the reference product (RP; Remicade). OBJECTIVE: The aim was to assess the comparability of Remicade- and CT-P13-tagged immunoassays for the detection of ADAs and NAbs using data from these trials, in order to determine the cross-reactivity of CT-P13 and RP ADAs...
June 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28473425/a-nationwide-non-medical-switch-from-originator-infliximab-to-biosimilar-ct-p13-in-802-patients-with-inflammatory-arthritis-1-year-clinical-outcomes-from-the-danbio-registry
#10
Bente Glintborg, Inge Juul Sørensen, Anne Gitte Loft, Hanne Lindegaard, Asta Linauskas, Oliver Hendricks, Inger Marie Jensen Hansen, Dorte Vendelbo Jensen, Natalia Manilo, Jakob Espesen, Mette Klarlund, Jolanta Grydehøj, Sabine Sparre Dieperink, Salome Kristensen, Jimmi Sloth Olsen, Henrik Nordin, Stavros Chrysidis, Dorte Dalsgaard Pedersen, Michael Veedfald Sørensen, Lis Smedegaard Andersen, Kathrine Lederballe Grøn, Niels Steen Krogh, Lars Pedersen, Merete Lund Hetland
OBJECTIVES: According to guidelines, a nationwide non-medical switch from originator (INX, Remicade) to biosimilar infliximab (Remsima, CT-P13) was conducted in Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). We investigated disease activity before/after switching and retention rates in the DANBIO registry. METHODS: Disease activities 3 months before and after switch and changes over time were calculated...
August 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28448684/statistical-modeling-for-bayesian-extrapolation-of-adult-clinical-trial-information-in-pediatric-drug-evaluation
#11
Margaret Gamalo-Siebers, Jasmina Savic, Cynthia Basu, Xin Zhao, Mathangi Gopalakrishnan, Aijun Gao, Guochen Song, Simin Baygani, Laura Thompson, H Amy Xia, Karen Price, Ram Tiwari, Bradley P Carlin
Children represent a large underserved population of "therapeutic orphans," as an estimated 80% of children are treated off-label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population...
April 27, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28421849/infliximab-crystal-structures-reveal-insights-into-self-association
#12
Thomas F Lerch, Penelope Sharpe, Stephen J Mayclin, Thomas E Edwards, Eunhee Lee, Hugh D Conlon, Sharon Polleck, Jason C Rouse, Yin Luo, Qin Zou
Aggregation and self-association in protein-based biotherapeutics are critical quality attributes that are tightly controlled by the manufacturing process. Aggregates have the potential to elicit immune reactions, including neutralizing anti-drug antibodies, which can diminish the drug's efficacy upon subsequent dosing. The structural basis of reversible self-association, a form of non-covalent aggregation in the native state, is only beginning to emerge for many biologics and is often unique to a given molecule...
July 2017: MAbs
https://www.readbyqxmd.com/read/28401824/-biosimilar-registered-despite-the-netherlands-opposing-vote-greater-uncertainty-about-authorised-drugs-in-the-netherlands
#13
A G Vulto
On 1 April 2016 the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a new biological medicine, Flixabi®, a biosimilar to infliximab (Remicade®); however, in the appendix of the European Public Assessment Report (EPAR) it appeared that an important minority (14 of 33 votes) opposed this decision, among them the Netherlands representative. In an original article, the Dutch Medicines Board (CBG-MEB) explained the reason for this decision, but still allowed the drug on the market...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28365979/a-multidimensional-analytical-comparison-of-remicade-and-the-biosimilar-remsima
#14
Karthik Pisupati, Yuwei Tian, Solomon Okbazghi, Alexander Benet, Rose Ackermann, Michael Ford, Sergei Saveliev, Christopher M Hosfield, Marjeta Urh, Eric Carlson, Christopher Becker, Thomas J Tolbert, Steven P Schwendeman, Brandon T Ruotolo, Anna Schwendeman
In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal antibody (mAb), Inflectra/Remsima (Celltrion), based off the original product Remicade (infliximab, Janssen). Biosimilars promise significant cost savings for patients, but the unavoidable differences between innovator and copycat biologics raise questions regarding product interchangeability. In this study, Remicade and Remsima were examined by native mass spectrometry, ion mobility, and quantitative peptide mapping. The levels of oxidation, deamidation, and mutation of individual amino acids were remarkably similar...
May 2, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28281165/effectiveness-and-safety-of-ct-p13-biosimilar-infliximab-in-patients-with-inflammatory-bowel-disease-in-real-life-at-6%C3%A2-months
#15
F Argüelles-Arias, M F Guerra Veloz, R Perea Amarillo, A Vilches-Arenas, L Castro Laria, B Maldonado Pérez, D Chaaro, A Benítez Roldán, V Merino, G Ramírez, A Caunedo Álvarez, M Romero Gómez
BACKGROUND: CT-P13 is a biosimilar of Remicade(®), an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13...
May 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28273042/bioadvance-patient-support-program-survey-positive-perception-of-intravenous-infusions-of-infliximab
#16
Jennifer Jones, Mark Borgaonkar, Jesse Siffledeen, Ryan O#x02019;Reilly, Dana Anger, Dorota Dajnowiec, Martin Williamson, Peter Dyrda
PURPOSE: To understand the perception of intravenous infusions in patients receiving infliximab (Remicade) within the BioAdvance patient support program (PSP). DESIGN: Intravenous infusion of infliximab occurs at approximately 200 clinics across Canada and is managed via the BioAdvance PSP. Patients were invited to complete a 28-question survey on demographics, disease/treatment characteristics, health rating, lifestyle, employment, and perception of intravenous infusions and the BioAdvance program...
February 2017: Managed Care
https://www.readbyqxmd.com/read/28208257/hydrophilic-interaction-chromatography-hyphenated-with-mass-spectrometry-a-powerful-analytical-tool-for-the-comparison-of-originator-and-biosimilar-therapeutic-monoclonal-antibodies-at-the-middle-up-level-of-analysis
#17
Valentina D'Atri, Szabolcs Fekete, Alain Beck, Matthew Lauber, Davy Guillarme
The development and approval processes of biosimilar mAbs depend on their comparability to originators. Therefore, analytical comparisons are required to assess structural features and post-translational modifications (PTM) and thereby minimize the risk of being clinically meaningful differences between biosimilar and originator drug products. The glycosylation pattern of mAbs is considered to be an important critical quality attribute (CQA), and several analytical approaches have been proposed that facilitate characterizing and monitoring a glycosylation profile, albeit mainly at a glycan and glycopeptide level of analysis...
February 7, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28175254/p661-comparable-clinical-efficacy-safety-and-immunogenicity-of-infliximab-biosimilar-ct-p13-after-transition-from-reference-infliximab-remicade%C3%A2-in-children-with-established-inflammatory-bowel-disease-a-multi-centre-prospective-observational-study
#18
M Sladek, A Vultaggio, S Ghione, F Nencini, A Matucci, S Pratesi, F Zanieri, P M Maggi, M Paci, K Ponanta-Gawron, K Kulig, A Wasilewska, P Lionetti
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175207/p632-comparative-analysis-of-the-pharmacokinetics-of-inflectra%C3%A2-biosimilar-with-remicade%C3%A2-in-the-induction-phase-of-remission-in-patients-with-crohn-s-disease
#19
G Juan, M Mora, A Alvariño, N Maroto, I Ferrer, E Hinojosa, M D Hinojosa, P Ferrandis, J Hinojosa
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175088/p383-increasing-treatment-time-on-remicade%C3%A2-infliximab-predicts-subsequent-long-term-retention-in-stable-infliximab-inflammatory-bowel-disease-patients-in-canada
#20
J K Marshall, A M Marrache, E Ewara
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
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