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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
#1
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...
March 9, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28273042/bioadvance-patient-support-program-survey-positive-perception-of-intravenous-infusions-of-inflixmab
#2
(no author information available yet)
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
#3
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
#4
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
#5
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
#6
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
https://www.readbyqxmd.com/read/28172988/p545-clinical-outcomes-following-a-switch-from-remicade%C3%A2-to-the-biosimilar-ct-p13-in-inflammatory-bowel-disease-patients-in-clinical-remission-preliminary-results
#7
L N Guerrero Puente, E Iglesias Flores, J M Benítez Cantero, M J Cárdenas Aranzana, R Medina Medina, I Salgueiro Rodríguez, P Aguilar Melero, B Manzanares Martin, V García-Sánchez
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172986/p663-switching-from-remicade%C3%A2-to-biosimilar-ct-p13-in-inflammatory-bowel-disease-patients-one-year-follow-up-of-a-prospective-observational-cohort-study
#8
L Smits, A Grelack, J Drenth, D de Jong, R Boshuizen, A van Esch, L Derikx, F Hoentjen
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28147374/experience-with-biosimilar-infliximab-remsima%C3%A2-in-norway
#9
Jørgen Jahnsen, Kristin Kaasen Jørgensen
BACKGROUND: The first monoclonal antibody biosimilar to be used in clinical practice is the tumour necrosis factor-alpha inhibitor Remsima® (CT-P13). The drug is approved for all indications as the originator infliximab (Remicade®) although clinical efficacy has been demonstrated only in rheumatic diseases. Since the fall of 2013, Remsima® has been available in Norway and from January 2014, it has been the drug of choice when initiating biological treatment in biologics naïve patients with inflammatory bowel disease (IBD)...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28147370/does-the-introduction-of-biosimilars-change-our-understanding-about-treatment-modalities-for-inflammatory-bowel-disease
#10
L Buer, M L Høivik, A W Medhus, B Moum
BACKGROUND: Biological agents, mainly tumor necrosis factor-α inhibitors, play an important role in the treatment of inflammatory bowel disease (IBD). These drugs are expensive and constitute a major cost in the IBD care. In 2013, the first biosimilar monoclonal antibody, infliximab (IFX), was approved in the EU. Key Messages: There has been considerable skepticism regarding the use of biosimilars. Both clinicians and patients have questioned the safety and efficacy of these new drugs...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28025307/five-year-safety-data-from-encore-a-european-observational-safety-registry-for-adults-with-crohn-s-disease-treated-with-infliximab-remicade%C3%A2-or-conventional-therapy
#11
Geert D'Haens, Walter Reinisch, Jean-Frederic Colombel, Julian Panes, Subrata Ghosh, Cosimo Prantera, Stefan Lindgren, Daniel W Hommes, Zhiping Huang, Judith Boice, Susan Huyck, Freddy Cornillie
BACKGROUND AND AIMS: The ENCORE registry aimed at comparing the long-term safety of Crohn's disease [CD] treatment with infliximab [Remicade(®)] and with conventional therapies in real-world clinical practice. METHODS: The 5-year, prospective, observational ENCORE registry followed patients with CD in nine European countries, who received treatment with infliximab, conventional therapies, or switched to infliximab from conventional therapy. Adverse events [AEs] in pre-specified categories and serious AEs were recorded at least every 6 months of the 5-year observation period...
December 26, 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28005456/physicochemical-and-biological-characterization-of-sb2-a-biosimilar-of-remicade%C3%A2-infliximab
#12
Juyong Hong, Yuhwa Lee, Changsoo Lee, Suhyeon Eo, Soyeon Kim, Nayoung Lee, Jongmin Park, Seungkyu Park, Donghyuck Seo, Min Jeong, Youngji Lee, Soojeong Yeon, George Bou-Assaf, Zoran Sosic, Wei Zhang, Orlando Jaquez
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product. Biosimilarity to the reference product (RP) in terms of quality characteristics, such as physicochemical and biological properties, safety, and efficacy, based on a comprehensive comparability exercise needs to be established. SB2 (Flixabi® and Renflexis®) is a biosimilar to Remicade® (infliximab). The development of SB2 was performed in accordance with relevant guidelines of the International Conference on Harmonisation, the European Medicines Agency, and the United States Food and Drug Administration...
February 2017: MAbs
https://www.readbyqxmd.com/read/27971687/cost-of-switching-from-an-originator-biologic-remicade-to-a-biosimilar
#13
C N Brown, E McCann
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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
#14
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/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
#15
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/27660339/switching-from-remicade%C3%A2-to-remsima%C3%A2-is-well-tolerated-and-feasible-a-prospective-open-label-study
#16
Lydia C T Buer, Bjørn A Moum, Milada Cvancarova, David J Warren, Asle W Medhus, Marte Lie Høivik
BACKGROUND AND AIMS: A biosimilar version of infliximab [CT-P13/Remsima®] recently entered the European market. The clinical data on its use in inflammatory bowel disease [IBD] are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade to Remsima in a real-life IBD population. METHODS: All adult patients who were treated with Remicade in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima...
September 22, 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/27650650/infliximab-biosimilar-ct-p13-infliximab-dyyb-a-review-in-autoimmune-inflammatory-diseases
#17
REVIEW
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27600137/comparisons-of-serum-infliximab-and-antibodies-to-infliximab-tests-used-in-inflammatory-bowel-disease-clinical-trials-of-remicade%C3%A2
#18
Joseph C Marini, Jocelyn Sendecki, Freddy Cornillie, John W Popp, Shawn Black, Marion Blank, Ann Gils, Thomas Van Stappen, Dörte Hamann, Theo Rispens, Lina Thérien, Kelly Chun, Gopi Shankar
Monitoring infliximab (IFX) concentrations and antibodies-to-IFX (ATI) titers during inflammatory bowel disease treatment may allow more informed decisions in assessing exposure/response and determining appropriate dosing. To aid in interpreting results from different commercial tests in the context of Janssen's published Remicade® results, the reliability of Janssen's IFX and ATI assays was compared with commercial assays from KU Leuven, Sanquin, Dynacare, and LabCorp. Test results were independently reported to Janssen...
January 2017: AAPS Journal
https://www.readbyqxmd.com/read/27585978/nonclinical-evaluation-of-pf-06438179-a-potential-biosimilar-to-remicade-%C3%A2-infliximab
#19
Mazin Derzi, Theodore R Johnson, Ahmed M Shoieb, Hugh D Conlon, Penny Sharpe, Andrew Saati, Sarah Koob, Michael W Bolt, Leslie G Lorello, Jim McNally, Carol F Kirchhoff, Teresa A Smolarek, Michael W Leach
INTRODUCTION: PF-06438179, a potential biosimilar to Remicade(®) (infliximab, Janssen Biotech, Inc.), is a chimeric mouse-human monoclonal antibody targeting human tumor necrosis factor alpha (TNF). METHODS: Analytical (small subset reported here) and nonclinical studies compared the structural, functional, and in vivo nonclinical similarity of PF-06438179 with Remicade sourced from the United States (infliximab-US) and/or European Union (infliximab-EU). RESULTS: The peptide map profiles were superimposable, and peptide masses were the same, indicating identical amino acid sequences...
November 2016: Advances in Therapy
https://www.readbyqxmd.com/read/27435444/ct-p13-inflectra%C3%A2-remsima%C3%A2-monitoring-in-patients-with-inflammatory-bowel-disease
#20
Kornelius Schulze, Nadine Koppka, Frederik Lutter, Gunnar Brandhorst, Stefan Schreiber, Ulf Helwig
The approval of infliximab biosimilars Remsima™ and Inflectra™ (CT-P13) for patients with inflammatory bowel disease (IBD) is a promising step to reduce treatment costs. Since monitoring of Remicade™ serum trough levels and anti-Remicade™ immunogenicity hold an important significance in treatment modalities, no data about monitoring of drug serum trough levels or anti-drug antibody levels in IBD patients treated with Remsima™ or Inflectra™ are present to date. Therefore, in this study we applied a Remicade™-validated ELISA to determine drug serum levels of Remsima™ or Inflectra™...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
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