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https://www.readbyqxmd.com/read/29606565/infliximab-biosimilar-ct-p13-for-inflammatory-bowel-disease
#1
Stefanos Bonovas, Laurent Peyrin-Biroulet, Silvio Danese
No abstract text is available yet for this article.
March 29, 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29606564/serum-concentrations-after-switching-from-originator-infliximab-to-the-biosimilar-ct-p13-in-patients-with-quiescent-inflammatory-bowel-disease-secure-an-open-label-multicentre-phase-4-non-inferiority-trial
#2
Anne S Strik, Wim van de Vrie, Joanne P J Bloemsaat-Minekus, Michael Nurmohamed, Peter J J Bossuyt, Alexander Bodelier, Theo Rispens, Yvonne J B van Megen, Geert R D'Haens
BACKGROUND: Biological treatment of chronic inflammatory diseases has improved patient outcomes but increased health-care costs. Switching patients from originator infliximab to a biosimilar can reduce costs, but prospective data about pharmacokinetics and potential immunogenicity are scarce. We aimed to show that infliximab serum concentrations with biosimilar CT-P13 are non-inferior to those with originator infliximab after switching from originator infliximab in patients with inflammatory bowel disease...
March 29, 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29538037/switching-to-a-infliximab-biosimilar-short-term-results-of-clinical-monitoring-in-patients-with-inflammatory-bowel-disease
#3
Lisette Binkhorst, Annemieke Sobels, Rogier Stuyt, Elsbeth M Westerman, Rachel L West
OBJECTIVE: Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab. PATIENTS AND METHODS: At two large general hospitals in The Netherlands, adult patients with a diagnosis of Crohn's disease or ulcerative colitis being treated with Remicade were asked to switch to the biosimilar infliximab (CT-P13)...
March 13, 2018: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29527903/update-of-the-sepd-position-statement-on-the-use-of-biosimilars-for-inflammatory-bowel-disease
#4
Federico Argüelles Arias, Joaquín Hinojosa Del Val, Isabel Vera Mendoza
In 2013, the European Medicines Agency (EMA) approved the biosimilar infliximab (CT-P13) for the full range of indications of the originator product, based on data from two trials conducted in rheumatoid arthritis and ankylosing spondylitis. The same year, our Society published a position statement that was later reviewed.
March 12, 2018: Revista Española de Enfermedades Digestivas
https://www.readbyqxmd.com/read/29462402/full-interchangeability-in-regards-to-immunogenicity-between-the-infliximab-reference-biologic-and-biosimilars-ct-p13-and-sb2-in-inflammatory-bowel-disease
#5
Konstantinos H Katsanos, Konstantinos Papamichael, Adam S Cheifetz, Dimitrios K Christodoulou
No abstract text is available yet for this article.
February 15, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29462398/full-interchangeability-in-regard-to-immunogenicity-between-the-infliximab-reference-biologic-and-biosimilars-ct-p13-and-sb2-in-inflammatory-bowel-disease
#6
Gionata Fiorino, M Begoña Ruiz-Argüello, Ainara Maguregui, Daniel Nagore, Carmen Correale, Simona Radice, Daniela Gilardi, Mariangela Allocca, Federica Furfaro, Antonio Martínez, Silvio Danese
Background: Infliximab (IFX) biosimilars CT-P13 and SB2 have comparable efficacy, safety, and immunogenicity to the originator Remicade (RMC). However, concerns about cross-switching patients between the 3 brands were raised in the absence of cross reactivity data between them. We aimed to determine whether antibodies to infliximab (ATI) in inflammatory bowel disease (IBD) patients cross-react with RMC, CT-P13, and SB2. Methods: Based on previous ATI status, samples from 34 patients participating in the BIOSIM01 study (13 RMC, 9 CT-P13, and 12 switchers) were selected...
February 15, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29461286/recent-advances-in-the-treatment-of-rheumatoid-arthritis
#7
Tina D Mahajan, Ted R Mikuls
PURPOSE OF REVIEW: Therapies for rheumatoid arthritis (RA) continue to expand rapidly. The purpose of this review is to discuss novel treatment options, including biosimilars, that are available, as well as to highlight promising agents in development. The purpose is also to discuss new emerging safety signals associated with these drugs and to discuss strategies in tapering therapy. RECENT FINDINGS: There are several novel RA therapies. These include the interleukin-6 (IL-6) receptor blocker sarilumab, which was approved in 2017...
May 2018: Current Opinion in Rheumatology
https://www.readbyqxmd.com/read/29439591/assessment-of-effectiveness-and-safety-of-biosimilar-infliximab-ct-p13-in-a-real-life-setting-for-treatment-of-patients-with-active-rheumatoid-arthritis-or-ankylosing-spondylitis
#8
Cătălin Codreanu, Klára Šírová, Katerina Jarošová, Anastas Batalov
OBJECTIVE: To assess the effectiveness and safety of infliximab biosimilar, CT-P13, administered in a real-life setting to adult patients with active rheumatoid arthritis (RA) or ankylosing spondylitis (AS). METHODS: This multicentre, non-interventional, observational study was conducted in Bulgaria, Czech Republic and Romania. A total of 151 patients with severe active RA (n = 81) or AS (n = 70) were enrolled and treated with CT-P13 for 24 weeks, according to current medical recommendations...
February 13, 2018: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/29390113/long-term-outcomes-after-switching-to-ct-p13-in-pediatric-onset-inflammatory-bowel-disease-a-single-center-prospective-observational-study
#9
Ben Kang, Yoon Lee, Kiwuk Lee, Young Ok Choi, Yon Ho Choe
Background: The relatively high cost and patent expiry of infliximab, an anti-tumor necrosis factor monoclonal antibody used in inflammatory bowel disease (IBD), has led to the development of biosimilar versions of the reference product (RP). This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP in pediatric-onset IBD patients. Methods: In this prospective observational study, patients with pediatric-onset IBD receiving maintenance infliximab RP were followed for 1 year after continuing infliximab RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group)...
January 30, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29310493/drug-concentrations-and-anti-drug-antibodies-during-treatment-with-biosimilar-infliximab-ct-p13-in-routine-care
#10
B Glintborg, T Kringelbach, N Bolstad, D J Warren, G Eng, I J Sørensen, A G Loft, O Hendricks, Imj Hansen, A Linauskas, H Nordin, S Kristensen, H Lindegaard, D V Jensen, G L Goll, E Høgdall, J Gehin, C Enevold, C H Nielsen, N S Krogh, J S Johansen, M L Hetland
No abstract text is available yet for this article.
January 9, 2018: Scandinavian Journal of Rheumatology
https://www.readbyqxmd.com/read/29274242/phosphorylation-of-intracellular-signaling-molecules-in-peripheral-blood-cells-from-psoriasis-patients-on-originator-or-biosimilar-infliximab
#11
A K Aarebrot, S M Solberg, R Davies, L I Bader, T D Holmes, S Gavasso, Y T Bryceson, R Jonsson, L F Sandvik, S Appel
BACKGROUND: Psoriasis vulgaris is a chronic, inflammatory skin disease characterized by a dysregulated immune response and it is associated with substantial systemic comorbidities. Biological drugs like tumor necrosis factor (TNF) inhibitors can ameliorate the disease but are expensive. Biosimilar drugs have the same amino acid sequence as the originator, but differences in manufacturing can affect biological activity, efficacy and tolerability. OBJECTIVES: We aimed to explore potential differences in intracellular phosphorylation of signaling molecules in peripheral blood cells from TNF inhibitor infliximab treated psoriasis patients compared to healthy controls, and to investigate if the phosphorylation pattern was influenced by switching from originator infliximab to biosimilar CT-P13...
December 23, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/29189135/the-experience-with-biosimilars-of-infliximab-in-rheumatic-diseases
#12
Valderilio Feijo Azevedo, Igor Age Kos, Leonardo Ariello
BACKGROUND: Infliximab biosimilars are the first biosimilars of monoclonal antibodies approved by the main regulatory agencies. Up to the present day, two infliximab biosimilars have been approved: CT-P13 (Celltrion), and SB2 (Biogen), but other companies have been developing candidate infliximab biosimilars that are on clinical trials: PF 06438179 (Pfizer), the ABP710 (bioCentury/Amgen) the BCD055 (JSC Biocad Russica) and BOW015 (Epirus). METHODS: We have made a literature search in MedLine database using the key words [Infliximab] and [biosimilars] and [rheumatic diseases] and [rheumatisms]...
2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29189127/biosimilars-from-extrapolation-into-off-label-use
#13
Sizheng Zhao, Jagdish R Nair, Robert J Moots
BACKGROUND: Biologic drugs have revolutionised the management of many inflammatory conditions. Patent expirations have stimulated development of highly similar but non-identical molecules, the biosimilars. Extrapolation of indications is a key concept in the development of biosimilars. However, this has been met with concerns around mechanisms of action, equivalence in efficacy and immunogenicity, which are reviewed in this article. METHODS: Narrative overview composed from literature search and the authors' experience...
November 29, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29172717/comparative-effectiveness-of-the-biosimilar-ct-p13
#14
Dae Hyun Yoo
The first biosimilar infliximab, CT-P13 (infliximab-dyyb) has been used for the treatment of inflammatory diseases for 4 years. CT-P13 has highly similar efficacy and safety profiles with a lower price than the originator infliximab and has been approved in 81 countries. Despite approval for clinical use, some knowledge gaps still limit the widespread and pertinent use of biosimilar CT-P13. One of the most important factors for proper utilization of CT-P13 for the treatment of immune-mediated inflammatory diseases is confidence in CT-P13, which could be enhanced by scientific evidence supporting the biosimilarity of CT-P13...
November 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/29154920/switching-from-originator-infliximab-to-biosimilar-ct-p13-in-real-life-the-weight-of-patient-acceptance
#15
Marc Scherlinger, Vincent Germain, Céline Labadie, Thomas Barnetche, Marie-Elise Truchetet, Bernard Bannwarth, Nadia Mehsen-Cetre, Christophe Richez, Thierry Schaeverbeke
OBJECTIVE: To explore acceptance and retention rate of biosimilar CT-P13 after switching from originator infliximab (OI) in patients with various rheumatic diseases. METHODS: Patients with stable rheumatoid arthritis (RA), ankylosing spondylitis (AS) or psoriatic arthritis (PsA) under OI were proposed to switch to CT-P13 at the same regimen. A prospective cohort of infliximab-naïve patients beginning CT-P13 and a retrospective cohort of patients treated with OI were used as controls...
November 14, 2017: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/29124994/a-review-on-biosimilar-infliximab-ct-p13-in-the-treatment-of-inflammatory-bowel-disease
#16
Klaudia Farkas, Tamás Molnár
The introduction of biological agents has led to significant changes in the treatment of inflammatory bowel disease (IBD). The relatively high price of infliximab (IFX) and the expiration of the patents led to the introduction of biosimilar agents. CT-P13 was the first IFX biosimilar approved in the same indications as the reference product; however, the approval was based on randomized clinical trials conducted in patients with rheumatoid arthritis and ankylosing spondylitis. In the past 2-3 years, new findings from prospective observational studies supported the short-, medium- and long-term clinical efficacy and safety of CT-P13 in patients with IBD...
February 2018: Immunotherapy
https://www.readbyqxmd.com/read/29079905/anti-tumour-necrosis-factor-therapy-for-paediatric-crohn-s-disease-improved-benefits-through-treatment-optimisation-deeper-understanding-of-its-risks-and-reduced-costs-due-to-biosimilar-availability
#17
M A Cozijnsen, J N Samsom, L de Ridder
Antibodies directed to tumour necrosis factor-α (TNF-α) are very effective in treating paediatric Crohn's disease (CD). Over the last few years, research has provided important new insights into how to optimise this treatment's effectiveness. Research on predictors for anti-TNF treatment responsiveness has revealed potential markers, but data on their accuracy in paediatric CD patients are lagging behind. Also, new evidence has become available on the safety profile of anti-TNF antibodies that suggests the assumed increased malignancy risk seen in patients on anti-TNF and thiopurine combination treatment may be linked more to thiopurine use and not to anti-TNF treatment...
February 2018: Paediatric Drugs
https://www.readbyqxmd.com/read/29045077/subjective-complaints-as-the-main-reason-for-biosimilar-discontinuation-after-open-label-transition-from-reference-infliximab-to-biosimilar-infliximab
#18
Lieke Tweehuysen, Bart J F van den Bemt, Iris L van Ingen, Alphons J L de Jong, Willemijn H van der Laan, Frank H J van den Hoogen, Alfons A den Broeder
OBJECTIVE: To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity, and safety in daily practice after transitioning treatment from original reference infliximab (Remicade [REM]) to a biosimilar infliximab (CT-P13 [Remsima; Inflectra]) in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. METHODS: Of the initial 222 REM-treated patients, 192 agreed to transition to CT-P13 and were included in this multicenter prospective cohort study...
January 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28932268/therapeutic-drug-monitoring-of-ct-p13-a-comparison-of-four-different-immunoassays
#19
Joana Afonso, Helena Tavares de Sousa, Isadora Rosa, João Carvalho, Cláudia Camila Dias, Fernando Magro
BACKGROUND: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. METHODS: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28927246/biosimilar-ct-p13-in-treating-ulcerative-colitis-in-the-real-world
#20
Davide G Ribaldone, Marco Astegiano
No abstract text is available yet for this article.
December 2017: Minerva Gastroenterologica e Dietologica
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