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https://www.readbyqxmd.com/read/28239873/systematic-review-with-meta-analysis-the-efficacy-and-safety-of-ct-p13-a-biosimilar-of-anti-tumour-necrosis-factor-%C3%AE-agent-infliximab-in-inflammatory-bowel-diseases
#1
REVIEW
Y Komaki, A Yamada, F Komaki, D Micic, A Ido, A Sakuraba
BACKGROUND: Biosimilars of anti-tumour necrosis factor (TNF)-α agents have now become clinically available for the treatment of inflammatory bowel diseases (IBD). AIM: We performed a systematic review and meta-analysis to evaluate the efficacy and safety of biosimilars of anti-TNF-α agents in patients with IBD. METHODS: Electronic databases were searched. The outcomes were the pooled rates of clinical response or remission, sustained clinical response or remission, and adverse events in patients with IBD induced with or switched to biosimilars of anti-TNF-α agents...
February 26, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28175221/p665-unchanged-infliximab-serum-concentrations-after-switching-from-the-reference-infliximab-to-the-biosimilar-ct-p13-in-patients-with-quiescent-crohn-s-disease-a-prospective-study
#2
A Strik, W van de Vrie, Y van Megen, J Bloemsaat-Minekus, T Rispens, G D'Haens
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
#3
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/28175199/p675-infliximab-biosimilar-ct-p13-therapy-is-effective-in-maintaining-clinical-remission-in-crohn-s-disease-and-ulcerative-colitis-54-week-data
#4
T Molnár, K Farkas, M Rutka, T Ferenci, F Nagy, A Bálint, R Bor, A Milassin, A Fábián, Z Végh, Z Kürti, P L Lakatos, Z Szepes
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172698/p425-biosimilar-infliximab-in-real-life-crohn-s-disease-treatment-in-anti-tnf-alpha-na%C3%A3-ve-and-non-na%C3%A3-ve-patients-in-comparison-to-biologic-originator-a%C3%A2-comparative-observational-cohort-study
#5
M Kaniewska, A Moniuszko, K Maciejewska, G Rydzewska
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172472/dop062-biosimilar-infliximab-ct-p13-is-not-inferior-to-originator-infliximab-explorative-ibd-subgroup-analyses-in-crohn-s-disease-and-ulcerative-colitis-from-the-nor-switch-trial
#6
K K Jørgensen, I C Olsen, G L Goll, M Lorentzen, N Bolstad, I P Berset, E A Haavardsholm, K E Lundin, C Mørk, T K Kvien, J Jahnsen
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172425/dop061-phase-iii-randomised-double-blind-controlled-trial-to-compare-biosimilar-infliximab-ct-p13-with-innovator-infliximab-in-patients-with-active-crohn-s-disease-early-efficacy-and-safety-results
#7
Y H Kim, B D Ye, M Pesegova, O Alexeeva, M Osipenko, A Lahat, A Dorofeyev, A Salamon, S Fishman, O Levchenko, J H Cheon, M L Scribano, R-B Mateescu, K M Lee, C S Eun, S J Lee, S Y Lee
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
#8
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/28147356/infliximab-biosimilar-remsima%C3%A2-in-therapy-of-inflammatory-bowel-diseases-patients-experience-from-one-tertiary-inflammatory-bowel-diseases-centre
#9
M Kolar, D Duricova, M Bortlik, V Hruba, N Machkova, K Mitrova, K Malickova, M Lukas, Milan Lukas
BACKGROUND: The evidence on the efficacy and safety of biosimilar infliximab (IFX) in patients with inflammatory bowel diseases (IBD) is sparse. METHODS: Consecutive IBD patients visiting our centre were included. One cohort composed of prospectively followed patients who were switched from original to biosimilar IFX between January and March 2015. The second cohort included retrospectively assessed anti-tumor necrosis factor α-naïve patients who started therapy between January 2015 and January 2016...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28130330/biosimilar-infliximab-in-inflammatory-bowel-disease-outcomes-of-a-managed-switching-programme
#10
Violeta Razanskaite, Marion Bettey, Louise Downey, Julia Wright, James Callaghan, Miles Rush, Simon Whiteoak, Sarah Ker, Kim Perry, Caron Underhill, Eren Efrem, Iftikar Ahmed, Fraser Cummings
BACKGROUND AND AIMS: Biosimilar infliximab CT-P13 offers the potential for large drug acquisition cost savings. However, there are limited published data regarding its efficacy, safety, and immunogenicity in inflammatory bowel disease [IBD], particularly in switching IBD patients from originator to biosimilar infliximab. We present the outcomes of a service evaluation of switching IBD patients established on originator infliximab to biosimilar, using a managed switching programme funded via a gain share agreement in a UK teaching hospital...
January 27, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#11
Sean McConachie, Sheila M Wilhelm, Pramodini B Kale-Pradhan
Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states...
January 29, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28092307/the-prosit-bio-cohort-a-prospective-observational-study-of-patients-with-inflammatory-bowel-disease-treated-with-infliximab-biosimilar
#12
Gionata Fiorino, Natalia Manetti, Alessandro Armuzzi, Ambrogio Orlando, Angela Variola, Stefanos Bonovas, Fabrizio Bossa, Giovanni Maconi, Renata DʼIncà, Paolo Lionetti, Laura Cantoro, Walter Fries, Maria L Annunziata, Francesco Costa, Maria M Terpin, Livia Biancone, Claudio C Cortelezzi, Arnaldo Amato, Sandro Ardizzone, Silvio Danese, Luisa Guidi, Giulia Rizzuto, Arianna Massella, Angelo Andriulli, Alessandro Massari, Greta Lorenzon, Silvia Ghione, Anna Kohn, Agostino Ventra, Vito Annese
BACKGROUND: Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease. METHODS: A prospective, multicenter, cohort study using a structured database. RESULTS: Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28035633/infliximab-biosimilars-in-the-treatment-of-inflammatory-bowel-diseases-a-systematic-review
#13
REVIEW
Massimo Radin, Savino Sciascia, Dario Roccatello, Maria Jose Cuadrado
BACKGROUND: Biological therapies represent a fundamental innovation for the management of inflammatory bowel diseases (IBD). However, many biological originators have reached, or are about to reach, patent expiry and long-term therapy costs have become progressively unsustainable. CT-P13, a biosimilar of the anti-tumor necrosis factor (anti-TNF) monoclonal antibody infliximab, might represent a significant alternative to its originator, with the potential to decrease medical care costs and, therefore, become available to a large number of patients...
February 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27885553/biosimilars-for-the-treatment-of-chronic-inflammatory-diseases-a-systematic-review-of-published-evidence
#14
REVIEW
Ira Jacobs, Danielle Petersel, Leah Isakov, Sadiq Lula, K Lea Sewell
BACKGROUND: Clinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications. OBJECTIVES: The objective of this study was to systematically collate all published data in order to assess the weight (quantity and quality) of available evidence for each molecule and inform and support healthcare decision-making in chronic inflammatory diseases. METHODS: MEDLINE(®), EMBASE(®), and ISI Web of Science(®) were searched to September 2015...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27758715/efficacy-safety-and-immunogenicity-of-biosimilars-in-inflammatory-bowel-diseases-a-systematic-review
#15
Laura Martelli, Laurent Peyrin-Biroulet
BACKGROUND: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD...
October 14, 2016: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/27711946/-biosimilars-in-inflammatory-bowel-disease
#16
B Siegmund, R Atreya, B Bokemeyer, W Kruis, J Mudter, C Sander, S Schreiber, W Reindl, S Zeissig, T Kucharzik
After the expiry date of the patent protection for Infliximab in 2013, the biosimilar CT‑P13 was approved for indications in Crohn's disease and ulcerative colitis in adults as well as in children. The approval has been based on two randomized clinical studies indicating equivalence for the biosimilar with regard to pharmacokinetics, efficacy, as well as side-effects. The clinical experience since, in addition to multiple non-randomized studies, indicate a comparable efficacy and immunogenicity of the Infliximab biosimilar CT-P13 in inflammatory bowel disease...
November 2016: Zeitschrift Für Gastroenterologie
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
#17
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
#18
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/27604979/are-we-ready-to-abandon-placebo-in-randomised-clinical-trials-for-inflammatory-bowel-disease-pros-and-cons
#19
Silvio Danese, Elmer Schabel, Johan Masure, Scott Plevy, Stefan Schreiber
The role of placebo in clinical trials for drug development in inflammatory bowel disease [IBD] was the topic of a panel discussion held during the 10th Congress of the European Crohn's and Colitis Organisation [ECCO], in Barcelona, Spain, in 2015. Panellists discussed a number of issues around placebo-controlled trials in IBD, noting issues such as difficulties with recruitment, leading to less then representative patient populations in clinical studies. It was noted that, whereas the easiest answer may be to drop placebo, it is much more complicated than that...
September 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/27587010/inflammatory-bowel-diseases-crohn%C3%A2-s-disease-and-ulcerative-colitis-cost-of-treatment-in-serbia-and-the-implications
#20
Marina Kostić, Ljiljan Djakovic, Raša Šujić, Brian Godman, Slobodan M Janković
BACKGROUND: Although the costs of treating inflammatory bowel disease (IBD) in developed countries are well established, they remain largely unknown in countries with recent histories of socio-economic transition including Serbia. OBJECTIVE: To estimate the costs of treatment including the resources used by patients with IBD in Serbia from a societal perspective. This includes both Crohn's disease and ulcerative colitis. METHODS: This cost-of-illness study was conducted to identify direct, indirect and out-of-pocket costs of treating patients with IBD in Serbia...
February 2017: Applied Health Economics and Health Policy
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