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Biosimilars crohn's

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https://www.readbyqxmd.com/read/28542043/induction-therapy-with-biosimilar-infliximab-in-children-with-crohn-s-disease
#1
Joanna Sieczkowska-Golub, Monika Meglicka, Anna Plocek, Aleksandra Banaszkiewicz, Dorota Jarzębicka, Ewa Toporowska-Kowalska, Agnieszka Gawronska, Grzegorz Oracz, Jaroslaw Kierkus
INTRODUCTION: In most European countries, an infliximab biosimilar (CT-P13) is currently in common use. In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab. CT-P13 was licensed for use in patients with Crohn's diseases (CD) based on the extrapolation of data from preclinical studies and clinical trials in rheumatology indications. The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients...
May 24, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28502609/switching-from-originator-infliximab-to-biosimilar-ct-p13-compared-with-maintained-treatment-with-originator-infliximab-nor-switch-a-52-week-randomised-double-blind-non-inferiority-trial
#2
Kristin K Jørgensen, Inge C Olsen, Guro L Goll, Merete Lorentzen, Nils Bolstad, Espen A Haavardsholm, Knut E A Lundin, Cato Mørk, Jørgen Jahnsen, Tore K Kvien
BACKGROUND: TNF inhibitors have improved treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, but are expensive therapies. The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. METHODS: The study is a randomised, non-inferiority, double-blind, phase 4 trial with 52 weeks of follow-up...
May 11, 2017: Lancet
https://www.readbyqxmd.com/read/28434387/cost-utility-of-biological-treatment-sequences-for-luminal-crohn-s-disease-in-europe
#3
Fanni Rencz, László Gulácsi, Márta Péntek, Krisztina B Gecse, Axel Dignass, Jonas Halfvarson, Fernando Gomollón, Petra Baji, Laurent Peyrin-Biroulet, Péter L Lakatos, Valentin Brodszky
OBJECTIVES: To compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials. Country-specific unit costs, discount rates and a third-party payer perspective were applied...
April 24, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28410403/assessing-gastroenterologist-and-patient-acceptance-of-biosimilars-in-ulcerative-colitis-and-crohn-s-disease-across-germany
#4
Emma Sullivan, James Piercy, John Waller, Christopher M Black, Sumesh Kachroo
OBJECTIVES: This study examined gastroenterologists' motivation for prescribing biosimilars, assessed their treatment preferences in relation to prescribing behaviour, and explored patient attitudes to biosimilars. METHODS: Data were taken from the Adelphi Real World Biosimilars Programme, a real-world, cross-sectional study undertaken in 2015-2016 with German gastroenterologists and patients with ulcerative colitis or Crohn's disease. Gastroenterologists provided data on their prescribing behaviour and attitudes towards biosimilars, and invited the next eight eligible consecutive consulting patients to complete a detailed questionnaire...
2017: PloS One
https://www.readbyqxmd.com/read/28393687/biosimilars-for-the-management-of-inflammatory-bowel-diseases-economic-considerations
#5
Laszlo Gulacsi, Marta Pentek, Fanni Rencz, Valentin Brodszky, Petra Baji, Zsuzsanna Vegh, Krisztina B Gecse, Silvio Danese, Laurent Peyrin-Biroulet, Peter L Lakatos
Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals, due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals...
April 6, 2017: Current Medicinal 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
#6
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/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
#7
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: To perform 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...
April 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
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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...
June 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#17
REVIEW
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...
April 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
#18
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
#19
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
#20
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
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