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https://www.readbyqxmd.com/read/29697550/use-of-infliximab-biosimilar-versus-originator-in-a-paediatric-united-kingdom-inflammatory-bowel-disease-induction-cohort
#1
Neil Chanchlani, Kajal Mortier, Linda J Williams, Rafeeq Muhammed, Marcus K H Auth, Mike Cosgrove, Andrew Fagbemi, John Fell, Sonny Chong, Veena Zamvar, Warren Hyer, W Michael Bisset, Mary-Anne Morris, Astor Rodrigues, Sally G Mitton, Su Bunn, R Mark Beattie, Anne Willmott, David C Wilson, Richard K Russell
OBJECTIVES: To summarize short-term effectiveness, safety, and cost of using infliximab biosimilar (IFX-B) drugs, (Inflectra™ and Remsima™) compared to originator infliximab (IFX-O) (Remicade®) in biologic naive pediatric inflammatory bowel disease in the United Kingdom. METHODS: Prospective audit of patients starting anti-TNF therapy. Disease severity, response to treatment, and remission rate was measured by Pediatric Crohn's Disease Activity Index (PCDAI) and/or Physician Global Assessment (PGA)...
April 23, 2018: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/29685744/update-on-biosimilars-in-inflammatory-bowel-disease-position-and-recommendations-in-mexico
#2
A Mayoral-Zavala, A Esquivel-Aguilar, C M Del Real-Calzada, Y Gutiérrez-Grobe, J Ramos-García, J L Rocha-Ramírez, M F Rojas-Illanes, B Rubio-Martínez, X Sánchez-Chávez, J K Yamamoto-Furusho
The biotechnology-derived medicines known as biosimilars are defined as non-originator treatments that have demonstrated quality, efficacy, and safety comparable to the reference biologic drug. Clinical trials have shown that the infliximab biosimilar, CT-P13, and the candidates for the adalimumab biosimilars, ABP 501 and ZRC 3197, are not significantly different, with respect to efficacy and safety, from the originator drugs in patients with other autoimmune diseases. However, controversy has arisen over the use of biosimilars in inflammatory bowel disease, due to the incipient evidence not only in patients with no previous biotechnology treatment, but also in patients in remission, that could be switched to a biosimilar for non-medical reasons...
April 20, 2018: Revista de Gastroenterología de México
https://www.readbyqxmd.com/read/29623492/therapy-for-crohn-s-disease-a-review-of-recent-developments
#3
REVIEW
Gregory J Eustace, Gil Y Melmed
PURPOSE OF REVIEW: To review recent advances in the treatment of Crohn's disease. RECENT FINDINGS: Several key advances are highlighted, including the increasing role of treatment algorithms and where new therapies can be used most effectively, the appropriate use of therapeutic drug monitoring, optimal management of post-surgical patients, and the role of multi-disciplinary clinics. The last several years have seen a number of exciting developments in the field of Crohn's therapy...
April 5, 2018: Current Gastroenterology Reports
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
#4
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
#5
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/29519679/acute-severe-pulmonary-toxicity-due-to-biosimilar-infliximab-in-a-crohn-s-disease-patient
#6
R Ríos León, A Jaureguizar Oriol, A López-Sanromán, D Jiménez Castro, R Nieto Royo, A Albillos Martínez
No abstract text is available yet for this article.
March 5, 2018: Gastroenterología y Hepatología
https://www.readbyqxmd.com/read/29511561/cost-effectiveness-of-biological-treatment-sequences-for-fistulising-crohn-s-disease-across-europe
#7
Petra Baji, László Gulácsi, Valentin Brodszky, Zsuzsanna Végh, Silvio Danese, Peter M Irving, Laurent Peyrin-Biroulet, Stefan Schreiber, Fanni Rencz, Péter L Lakatos, Márta Péntek
Background: In clinical practice, treatment sequences of biologicals are applied for active fistulising Crohn's disease, however underlying health economic analyses are lacking. Objective: The purpose of this study was to analyse the cost-effectiveness of different biological sequences including infliximab, biosimilar-infliximab, adalimumab and vedolizumab in nine European countries. Methods: A Markov model was developed to compare treatment sequences of one, two and three biologicals from the payer's perspective on a five-year time horizon...
March 2018: United European Gastroenterology Journal
https://www.readbyqxmd.com/read/29492747/biosimilars-in-the-treatment-of-inflammatory-bowel-disease-supporting-evidence-in-2017
#8
REVIEW
Frank I Scott, Gary R Lichtenstein
PURPOSE OF REVIEW: Monoclonal antibodies targeting tumor necrosis factor-alpha, integrin molecules, and interleukin-12/23 have become backbone therapies for Crohn's disease and ulcerative colitis. While clinically effective, these biologic therapies come with significant expense, contributing to overall healthcare spending in the USA. Biosimilars have the potential to significantly reduce expenditures secondary to the use of biologic medications such as infliximab and adalimumab, though their complicated manufacturing process results in inherent differences in structure when compared to the originator compounds...
March 2018: Current Treatment Options in Gastroenterology
https://www.readbyqxmd.com/read/29368188/the-nocebo-effect-challenges-the-non-medical-infliximab-switch-in-practice
#9
N W Boone, L Liu, M J Romberg-Camps, L Duijsens, C Houwen, P H M van der Kuy, R Janknegt, R Peeters, R B M Landewé, B Winkens, A A van Bodegraven
BACKGROUND: In clinical practice, non-medical switching of biological medication may provoke nocebo effects due to unexplained deterioration of therapeutic benefits. Indication extrapolation, idiosyncratic reactions, and interchangeability remain challenged in clinical practice after biosimilar approval by the European Medicines Agency. The principle of "first do no harm" may be challenged in a patient when switching from originator to biosimilar biological. AIM: To describe the 1-year results of a pragmatic study on infliximab biosimilar implementation in immune-mediated inflammatory disease patients on the basis of shared decision-making under effectiveness and safety monitoring...
January 24, 2018: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29349829/physicians-perspective-on-the-clinical-meaningfulness-of-inflammatory-bowel-disease-trial-results-an-international-organization-for-the-study-of-inflammatory-bowel-disease-ioibd-survey
#10
P Olivera, W J Sandborn, J Panés, C Baumann, G D'Haens, S Vermeire, S Danese, L Peyrin-Biroulet
BACKGROUND: Several novel compounds are being developed for inflammatory bowel diseases (IBD). In addition, biosimilar drugs are being approved. An increasing number of head-to-head, superiority and non-inferiority trials in patients with IBD are expected in the future. The clinical relevance of the magnitude of the effect size is often debated. AIM: To better understand physicians' perspectives on the clinical meaningfulness of IBD trial results. METHODS: We conducted an online survey among all IOIBD (International Organization for the Study of Inflammatory Bowel Diseases) members, asking their opinion on the clinical relevance of the results of IBD trials...
March 2018: Alimentary Pharmacology & Therapeutics
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
#11
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/28988215/biosimilar-infliximab-use-in-paediatric-ibd
#12
Lisa Richmond, Lee Curtis, Victoria Garrick, Pam Rogers, Michelle Wilson, Rachel Tayler, Paul Henderson, Richard Hansen, David C Wilson, Richard K Russell
BACKGROUND: Biosimilar infliximab became available in the UK in 2015. Paediatric experience to date on its use is limited. We prospectively evaluated the safety and efficacy of biosimilar infliximab (Remsima) in two paediatric gastroenterology networks in patients with inflammatory bowel disease. METHODS: Prospective clinical data were collected from laboratory reports, electronic patient records and case notes of 40 patients starting Remsima for the first time...
January 2018: Archives of Disease in Childhood
https://www.readbyqxmd.com/read/28974896/access-to-biologicals-in-crohn-s-disease-in-ten-european-countries
#13
Márta Péntek, Peter L Lakatos, Talitha Oorsprong, László Gulácsi, Milena Pavlova, Wim Groot, Fanni Rencz, Valentin Brodszky, Petra Baji, Crohn's Disease Research Group
AIM: To analyze access (availability, affordability and acceptability) to biologicals for Crohn's disease (CD) in ten European countries and to explore the associations between these dimensions, the uptake of biologicals and economic development. METHODS: A questionnaire-based survey combined with desk research was carried out in May 2016. Gastroenterologists from the Czech Republic, France, Germany, Hungary, Latvia, Poland, Romania, Slovakia, Spain and Sweden were invited to participate and provide data on the availability of biologicals/biosimilars, reimbursement criteria, clinical practice and prices, and use of biologicals...
September 14, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28973005/a-systematic-review-of-cost-effectiveness-studies-comparing-conventional-biological-and-surgical-interventions-for-inflammatory-bowel-disease
#14
REVIEW
Nadia Pillai, Mark Dusheiko, Bernard Burnand, Valérie Pittet
BACKGROUND: Inflammatory bowel disease (IBD) is a chronic disease placing a large health and economic burden on health systems worldwide. The treatment landscape is complex with multiple strategies to induce and maintain remission while avoiding long-term complications. The extent to which rising treatment costs, due to expensive biologic agents, are offset by improved outcomes and fewer hospitalisations and surgeries needs to be evaluated. This systematic review aimed to assess the cost-effectiveness of treatment strategies for IBD...
2017: PloS One
https://www.readbyqxmd.com/read/28961959/the-expanding-therapeutic-armamentarium-for-inflammatory-bowel-disease-how-to-choose-the-right-drug-s-for-our-patients
#15
Pieter Hindryckx, Niels Vande Casteele, Gregor Novak, Reena Khanna, Geert D'Haens, William J Sandborn, Silvio Danese, Vipul Jairath, Brian G Feagan
The therapeutic landscape for inflammatory bowel disease [IBD] is rapidly evolving. Two new biologic drugs, vedolizumab and ustekinumab, have recently entered the marketplace, the first biosimilars have been introduced, and several other agents are at an advanced stage of clinical development. In parallel, therapeutic goals have shifted from symptom control towards mucosal healing and prevention of bowel damage. In the coming years, gastroenterologists will be faced with unprecedented choices when selecting the best treatment for their patients with IBD...
January 5, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28922253/long-term-efficacy-safety-and-immunogenicity-of-biosimilar-infliximab-after-one-year-in-a-prospective-nationwide-cohort
#16
Lorant Gonczi, Krisztina B Gecse, Zsuzsanna Vegh, Zsuzsanna Kurti, Mariann Rutka, Klaudia Farkas, Petra A Golovics, Barbara D Lovasz, Janos Banai, Laszlo Bene, Bea Gasztonyi, Tunde Kristof, Laszlo Lakatos, Pal Miheller, Ferenc Nagy, Karoly Palatka, Maria Papp, Arpad Patai, Agnes Salamon, Tamas Szamosi, Zoltan Szepes, Gabor T Toth, Aron Vincze, Balazs Szalay, Tamas Molnar, Peter L Lakatos
BACKGROUND: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. METHODS: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC)...
November 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28902041/switching-from-reference-infliximab-to-ct-p13-in-patients-with-inflammatory-bowel-disease-12-months-results
#17
Federico Argüelles-Arias, Maria Fernanda Guerra Veloz, Raul Perea Amarillo, Angel Vilches-Arenas, Luisa Castro Laria, Belen Maldonado Pérez, Dina Chaaro Benallal, Antonio Benítez Roldán, Vicente Merino, Gabriel Ramirez, Miguel Angel Calleja-Hernández, Angel Caunedo Álvarez, Manuel Romero Gómez
BACKGROUND: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. MATERIALS AND METHODS: This was a prospective single-center observational study in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC)...
November 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28838273/switching-maintenance-infliximab-therapy-to-biosimilar-infliximab-in-inflammatory-bowel-disease-patients
#18
Anja Eberl, Saara Huoponen, Tapio Pahikkala, Marja Blom, Perttu Arkkila, Taina Sipponen
BACKGROUND: Clinical use of biosimilar infliximab (CT-P13) in inflammatory bowel diseases (IBDs) is based on extrapolation of indication from clinical studies performed in rheumatological diseases. Only few data exist of behaviour of infliximab trough levels (TLs) and anti-drug antibodies (ADAs) during switching. AIM: The objective of this study was to evaluate changes in TLs, ADA formation and disease activity after switching from originator infliximab to biosimilar one...
December 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28836746/review-of-biosimilars-of-adalimumab
#19
V V Kaushik
A first fully humanized monoclonal antibody approved by US Food and Drug Administration (FDA) in 2002 was Adalimumab. Clinical efficacy and safety of adalimumab has been assessed in various trials in rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis. It is one of the major sales success among biological and still one of the greatest blockbuster amongst monoclonal antibodies. With the advent of patent expiry of the parent drug HUMIRA, several potential biosimilars have debuted in various markets worldwide...
May 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28819991/infliximab-biosimilar-ct-p13-therapy-is-effective-and-safe-in-maintaining-remission-in-crohn-s-disease-and-ulcerative-colitis-experiences-from-a-single-center
#20
Klaudia Farkas, Mariann Rutka, Tamás Ferenci, Ferenc Nagy, Anita Bálint, Renáta Bor, Ágnes Milassin, Anna Fábián, Kata Szántó, Zsuzsanna Végh, Zsuzsanna Kürti, Péter L Lakatos, Zoltán Szepes, Tamás Molnár
BACKGROUND: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has been confirmed to be efficacious in inducing remission in inflammatory bowel diseases (IBD). The aim of this study was to evaluate the long-term efficacy and safety of CT-P13 therapy in Crohn's disease (CD) and ulcerative colitis (UC), and to identify predictors of sustained clinical response during a 54-week CT-P13 treatment period. PATIENTS AND METHODS: Patients with CD and UC, who were administered CT-P13, were prospectively enrolled...
November 2017: Expert Opinion on Biological Therapy
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