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Biosimilars crohn's

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
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
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
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 1, 2018: Current Treatment Options in Gastroenterology
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
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...
January 19, 2018: Alimentary Pharmacology & Therapeutics
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...
October 27, 2017: Paediatric Drugs
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
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
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
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
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
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
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
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
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...
August 18, 2017: Expert Opinion on Biological Therapy
Yvette N Lamb, Lesley J Scott, Emma D Deeks
SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA and Australia. Characterization of SB2 in preclinical studies showed that it is similar to reference infliximab...
October 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Michele B Kaufman
Naldemedine (Symproic) for opioid-induced constipation; deutetrabenazine (Austedo) for chorea associated with Huntington's disease; and infliximab-abda (Renflexis), a Remicade biosimilar, for the treatment of Crohn's disease, rheumatoid arthritis, and other diseases.
August 2017: P & T: a Peer-reviewed Journal for Formulary Management
Lisa J T Smits, Anna Grelack, Lauranne A A P Derikx, Dirk J de Jong, Aura A J van Esch, Ronald S Boshuizen, Joost P H Drenth, Frank Hoentjen
BACKGROUND: Limited data are available on long-term clinical outcomes regarding the switch from Remicade(®) to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients. AIMS: To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity. METHODS: We performed a single-center prospective observational cohort study following an elective switch from Remicade(®) to CT-P13 in IBD patients. RESULTS: Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up...
November 2017: Digestive Diseases and Sciences
Tim A Kanters, Jelena Stevanovic, Isabelle Huys, Arnold G Vulto, Steven Simoens
Introduction: Introducing biosimilar infliximab for the treatment in rheumatology (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohn's disease and ulcerative colitis) may reduce treatment costs associated with biologics. This study aimed to investigate the budget impact of adopting biosimilar infliximab in five European countries, considering that the budget impact includes the adoption of biosimilar infliximab and the availability of biologic alternatives such as vedolizumab, biosimilar etanercept, biosimilar rituximab, and other relevant factors...
2017: Frontiers in Pharmacology
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