keyword
MENU ▼
Read by QxMD icon Read
search

Biosimilars crohn's

keyword
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
#1
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
https://www.readbyqxmd.com/read/28988215/biosimilar-infliximab-use-in-paediatric-ibd
#2
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...
October 7, 2017: Archives of Disease in Childhood
https://www.readbyqxmd.com/read/28974896/access-to-biologicals-in-crohn-s-disease-in-ten-european-countries
#3
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
#4
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
#5
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...
August 25, 2017: 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
#6
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
#7
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
#8
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...
August 24, 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28836746/review-of-biosimilars-of-adalimumab
#9
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
#10
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
https://www.readbyqxmd.com/read/28803431/sb2-an-infliximab-biosimilar
#11
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
https://www.readbyqxmd.com/read/28781502/pharmaceutical-approval-update
#12
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
https://www.readbyqxmd.com/read/28667429/long-term-clinical-outcomes-after-switching-from-remicade-%C3%A2-to-biosimilar-ct-p13-in-inflammatory-bowel-disease
#13
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
https://www.readbyqxmd.com/read/28620302/adoption-of-biosimilar-infliximab-for-rheumatoid-arthritis-ankylosing-spondylitis-and-inflammatory-bowel-diseases-in-the-eu5-a-budget-impact-analysis-using-a-delphi-panel
#14
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
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#15
REVIEW
Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall
OBJECTIVES: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. METHODS: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28542043/induction-therapy-with-biosimilar-infliximab-in-children-with-crohn-s-disease
#16
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
#17
RANDOMIZED CONTROLLED TRIAL
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...
June 10, 2017: Lancet
https://www.readbyqxmd.com/read/28434387/cost-utility-of-biological-treatment-sequences-for-luminal-crohn-s-disease-in-europe
#18
Fanni Rencz, László Gulácsi, Márta Péntek, Krisztina B Gecse, Axel Dignass, Jonas Halfvarson, Fernando Gomollón, Petra Baji, Laurent Peyrin-Biroulet, Peter L Lakatos, Valentin Brodszky
BACKGROUND: This study aims 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...
December 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
#19
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
#20
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
keyword
keyword
44833
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"