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https://www.readbyqxmd.com/read/28922253/long-term-efficacy-safety-and-immunogenicity-of-biosimilar-infliximab-after-one-year-in-a-prospective-nationwide-cohort
#1
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)...
August 23, 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
#2
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)...
September 15, 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28838273/switching-maintenance-infliximab-therapy-to-biosimilar-infliximab-in-inflammatory-bowel-disease-patients
#3
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
#4
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
#5
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
#6
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...
August 12, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28781502/pharmaceutical-approval-update
#7
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
#8
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...
June 30, 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
#9
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
#10
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
#11
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
#12
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
#13
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...
April 28, 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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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