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https://www.readbyqxmd.com/read/28623625/switching-between-reference-biologics-and-biosimilars-for-the-treatment-of-rheumatology-gastroenterology-and-dermatology-inflammatory-conditions-considerations-for-the-clinician
#1
REVIEW
Robert Moots, Valderilio Azevedo, Javier L Coindreau, Thomas Dörner, Ehab Mahgoub, Eduardo Mysler, Morton Scheinberg, Lisa Marshall
PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2)...
June 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#2
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/28571501/ct-p13-in-the-treatment-of-rheumatoid-arthritis
#3
Dae Hyun Yoo
The first biosimilar infliximab, CT-P13 infliximab-dyyb was approved in 2013 by the European Medicines Agency (EMA) and in 2016 by the United States Food and Drug Administration (FDA) and has been used for the treatment of rheumatoid arthritis (RA) for 4 years. Areas covered: CT-P13 with the three brand names on the market has highly similar efficacy and safety profiles but lower price than originator infliximab and are approved in more than 80 countries. One of the most important determinants of the implementation of CT-P13 in the treatment of RA is scientific evidence from clinical studies and real-world pharmacovigilance data...
July 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28542043/induction-therapy-with-biosimilar-infliximab-in-children-with-crohn-s-disease
#4
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/28504555/frequency-and-characteristics-of-infusion-reactions-during-biosimilar-infliximab-treatment-in-inflammatory-bowel-diseases-results-from-central-european-nationwide-cohort
#5
Anita Bálint, Mariann Rutka, Zsuzsanna Végh, Zsuzsanna Kürti, Krisztina B Gecse, János Banai, László Bene, Beáta Gasztonyi, Tünde Kristóf, László Lakatos, Pál Miheller, Károly Palatka, Árpád Patai, Ágnes Salamon, Tamás Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Renáta Bor, Ágnes Milassin, Anna Fábián, Ferenc Nagy, Martin Kolar, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukas, Péter L Lakatos, Tamás Molnár, Klaudia Farkas
BACKGROUND: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. METHODS: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically...
May 26, 2017: Expert Opinion on Drug Safety
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
#6
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/28497221/evaluation-of-the-cross-reactivity-of-antidrug-antibodies-to-ct-p13-and-infliximab-reference-product-remicade-an-analysis-using-immunoassays-tagged-with-both-agents
#7
Walter Reinisch, Jørgen Jahnsen, Stefan Schreiber, Silvio Danese, Julián Panés, Alejandro Balsa, Won Park, JiSoo Kim, Jee Un Lee, Dae Hyun Yoo
BACKGROUND: During two pivotal clinical trials of the infliximab biosimilar CT-P13 (PLANETAS and PLANETRA), antidrug antibodies (ADAs) and neutralising antibodies (NAbs) were detected in the sera of patients treated with CT-P13 and the reference product (RP; Remicade). OBJECTIVE: The aim was to assess the comparability of Remicade- and CT-P13-tagged immunoassays for the detection of ADAs and NAbs using data from these trials, in order to determine the cross-reactivity of CT-P13 and RP ADAs...
June 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28482701/looking-to-the-future-and-learning-lessons-from-the-recent-past-changing-stakeholder-perceptions-of-biosimilars-in-cancer
#8
Won Seog Kim, Michinori Ogura, Hyuk-Chan Kwon, Dasom Choi
As the patents for many biologic anticancer drugs expire, significant growth in the use of biosimilars is predicted, offering an opportunity to help combat the rising costs of treatment and increase patient access to biologic therapy. Attainment of regulatory approval, involving numerous nonclinical and clinical comparative studies versus each reference product, is only one of several barriers to realize the potential gains offered by biosimilars. It is important to understand the current perceptions and informational needs of different stakeholders if biosimilars are to be accepted and widely used in the clinic...
May 2017: Future Oncology
https://www.readbyqxmd.com/read/28473425/a-nationwide-non-medical-switch-from-originator-infliximab-to-biosimilar-ct-p13-in-802-patients-with-inflammatory-arthritis-1-year-clinical-outcomes-from-the-danbio-registry
#9
Bente Glintborg, Inge Juul Sørensen, Anne Gitte Loft, Hanne Lindegaard, Asta Linauskas, Oliver Hendricks, Inger Marie Jensen Hansen, Dorte Vendelbo Jensen, Natalia Manilo, Jakob Espesen, Mette Klarlund, Jolanta Grydehøj, Sabine Sparre Dieperink, Salome Kristensen, Jimmi Sloth Olsen, Henrik Nordin, Stavros Chrysidis, Dorte Dalsgaard Pedersen, Michael Veedfald Sørensen, Lis Smedegaard Andersen, Kathrine Lederballe Grøn, Niels Steen Krogh, Lars Pedersen, Merete Lund Hetland
OBJECTIVES: According to guidelines, a nationwide non-medical switch from originator (INX, Remicade) to biosimilar infliximab (Remsima, CT-P13) was conducted in Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). We investigated disease activity before/after switching and retention rates in the DANBIO registry. METHODS: Disease activities 3 months before and after switch and changes over time were calculated...
May 4, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28453766/comparable-immune-function-inhibition-by-the-infliximab-biosimilar-ct-p13-implications-for-treatment-of-inflammatory-bowel-disease
#10
Ki Jung Lim, So Jung Lee, Sunghwan Kim, Su Yeon Lee, Min Seob Lee, Yoon A Park, Eun Jin Choi, Eun Beom Lee, Hwang Keun Jun, Jong Moon Cho, SooYoung Lee, Ki Sung Kwon, Byung Pil Lim, Myung-Shin Jeon, Eui Cheol Shin, Yong Sung Choi, Ella Fudim, Orit Picard, Miri Yavzori, Shomron Ben-Horin, Shin Jae Chang
Background and Aims: CT-P13 is the first biosimilar monoclonal antibody to infliximab, and was recently approved in the European Union, Japan, Korea, and USA for all six indications of infliximab. However, studies directly assessing the biologic activity of CT-P13 versus inflximab in the context of inflammatory bowel disease [IBD] are still scanty. In the present study, we aimed to compare the biological activities of CT-P13 and infliximab with specific focus on intestinal cells so as to gain insight into the potential biosimilarity of these two agents for treatment of IBD...
May 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28417494/editorial-ct-p13-a-biosimilar-of-anti-tumour-necrosis-factor-alpha-agent-infliximab-in-inflammatory-bowel-diseases-authors-reply
#11
EDITORIAL
Y Komaki, A Yamada, F Komaki, D Micic, A Ido, A Sakuraba
No abstract text is available yet for this article.
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28417492/editorial-ct-p13-a-biosimilar-of-anti-tumour-necrosis-factor-alpha-agent-infliximab-in-inflammatory-bowel-diseases
#12
EDITORIAL
R Felwick, J R F Cummings
No abstract text is available yet for this article.
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28293938/effectiveness-and-safety-of-infliximab-biosimilar-ct-p13-in-treating-ulcerative-colitis-a-real-life-experience-in-ibd-primary-centers
#13
Antonio Tursi, Leonardo Allegretta, Stefania Chiri, Nicola Della Valle, Walter Elisei, Giacomo Forti, Roberto Lorenzetti, Giammarco Mocci, Antonio Penna, Giuseppe Pranzo, Cristina Ricciardelli, Marcello Picchio
BACKGROUND: To assess the efficacy and safety of biosimilar infliximab (IFX) IFX CT-P13 in inducing and maintain remission in Ulcerative Colitis (UC) outpatients in Italian primary gastroenterology centers. METHODS: Patients were prospectively assessed at entry, after 8, 12, 24, 36, and therefore 52 weeks. Clinical activity was scored according to the Mayo score. The primary endpoint was reaching of clinical remission (Mayo score ≤2). Several secondary endpoints were clinical response to treatment, reaching of mucosal healing (MH), safety of the drug...
March 14, 2017: Minerva Gastroenterologica e Dietologica
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
#14
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
#15
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/28176515/biosimilars-in-inflammatory-bowel-disease
#16
REVIEW
Carla J Gargallo, Alberto Lué, Fernando Gomollón
The introduction of biologic therapies has revolutionized the treatment of inflammatory bowel disease (IBD) and has significantly improved the disease course and outcomes for many patients. Biologics are the main drivers of cost in many IBD units and biosimilars, although are not better than originators, are usually cheaper and thus can increase the availability of this type of therapy. Biosimilar are highly similar to innovator but, due to the complex structures of innovators and the variability inherent in the manufacturing process, they are no identical...
June 2017: Minerva Medica
https://www.readbyqxmd.com/read/28175254/p661-comparable-clinical-efficacy-safety-and-immunogenicity-of-infliximab-biosimilar-ct-p13-after-transition-from-reference-infliximab-remicade%C3%A2-in-children-with-established-inflammatory-bowel-disease-a-multi-centre-prospective-observational-study
#17
M Sladek, A Vultaggio, S Ghione, F Nencini, A Matucci, S Pratesi, F Zanieri, P M Maggi, M Paci, K Ponanta-Gawron, K Kulig, A Wasilewska, P Lionetti
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
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/28175213/p679-infliximab-biosimilar-ct-p13-in-inflammatory-bowel-disease-patients-that-require-intensification-treatment
#19
M Gompertz, I Alfaro, E Ricart, A Lόpez, J Panés, M Gallego, R Barastegui, A Giner, A Vara, M Masamunt, I Ordás
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175208/p633-antibodies-to-infliximab-in-patients-treated-with-either-the-reference-biologic-or-the-biosimilar-ct-p13-show-identical-reactivity-towards-biosimilars-ct-p13-and-sb2-in-inflammatory-bowel-disease
#20
G Fiorino, M B Ruiz-Agüello, A Maguregui, D Nagore, S Radice, D Gilardi, C Correale, M Allocca, F Furfaro, M Alfieri, A Martínez, S Danese
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
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