Article
Gastroenterology & Hepatology
Stefan Schreiber, Shomron Ben-Horin, Jaroslaw Leszczyszyn, Robert Dudkowiak, Adi Lahat, Beata Gawdis-Wojnarska, Aldis Pukitis, Marek Horynski, Katalin Farkas, Jaroslaw Kierkus, Maciej Kowalski, Sang Joon Lee, Sung Hyun Kim, Jee Hye Suh, Mi Rim Kim, Seul Gi Lee, Byong Duk Ye, Walter Reinisch
Summary: This study demonstrated the pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, with comparable clinical remission rates between the two formulations.
Article
Gastroenterology & Hepatology
Xavier Roblin, Pauline Veyrard, Laetitia Bastide, Anne E. Berger, Mathilde Barrau, Anne-Sophie Paucelle, Louis Waeckel, Sany Kwiatek, Bernard Flourie, Stephane Nancey, Stephane Paul
Summary: This study aimed to investigate the intra-individual variations of IFX drug levels in Crohn's disease patients during two consecutive cycles of maintenance therapy with CT-P13 sc. The results showed that IFX drug levels were quite stable within the 14-day treatment cycle, and therapeutic drug monitoring of IFX can be performed at any time between two CT-P13 sc injections in patients with inactive CD.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2022)
Article
Gastroenterology & Hepatology
Shaden Mahmmod, Johannes P. D. Schultheiss, Ad A. van Bodegraven, Gerard Dijkstra, Lennard P. L. Gilissen, Frank Hoentjen, Maurice W. M. D. Lutgens, Nofel Mahmmod, Andrea E. Van der Meulen-de Jong, Lisa J. T. Smits, Adriaan C. I. T. L. Tan, Bas Oldenburg, Herma H. Fidder
Summary: In a retrospective multicenter cohort study, about 9.9% of IBD patients who were switched from originator infliximab to biosimilar CT-P13 experienced reverse switching, predominantly due to biosimilar-attributed adverse effects. Some patients showed symptom improvement after reverse switching, with a good response seen in those who had lost response to CT-P13.
INFLAMMATORY BOWEL DISEASES
(2021)
Article
Medicine, General & Internal
Jose Maria Huguet, Xavier Cortes, Marta Maia Bosca-Watts, Marian Aguas, Nuria Maroto, Lidia Marti, Cirilo Amoros, Jose Maria Paredes
Summary: This study analyzed clinical response rates and adverse events in IBD patients treated with CT-P13 in real-life practice. The results showed that CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD, with sustained clinical remission and response rates over 12 months.
WORLD JOURNAL OF CLINICAL CASES
(2021)
Review
Biotechnology & Applied Microbiology
Tommaso Lorenzo Parigi, Ferdinando D'Amico, Laurent Peyrin-Biroulet, Silvio Danese
Summary: Biologic drugs have significantly improved the treatment of ulcerative colitis (UC) and Crohn's disease (CD), but their high cost limits availability. CT-P13, a biosimilar of infliximab, has shown promising results in phase I and II trials for both CD and UC, with stable serum drug doses and potential availability as a subcutaneous version in the future.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2021)
Article
Surgery
Anita Paisant, Jeanne Burgmaier, Paul Calame, Melanie Loison, Sebastien Moliere, Cecile Brigand, Dihia Belabbas, Emilie Duchalais, Jean-Marc Regimbeau, Thierry Yzet, Arnaud Alves, Audrey Fohlen, Damien Bergeat, Estelle Vauclair, Julie Pellegrini, Emilia Ragot, Alexandre Lansier, Emeric Abet, Alexandre Nevot, Pascal Rousset, Mehdi Ouaissi, Marie Besson, Maxime Ronot, Massimo Giacca, Edouard Girard, Yann Tessier, Damien Massalou, Florent Poirier, Zaher Lakkis, Christophe Aube, Jean Francois Hamel, Guillaume Passot, Aurelien Venara
Summary: This study aimed to evaluate the association between the radiological score and the failure of conservative management in adhesive small bowel obstructions (aSBO). The results showed that a history of previous surgery was not a significant risk factor for conservative treatment failure, while a previous episode of aSBO was protective against treatment failure. Additionally, an Angers CT score of >= 5 was identified as an individual risk factor.
WORLD JOURNAL OF SURGERY
(2023)
Article
Public, Environmental & Occupational Health
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka, Toshifumi Hibi
Summary: This study provides long-term safety and efficacy data of CT-P13 in a real-world clinical setting through an integrated analysis of three post-marketing studies. The results show significant efficacy of CT-P13 treatment in patients with rheumatoid arthritis, psoriasis, Crohn's disease, and ulcerative colitis.
Article
Medicine, Research & Experimental
Jae Hee Cheon, Seongsu Nah, Hyoun Woo Kang, Yun Jeong Lim, Sang-Hoon Lee, Sang Joon Lee, Sung Hyun Kim, Na Hyun Jung, Jeong Eun Park, Yeo Jin Lee, Da Bee Jeon, Yeon Mi Lee, Jong Min Kim, Sung-Hwan Park
Summary: This analysis evaluated long-term safety and effectiveness data of infliximab biosimilar CT-P13 in patients with RA, IBD, and AS over 5 years, finding no new safety concerns and an increase in treatment effectiveness over time.
ADVANCES IN THERAPY
(2021)
Article
Health Care Sciences & Services
Hyun Kyeong Yoo, Han Geul Byun, Flavio Caprioli, Mathurin Fumery, Laurent Peyrin-Biroulet, Subramanian Sreedhar, James Potter, Minyoung Jang
Summary: This article presents a budget impact analysis on the introduction of infliximab SC to European markets. The results show that the use of infliximab SC for the treatment of inflammatory bowel disease can lead to budget savings in the UK, Germany, France, and Italy.
BMC HEALTH SERVICES RESEARCH
(2022)
Article
Gastroenterology & Hepatology
Rosa Lovero, Giuseppe Losurdo, Rosa Federica La Fortezza, Fulvia Terracciano, Giuseppe Biscaglia, Giuseppina Martino, Marianna Nardella, Alfredo Di Leo, Mariabeatrice Principi, Angelo Andriulli, Fabrizio Bossa
Summary: Switching from CT-P13 to SB2 is safe and effective for patients with inflammatory bowel diseases, whether they undergo a single switch or multiple switches between different infliximab compounds.
EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY
(2021)
Article
Biotechnology & Applied Microbiology
Bernd Bokemeyer, Tibor Hlavaty, Matthieu Allez, Pamela Selema, Shahrzad Moosavi, Mary Jane Cadatal, Heather Fowler, Markus Mueller, Katherine F. Liau, Javier P. Gisbert
Summary: This study investigated the use of CT-P13 in the treatment of patients with Crohn's disease and ulcerative colitis. The results showed that the safety information for CT-P13 was consistent with the known safety profile for IFX and did not alter the established benefit-risk profile of CT-P13.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2023)
Article
Biotechnology & Applied Microbiology
Antonio Tursi, Giammarco Mocci, Leonardo Allegretta, Giovanni Aragona, Maria Antonia Bianco, Raffaele Colucci, Antonio Cuomo, Nicola Della Valle, Antonio Ferronato, Giacomo Forti, Federica Gaiani, Maria Giovanna Graziani, Roberto Lorenzetti, Francesco Luzza, Pietro Paese, Antonio Penna, Roberta Pica, Giuseppe Pranzo, Stefano Rodino, Antonella Scarcelli, Costantino Zampaletta, Lorenzo Brozzi, Clelia Cicerone, Andrea Cocco, Gianluigi de Angelis, Laura Donnarumma, Serafina Fiorella, Chiara Iannelli, Tiziana Larussa, Marco Le Grazie, Ileana Luppino, Costantino Meucci, Roberto Faggianl, Cristiano Pagnini, Patrizia Perazzo, Kryssia Isabel Rodriguez-Castro, Rodolfo Sacco, Ladislava Sebkova, Mariaelena Serio, Alberta De Monti, Marcello Picchio, Daniele Napolitano, Elisa Schiavoni, Laura Turchini, Franco Scaldaferri, Daniela Pugliese, Luisa Guidi, Lucrezia Laterza, Giuseppe Privitera, Marco Pizzoferrato, Loris R. Lopetuso, Alessandro Armuzzi, Walter Elisei, Giovanni Maconi, Alfredo Papa
Summary: The study showed that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients in Italy.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2022)
Article
Medicine, General & Internal
Kisoo Pahk, Eung Ju Kim, Hyun Woo Kwon, Chanmin Joung, Hong Seog Seo, Sungeun Kim
Summary: This study found that metabolic activity of psoas muscle is associated with carotid artery inflammation and acute myocardial infarction (AMI), suggesting that psoas muscle activity is related to coronary plaque vulnerability and may be useful for predicting the risk of AMI.
Letter
Gastroenterology & Hepatology
Philippe Rouanet, Florence Castan, Thibault Mazard, Claire Lemanski, Stephanie Nougaret, Emmanuel Deshayes, Patrick Chalbos, Sophie Gourgou, Christophe Taoum, GRECCAR, PRODIGE Study Grp
Summary: The GRECCAR 14 trial aims to personalize treatment strategy for locally advanced rectal carcinoma patients based on their early tumour response, which has shown to have good long-term effects and safety. If successful, this trial could lead to changes in clinical practice.
COLORECTAL DISEASE
(2023)
Article
Gastroenterology & Hepatology
Jihye Park, Jae Hee Cheon, Kang-Moon Lee, Young-Ho Kim, Byong Duk Ye, Chang Soo Eun, Sung Hyun Kim, Sun Hee Lee, Joon Ho Lee, Stefan Schreiber
Summary: This study aimed to compare the clinical efficacy and safety of CT-P13 and originator infliximab in Crohn's disease treatment. The study found a significant correlation between early serum infliximab trough levels and treatment outcomes, and there were no statistical differences in serum trough levels and anti-drug antibody levels between CT-P13 and originator infliximab.