Use the keywords feature with a free QxMD account.
Use Read by QxMD to access full text via your institution or open access sources.
Read also provides personalized recommendations to keep you up to date in your field.
Existing User
Sign InNew to Read
Sign Up#61
Shin Kashima, Koji Sawada, Kentaro Moriichi, Mikihiro Fujiya
Inflammatory bowel diseases (IBDs) are chronic immune disorders of unclear etiology. Tumor necrosis factor (TNF) inhibitors are effective for IBD treatment and are cost-effective because they reduce hospital admissions and are associated with fewer surgery requirements and a better quality of life in IBD patients. A large number of clinical trials of infliximab biosimilar (CT-P13) have suggested that the administration of biosimilars provides high efficacy and safety similar to that of the originators, with a lower cost, so switching from the original to a biosimilar is considered an acceptable treatment...
2022: Therapeutic Advances in Drug Safety
#62
REVIEW
Stefan Schreiber, Luis Puig, João Gonçalves, Philip J Mease, Remo Panaccione, Paul Emery
Biosimilars represent a novel category in the world of follow-up medicinal products with the requirement that they are highly similar but not identical to an approved originator biologic medicine, with no clinically meaningful differences in safety, purity, and potency. In this review, we discuss recent pivotal biosimilar developments for anti-inflammatory therapy in rheumatology, gastroenterology, and dermatology, and the influence of biosimilar availability on patients and payers. Finally, we provide our perspective on the evolution of biosimilar use in these indications in the United States (US) and in Europe and on where this evolution in biopharmaceuticals may lead in the future...
May 7, 2022: Seminars in Arthritis and Rheumatism
#63
JOURNAL ARTICLE
Seisuke Saito, Nobuhiro Ueno, Yuki Kamikokura, Yuya Sugiyama, Yu Kobayashi, Yuki Murakami, Takehito Kunogi, Takahiro Sasaki, Keitaro Takahashi, Katsuyoshi Ando, Shin Kashima, Kentaro Moriichi, Hiroki Tanabe, Mishie Tanino, Toshikatsu Okumura, Mikihiro Fujiya
A 24-year-old woman was admitted to our hospital due to abdominal pain and a high fever. She was diagnosed with ileocolonic Crohn's disease (CD), complicated with a gastro-colic fistula and splenomegaly. After initial treatment with an infliximab-biosimilar, all blood cell line counts markedly decreased. Three-dimensional reconstructed computed tomography revealed splenic vein narrowing. Thus, her pancytopenia was deemed to have likely been caused by hypersplenism. Surgery was performed, and clinical remission was maintained without pancytopenia...
May 21, 2022: Internal Medicine
#64
JOURNAL ARTICLE
Antonio Tursi, Giammarco Mocci, Leonardo Allegretta, Giovanni Aragona, Maria Antonia Bianco, Raffaele Colucci, Antonio Cuomo, Nicola Della Valle, Antonio Ferronato, Giacomo Forti, Federica Gaiani, GianMarco Giorgetti, Maria Giovanna Graziani, Katia Lofano, Roberto Lorenzetti, Tiziana Larussa, Antonio Penna, Roberta Pica, Giuseppe Pranzo, Stefano Rodino', Antonella Scarcelli, Costantino Zampaletta, Gabrio Bassotti, Alessia Immacolata Cazzato, Stefania Chiri, Valeria Clemente, Andrea Cocco, Gianluigi De' Angelis, Laura Donnarumma, Roberto Faggiani, Camilla Graziosi, Marco Le Grazie, Francesco Luzza, Costantino Meucci, Rita Monterubbianesi, Cristiano Pagnini, Patrizia Perazzo, Marcello Picchio, Rodolfo Sacco, Ladislava Sebkova, Mariaelena Serio, Daniele Napolitano, Daniela Pugliese, Franco Scaldaferri, Elisa Schiavoni, Laura Turchini, Alessandro Armuzzi, Walter Elisei, Giovanni Maconi, Alfredo Papa
BACKGROUND: Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce.We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. METHODS: A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data...
May 17, 2022: Inflammatory Bowel Diseases
#65
REVIEW
Raja Atreya, Markus F Neurath
Increasing insights into the immunopathogenesis of inflammatory bowel diseases [IBD] have led to the advent of targeted therapies that inhibit crucial mediators of the inflammatory process, thereby widening our available therapeutic armamentarium. Anti-tumour necrosis factor [anti-TNF] agents are still a mainstay of our therapeutic endeavours and the introduction of corresponding biosimilars has further widened their use. Nevertheless, only a subgroup of treated patients benefit from the initiated treatment and there is secondary non-response in the course of therapy...
May 11, 2022: Journal of Crohn's & Colitis
#66
JOURNAL ARTICLE
Eun Soo Kim, Sung Kook Kim, Dong Il Park, Hyo Jong Kim, Yoo Jin Lee, Ja Seol Koo, Eun Sun Kim, Hyuk Yoon, Ji Hyun Lee, Ji Won Kim, Sung Jae Shin, Hyung Wook Kim, Hyun-Soo Kim, Young Sook Park, You Sun Kim, Tae Oh Kim, Jun Lee, Chang Hwan Choi, Dong Soo Han, Jaeyoung Chun, Hyun Soo Kim
BACKGROUND: We aimed to compare trough infliximab levels and the development of antidrug antibody (ADA) for 1 year between Crohn's disease (CD) and ulcerative colitis (UC) patients who were biologic-naive, and to evaluate their impact on clinical outcomes. METHODS: This was a prospective, multicenter, observational study. Biologic-naive patients with moderate to severe CD or UC who started CT-P13, an infliximab biosimilar, therapy were enrolled. Trough drug and ADA levels were measured periodically for 1 year after CT-P13 initiation...
April 26, 2022: Journal of Clinical Gastroenterology
#67
REVIEW
Biljana Tubić, Saša Jungić
The use of the biological medicines, also called "biologics," has contributed to the progress of the treatment of many chronic diseases, such as cancer, rheumatoid arthritis, Crohn's disease, multiple sclerosis, and psoriasis. However, biologicals are expensive for healthcare systems in several countries. Their availability has been a global issue, which has affected many patients that suffer from various diseases. A biosimilar medicine, also called "biosimilar," is a medicine with similar characteristics in terms of quality, biological activity, safety, and efficacy as the approved original biological medicine, known as "originator biologic...
March 23, 2022: Bosnian Journal of Basic Medical Sciences
#68
JOURNAL ARTICLE
Shubha Bhat, Maitri Patel, Kristine Duly, David Choi
OBJECTIVE: The objective of the study was to review the pharmacologic and clinical profile of adalimumab-adbm (BI 695501), the first interchangeable biosimilar for treatment of inflammatory diseases. DATA SOURCES: A PubMed search was conducted from inception to December 2021 using the keywords BI 695501 and adalimumab-adbm . Information was also obtained from published abstracts and package inserts. STUDY SELECTION AND DATA EXTRACTION: Phase 1, 2 and 3 studies plus relevant literature on adalimumab-adbm pharmacologic and clinical profile were reviewed...
April 7, 2022: Annals of Pharmacotherapy
#69
Valeria Dipasquale, Giuseppe Cicala, Edoardo Spina, Claudio Romano
Background: Many pediatric inflammatory bowel disease (IBD) patients are now using biosimilars of anti-tumor necrosis factor-α (TNF-α), with increasing trends in recent years. This study reviewed all available data regarding the use of biosimilars in children with IBD. Methods: PubMed, Google Scholar, Scopus, and CENTRAL databases were searched through keywords; inflammatory bowel diseases, Crohn's disease, ulcerative colitis, biosimilar and child were combined using "AND" and "OR." Original research articles involving pediatric patients receiving one of the biosimilar medications based on the anti-TNF-α biologic drugs approved for pediatric IBD treatment, independently from efficacy and drug response, were included...
2022: Frontiers in Pharmacology
#70
JOURNAL ARTICLE
Seema A Patil, Shubha Bhat, Jimmy K Limdi, Francis A Farraye, Raymond K Cross
No abstract text is available yet for this article.
March 30, 2022: Inflammatory Bowel Diseases
#71
JOURNAL ARTICLE
Iris Lin, Richard Melsheimer, Rachel H Bhak, Patrick Lefebvre, Maral DerSarkissian, Bruno Emond, Angela Lax, Catherine Nguyen, Melody Wu, Yinong Young-Xu
OBJECTIVE: To compare treatment patterns of United States (US) veterans stable on innovator infliximab (IFX) who switched to an IFX biosimilar (switchers) or remained on innovator IFX (continuers). METHODS: US Veterans Healthcare Administration data (01/2012-12/2019) were used to identify adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), or Crohn's disease and ulcerative colitis (i.e., inflammatory bowel disease [IBD]), treated with innovator or biosimilar IFX...
February 7, 2022: Current Medical Research and Opinion
#72
JOURNAL ARTICLE
Jose María Huguet, Xavier Cortés, Marta Maia Bosca-Watts, Marian Aguas, Nuria Maroto, Lidia Martí, Cirilo Amorós, Jose María Paredes
BACKGROUND: In recent years, biological therapies have revolutionized the management of inflammatory bowel disease (IBD); however, they are expensive. The development of biosimilar products has allowed us to reduce healthcare costs and improve patients' access to these treatments. Although various studies support the similarity between infliximab and its biosimilar CT-P13 in terms of efficacy and safety, there are unmet needs regarding research on these agents in the context of IBD. AIM: To analyze clinical response rates to CT-P13 and adverse events in IBD patients treated in real-life practice...
December 26, 2021: World Journal of Clinical Cases
#73
REVIEW
Philip Esters, Christopher Hackenberg, Herrmann Schulze, Axel U Dignass
BACKGROUND: In addition to conventional anti-inflammatory treatment for chronic inflammatory bowel disease (IBD), there has been an evolution of new treatment options over the past 20 years. Already approved biologics provide multiple treatment alternatives but also make the treatment algorithms more complex. This development results in a substantial improvement in patient care. The ambitious treatment targets are associated with a higher quality of life and the reduction of long-term disability and morbidity...
January 17, 2022: Der Internist
#74
JOURNAL ARTICLE
Fabien Francois, Loubna Naimi, Xavier Roblin, Anne-Emmanuelle Berger, Stephane Paul
BACKGROUND: ABP501 is a biosimilar to Reference Adalimumab (HUMIRA®) produced by AMGEN. Adalimumab (ADA) has a marketing authorization for Crohn's disease, ulcerative colitis and other inflammatory or autoimmune diseases. The aim of this study was to evaluate the LISA-TRACKER assays developed by Theradiag (France), for the monitoring of ABP501 and anti-ABP501 antibodies in human serum. RESULTS: 68 ABP501 clinical samples were measured with the LISA TRACKER Duo Adalimumab assay...
December 25, 2021: BMC Immunology
#75
JOURNAL ARTICLE
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 Rodinò, 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 FaggianI, 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
BACKGROUND: To compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy. RESEARCH DESIGN AND METHODS: 380 IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint. RESULTS: : 197 patients with Ulcerative Colitis (UC) and 183 patients with Crohn's Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6-36) months were compared: 230 (60...
December 14, 2021: Expert Opinion on Biological Therapy
#76
JOURNAL ARTICLE
Anna Pękala, Rafał Filip
BACKGROUND: Primary lack or secondary loss of response to therapy with infliximab is a significant problem. This study aimed to evaluate the response to treatment in patients with Crohn's disease (CD) and ulcerative colitis (UC) achieving therapeutic and sub-therapeutic trough levels of biosimilar infliximab (CT-P13). RESULTS: A total of 65 patients (32 with CD and 33 with UC) were recruited. The overall response rate in both CD and UC patients exceeded 80%. There were no significant differences in treatment response and CT-P13 levels for patients with CD or UC...
November 15, 2021: Journal of Clinical Medicine
#77
REVIEW
Matt Shirley
CT-P13 (Remsima® ; Inflectra® ), a biosimilar of reference infliximab (Remicade® ), provides a useful alternative for patients requiring infliximab therapy and, as with other biosimilar agents, has the potential to reduce treatment costs. Furthermore, the availability of CT-P13 in a subcutaneous formulation (CT-P13 SC), with the possibility (after adequate training) of self-administration at home, has the potential to both improve patient convenience and reduce the burden on the healthcare system. The initial approval of CT-P13 SC, for use in the treatment of rheumatoid arthritis in adults, was based on the findings of a randomised, double-blind phase I/III trial which demonstrated the non-inferiority of CT-P13 SC administered once every 2 weeks to intravenous CT-P13 (CT-P13 IV) administered once every 8 weeks in reducing disease activity in patients with active rheumatoid arthritis...
November 2, 2021: Clinical Drug Investigation
#78
REVIEW
Shin Kashima, Kentaro Moriichi, Katsuyoshi Ando, Nobuhiro Ueno, Hiroki Tanabe, Sayaka Yuzawa, Mikihiro Fujiya
BACKGROUND: Inflammatory bowel disease (IBD) is chronic inflammation of the gastrointestinal tract, although its etiology has largely been unclear. Tumor necrosis factor inhibitors (TNF-I) are effective for the treatment. Recently, biosimilars of TNF-I, such as CT-P13, have been developed and are thought to possess equal efficacy and safety to the original TNF-I. Sarcoidosis is also a systemic granulomatous disease of unknown etiology. In steroid-resistant cases of sarcoidosis, TNF-I have been reported effective for achieving resolution...
October 12, 2021: BMC Gastroenterology
#79
JOURNAL ARTICLE
Magdalena Kaniewska, Mariusz Rosolowski, Andrzej Moniuszko, Grazyna Rydzewska
Introduction: Data comparing response to originator and biosimilar infliximab in anti-TNF-α naïve and non-naïve Crohn's disease patients is limited. Aim: To assess the efficacy, safety, and tolerability of a biosimilar infliximab in comparison to the originator drug in anti-TNF-α naïve and non-naïve Crohn's disease patients. Data comparing response in those two groups of patients are limited. Material and methods: This retrospective single-centre study enrolled 168 adult Crohn's disease patients treated for 1 year with infliximab originator or biosimilar...
2021: Przegla̜d Gastroenterologiczny
#80
JOURNAL ARTICLE
Jurij Hanzel, Laura H Bukkems, Krisztina B Gecse, Geert R D'Haens, Ron A A Mathôt
BACKGROUND: Infliximab is a chimeric monoclonal antibody against tumour necrosis factor-alpha for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). Recently, a subcutaneous formulation of CT-P13, an infliximab biosimilar, was approved for clinical use. AIMS: To characterise CT-P13 pharmacokinetics (PK) and its clinically relevant determinants after subcutaneous administration through population PK modelling. METHODS: Data from a two-part Phase I study with intravenous (5 mg/kg) and variable maintenance subcutaneous dosing of CT-P13 with frequent PK sampling in patients with CD or UC were used...
November 2021: Alimentary Pharmacology & Therapeutics
Make the most of Read.
Download the mobile app.
Download the mobile app.
Fetching more papers... 
