Results 61 to 70 of about 1,181,836 (211)

P524 Predictors of immunogenicity in patients with Inflammatory Bowel Disease treated with infliximab: A post hoc analysis of the randomised phase I CT-P13 SC study

Journal of Crohn's & Colitis, 2023
CT-P13 SC is the only subcutaneous (SC) formulation of infliximab (IFX) approved to treat Crohn’s disease (CD) or ulcerative colitis (UC).
Stefan Schreiber, S. Ben-Horin, B. Ye, Dong-Hyeon Kim, W. Reinisch   +4 more
semanticscholar   +1 more source

Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study [PDF]

Annals of the Rheumatic Diseases, 2017
To investigate the efficacy and safety of switching from infliximab reference product (RP) to its biosimilar or maintaining biosimilar treatment in patients with ankylosing spondylitis (AS).This open-label extension study recruited patients with AS who completed a 54-week, randomised controlled study comparing CT-P13 with RP (PLANETAS). CT-P13 (5 mg/kg)
Park, Won, Yoo, Dae Hyun, Miranda, Pedro, Brzosko, Marek, Wiland, Piotr, Gutierrez-Ureña, Sergio, Mikazane, Helena, Lee, Yeon Ah, Smiyan, Svitlana, Lim, Mie Jin, Kadinov, Vladimir, Abud-Mendoza, Carlos, Kim, Houng, Lee, Sang Joon, Bae, Yunju, Kim, Suyeon, Braun, Jürgen   +16 more
openaire   +3 more sources

Patients with Ankylosing Spondylitis Can Maintain Clinical and Functional Improvement after Switching from Infliximab Reference Product to Infliximab Biosimilar (REMSIMA): 12 Months Comparative Open-Label Study

Journal of Clinical Rheumatology and Immunology, 2022
Objective: Efficacy, tolerance, and safety of infliximab biosimilar are the same as infliximab reference product (RP) in the management of ankylosing spondylitis (AS) patients previously were on infliximab RP.
Abdulsatar J. Mathkhor, Ali Altaqi, Abdulnasser Abdullah, Amer Khudhairy   +3 more
doaj   +1 more source

Korean clinical practice guidelines on biologics for moderate to severe Crohn’s disease [PDF]

Intestinal Research, 2023
Crohn’s disease (CD) is a relapsing and progressive condition characterized by diarrhea, abdominal pain, weight loss, and hematochezia that results in serious complications such as perforations, fistulas, and abscesses. Various medications, interventions,
Seong-Joon Koh, Sung Noh Hong, Soo-Kyung Park, Byong Duk Ye, Kyeong Ok Kim, Jeong Eun Shin, Yong Sik Yoon, Hong Sub Lee, Sung Hoon Jung, Miyoung Choi, Soo-Young Na, Chang Hwan Choi, Joo Sung Kim,   +13 more
doaj   +1 more source

Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD)

Expert Opinion on Biological Therapy, 2023
Background The objective of this non-interventional, observational prospective cohort study (CONNECT-IBD) was to assess the use of CT-P13 (Inflectra®) in the treatment of patients with Crohn’s disease (CD) and ulcerative colitis (UC) in the context of ...
B. Bokemeyer, T. Hlavatý, M. Allez, P. Selema, Shahrzad Moosavi, M. J. Cadatal, Heather Fowler, Markus Mueller, Katherine F Liau, J. Gisbert   +9 more
semanticscholar   +1 more source

Antigenic response to CT-P13 and infliximab originator in inflammatory bowel disease patients shows similar epitope recognition [PDF]

, 2018
Funding Information: Declaration of personal interests: JG received consultancy fees and/or research support from Pfizer, Merck, Biogen, Celltrion, and Samsung Bioepis.
Acurcio, R., Aires da Silva, F., Alcobia, A., Barbas, A., Barbosa, I., Ben-Horin, S., Cardoso, M., Carey, J. J., Catarina Cunha-Santos, A., Cavaco, M., Correia, L., D'Haens, G., Danese, S., Delgado Alves, J., Dörner, T., Eurico Fonseca, J., Fiorino, G., Galvão, J., Goncalves, J., Gouveia, L., Iria, I., Lakatos, P. L., Lima Vieira, C., Magro, F., Matos Brito, P., Palmela, C., Rosa, I., Santos, M., Strik, A., Torres, J., Trabuco, D., Yavzori, M.   +31 more
core   +1 more source

Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease [PDF]

, 2019
BACKGROUND AND AIMS: To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®. METHODS: Patients under Remicade® who were in clinical remission with standard dosage
Alcaide, N., Amo, V., Arguelles, F., Barreiro de Acosta, Manuel, Benitez, J. M., Bermejo, F., Bernardo, D., Bujanda, L., Calvet, X., Carbajo, A. Y., Chaparro, M., De Castro Parga, María Luisa, De Castro, M. L., Garre, A., Gisbert, J. P., Gomollon, F., Gutierrez, A., Iborra, M., Jimenez, I., Kolle, L., Leo, E., Lorente, R., Manosa, M., Morell, A., Moron, J. M. V., Ramirez, E., Riestra, S., Rivero, M., Rodriguez, E., Rojas-Feria, M., Van Domselaar, M., Veloz, M. F. G.   +31 more
core   +4 more sources

Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial [PDF]

, 2020
Objective. To assess non-inferiority of s.c. to i.v. CT-P13 in RA. Methods. Patients with active RA and inadequate response to MTX participated in this phase I/III double-blind study at 76 sites. Patients received CT-P13 i.v. 3 mg/kg [week (W) 0 and W2]
Bala´ zs, E´ va, Dae Hyun, Yoo, El-Khouri, Elias Chalouhi, Eliseeva, Larisa, Han, Noo Ri, Hrycaj, Paweł, Ivanova, Delina, Jaworski, Janusz, Kasay, Alfredo Berrocal, Kim, Sung Hyun, Lee, Sang Joon, Lee, Seul Gi, Shesternya, Pavel, Shevchuk, Sergii, Stanislavchuk, Mykola, Suh, Jee Hye, Trefler, Jakub, Westhovens, Rene, Wiland, Piotr, Yatsyshyn, Roman, Zawadzki, Marek, Zhdan, Vyacheslav, Ждан, Вячеслав Миколайович   +22 more
core   +1 more source

Clinical Outcomes and Patient Experience of Biosimilar to Biosimilar Infliximab Switching in Patients with Inflammatory Bowel Disease: A Prospective, Single-Centre, Phase IV Interventional Study with a Nested Qualitative Study

GastroHep, 2023
Background and Aims. Regulatory pathways compare biosimilars with originator molecules only and not with other biosimilars. With the development of multiple infliximab biosimilars, patients may be asked to transition between them.
Clare Harris, Richard James Harris, David Young, Martin McDonnell, Bridget Clancy, Justin Harvey, Carlos Araujo, Ines Iria, Joao Goncalves, Susan Latter, J. R. Fraser Cummings   +10 more
doaj   +1 more source

Scientific rationale behind the development and approval of biosimilar infliximab (CT-P13) in Europe [PDF]

Expert Review of Clinical Immunology, 2015
Biosimilars are drugs developed to be highly similar to their originator biologic (or ‘reference medicinal product’) with no clinically meaningful differences in purity, efficacy or safety. Production of biologics and biosimilars is highly complex and sensitive, with any change in manufacturing process having a potential impact on efficacy and safety ...
Ulf, Müller-Ladner, SeungSuh, Hong, Choongseob, Oh, Peter, Taylor   +3 more
openaire   +2 more sources