CT-P13: design, development, and place in therapy [PDF]
Drug Design, Development and Therapy, 2017 Tommaso Gabbani,1 Simona Deiana,2 Vito Annese3 1Gastroenterology Unit, Morgagni-Pierantoni Hospital, AUSL Romagna, Forlì, 2Division of Gastroenterology, AOU Careggi University Hospital, Florence, Italy; 3Gastroenterology Department, Valiant ...
Gabbani T, Deiana S, Annese V
doaj +7 more sources
Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays [PDF]
Therapeutic Advances in Gastroenterology, 2017 Background: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies.
Claudia Camila Dias +2 more
exaly +7 more sources
Comparison of endoscopic healing and durability between infliximab originator and CT-P13 in pediatric patients with inflammatory bowel disease [PDF]
Frontiers in ImmunologyBackground and aimsFavourable clinical data were published on the efficacy of CT-P13, the first biosimilar of infliximab (IFX), in pediatric inflammatory bowel disease (IBD); however, few studies have compared the effect on endoscopic healing (EH) and ...
Eun Sil Kim +31 more
doaj +6 more sources
Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients [PDF]
Therapeutic Advances in Gastroenterology, 2016 Many reference biological therapies have now reached or are near to patent expiry, and therefore a number of biosimilars have been or will be developed.
Jørgen Jahnsen
doaj +4 more sources
Efficacy, pharmacokinetics and safety of subcutaneous versus intravenous CT-P13 in rheumatoid arthritis: a randomized phase I/III trial [PDF]
Rheumatology, 2021 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.
Pavel Shesternya +2 more
exaly +3 more sources
A critical review of the United States regulatory pathways for determining the equivalence of efficacy between CT-P13 and original infliximab (Remicade®). [PDF]
Drug Des Devel Ther, 2020 To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions.This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel ...
Kim S, Kim S, Lee H.
europepmc +10 more sources
Comparative effectiveness of the biosimilar CT-P13
Journal of Comparative Effectiveness Research, 2017 The first biosimilar infliximab, CT-P13 (infliximab-dyyb) has been used for the treatment of inflammatory diseases for 4 years. CT-P13 has highly similar efficacy and safety profiles with a lower price than the originator infliximab and has been approved in 81 countries.
Dae Hyun Yoo
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Efficacy and Safety of CT-P13 as First- and Second-Line Treatment in Patients with Ankylosing Spondylitis. [PDF]
J Clin MedBackground/Objectives: CT-P13 is a biosimilar version of infliximab, a monoclonal antibody. In individuals with ankylosing spondylitis (AS), CT-P13 has been shown to be effective and to have a well-tolerated safety profile. The aim of this study was to evaluate the long-term drug persistence, safety, and efficacy of infliximab biosimilar CT-P13 in ...
Uslu S +27 more
europepmc +7 more sources
Population pharmacokinetics of subcutaneous infliximab CT-P13 in Crohn's disease and ulcerative colitis. [PDF]
Aliment Pharmacol Ther, 2021 SummaryBackgroundInfliximab 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.AimsTo characterise CT‐P13 pharmacokinetics (PK) and its clinically relevant ...
Hanzel J +4 more
europepmc +6 more sources
Subcutaneous Infliximab [CT-P13], a True Biologic 2.0. Real Clinical Practice Multicentre Study [PDF]
Biomedicines, 2022 Background: Inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, is characterized by chronic relapsing intestinal inflammation.
Jose M. Huguet +11 more
doaj +2 more sources