Frontiers in Pharmacology, 2022 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.
Valeria Dipasquale +3 more
doaj +1 more source
Switching from IFX originator to biosimilar CT-P13 does not impact effectiveness,safety and immunogenicity in a large cohort of IBD patients [PDF]
, 2021 Background: Switching from IFX originator to CT-P13 is safe; however, little data on immunogenicity exists. Research design and methods: Consecutive IBD patients on IFX originator were switched to CT-P13 and followed-up for 12 months.
Armuzzi, Alessandro +15 more
core +1 more source
Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease [PDF]
, 2021 BACKGROUND: Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are "reverse switched" to treatment with the originator.
Dijkstra, Gerard +12 more
core +4 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 Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima®, Inflectra®) is approved in several countries for use in all indications for which reference infliximab (Remicade®) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis.
Kim S, Kim S, Lee H.
europepmc +3 more sources
Current status of biosimilars in the treatment of inflammatory bowel diseases [PDF]
Intestinal Research, 2016 Introduction of biological therapies have led to dramatic changes in the management of debilitating immune-mediated inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn's disease. However, the long term use of these agents may be very
Dong Il Park
doaj +1 more source
Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. [PDF]
Ann Rheum Dis, 2017 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 ...
Yoo DH +14 more
europepmc +6 more sources
Long-Term Efficacy and Safety in Patients With Rheumatoid Arthritis Continuing on SB4 or Switching From Reference Etanercept to SB4 [PDF]
, 2017 Objectives: SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA).
Anna Sylwestrzak +27 more
core +4 more sources
Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease [PDF]
Gastroenterology, 2021 This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD).This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor ...
Stefan Schreiber +17 more
openaire +2 more sources
Patterns of Tumor Necrosis Factor Inhibitor (TNFi) Biosimilar Use Across United States Rheumatology Practices. [PDF]
, 2020 ObjectiveIt is unclear if biosimilars of biologics for inflammatory arthritis are realizing their promise to increase competition and improve accessibility.
Bansback, Nick +8 more
core +1 more source
Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort [PDF]
, 2016 Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking.
Balázs Szalay +24 more
core +3 more sources