Evaluating Efficacy, Safety, and Pharmacokinetics After Switching From Infliximab Originator to Biosimilar CT-P13: Experience From a Large Tertiary Referral Center.

Evaluating Efficacy, Safety, and Pharmacokinetics After Switching From Infliximab Originator to Biosimilar CT-P13: Experience From a Large Tertiary Referral Center. Inflamm Bowel Dis. 2019 Aug 10;: Authors: Bronswijk M, Moens A, Lenfant M, Tops S, Compernolle G, Van Assche G, Vermeire S, Gils A, Ferrante M Abstract BACKGROUND: The use of infliximab biosimilar CT-P13 has increased in patients with inflammatory bowel disease. Nevertheless, doubts about switching from infliximab originator to biosimilar still exist among patients and health care professionals. METHODS: Our tertiary referral center underwent a mandatory switch from infliximab…

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The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis in real-life.

The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis in real-life. Aliment Pharmacol Ther. 2019 May 22;: Authors: Meyer A, Rudant J, Drouin J, Coste J, Carbonnel F, Weill A Abstract BACKGROUND: CT-P13, a biosimilar of the reference product infliximab, has been approved for the treatment of ulcerative colitis on the basis of the results of trials conducted in patients with spondyloarthritis and rheumatoid arthritis. AIM: To compare the effectiveness and safety of CT-P13 and the reference product in infliximab-naive patients with ulcerative…

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Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study.

Related Articles Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn’s disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Mar 28;: Authors: Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH Abstract BACKGROUND: The infliximab biosimilar CT-P13 was approved for use in Crohn’s disease after clinical comparison with originator infliximab…

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Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study.

Related Articles Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J Gastroenterol Hepatol. 2019 Mar 03;: Authors: Kim NH, Lee JH, Hong SN, Yoon H, Kang HW, Lee SH, Im JP, Cha JM, Eun CS, Kim JW, Choi CH, Park DI Abstract BACKGROUND AND AIM: A biosimilar of infliximab, CT-P13 (Remsima®) has the potential to reduce treatment costs and enhance access to biological therapy for inflammatory bowel disease (IBD) patients. However, long-term clinical data on its use for…

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Outcomes of Patients With Inflammatory Bowel Diseases Switched from Maintenance Therapy with a Biosimilar to Remicade.

Outcomes of Patients With Inflammatory Bowel Diseases Switched from Maintenance Therapy with a Biosimilar to Remicade. Clin Gastroenterol Hepatol. 2019 Jan 07;: Authors: Ilias A, Szanto K, Gonczi L, Kurti Z, Golovics PA, Farkas K, Schafer E, Szepes Z, Szalay B, Vincze A, Szamosi T, Molnar T, Lakatos PL Abstract BACKGROUND & AIMS: There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is known about outcomes of reverse…

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Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease.

Related Articles Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease. World J Gastroenterol. 2018 Dec 14;24(46):5288-5296 Authors: Guerra Veloz MF, Argüelles-Arias F, Castro Laria L, Maldonado Pérez B, Benítez Roldan A, Perea Amarillo R, Merino Bohórquez V, Calleja MA, Caunedo Álvarez Á, Vilches Arenas Á Abstract BACKGROUND: Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the…

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Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab.

Related Articles Systematic review: efficacy and safety of switching patients between reference and biosimilar infliximab. Aliment Pharmacol Ther. 2018 Nov 08;: Authors: Feagan BG, Lam G, Ma C, Lichtenstein GR Abstract BACKGROUND: Biosimilar versions of widely prescribed drugs, including the tumour-necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that…

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Letter: is there a role for infliximab biosimilar in patients with inflammatory bowel disease with secondary loss of response to infliximab innovator?

Related Articles Letter: is there a role for infliximab biosimilar in patients with inflammatory bowel disease with secondary loss of response to infliximab innovator? Aliment Pharmacol Ther. 2018 Nov;48(9):1037-1038 Authors: Orfanoudaki E, Drygiannakis I, Koutroubakis IE PMID: 30318690 [PubMed – in process] PubMed Link: https://www.ncbi.nlm.nih.gov/pubmed/30318690?dopt=Abstract

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