Efficacy and tolerability of initiating, or switching to, infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD): a large single-centre experience

References

• Podolsky DK. Inflammatory bowel disease (2). N Engl J Med. 1991;325:1008–1016.
   PubMed Web of Science ®Google Scholar
• Papadakis KA, Targan SR. Role of cytokines in the pathogenesis of inflammatory bowel disease. Annu Rev Med. 2000;51:289–298.
   PubMed Web of Science ®Google Scholar
• Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. The Lancet. 2007;369:1627–1640.
   PubMed Web of Science ®Google Scholar
• Côté-Daigneault J, Bouin M, Lahaie R, et al. Biologics in inflammatory bowel disease: what are the data?. United Eur Gastroenterol J. 2015;3:419–428.
   PubMed Web of Science ®Google Scholar
• Kuek A, Hazleman BL, Östör AJ. Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution. Postgrad Med J. 2007;83:251–260.
   PubMed Web of Science ®Google Scholar
• Tracey D, Klareskog L, Sasso EH, et al. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117:244–279.
   PubMed Web of Science ®Google Scholar
• Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549.
   PubMed Web of Science ®Google Scholar
• Rutgeerts P, Sandborn WJ, Feagan BG, et al. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005;353:2462–2476.
   PubMed Web of Science ®Google Scholar
• Bodger K, Kikuchi T, Hughes D. Cost‐effectiveness of biological therapy for Crohn’s disease: Markov cohort analyses incorporating United Kingdom patient‐level cost data. Aliment Pharmacol Therap. 2009;30:265–274.
   PubMed Web of Science ®Google Scholar
• Jung SK, Lee KH, Jeon JW, et al. Physicochemical characterization of Remsima®. In: MAbs. 2014;6:1163–1177.
   Google Scholar
• European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment Report: Infectra. [cited 2017 Jul 5] 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf
   Google Scholar
• Park W, Hrycaj P, Jeka S, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72:1605–1612.
   PubMed Web of Science ®Google Scholar
• Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10): 1613–1620.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment Report: Remsima. [cited 2017 Jul 5] 2013. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf
   Google Scholar
• Argüelles-Arias F, Veloz MG, Amarillo RP, et al. Effectiveness and safety of CT-P13 (biosimilar infliximab) in patients with inflammatory bowel disease in real life at 6 months. Dig Dis Sci. 2017;62:1305–1312.
   PubMed Web of Science ®Google Scholar
• Gecse KB, Lovász BD, Farkas K, et al. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. Eccojc. 2015;10:133–140.
   Google Scholar
• Jung YS, Park DI, Kim YH, et al. Efficacy and safety of CT‐P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study. J Gastroenterol Hepatol. 2015;30:1705–1712.
   PubMed Web of Science ®Google Scholar
• Sieczkowska J, Jarzębicka D, Banaszkiewicz A, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. Eccojc. 2015;10:127–132.
   Google Scholar
• Farkas K, Rutka M, Bálint A, et al. Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis–experiences from a single center. Expert Opin Biol Ther. 2015;15:1257–1262.
   PubMed Web of Science ®Google Scholar
• Jahnsen J, Detlie TE, Vatn S, et al. Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study. Expert Rev Gastroenterol Hepatol. 2015;9(sup1):45–52.
   Google Scholar
• Keil R, Wasserbauer M, Zádorová Z, et al. Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis. Scand J Gastroenterol. 2016;51: 1062–1068.
   PubMed Web of Science ®Google Scholar
• Smits LJ, Derikx LA, de Jong DJ, et al. Clinical outcomes following a switch from Remicade® to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study. Eccojc. 2016;10:1287–1293.
   Google Scholar
• Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304–2316.
   PubMed Web of Science ®Google Scholar
• Immunodiagnostik. IDKmonitor® Infliximab drug level ELISA. [cited 2018 Mar 27] 2016. Available from: http://www.immundiagnostik.com/fileadmin/pdf/IDKmonitor_Infliximab_K9655.pdf
   Google Scholar
• National Institute of Clinical Excellence. Infliximab, Adalimumab And Golimumab For Treating Moderately To Severely Active Ulcerative Colitis After The Failure Of Conventional Therapy. [cited 2017 Jul 8] 2015. Available from: https://www.nice.org.uk/guidance/ta329/resources/infliximab-adalimumab-and-golimumab-for-treating-moderately-to-severely-active-ulcerative-colitis-after-the-failure-of-conventional-therapy-pdf-82602495307717. Accessed July 8
   Google Scholar
• Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to infliximab on clinical outcomes and serum infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013;108:40.
   PubMed Web of Science ®Google Scholar