1,481
Views
7
CrossRef citations to date
0
Altmetric
Gastroenterology

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn’s disease or ulcerative colitis

, &
Pages 129-134 | Received 17 Jan 2019, Accepted 30 May 2019, Published online: 18 Jun 2019

References

  • Randall CW, Vizuete JA, Martinez N, et al. From historical perspectives to modern therapy: a review of current and future biological treatments for Crohn’s disease. Therap Adv Gastroenterol. 2015;8:143–159.
  • Park SC, Jeen YT. Current and emerging biologics for ulcerative colitis. Gut Liver. 2015;9:18–27.
  • Stawowczyk E, Kawalec P. Cost-effectiveness of biological treatment of ulcerative colitis – a systematic review. PG. 2017;12:90–97.
  • Bonovas S, Peyrin-Biroulet L, Danese S. Clinical development of biologicals and biosimilars - safety concerns. Exp Rev Clinical Pharmacol. 2017;10:567–569.
  • 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.
  • Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016;18:25.
  • 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;72:1613–1620.
  • Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016;18:82.
  • Inflectra, INN-infliximab. Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002778/WC500151489.pdf [Accessed 29 August 2018].
  • Remsima (infliximab). European Public Assessment Report (EPAR). http://www.ema.europa.eu:80/ema/index.jsp?curl=pages/medicines/human/medicines/002576/human_med_001682.jsp&mid=WC0b01ac058001d124 [Accessed 29 August 2018].
  • Sandborn WJ, Feagan BG, Hanauer SB, et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn’s disease. Gastroenterology. 2002;122:512–530.
  • Rachmilewitz D. Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial. BMJ. 1989;298:82–86.
  • Cortot A, Maetz D, Degoutte E, et al. Mesalamine foam enema versus mesalamine liquid enema in active left-sided ulcerative colitis. Am J Gastroenterol. 2008;103:3106–3114.
  • Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: A quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996;91:1571–1578.
  • Komaki Y, Yamada A, Komaki F, et al. Systematic review with meta-analysis: the efficacy and safety of CT-P13, a biosimilar of anti-tumour necrosis factor-α agent (infliximab), in inflammatory bowel diseases. Aliment Pharmacol Ther. 2017;45:1043–1057.
  • Gisbert JP, Chaparro M. Switching from an originator anti-TNF to a biosimilar in patients with inflammatory bowel disease: Can it be recommended? A systematic review. Gastroenterol Hepatol. 2018;41:389–405.
  • Strik AS, van de Vrie W, Bloemsaat-Minekus JPJ, et al. Serum concentrations after switching from originator infliximab to the biosimilar CT-P13 in patients with quiescent inflammatory bowel disease (SECURE): an open-label, multicentre, phase 4 non-inferiority trial. Lancet Gastroenterol Hepatol. 2018;3:404–412.
  • Armuzzi A, Fiorino G, Variola A, et al. The PROSIT cohort of infliximab biosimilar in IBD: a prolonged follow-up on the effectiveness and safety across Italy. Inflamm Bowel Dis. 2019;25:568–579.
  • Guerra Veloz MF, Vázquez Morón JM, Belvis Jiménez M, et al. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months. Rev Esp Enferm Dig. 2018;110:564–570.
  • Høivik ML, Buer LCT, Cvancarova M, et al. Switching from originator to biosimilar infliximab – real world data of a prospective 18 months follow-up of a single-centre IBD population. Scand J Gastroenterol. 2018;53:692–699.
  • Kaniewska M, Moniuszko A, Rydzewska G. The efficacy and safety of the biosimilar product (Inflectra(®)) compared to the reference drug (Remicade(®)) in rescue therapy in adult patients with ulcerative colitis. Pg. 2017;12:169–174.
  • Ratnakumaran R, To N, Gracie DJ, et al. Efficacy and tolerability of initiating, or switching to, infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD): a large single-centre experience. Scand J Gastroenterol. 2018;53:700–707.
  • Gisbert JP, Marín AC, McNicholl AG, et al. Systematic review with meta-analysis: the efficacy of a second anti-TNF in patients with inflammatory bowel disease whose previous anti-TNF treatment has failed. Aliment Pharmacol Ther. 2015;41:613–623.
  • Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of biologics in chronic inflammatory diseases: a systematic review. BioDrugs. 2017;31:299–316.
  • Bálint A, Rutka M, Végh Z, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort. Expert Opin Drug Saf. 2017;16:885–890.
  • Brodszky V, Rencz F, Péntek M, et al. A budget impact model for biosimilar infliximab in Crohn's disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia. Expert Rev Pharmacoecon Outcomes Res. 2016;16:119–125.
  • Severs M, Oldenburg B, van Bodegraven AA, et al. The economic impact of the introduction of biosimilars in inflammatory bowel disease. J Crohns Colitis. 2017;11:289–296.
  • Jha A, Upton A, Dunlop WC, et al. The budget impact of biosimilar infliximab (Remsima®) for the treatment of autoimmune diseases in five European countries. Adv Ther. 2015;32:742–756.