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Original Article

Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients

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Pages 1348-1353 | Received 13 May 2017, Accepted 10 Aug 2017, Published online: 24 Aug 2017

References

  • Kornbluth A. Infliximab approved for use in Crohn’s disease: a report on the FDA GI Advisory Committee conference. Inflamm Bowel Dis. 1998;4:328–329.
  • Hyams J, Crandall W, Kugathasan S, et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn’s disease in children. Gastroenterology. 2007;132:863–873.
  • Hyams J, Walters TD, Crandall W, et al. Safety and efficacy of maintenance infliximab therapy for moderate-to-severe Crohn’s disease in children: REACH open-label extension. Curr Med Res Opin. 2011;27:651–662.
  • 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.
  • Eidelwein AP, Cuffari C, Abadom V, et al. Infliximab efficacy in pediatric ulcerative colitis. Inflamm Bowel Dis. 2005;11:213–218.
  • McGinnis JK, Murray KF. Infliximab for ulcerative colitis in children and adolescents. J Clin Gastroenterol. 2008;42:875–879.
  • Vande Casteele N, Khanna R, Levesque BG, et al. The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn’s disease. Gut. 2015;64:1539–1545.
  • Vande Casteele N, Ferrante M, Van Assche G, et al. Trough concentrations of infliximab guide dosing for patients with inflammatory bowel disease. Gastroenterology. 2015;148:1320–1329.e3.
  • Afif W, Loftus EV, Faubion WA, et al. Clinical utility of measuring infliximab and human anti-chimeric antibody concentrations in patients with inflammatory bowel disease. Am J Gastroenterol. 2010;105:1133–1139.
  • Yanai H, Hanauer SB. Assessing response and loss of response to biological therapies in IBD. Am J Gastroenterol. 2011;106:685–698.
  • Ben-Horin S, Yavzori M, Benhar I, et al. Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2016;65:1132–1138.
  • European Medicines Agency, Committee for Medicinal Products for Human Use. Assessment Report. 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Public_assessment_report/human/002576/WC500151486.pdf
  • 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.
  • 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.
  • Danese S, Gomollon F. ECCO GBaOBo. ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). J Crohns Colitis. 2013;7:586–589.
  • 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. J Crohns Colitis. 2016;10:133–140.
  • 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.
  • Fiorino G, Manetti N, Armuzzi A, et al. The PROSIT-BIO cohort: a prospective observational study of patients with inflammatory bowel disease treated with infliximab biosimilar. Inflamm Bowel Dis. 2017;23:233–243.
  • Razanskaite V, Bettey M, Downey L, et al. Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme. J Crohns Colitis. 2017;11:690–696.
  • 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. J Crohns Colitis. 2016;10:1287–1293.
  • Smits LJT, Grelack A, Derikx L, et al. Long-term clinical outcomes after switching from Remicade® to biosimilar CT-P13 in inflammatory bowel disease. Dig Dis Sci. Forthcoming. [cited 2017 Jun 30]. DOI:10.1007/s10620-017-4661-4
  • Arguelles-Arias F, Guerra Veloz MF, Perea Amarillo R, 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.
  • Buer LC, Moum BA, Cvancarova M, et al. Switching from Remicade® to Remsima® is well tolerated and feasible: a prospective, open-label study. J Crohns Colitis. 2017;11:297–304.
  • Jorgensen 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.
  • Sieczkowska J, Jarzębicka D, Banaszkiewicz A, et al. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis. 2016;10:127–132.
  • Best WR. Predicting the Crohn’s disease activity index from the Harvey–Bradshaw index. Inflamm Bowel Dis. 2006;12:304–310.
  • Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008;14:1660–1666.
  • Sipponen T, Kolho KL. Fecal calprotectin in diagnosis and clinical assessment of inflammatory bowel disease. Scand J Gastroenterol. 2015;50:74–80.
  • Mara CA, Cribbie RA. Paired-samples tests of equivalence. Commun Stat Simul Comput. 2012;41:1928–1943.
  • Dotan I, Ron Y, Yanai H, et al. Patient factors that increase infliximab clearance and shorten half-life in inflammatory bowel disease: a population pharmacokinetic study. Inflamm Bowel Dis. 2014;20:2247–2259.
  • Vande Casteele N, Gils A. Pharmacokinetics of anti-TNF monoclonal antibodies in inflammatory bowel disease: adding value to current practice. J Clin Pharmacol. 2015;55:S39–S50.
  • Vermeire S, Noman M, Van Assche G, et al. Effectiveness of concomitant immunosuppressive therapy in suppressing the formation of antibodies to infliximab in Crohn’s disease. Gut. 2007;56:1226–1231.
  • Schulze K, Koppka N, Lutter F, et al. CT-P13 (Inflectra™, Remsima™) monitoring in patients with inflammatory bowel disease. Biologicals. 2016;44:463–466.
  • Yarur AJ, Kanagala V, Stein DJ, et al. Higher infliximab trough levels are associated with perianal fistula healing in patients with Crohn’s disease. Aliment Pharmacol Ther. 2017;45:933–940.

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