4,444
Views
15
CrossRef citations to date
0
Altmetric
Review

Anti-TNF biosimilars in Crohn’s Disease: a patient-centric interdisciplinary approach

, , , , , & show all
Pages 731-738 | Received 18 Mar 2019, Accepted 12 Jul 2019, Published online: 26 Jul 2019

References

  • Danese S, Bonovas S, Peyrin-Biroulet L. Biosimilars in IBD: from theory to practice. Nat Rev Gastroenterol Hepatol. 2017;14:22–31.
  • Allen PB, Gower-Rousseau C, Danese S, et al. Preventing disability in inflammatory bowel disease. Therap Adv Gastroenterol. 2017;10:865–876.
  • Mao EJ, Hazlewood GS, Kaplan GG, et al. Systematic review with meta-analysis: comparative efficacy of immunosuppressants and biologics for reducing hospitalisation and surgery in Crohn’s disease and ulcerative colitis. Aliment Pharmacol Ther. 2017;45:3–13.
  • Cholapranee A, Hazlewood GS, Kaplan GG, et al. Systematic review with meta-analysis: comparative efficacy of biologics for induction and maintenance of mucosal healing in Crohn’s disease and ulcerative colitis controlled trials. Aliment Pharmacol Ther. 2017;45:1291–1302.
  • Hindryckx P, Vande Casteele N, Novak G, et al. The expanding therapeutic armamentarium for inflammatory bowel disease: how to choose the right drugs for our patients? J Crohns Colitis. 2018;12:105–119.
  • Rogler G. Top-down or step-up treatment in Crohn’s disease? Dig Dis. 2013;31:83–90.
  • McQuaid RR. Chapter 62. Drugs used in the treatment of gastrointestinal diseases. In: Katzung BG, Trevor AJ, editors. Basic and Clinical Pharmacology; 2015.
  • Rawla P, Sunkara T, Raj JP. Role of biologics and biosimilars in inflammatory bowel disease: current trends and future perspectives. J Inflamm Res. 2018;11:215–226.
  • US Food and Drug Administration. Biosimilar product information [Internet]. Silver Spring, MD, USA; [Updated 18 Jan 2019; cited Feb 2019]. Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm
  • van der Valk ME, Mangen M-J-J, Leenders M, et al. Healthcare costs of inflammatory bowel disease have shifted from hospitalisation and surgery towards anti-TNFα therapy: results from the COIN study. Gut. 2014;63:72–79.
  • European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues [Internet]. London, UK; 18 December 2014 [cited Dec 2018]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf.
  • Declerck P, Farouk Rezk M. The road from development to approval: evaluating the body of evidence to confirm biosimilarity. Rheumatology (Oxford). 2017;56:iv4–iv13.
  • Rezk MF, Pieper B. Treatment outcomes with biosimilars: be aware of the nocebo effect. Rheumatol Ther. 2017;4:209–218.
  • US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. [Internet]. Silver Spring, MD, USA; April 2015 [cited Dec 2018]. Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291128.pdf.
  • Hong J, Lee Y, Lee C, et al. Physicochemical and biological characterization of SB2, a biosimilar of Remicade® (infliximab). MAbs. 2017;9:364–382.
  • Choe J-Y, Prodanovic N, Niebrzydowski J, et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76:58–64.
  • Smolen JS, Choe J-Y, Prodanovic N, et al. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology (Oxford). 2017;56:1771–1779.
  • Smolen JS, Choe J-Y, Prodanovic N, et al. Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study. Ann Rheum Dis. 2018;77:234–240.
  • Fiorino G, Gilardi D, Correale C, et al. Biosimilars of adalimumab: the upcoming challenge in IBD. Expert Opin Biol Ther. 2019. Epub ahead of print. doi:10.1080/14712598.2019.1564033.
  • Pariente B, Cosnes J, Danese S, et al. Development of the Crohn’s disease digestive damage score, the Lémann score. Inflamm Bowel Dis. 2011;17:1415–1422.
  • Peyrin-Biroulet L, Loftus EV, Colombel J-F, et al. Early Crohn disease: a proposed definition for use in disease-modification trials. Gut. 2010;59:141–147.
  • Colombel JF, Sandborn WJ, Reinisch W, et al. Infliximab, azathioprine, or combination therapy for Crohn’s disease. N Engl J Med. 2010;362:1383–1395.
  • Colombel J-F, Panaccione R, Bossuyt P, et al. Effect of tight control management on Crohn’s disease (CALM): a multicentre, randomised, controlled phase 3 trial. Lancet. 2018;390:2779–2789.
  • Colombel J-F, Sandborn WJ, Rutgeerts P, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trial. Gastroenterology. 2007;132:52–65.
  • D’Haens G, Baert F, van Assche G, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial. Lancet. 2008;371:660–667.
  • Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet. 2002;359:1541–1549.
  • 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. quiz 1165-6
  • Colombel J-F, Rutgeerts P, Reinisch W, et al. One year data from the SONIC study: a randomized, double-blind trial comparing infliximab and infliximab plus azathioprine to azathioprine in patients with Crohn’s disease naive to immunomodulators and biologic therapy. Gut. 2009;58:A69.
  • Severs M, Oldenburg B, van Bodegraven AA, et al. initiative of Crohn’s and Colitis. The economic impact of the introduction of biosimilars in inflammatory bowel disease. J Crohns Colitis. 2017;11:289–296.
  • Hirschmann S, Neurath MF. Top-down approach to biological therapy of Crohn’s disease. Expert Opin Biol Ther. 2017;17:285–293.
  • Peyrin-Biroulet L, Billioud V, D’Haens G, et al. Development of the Paris definition of early Crohn’s disease for disease-modification trials: results of an international expert opinion process. Am J Gastroenterol. 2012;107:1770–1776.
  • Fiorino G, Morin M, Bonovas S, et al. Prevalence of bowel damage assessed by cross-sectional imaging in early Crohn’s disease and its impact on disease outcome. J Crohns Colitis. 2017;11:274–280.
  • Cosnes J, Cattan S, Blain A, et al. Long-term evolution of disease behavior of Crohn’s disease. Inflamm Bowel Dis. 2002;8:244–250.
  • Ghosh S, Mitchell R. Impact of inflammatory bowel disease on quality of life: results of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) patient survey. J Crohns Colitis. 2007;1:10–20.
  • Schoepfer AM, Dehlavi M-A, Fournier N, et al. Diagnostic delay in Crohn’s disease is associated with a complicated disease course and increased operation rate. Am J Gastroenterol. 2013;108:1744–1753. quiz 1754
  • Danese S, Fiorino G, Fernandes C, et al. Catching the therapeutic window of opportunity in early Crohn’s disease. Curr Drug Targets. 2014;15:1056–1063.
  • Danese S, Fiorino G, Mary J-Y, et al. Development of Red Flags Index for early referral of adults with symptoms and signs suggestive of Crohn’s disease: an IOIBD initiative. J Crohns Colitis. 2015;9:601–606.
  • Boone NW, Liu L, Romberg-Camps MJ, et al. The nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol. 2018;74:655–661.
  • Gils A. Combining therapeutic drug monitoring with biosimilars, a strategy to improve the efficacy of biologicals for treating inflammatory bowel diseases at an affordable cost. Dig Dis. 2017;35:61–68.
  • Martelli L, Olivera P, Roblin X, et al. Cost-effectiveness of drug monitoring of anti-TNF therapy in inflammatory bowel disease and rheumatoid arthritis: a systematic review. J Gastroenterol. 2017;52:19–25.
  • Afonso J, de Sousa HT, Rosa I, et al. Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays. Therap Adv Gastroenterol. 2017;10:661–671.
  • Fiorino G, Ruiz-Agüello MB, Maguregui A, et al. P633 Antibodies to infliximab in patients treated with either the reference biologic or the biosimilar CT-P13 show identical reactivity towards biosimilars CT-P13 and SB2 in inflammatory bowel disease. Eur Crohn’s Colitis Organ Congr Abstr. 2017; 11(S1):S403–S404. doi:10.1093/ecco-jcc/jjx002.757.
  • Ruiz-Agüello MB, Maguregui A, Martínez A, et al. P387 Infliximab therapeutic drug monitoring test validated for measuring CT-P13 and SB2 biosimilar. Eur Crohn’s Colitis Organ Congr Abstr. 2018;12(S1):S299. doi:10.1093/ecco-jcc/jjx180.514.
  • Magro F, Rocha C, Vieira AI, et al. P229 The new biosimilar of infliximab SB2 can be quantified by IFX-optimised therapeutic drug monitoring assays. Eur Crohn’s Colitis Organ Congr Abstr. 2018;12(S1):S216. doi:10.1093/ecco-jcc/jjx180.356.
  • 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.
  • Goncalves J, Santos M, Acurcio R, et al. Antigenic response to CT-P13 and infliximab originator in inflammatory bowel disease patients shows similar epitope recognition. Aliment Pharmacol Ther. 2018;48:507– 522.
  • Argüelles-Arias F, Guerra Veloz MF, Perea Amarillo R, et al. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results. Eur J Gastroenterol Hepatol. 2017;29:1290–1295.
  • Eberl A, Huoponen S, Pahikkala T, et al. Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients. Scand J Gastroenterol. 2017;52:1348–1353.
  • 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.
  • Kolar M, Duricova D, Bortlik M, et al. Infliximab biosimilar (Remsima™) in therapy of inflammatory bowel diseases patients: experience from one tertiary inflammatory bowel diseases centre. Dig Dis. 2017;35:91–100.
  • 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 LJT, Grelack A, Derikx LAAP, et al. Long-term clinical outcomes after switching from Remicade® to biosimilar CT-P13 in inflammatory bowel disease. Dig Dis Sci. 2017;62:3117–3122.
  • Macaluso FS, Cappello M, Giuffrida E, et al. Letter: SPOSIB SB2-a Sicilian prospective observational study of IBD patients treated with infliximab biosimilar SB2. Aliment Pharmacol Ther. 2019;49:234–236.
  • Fischer S, Klenske E, Schmitt H, et al. P1592 Effectiveness, immunogenicity, safety and pharmacoeconomic aspects following a switch from reference infliximab to the biosimilar SB2 in inflammatory bowel disease patients: a 6 months prospective cohort study. United European Gastroenterol J. 2018;6(8_suppl).
  • Armuzzi A, Avedano L, Greveson K, et al. Nurses are critical in aiding patients transitioning to biosimilars in inflammatory bowel disease: education and communication strategies. J Crohns Colitis. 2019;13:259–266.
  • England NHS. Principles for sharing the benefits associated with more efficient use of medicines not reimbursed through national prices [Internet]. England; 2014 [cited Jan 2018]. Available from: https://www.england.nhs.uk/wp-content/uploads/2014/01/princ-shar-benefits.pdf.
  • Kemp K, Dibley L, Chauhan U, et al. Second N-ECCO consensus statements on the European nursing roles in caring for patients with Crohn’s disease or ulcerative colitis. J Crohns Colitis. 2018;12:760–776.