Año 2018 / Volumen 110 / Número 9
Original
Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months

564-570

DOI: 10.17235/reed.2018.5368/2017

María Fernanda Guerra Veloz, Juan María Vázquez Morón, María Belvis Jiménez, Héctor Pallarés Manrique, Teresa Valdés Delgado, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldán, Raúl Perea Amarillo, Vicente Merino, Ángel Caunedo Álvarez, Ángel Vilches-Arenas, Federico Argüelles Arias,

Resumen
Background and aims: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. Methods: this was a multicenter prospective observational study in patients with Crohn’s disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade®) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study. Results: a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases. Conclusion: switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%.
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25/05/2021 6:54:35
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Bibliografía
1. Cote-Daigneault J, Bouin M, Lahaie R, Colombel JF, Poitras P. Biologics in inflammatory bowel disease: what are the data? United European Gastroenterol J 2015; 3(5): 419-428 [PMID: 26535119 DOI: 10.1177/2050640615590302]
2 European Medicines Agency. European public assessment reports - Infliximab. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124&source=homeMedSearch&keyword=infliximab&category=human&isNewQuery=true. Accessed on January 23, 2017.
3 European Medicines Agency. European public assessment reports - Adalimumab. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=%0AWC0b01ac058001d124&source=homeMedSearch&keyword=adalimumab&category=human&isNewQuery=true. Accessed on January 23, 2017.
4 European Medicines Agency. European public assessment reports - Simponi (golimumab). Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000992/human_med_001053.jsp&mid=WC0b01ac058001d124. Accessed on January 23, 2017.
5. Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther 2008; 117(2): 244-279 [PMID: 18155297 DOI: 10.1016/j.pharmthera.2007.10.001]
6 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 Ther 2009; 30(3): 265-274 [PMID: 19438428 DOI: 10.1111/j.1365-2036.2009.04033.x]
7 World Health Organization. Expert Committee on biological standarization. Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). Available at: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed on January 23, 2017.
8 Haustein R, de Millas C, Höer A, Häyssker B. Saving money in the European healthcare systems with biosimilars. GaBI J 2012; 1(3-4): 120-126 [DOI: DOI: 10.5639/gabij.2012.0103-4.036]
9 European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Assessment report: Remsima (infliximab). 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf. Accessed on January 23, 2017.
10 INFLECTRA prescribing information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125544s000lbl.pdf. Accessed January 1, 2017
11 Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. 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 [PMID: 23687260 DOI: 10.1136/annrheumdis-2012-203090]
12 Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Urena S, Lim M, Lee YA, Lee SJ, Kim H, Yoo DH, Braun J. 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(10): 1605-1612 [PMID: 23687259 DOI: 10.1136/annrheumdis-2012-203091]
13 Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. 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 [PMID: 27038608 DOI: 10.1186/s13075-016-0981-6]
14 Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J. 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 [PMID: 26795209 DOI: 10.1186/s13075-016-0930-4]
15 Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, Baranauskaite A, Wiland P, Abud-Mendoza C, Oparanov B, Smiyan S, Kim H, Lee SJ, Kim S, Park W. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017; 76(2): 355-363 [PMID: 27130908 DOI: 10.1136/annrheumdis-2015-208786]
16 Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Urena S, Mikazane H, Lee YA, Smiyan S, Lim MJ, Kadinov V, Abud-Mendoza C, Kim H, Lee SJ, Bae Y, Kim S, Braun J. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2017; 76(2): 346-354 [PMID: 27117698 DOI: 10.1136/annrheumdis-2015-208783]
17 Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, Kang HW, Kim JW. 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(12): 1705-1712 [PMID: 25974251 DOI: 10.1111/jgh.12997]
18 Argüelles-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. Digestive Diseases and Sciences. 2017;62(5):1305-1312. doi:10.1007/s10620-017-4511-4.
19 Gecse KB, Lovasz BD, Farkas K, Banai J, Bene L, Gasztonyi B, Golovics PA, Kristof T, Lakatos L, Csontos AA, Juhasz M, Nagy F, Palatka K, Papp M, Patai A, Lakner L, Salamon A, Szamosi T, Szepes Z, Toth GT, Vincze A, Szalay B, Molnar T, Lakatos PL. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J Crohns Colitis 2016; 10(2): 133-140 [PMID: 26661272 DOI: 10.1093/ecco-jcc/jjv220]
20 Park SH, Kim YH, Lee JH, Kwon HJ, Lee SH, Park DI, Kim HK, Cheon JH, Im JP, Kim YS, Lee SY, Lee SJ. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 2015; 9 Suppl 1: 35-44 [PMID: 26395533 DOI: 10.1586/17474124.2015.1091309]
21 Farkas K, Rutka M, Golovics PA, Vegh Z, Lovasz BD, Nyari T, Gecse KB, Kolar M, Bortlik M, Duricova D, Machkova N, Hruba V, Lukas M, Mitrova K, Malickova K, Balint A, Nagy F, Bor R, Milassin A, Szepes Z, Palatka K, Lakatos PL, Lukas M, Molnar T. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis. J Crohns Colitis 2016; 10(11): 1273-1278 [PMID: 27106537 DOI: 10.1093/ecco-jcc/jjw085]
22 Jahnsen J. Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients. Therap Adv Gastroenterol 2016; 9(3): 322-329 [PMID: 27134662 DOI: 10.1177/1756283x16636764]
23 Smits LJ, Derikx LA, de Jong DJ, Boshuizen RS, van Esch AA, Drenth JP, Hoentjen F. Clinical outcomes following a switch from Remicade(R) to the biosimilar CT-P13 in inflammatory bowel disease patients: A prospective observational cohort study. J Crohns Colitis 2016; 10(11): 1287-1293 [PMID: 27095751 DOI: 10.1093/ecco-jcc/jjw087]
24 Sieczkowska J, Jarzebicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, Oracz G, Meglicka M, Kierkus J. Switching between infliximab originator and biosimilar in paediatric patients with inflammatory bowel disease. Preliminary observations. J Crohns Colitis 2016; 10(2): 127-132 [PMID: 26721942 DOI: 10.1093/ecco-jcc/jjv233]
25 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 Jun 30. doi: 10.1007/s10620-017-4661-4. [Epub ahead of print].
26 Gonczi L, Gecse KB, Vegh Z, et al. Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort. Inflamm Bowel Dis. 2017 Nov;23(11):1908-1915. doi: 10.1097/MIB.0000000000001237
27 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 Nov;29(11):1290-1295. doi: 10.1097/MEG.0000000000000953.
28. Jørgensen KK, Olsen IC, Goll GL, et al. NOR-SWITCH study group. 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 Jun 10;389(10086):2304-2316. doi: 10.1016/S0140-6736(17)30068-5. Epub 2017 May 11.
29 Danese S, Fiorino G, Raine T, et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease-an update. J Crohns Colitis 2017; 11(1): 26-34 [PMID: 27927718 DOI: 10.1093/ecco-jcc/jjw198]
30 European Medicines Agency. Ficha técnica de Remsima, INN - infliximab. Available at: http://www.ema.europa.eu/docs/es_ES/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf. Accessed on January 23, 2017.
31 US Department of Health and Human Services - Office for Human Research Protections. Unanticipated problems involving risks & adverse events guidance (2007). Available at: http://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html. Accessed on January 23, 2017.
32 Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet 2002; 359(9317): 1541-1549 [PMID: 12047962 DOI: 10.1016/s0140-6736(02)08512-4]
33 Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol 2009; 104(3): 760-767 [PMID: 19174781 DOI: 10.1038/ajg.2008.88]
34 Chaparro M, Panes J, Garcia V, et al. Long-term durability of infliximab treatment in Crohn’s disease and efficacy of dose “escalation” in patients losing response. J Clin Gastroenterol 2011; 45: 113–8
35 Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJS, Present D, Sands BE, Colombel JF. Infliximab for Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med 2005; 353(23): 2462-2476 [PMID: 16339095 DOI: doi:10.1056/NEJMoa050516]
36 Reinisch W, Sandborn WJ, Rutgeerts P, Feagan BG, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJS, Blank M, Lang Y, Johanns J, Colombel JF, Present D, Sands BE. Long term infliximab maintenance therapy for ulcerative colitis: the ACT1 and ACT2 extension studies. Inflamm Bowel Dis 2012; 18(2): 201-211 [PMID: 00054725-201202000-00001 DOI: 10.1002/ibd.21697]
37 Fiorino G, Manetti N, Armuzzi A, Orlando A, Variola A, Bonovas S, et al. The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar. Inflammatory bowel diseases 2017; 23 (2):233-243.
38 Komaki Y, Yamada A, Komaki F, Micic D, Ido A, Sakuraba A. 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 Apr;45(8):1043-1057. doi: 10.1111/apt.13990. Epub 2017 Feb
39 Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, Hinojosa J, Tejerina T. Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig 2013;105:37-43
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Instrucciones para citar
Guerra Veloz M, Vázquez Morón J, Belvis Jiménez M, Pallarés Manrique H, Valdés Delgado T, Castro Laria L, et all. Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months . 5368/2017


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Recibido: 10/11/2017

Aceptado: 19/03/2018

Prepublicado: 12/06/2018

Publicado: 31/08/2018

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Tiempo de prepublicación: 214 días

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