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Patología Intestinal S 24 Manej o de la de c oliti s u lcer osa grave en Chi le - C. Agüero L . et al. y a la semana 30 de 52 y 47%. La experiencia con el biosimilar en Corea del Sur, Noruega, República Checa y Hungría ha incluido a 257 pacientes con CU sin tratamiento previo de biológicos. La respuesta clínica ha sido de 56 a 78% a las 8 y 14 semanas, y de 46 a 68% a las 30 semanas. Lo que ha permitido demostrar su efectividad. En relación a la inmunogenicidad, los estudios en CU son escasos, sin embargo, no se ha logrado encontrar diferencias en la formación de anticuerpos antidroga con los pacientes que utilizan el fármaco de referencia. El cambio desde el medicamento de referencia al biosimilar también es un punto de debate. Existen estudios en curso con financiamiento gubernamental en Noruega (NOR-SWITCH STUDY-RCT NCT 02148640) que prontamente entregarán resultados, sin embargo, la experiencia inicial presentada en congresos parece ser alentadora. Referencias 1.- Truelove SC, Witts LJ. Cortisone in ulcerative colitis: final report on a therapeutic trial. Br Med J 1955; 29; 2: 1041-8. 2.- Scott KP, Antoine JM, Midtvedt T, van Hemert S. Manipulating the gut microbiota to maintain health and treat disease. Microb Ecol Health Dis 2015; 26: 25877. 3.- Sartor RB. Therapeutic manipulation of the enteric microflora in inflammatory bowel diseases: antibiotics, probiotics, and prebiotics. Gastroenterology 2004; 126: 1620-33. 4.- Mantzaris GJ, Hatzis A, Kontogiannis P, Triadaphyllou G. Intravenous tobramycin and metronidazole as an adjunct to corticosteroids in acute, severe ulcerative colitis. Am J Gastroenterol 1994; 89: 43-6. 5.- Kim JJ, Simpson N, Klipfel N, Debose R, Barr N, Laine L. Cytomegalovirus infection in patients with active inflammatory bowel disease. Dig Dis Sci 2010; 55: 1059-65. 6.- Dimitroulia E, Spanakis N, Konstantinidou AE, Legakis NJ, Tsakris A. Frequent detection of cytomegalovirus in the intestine of patients with inflammatory bowel disease. Inflamm Bowel Dis 2006; 12: 879-84. 7.- Kim YS, Kim YH, Kim JS, Cheon JH, Ye BD, Jung SA, et al. The prevalence and efficacy of ganciclovir on steroidrefractory ulcerative colitis with cytomegalovirus infection: a prospective multicenter study. J Clin Gastroenterol 2012; 46: 51-6. 8.- Cottone M, Pietrosi G, Martorana G, Casa A, Pecoraro G, Oliva L, et al. Prevalence of cytomegalovirus infection in severe refractory ulcerative and Crohn’s colitis. Am J Gastroenterol 2001; 96: 773-5. 9.- Rowshani AT, Bemelman FJ, van Leeuwen EM, van Lier RA, ten Berge IJ. Clinical and immunologic aspects of cytomegalovirus infection in solid organ transplant recipients. Transplantation 2005; 79: 381-6. 10.- Matsuoka K, Iwao Y, Mori T, Sakuraba A, Yajima T, Hisamatsu T, et al. Cytomegalovirus is frequently reactivated and disappears without antiviral agents in ulcerative colitis patients. Am J Gastroenterol 2007; 102: 331-7. 11.- Rahier JF, Magro F, Abreu C, Armuzzi A, Ben.Horin S, Chowers Y, et al. Second European evidence based consensus on the prevention, diagnosis and management of opportunistic infections in inflammatory bowel disease. J Crohn’s Colitis 2014; 8: 443-68. 12.- Jones A, McCurdy JD, Loftus EV Jr, Bruinin DH, Enders FT, Killian JM, et al. Effects of antiviral therapy for patients with inflammatory bowel disease and a positive intestinal biopsy for cytomegalovirus. Clin Gastroenterol Hepatol 2015; 13: 949-55. 13.- Ormeci AC, Akyuz F, Baran B, Soyer OM, Gokturk S, Onel D, et al. Steroid-refractory inflammatory bowel disease is a risk factor for CMV infection. Eur Rev Med Pharmacol Sci 2016; 20: 858-65. 14.- Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multi-centre, parallel-group, prospective study comparing the pharmaco- kinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 2013; 72: 1605-12. 15.- Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, 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: 1613-20. 16.- European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Assessment report: Remsima (infliximab). 27 June 2013. Disponible en: http://www.ema.europa.eu/docs/ en GB/document library/EPAR-Public_ assessment_report/human/002576/ WC500151486.pdf. Consultado en línea el 1 de julio de 2016. 17.- Fiorino G, Danese S. The biosimilar road in inflammatory bowel disease: the right way? Best Pract Res Clin Gastroenterol 2014; 28: 465-41. 18.- Jung Y, Park D, Kim Y, Lee J, Seo P, Cheon J, 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: 1705-12. Gastroenterol. latinoam 2016; Vol 27, S upl Nº 1: S 22-S 25


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